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

medical ethics

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On this blog, we constantly discuss the shortcomings of clinical trials of (and other research into) alternative medicine. Yet, there can be no question that research into conventional medicine is often unreliable as well.

What might be the main reasons for this lamentable fact?

A recent BMJ article discussed 5 prominent reasons:

Firstly, much research fails to address questions that matter. For example, new drugs are tested against placebo rather than against usual treatments. Or the question may already have been answered, but the researchers haven’t undertaken a systematic review that would have told them the research was not needed. Or the research may use outcomes, perhaps surrogate measures, that are not useful.

Secondly, the methods of the studies may be inadequate. Many studies are too small, and more than half fail to deal adequately with bias. Studies are not replicated, and when people have tried to replicate studies they find that most do not have reproducible results.

Thirdly, research is not efficiently regulated and managed. Quality assurance systems fail to pick up the flaws in the research proposals. Or the bureaucracy involved in having research funded and approved may encourage researchers to conduct studies that are too small or too short term.

Fourthly, the research that is completed is not made fully accessible. Half of studies are never published at all, and there is a bias in what is published, meaning that treatments may seem to be more effective and safer than they actually are. Then not all outcome measures are reported, again with a bias towards those are positive.

Fifthly, published reports of research are often biased and unusable. In trials about a third of interventions are inadequately described meaning they cannot be implemented. Half of study outcomes are not reported.

END OF QUOTE

Apparently, these 5 issues are the reason why 85% of biomedical research is being wasted.

That is in CONVENTIONAL medicine, of course.

What about alternative medicine?

There is no question in my mind that the percentage figure must be even higher here. But do the same reasons apply? Let’s go through them again:

  1. Much research fails to address questions that matter. That is certainly true for alternative medicine – just think of the plethora of utterly useless surveys that are being published.
  2. The methods of the studies may be inadequate. Also true, as we have seen hundreds of time on this blog. Some of the most prevalent flaws include in my experience small sample sizes, lack of adequate controls (e.g. A+B vs B design) and misleading conclusions.
  3. Research is not efficiently regulated and managed. True, but probably not a specific feature of alternative medicine research.
  4. Research that is completed is not made fully accessible. most likely true but, due to lack of information and transparency, impossible to judge.
  5. Published reports of research are often biased and unusable. This is unquestionably a prominent feature of alternative medicine research.

All of this seems to indicate that the problems are very similar – similar but much more profound in the realm of alternative medicine, I’d say based on many years of experience (yes, what follows is opinion and not evidence because the latter is hardly available).

The thing is that, like almost any other job, research needs knowledge, skills, training, experience, integrity and impartiality to do it properly. It simply cannot be done well without such qualities. In alternative medicine, we do not have many individuals who have all or even most of these qualities. Instead, we have people who often are evangelic believers in alternative medicine, want to further their field by doing some research and therefore acquire a thin veneer of scientific expertise.

In my 25 years of experience in this area, I have not often seen researchers who knew that research is for testing hypotheses and not for trying to prove one’s hunches to be correct. In my own team, those who were the most enthusiastic about a particular therapy (and were thus seen as experts in its clinical application), were often the lousiest researchers who had the most difficulties coping with the scientific approach.

For me, this continues to be THE problem in alternative medicine research. The investigators – and some of them are now sufficiently skilled to bluff us to believe they are serious scientists – essentially start on the wrong foot. Because they never were properly trained and educated, they fail to appreciate how research proceeds. They hardly know how to properly establish a hypothesis, and – most crucially – they don’t know that, once that is done, you ought to conduct investigation after investigation to show that your hypothesis is incorrect. Only once all reasonable attempts to disprove it have failed, can your hypothesis be considered correct. These multiple attempts of disproving go entirely against the grain of an enthusiast who has plenty of emotional baggage and therefore cannot bring him/herself to honestly attempt to disprove his/her beloved hypothesis.

The plainly visible result of this situation is the fact that we have dozens of alternative medicine researchers who never publish a negative finding related to their pet therapy (some of them were admitted to what I call my HALL OF FAME on this blog, in case you want to verify this statement). And the lamentable consequence of all this is the fast-growing mountain of dangerously misleading (but often seemingly robust) articles about alternative treatments polluting Medline and other databases.

Doctor Jens Wurster is no stranger to this blog; previously I discussed his claim that he has treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases. So far, his claims were based not on evidence published in peer-reviewed journals (I cannot find a single Medline-listed paper by this man); but now Wurster has published an article in a German Journal (Wurster J. Zusatznutzen der Homöopathie … Deutsche Zeitschrift für Onkologie 2018; 50: 85–91; not Medline-listed, I am afraid). The paper is in German, but it has an English abstract; here it is:

____________________________________________________________________________

All over the world, oncology patients receive homeopathic treatment concomitant to conventional treatments, such as chemotherapy and radiation treatment, in order to reduce the side effects of these therapies. It has been shown that cancer patients, who are receiving homeopathic treatment in addition to conventional therapies, have a higher quality of life and a longer survival rate. Studies in cancer cell research have shown the direct effects of highly potentized homeopathic medicines on tumor cell lines. Tumor inhibiting properties of homeopathic medicines have been proven in vivo as well as in vitro. Research projects into complementary medicine (CAMbrella) and research into personalized immunotherapies as well as additive homeopathy open the door to the future of integrative oncology.

