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

ethics

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The efficacy or effectiveness of medical interventions is, of course, best tested in clinical trials. The principle of a clinical trial is fairly simple: typically, a group of patients is divided (preferably at random) into two subgroups, one (the ‘verum’ group) is treated with the experimental treatment and the other (the ‘control’ group) with another option (often a placebo), and the eventual outcomes of the two groups is compared. If done well, such studies are able to exclude biases and confounding factors such that their findings allow causal inference. In other words, they can tell us whether an outcome was caused by the intervention per se or by some other factor such as the natural history of the disease, regression towards the mean etc.

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

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

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

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

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

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

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

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

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

Whenever a new trial of an alternative intervention emerges which fails to confirm the wishful thinking of the proponents of that therapy, the world of alternative medicine is in turmoil. What can be done about yet another piece of unfavourable evidence? The easiest solution would be to ignore it, of course – and this is precisely what is often tried. But this tactic usually proves to be unsatisfactory; it does not neutralise the new evidence, and each time someone brings it up, one has to stick one’s head back into the sand. Rather than denying its existence, it would be preferable to have a tool which invalidates the study in question once and for all.

The ‘fatal flaw’ solution is simpler than anticipated! Alternative treatments are ‘very special’, and this notion must be emphasised, blown up beyond all proportions and used cleverly to discredit studies with unfavourable outcomes: the trick is simply to claim that studies with unfavourable results have a ‘fatal flaw’ in the way the alternative treatment was applied. As only the experts in the ‘very special’ treatment in question are able to judge the adequacy of their therapy, nobody is allowed to doubt their verdict.

Take acupuncture, for instance; it is an ancient ‘art’ which only the very best will ever master – at least that is what we are being told. So, all the proponents need to do in order to invalidate a trial, is read the methods section of the paper in full detail and state ‘ex cathedra’ that the way acupuncture was done in this particular study is completely ridiculous. The wrong points were stimulated, or the right points were stimulated but not long enough [or too long], or the needling was too deep [or too shallow], or the type of stimulus employed was not as recommended by TCM experts, or the contra-indications were not observed etc. etc.

As nobody can tell a correct acupuncture from an incorrect one, this ‘fatal flaw’ method is fairly fool-proof. It is also ever so simple: acupuncture-fans do not necessarily study hard to find the ‘fatal flaw’, they only have to look at the result of a study – if it was favourable, the treatment was obviously done perfectly by highly experienced experts; if it was unfavourable, the therapists clearly must have been morons who picked up their acupuncture skills in a single weekend course. The reasons for this judgement can always be found or, if all else fails, invented.

And the end-result of the ‘fatal flaw’ method is most satisfactory; what is more, it can be applied to all alternative therapies – homeopathy, herbal medicine, reflexology, Reiki healing, colonic irrigation…the method works for all of them! What is even more, the ‘fatal flaw’ method is adaptable to other aspects of scientific investigations such that it fits every conceivable circumstance.

An article documenting the ‘fatal flaw’ has to be published, of course – but this is no problem! There