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In the article, Wurster states that he has 20 years of experience in treating cancer with homeopathy as an add-on to conventional care, and that he can confirm homeopathy’s effectiveness. He claims that ‘very many’ patients have thus benefitted by experiencing less side-effects of conventional treatments. And he offers two case-reports to illustrate this.

[Nach 20 Jahren klinischer Erfahrung in der Clinica St. Croce im Tessin mit der Behandlung onkologischer Patienten mithilfe der Homöopathie können wir deutlich den Zusatznutzen der Homöopathie in der Onkologie bestätigen [1]. So gelang es unserem Ärzteteam in den zurückliegenden Jahren bei sehr vielen Patienten, durch gezielten Einsatz homöopathischer Mittel die Nebenwirkungen von Chemotherapien oder Bestrahlungen erfolgreich zu reduzieren [1]. Wie dabei Schulmedizin und Homöopathie in der Praxis zusammenwirken, zeigt folgendes Beispiel. ([1] Wurster J. Die homöopathische Behandlung und Heilung von Krebs und metastasierten Tumoren. Norderstedt: Books on Demand; 2015)]

The two case-reports lack detail and are less than convincing, in my view. Both patients have had conventional therapies and Wurster claims that his homeopathic remedies reduced their side-effects. There is no way of verifying this claim, and the improvements might have occurred also without homeopathy.

In the discussion section of his paper, Wurster then elaborates that oncologists throughout Europe are now realising the potential of homeopathy. In support he mentions paediatric oncologists in Klagenfurt who managed to spare pain-killers by giving homeopathics. Similarly, at the Inselspital in Bern, they are offering homeopathic consultations to complement conventional treatments.

[Inzwischen haben auch einige Onkologen erkannt, wie eine gezielt eingesetzte homöopathische Behandlung die Nebenwirkungen von Chemotherapien oder Bestrahlungen reduzieren kann. Wir arbeiten inzwischen mit einigen Onkologen aus ganz Europa zusammen, die den Zusatznutzen der Homöopathie in der Onkologie erlebt haben. In der Kinderonkologie in Klagenfurt beispielsweise konnten mithilfe der Homöopathie Schmerzmittel bei den Kindern eingespart werden. Auch am Inselspital Bern werden zusätzliche homöopathische Konsile in der Kinderonkologie angeboten, um die konventionelle Behandlung begleiten zu können [8].]

At this point, Wurster inserts his reference number 8. As several of his references are either books or websites, this reference to an article in a top journal seems interesting. Here is its abstract:

___________________________________________________________________________________

BACKGROUND:

Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM.

STUDY DESIGN:

All childhood cancer patients treated at the University Children‘s Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM.

RESULTS:

Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient’s general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects.

CONCLUSIONS:

Since many pediatric oncology patients use CAM, patients’ needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.

_______________________________________________________________________________________

Any hope that this paper might back up the statements made by Wurster is thus disappointed.

Altogether, this Wurster-paper contains no reliable evidence. The only clinical trial it seems to rely on is the one by Prof Frass which we have discussed previously here and here. The Frass-study is odd in several ways and, before we can take its results seriously, we need to see an independent replication of its findings. In this context, it is noteworthy that my own 2006 systematic review concluded that there is insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care. In view of all this, I feel that the new Wurster-paper provides no reliable evidence and no reason to change my now somewhat dated conclusion of 2006. Moreover, I would insist that those who claim otherwise are unethical and behave irresponsible.

And finally, I need to reiterate what I stated in my previous post: the Wurster-paper indicates that something is amiss with medical publishing. How can it be that, in 2018, the ‘Deutsche Zeitschrift für Onkologie’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? The editors of this journal (Univ.-Prof. Dr. med. Arndt Büssing, Witten/Herdecke; Dr. med. Peter Holzhauer, Bad Trissl und München) and its editorial board members (L. Auerbach, Wien; C. Bahne Bahnson, Kiel; J. Büntzel, Nordhausen; B. Freimüller-Kreutzer, Heidelberg; H.R. Maurer, Berlin; A. Mayr, Starnberg; R. Moss, New York; T. Ostermann, Witten/Herdecke; K. Prasad, Denver; G. Pulverer, Köln; H. Renner, Nürnberg; C.P. Siegers, Lübeck; W. Schmidt, Greifswald; G. Uhlenbruck, Köln; B. Wolf, München; K.S. Zänker, Witten/Herdecke) should ask themselves whether they are taking their moral obligations seriously enough, or whether their behaviour is not a violation of their most fundamental ethical duties.

In our book ‘MORE HARM THAN GOOD‘ we allude to such problems as follows: …Spurious results are frequently paraded by CAM advocates in support of implausible treatments… the more poorly conceived and executed a research project is, the more likely it is to produce false-positive results. These results then may lead to repetitive cycles of unproductive work to explain what was found—often to simply disprove the erroneous results. This is an unfortunate feature of various fields of scientific research, but it has particularly serious implications in medical research. Moreover, researchers who practice and behave as advocates of CAM may unintentionally or deliberately distort or exaggerate weak findings. Invalid CAM research claims tend not to be put to rest; instead they are repeatedly recycled…

And:

The CAM practitioner who promotes untruths has either failed to enlighten themselves as to the facts—this being a central requirement of professional ethics— or has chosen to deliberately deceive patients. Either of these reasons for promulgating falsehoods amounts to a serious breach in terms of virtue ethics. According to almost all forms of ethical theory, the truth-violating nature of CAM renders it immoral in both theory and practice.

The damage that can result from such violations of medical ethics is not merely a matter for the ‘ivory towers of academia’, it can virtually be a matter of life and death.

Currently, there are measles outbreaks almost everywhere. I have often pointed out that SCAM does not seem to be entirely innocent in this development. Now another study examined the relationship between SCAM-use and vaccination scepticism. Specifically, the researchers wanted to know whether a person’s more general health-related worldview might explain this relationship.

A cross-sectional online survey of adult Australians (N = 2697) included demographic, SCAM, and vaccination measures, as well as the holistic and magical health belief scales (HHB, MHB). HHB emphasises links between mind and body health, and the impact of general ‘wellness’ on specific ailments or resistance to disease, whilst MHB specifically taps ontological confusions and cognitive errors about health. SCAM and anti-vaccination were found to be linked primarily at the attitudinal level (r = -0.437). The researchers did not find evidence that this was due to SCAM practitioners influencing their clients. Applying a path-analytic approach, they found that individuals’ health worldview (HHB and MHB) accounted for a significant proportion (43.1%) of the covariance between SCAM and vaccination attitudes. MHB was by far the strongest predictor of both SCAM and vaccination attitudes in regressions including demographic predictors.

The researchers concluded that vaccination scepticism reflects part of a broader health worldview that discounts scientific knowledge in favour of magical or superstitious thinking. Therefore, persuasive messages reflecting this worldview may be more effective than fact-based campaigns in influencing vaccine sceptics.

Parents opposing vaccination of their kids are often fiercely determined. Numerous cases continue to make their way through the courts where parents oppose the vaccination of their children, often inspired by the views of both registered and unregistered health practitioners, including homeopaths and chiropractors. A recent article catalogued decisions by the courts in Australia, New Zealand, the UK and Canada. Most of them ruled in favour of vaccination and dismissed the arguments of those opposed to vaccination as unscientific. The author, an Australian barrister and Professor of Forensic Medicine, concluded that Australia should give serious consideration to emulating the model existing in multiple countries, including the United States, and should create a no-fault vaccination injury compensation scheme.

Such programs are based on the assumption that it is fair and reasonable that a community protected by a vaccination program accepts responsibility for and provides compensation in those rare instances where individuals are injured by it. To Me, this seems a prudent and ethical concept that should be considered everywhere.

I stumbled over an article entitled ‘The myths of homeopathy: Resounding answers‘. I thought it was great fun, so much so, that I copied it below – not just once but twice. The second time I took the liberty of replacing the little porkies told by homeopaths with the truth.

THE ORIGINAL

Homeopathic medicines are not placebos! Little “pellets” of sugar cannot have an effect!

Of course, the sugar in homeopathic pellets doesn’t have any effect. This is why we also have tablets and drops that contain homeopathic active substances.

The sugar is simply a medium for these active substances. The important element is what has been added to the sugar – the active ingredient!

As homeopathic remedies have very slow action, they cannot be used to treat acute illnesses!

This is incorrect. You can successfully use homeopathy in acute circumstances such as infections, fevers and colds.

Homeopathy seems to be a kind of magic!

Homeopathy is not magic! Homeopathy is a field of medicine that has the capacity to heal, but if course, it has its limits, just like any other medicine, including conventional medicine.

To give you a clear example – it’s unlikely that homeopathy will replace a surgical intervention.

During homeopathic treatment you have to follow a strict diet!

Well, it’s not such a bad thing…but of course, you need to eat healthily and avoid smoking, drinking alcohol and coffee.

In some cases you can’t eat onion or garlic as they contain sulphur, which is a homeopathic remedy in itself. All of these things have little to do with a strict diet.

Diabetes sufferers can’t use homeopathic remedies!

This is not true. The amount of sugar in the pellets is negligible. These homeopathic pellets could even be taken on a daily basis. The foods we eat contain much more sugar, even those that are especially for diabetics.

MY CORRECTED VERSION

Homeopathic medicines are not placebos! Little “pellets” of sugar cannot have an effect!

Of course, the sugar in homeopathic pellets doesn’t have any effect. And the drops added also contain no active substances.

In other words, there is no active ingredient!

As homeopathic remedies have very slow action, they cannot be used to treat acute illnesses!

This is correct. You cannot successfully use homeopathy in acute circumstances such as infections, fevers and colds. In fact, you cannot use it to cure any condition, chronic or acute.

Homeopathy seems to be a kind of magic!

Homeopathy is not magic! It relies on the placebo and other non-specific effects, and that is no magic.

During homeopathic treatment you have to follow a strict diet!

Hahnemann gave very clear instructions to avoid a whole range of things while taking homeopathic remedies – otherwise, they don’t work, he claimed. This is as wrong as everything else Hahnemann said about homeopathy: these remedies don’t work whatever you do.

Diabetes sufferers can’t use homeopathic remedies!

This is not true. The amount of sugar in the pellets is negligible. These homeopathic pellets could even be taken on a daily basis. The foods we eat contain much more sugar, even those that are especially for diabetics. But that does, of course, not mean that diabetics ought to take homeopathic remedies. There is no reason why they should; these remedies are pure placebos.

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Few people reading these lines will be surprised that the ‘resounding answers’ turn out to be resounding lies. And what I above called ‘great fun’, turns out to be a serious deception.

The fascinating thing here is, I think, the way homeopaths try to mislead the public: one seemingly innocent untruth about the ‘active substance’ is used as the basis for an entire house of cards. It tumbles at the slightest attempt to provide the facts. Sadly, many consumers do not know the facts and are therefore prone to fall victim of these resounding lies.

There is perhaps not a law against such lies, but there certainly are moral and ethical principles that must not be violated:

TELLING LIES OF THIS NATURE IS UNETHICAL AND ENDANGERS THE HEALTH OF THOSE WHO DO NOT KNOW THE FACTS.

Homeopaths are not generally known for the reliability of their recommendations. This advice by the UK Society of Homeopaths (SoH) was emailed to me a few days ago (how on earth did they know I was on holiday?). It is just too weird and wonderful – I cannot resist the temptation of showing it to you:

START OF QUOTE

Off on holiday? Whether you’re going abroad or ‘staycationing’, keep these remedies handy to tackle a range of minor ailments. We suggest 30c potencies for all remedies, using every 30- 90 minutes, two or three times depending on the severity of the condition. Always seek medical help for anything more than a minor injury or illness.

Aconite Great for shock, such as from fright, bad news or after having a fall. Also good for the onset of fever after exposure to acute cold, wind or heat.

Apis For bee or wasp stings and any allergic reaction which causes rapid swelling, redness and pain and where the affected area is puffy, white or rosy, feels hot and is better for cold compresses.

Arnica The classic remedy for trauma, injury and bruising. The typical arnica patient will tell you that they are fine but may well be confused or in shock. Also useful for fractures, strains after exertion such as lifting heavy objects and the early stages of a black eye and for jetlag.

Arsenicum This is a great remedy for food poisoning, especially from meat. The person will be very anxious and not easily pacified. The pains are often burning. Vomiting and diarrhoea accompanied by chills, exhaustion, and restless.

Belladonna Great for heatstroke or exhaustion, along with appropriate cooling and rehydration therapy, and for acute fevers or inflammations, which come on suddenly and lead to throbbing pain, redness and swelling. The skin is hot and red and the face flushed but, at the same time, the person can feel chilly and want to be covered.

Ledum This is the first remedy to think of with puncture wounds and for bites and stings which fester. Good for twisted or sprained joints, especially ankles.

Nux Vomica The main remedy for hangover or indigestion from over-eating but also useful for food poisoning in which there is constant retching.

Urtica urens Very useful for skin conditions such as urticaria with raised lumps like nettle rash and great for ‘prickly heat. Urtica can be used for minor burns and scalds as well where pains are stinging, like nettle rash, but not too sore to touch.

END OF QUOTE

I find the list and particularly the comments most revealing. To me, they suggest that homeopathy just do not have a cue. They recommend nonsense for conditions they know nothing about. They do not seem to know what real shock or food poisoning or heat stroke are. They do not seem to appreciate that they can be life-threatening problems. And by stating “Always seek medical help for anything more than a minor injury or illness”, they clearly admit that they are merely jokers of no significance whatsoever.

For what it’s worth, I here give my evidence-based view on the remedies listed:

Aconite No evidence to justify the claims mentioned above.

Apis No evidence to justify the claims mentioned above.

Arnica Some evidence to show that Arnica does not work.

Arsenicum No evidence to justify the claims mentioned above.

Belladonna No evidence to justify the claims mentioned above.

Ledum No evidence to justify the claims mentioned above.

Nux Vomica No evidence to justify the claims mentioned above.

Urtica urens No evidence to justify the claims mentioned above.

Oh, I almost forgot: the SoH is the organisation of ‘professional’ homeopaths in the UK (professional meaning they have no medical training). On their website, they state: “High standards are the cornerstone of the Society of Homeopaths. So we were delighted that our register was accredited by the Professional Standards Authority for Health and Social Care (PSA)  in 2014… This accreditation demonstrates our commitment to high professional standards, to enhancing safety and delivering a better service.”

One does wonder whether killing gullible holidaymakers via bad advice counts as high standards.

With depressing regularity, we hear that this or that VIP has decided to travel to Germany to get her/his cancer cured. As long as I can remember, cancer quackery has been wide-spread in Germany. More recently, dozens of private clinics have sprung up that seem to specialise in treating rich, foreign cancer patients. The message they like to send out is that, in Germany, one gets more advanced and effective treatments.

Having looked at some of the clinics’ websites, I do, however, not get the impression that this is true. For instance, one clinic that is often mentioned offers amongst other treatments the following (the descriptions are quotes from the clinic’s website):

  • Orthomolecular medicine aims to restore the 
ideal and beneficial environment of the body by correcting molecular imbalances, and this approach is used in cancer, infections, depression and atherosclerosis, among others.
  • Here at the Hallwang Private Oncology Clinic every patient receives a well-balanced supportive infusion program consisting of anti-inflammatory, potent anti-oxidant and detoxifying substances, which help you recover from previous treatments, minimize side effects from current treatments and strengthen your immune system to enhance treatment effects. Substances used are for example vitamin C, selenium, zinc, L-ornithine aspartate, glutathione, alpha lipoic acid, among many others.
  • Vitamin C, also known as ascorbic acid, is an essential vitamin. It is a potent antioxidant which helps to protect against free radical damage to our proteins, fats, carbohydrates, DNA and RNA. Vitamin C is used to boost the immune system.
  • Ozone is a powerful oxidizing agent. While high concentrations can be toxic, small ozone doses may increase naturally occurring antioxidants in the body. Antioxidants help to eliminate malignant calles and are needed to keep the body healthy. Ozone used for treatment is known for its bactericidal, fungicidal and virostatic properties. It also stimulates circulation and immune functions, and revitalizes the body.
  • Hyperbaric oxygen therapy is used to treat several medical conditions. It is a well-established treatment for decompression sickness, a hazard of scuba diving. Other conditions treated with hyperbaric oxygen therapy include serious infections, skin lesions or radiation injury. Wounds for example need oxygen to heal properly, and exposing a wound to 100 percent oxygen can improve and speed the healing process. This has been shown in a number of studies. The goal of this treatment is to increase the amount of oxygen your blood can carry in order to restore normal levels of blood gases and tissue function to promote healing and cure infection.
  • Whole body hyperthermia can be applied in a number of different diseases, including malignant, immunological, viral and other diseases. The aim of WBH is the destruction of malignant cells by induction of apoptosis via hyperthermia along with elimination of malignant cells that have become resistant to chemotherapy. With the help pf WBH, effects of other treatments, including chemotherapy and immunotherapy, can be enhanced.

END OF QUOTES

This does not look like cutting edge cancer therapy at all; in fact, none of these treatments are new and none have been shown to cure cancer or any other condition. Thus they are all examples of cancer quackery.

But, to be fair, the clinic in question (and most similar institutions in Germany) also employs a range of conventional cancer therapies. I am not an oncologist and therefore not competent to comment on these treatments; I leave this to someone who is competent; this is what David Gorski writes about them:  Hallwang uses very experimental treatments in a “blunderbuss” fashion, basically throwing everything but the kitchen sink together with no sophistication. We can’t even know if these doctors know what the hell they are doing. Patients are treated, and, as far as we can tell, no systematic record of how well these patients do and how long they survive is kept, or, if such records are kept, they are kept secret.

One might, of course, argue that many patients are suffering from terminal cancers. They are desperate and have a right to try anything. As good physicians, we must not take their hope away. I would not dispute that; on the contrary, these patients deserve the best care we can muster. But I would still warn them to be cautious, and again I concur with David GorskiPeople will often say of a terminal illness: How could things get any worse? The lesson of Hallwang tells us. Things can get worse if you’re induced into chasing false hope. Things can get worse if you are enticed into eschewing effective palliative treatment and suffer more than is necessary—or even die prematurely from the treatment. Things can get worse if you drain your life’s savings, leave nothing behind for your family, and spend the rest of your life chasing ever more money. Things can get worse if your family joins you in draining their life’s savings to pay for your treatments. Things can always get worse, and quack cancer clinics virtually guarantee that they will.

In view of all this, I feel strongly that it is high time the German regulators have a close look at the plethora of cancer quackery and find a way of stopping this unethical, despicable exploitation.

 

This study examined websites of naturopathic clinics and practitioners in the provinces of British Columbia and Alberta, looking for the presence of discourse that may contribute to vaccine hesitancy, and for recommendations for ‘alternatives’ to vaccines or flu shots.

Of the 330 naturopath websites analysed, 40 included vaccine hesitancy discourse and 26 offered vaccine or flu shot alternatives. Using these data, the authors explored the potential impact such statements could have on the phenomenon of vaccine hesitancy.

Next the researchers considered these misrepresentations in the context of Canadian law and policy, and outlined various legal methods of addressing them. They concluded that tightening advertising law, reducing CAM practitioners’ ability to self-regulate, and improving enforcement of existing common and criminal law standards would help limit naturopaths’ ability to spread inaccurate and science-free anti-vaccination and vaccine-hesitant perspectives.

The paper listed some poignant examples of vaccine hesitancy discourse:

1) ‘…children are now being given increasing numbers of vaccinations containing potentially harmful derivatives and substances such as mercury, thimerisol [sic], aluminum and formaldehydes. These harmful derivatives can become trapped in our tissues, clogging our filters and diminishing one’s ability of further toxins out.’ — www.evolvenaturopathic.com

2) ‘Vaccines given to children and adults contain mercury and aluminum. Babies are especially susceptible to small amounts of mercury injected directly into their tiny bodies. It is now suspected that the increase in autism and Asperger Syndrome is related to the mercury in childhood vaccinations.’ — www.vancouvernaturopathicclinic.com

3) ‘The conventional Flu Shot is a mixture of 3 strains of flu viruses mixed with a number of chemical preservatives and these strains are based on a prediction of what flu viruses some medical experts think will be the most problematic this season. This is really an impossible prediction to make when we have thousands of different strains of viruses that are continuously mutating.’ — www.advancednaturopathic.com

4) ‘A [sic] epidemiologist researcher from British Columbia, Dr. Danuta Skowronski, published a study earlier this year showing that people who were vaccinated consecutively in 2012, 2013 and 2014 appeared to have a higher risk of being infected with new strains of the flu.’ — www.drtas.ca

5) ‘Increasing evidence suggests that injecting a child with nearly three dozen doses of 10 different viral and bacterial vaccines before the age of five, while the immune system is still developing, can cause chronic immune dysfunction. The most that vaccines can do is lead to an increase in antibodies to a specific disease.’ — www.evolvevitality.com

6) ‘The bugs in question (on the Canadian Vaccine List) can enter our systems and depending on our bodies, our histories, and mostly the bugs’ propensity, they can cause serious harm. There are certainly questionable ingredients in vaccines that have the potential to do the same.’ — www.tharavayali.ca

The authors also considered that, in Canada, a naturopath who recommends homeopathic vaccines or who counsels against conventional vaccination could potentially be criminally negligent. Section 219 of the Criminal Code of Canada [Code] states that ‘[e]very one is criminally negligent who, in doing anything, or in omitting to do anything that it is his duty to do, shows wanton or reckless disregard for the lives or safety of other persons’. Subsection (2) goes on to state that, for the purposes of criminal negligence, ‘duty’ means a duty imposed by law; a legal duty in this context is one arising from statute or from the common law. The Code creates a legal duty for anyone ‘who undertakes to administer surgical or medical treatment to another person or to do any other lawful act that may endanger the life of another person’ to ‘have and to use reasonable knowledge, skill and care in so doing’. This duty is a uniform standard, meaning the requirement of reasonable knowledge, care, and skill is based on the treatment or lawful act in question, not on the level of experience of the person administering it. As such, naturopaths offering services similar to medical doctors will be held to the same standards under the Code.

Criminal negligence occurs due to the ‘failure to direct the mind to a risk of harm which [a] reasonable person would have appreciated’. Fault is premised on the wrongful act involved, rather than the guilty mind of the perpetrator. Naturopaths counseling patients against vaccination are arguably undertaking a lawful act that endangers the life of another person (especially in the case of a young child, elderly individual, or immunocompromised person), breaching s.216 of the Code. In addition, since relevant legal duties include those arising through the common law, naturopaths could alternatively be criminally negligent for failing to satisfy the aforementioned duty of reasonable disclosure inherent to standard of care in tort. In the context of a community with diminished vaccination rates, either failure could be considered wanton or reckless, as it may greatly and needlessly endanger the patient. However, under the standard for criminal negligence, the trier of fact must ‘assess whether the accused’s conduct, in view of his or her perception of the facts, constituted a marked and substantial departure from what would be reasonable in the circumstances’. This is similar to the standard of gross negligence, so ultimately a finding of criminal negligence would require meeting a rather onerous threshold.

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This, of course, is according to Canadian law; but I imagine that the law in other countries must be similar.

Therefore, this is a legal opinion which might be worth considering also outside Canada.

If there is a legal expert amongst my readers, please do post a comment.

The wishes of a patient do not over-rule medical knowledge!” (Patientenwunsch steht nicht über medizinischem Wissen)

This was one brave conclusion drawn in a discussion about homeopathy during a recent German radio programme. Specifically, the discussion was about the pros and cons of a leading paediatric hospital of the Ludwig Maximilian Universitaet (LMU) Munich offering homeopathy to its patients (they also run a course in homeopathy which we discussed previously).

The wishes of a patient does not over-rule medical knowledge!

This sentence made me think.

Is it correct?

An interesting question with ethical dimensions!

The short answer is NO, I believe..

Patients can always refuse to have a given therapy, if they so wish. Or they might opt for one evidence-based therapy instead of another. And in certain circumstances such wishes may well be completely against the current best medical knowledge.

But this is probably where the dominance of the patient’s wishes over medical knowledge ends — at least, if we only consider wishes paid for by the public purse (otherwise, anyone can, of course, buy almost any rubbish).

And that was not what the above-mentioned discussion was about. It focussed on the arguments by the LMU to justify their offer of homeopathy to sick children. Essentially, they seem to say:

  • We believe in evidence-based medicine (EBM) and are fully dedicated to its principles.
  • We know that homeopathy is not evidence-based.
  • Yet, many of the parents want us to use homeopathy in the treatment of their kids.
  • And the wish of a patient over-rules the medical evidence.

This is, of course, a flawed argument. One cannot subscribe to EBM and, at the same time, administer overt nonsensical, disproven treatments. A patient’s wish does not render a nonsensical treatment evidence-based. If one would follow the LMU logic, one would have to use any idiotic therapy … and could still pride oneself to follow EBM practice. In England, we call this ‘having the cake and eat it’; once you eat the cake, it’s gone and you cannot have it any longer.

What follows is simple: the decision makers at the LMU have been found out with (homeopathically potentised) egg on their faces (for some reason they had this homeopathy enclave for years, it is well-established and, I suspect, even better protected by some people of influence). They quickly tried to find a way out of their dilemma. Unfortunately, they did not think hard enough; the solution to bank on patient choice turns out to be a non-solution.

I therefore suggest they get in line with the role of a University hospital, with today’s medical thinking and medical ethics. This would mean re-considering their homeopathy course as well as their inclusion of homeopathy in publicly-funded routine care.

An article has just been published announcing the reform of the German Heilpraktiker, the profession of alternative practitioners that has been discussed repeatedly on this blog and criticised recently by the ‘Muensteraner Kreis’. As the new article is in German, I will try to summarise the essence of it here:

The health ministers of all German counties have decided yesterday that they will start reforming the profession of the Heilpraktiker that has attracted much criticism in recent months. The current laws are no longer fit for purpose. There is neither a mandatory agreement for the education of the Heilpraktiker, nor a uniform regulation of the profession.

The senator for health from Hamburg stated: “We feel that the Heilpraktiker should not be allowed to do certain thing, but be permitted to do plenty of activities that remain legal.” At present, the Heilpraktiker is allowed to treat fractures, malignancies, give injections, and even manufacture certain medicines. “We believe there is a need for regulation to protect patients.”

Now a working group will be formed to investigate and produce a report within a year. Remarkably, the German health secretary avoided commenting. In a statement, it was said that patients must be empowered to make decisions on the basis of quality-assured information.

The full German text is below.

__________________________________________________________________________________

Nach mehreren deutschlandweit Aufsehen erregenden Todesfällen beispielsweise von Krebspatienten, die kurz nach der Therapie durch einen Heilpraktiker in Brüggen-Bracht starben, will die Politik sich nun diesen Berufszweig vornehmen. Die Gesundheitsminister aller Bundesländer haben am Donnerstag beschlossen, eine Reform anzugehen. „Das unzureichend regulierte Heilpraktikerwesen mit seiner umfassenden Heilkundebefugnis steht unverändert in der Kritik“, heißt es in einer Erklärung. Das Heilpraktikergesetz könne dem heutigen Anspruch an den Gesundheitsschutz der Patienten nicht mehr gerecht werden. Für Heilpraktiker gebe es weder verbindliche Regeln zur Ausbildung noch eine einheitliche Berufsordnung. Andere Gesundheitsberufe müssten hingegen strenge Qualifikationskriterien erfüllen.

„Wir sehen es als kritisch an, dass einige Tätigkeiten zwar den Heilpraktikern untersagt sind, aber es noch eine Fülle von Tätigkeiten gibt, die zugelassen sind“, sagte die Hamburger Senatorin für Gesundheit, Cornelia Prüfer-Storcks, auf einer Pressekonferenz – sie hatte die Initiative maßgeblich  vorangetrieben.  So dürfen Heilpraktiker Knochenbrüche therapieren, schwere und bösartige Erkrankungen behandeln und Injektionen geben. Selbst die Herstellung von Arzneimitteln für bestimmte Patienten sei Heilpraktikern erlaubt. „Ohne die Prüfmechanismen, die wir normalerweise haben, wenn wir Arzneimittel zulassen und produzieren“, kritisierte Prüfer-Storcks. „Wir glauben, dass es hier Regelungsbedarf gibt aus Sicht des Patientenschutzes.“

„Die Ministerinnen und Minister, Senatorinnen und Senatoren für Gesundheit sehen eine zwingende Reformbedürftigkeit des Heilpraktikerwesens“, heißt es in dem kurzen, MedWatch vorliegenden Beschluss. „Der Bund wird gebeten, eine Bund-Länder-Arbeitsgruppe einzurichten, die eine grundlegende Reform des Heilpraktikerwesens prüft.“ Das Ergebnis der Prüfung solle bis zur Gesundheitsministerkonferenz in einem Jahr vorgelegt werden.

Bundesgesundheitsminister Jens Spahn erklärte auf der Pressekonferenz das Patientenwohl zwar zum entscheidenden Maßstab für die Gesundheitspolitik. „Deshalb finde ich es richtig, dass die Gesundheitsministerkonferenz bei der Patientenorientierung ihren Schwerpunkt setzt“, sagte er. Auf mögliche Reformen des Heilpraktikerberufes ging der Minister bei der Pressekonferenz jedoch nicht ein. Inwiefern sein Haus die von den Landesministern geforderte Reform des Heilpraktikerwesens mit unterstützen wird, bleibt offen. Auf Nachfrage, ob das Ministerium eine Bund-Länder-Arbeitsgruppe unterstützen würde, versteckte sich eine Sprecherin bereits im Mai hinter der Mini-Reform von Gröhe. Mit Blick auf die kurze Zeit seit Inkrafttreten dieser Änderungen sei es angemessen, zunächst zu prüfen, ob und inwieweit diese zum Schutz des Patientenwohles beiträgt, erklärte sie – „ehe weitere gesetzliche Maßnahmen in Betracht gezogen werden sollten“.

In einem Grundsatzbeschluss sprach sich die Gesundheitsministerkonferenz außerdem für „Patientenorientierung als Element einer zukunftsweisenden Gesundheitspolitik“ aus. „Das heißt, dass der Patient natürlich das Heft in der Hand haben muss, dass er versteht, was mit ihm gemacht wird, warum es mit ihm gemacht wird, mit welchen Chancen die Behandlung verbunden ist“, sagte NRW-Gesundheitsminister Karl Laumann. Auch in der Ausbildung des Gesundheitspersonals sollten diese Aspekte einen großen Stellenwert bekommen, betonte Laumann – und erwähnte zwar Ärzte als Berufsgruppe explizit, nicht aber Heilpraktiker. Der frühere Bundespatientenbeauftragte forderte außerdem mehr Transparenz ein. In Teilen des Gesundheitssystems gebe es wegen mangelnder Transparenz „eine gewisse Misstrauenskultur“, sagte er.

Die Minister wollen laut dem Beschluss die Patientensouveränität und der Orientierung im Gesundheitswesen verbessern, die Gesundheitskompetenz und gesundheitliche Eigenverantwortung beispielsweise durch die Einrichtung eines nationalen Gesundheitsportals deutlich stärken und Kommunikation und Wissenstransfer zwischen Patienten und allen Beteiligten im Gesundheitswesen fördern. „Patienten sollen so in die Lage versetzt werden, ihre Interessen besser zu vertreten und ihre Entscheidungen auf der Basis qualitätsgesicherter Informationen zu treffen“, heißt es.

Kommunikationskompetenz und wertschätzende Beziehungsgestaltung sei im Gesundheitswesen von wesentlicher Bedeutung für die Partizipation, Qualität, Sicherheit und den Erfolg der gesundheitlichen Prävention und der medizinischen Behandlung, betonen die Minister. Allgemeinverständliche „Patientenbriefe“ sollen als erster Schritt die Informiertheit von Patienten nach Krankenhausbehandlungen erhöhen. Außerdem soll das Bundesgesundheitsminister eine Pflicht schaffen, dass niedergelassene Ärzte ihren Patienten neutrale und evidenzbasierte schriftliche Informationen zu Zusatzangeboten – sogenannten „Individuellen Gesundheitsleistungen“ – zur Verfügung stellen müssen.

Bei Behandlungsfehlern sollen nach Ansicht der Landesminister auf Bundesebene weitere Erleichterungen umgesetzt werden: Die Beweislast und das Beweismaß soll zu Gunsten von Patienten überarbeitet werden. Außerdem sollten Krankenkassen gesetzlich verpflichtet werden, Patienten beim Nachweis eines Behandlungsfehlers besser zu unterstützen.

______________________________________________________________________________

I have been banging on about the German Heilpraktiker, its infamous history and its utter inadequacy since many years. This is what I published in 1996, for instance:

Complementary medicine is increasing in popularity. In most countries its practice is in the hands of non-medically trained practitioners, professions which are often not properly regulated. When discussing solutions to this problem the German “Heilpraktiker” is often mentioned. The history and present situation of this profession are briefly outlined. The reasons why the “Heilpraktiker concept” is not an optimal solution are discussed. It is concluded that the best way forward consists of regulation and filling the considerable gaps in knowledge relating to complementary medicine.

It goes without saying that, after so many tears of warning about the risks involved in allowing poorly trained practitioners, who are all too often unable to see the limits of their competency (and after many unnecessary fatalities), I am delighted that progress seems finally to be on the horizon.

An announcement by the UK Society of Homeopaths caught my attention. Here it is in its full and unabbreviated beauty:

START OF ANNOUNCEMENT

Homeopaths are being urged to contribute to an inquiry exploring ways to tackle a looming public health crisis threatened by ‘superbugs’ – bacteria resistant to antibiotics and other antimicrobial drugs.

The Commons Select Committee on Health and Social Care is inviting evidence for its investigation into the progress made by the government so far in responding to the challenge.

The two angles it is exploring are:

  • What results have been delivered by the current UK strategy on antimicrobial resistance (AMR), launched in 2013?
  • Key actions and priorities for the government’s next AMR strategy, due to be published at the end of 2018.

The Society of Homeopaths is putting together a submission and is asking members to submit their own evidence to the inquiry of using homeopathic alternatives to antimicrobials.

According to the inquiry background papers, antimicrobial resistance – in which bacteria have evolved into ‘superbugs’,  resistant to drugs devised to kill them – is a “significant and increasing threat” to public health in the UK and globally. EU data indicates that it is responsible for 700,000 deaths a year worldwide and at least 50,000 in the US and Europe.

The death toll could reach 10m people a year by 2050 if the rise in resistance is not headed off, it is estimated.

Society Chief Executive Mark Taylor said: “Our members know a great deal about the alternatives to antibiotics through their own practice and knowledge. This is a timely inquiry from the Health and Social Care Committee to assess the success of the existing strategy and an opportunity to make the case again for fresh thinking on this pressing public health challenge.”

END OF ANNOUNCEMENT

Yes, of course!

We have a crisis of antibiotic resistance.

Who is going to offer the solution?

THE HOMEOPATHS!!!

How?

They are going to treat us all with homeopathic remedies when the superbugs strike.

And the result?

No more crisis.

How come?

Because they have turned it into a catastrophe!!!

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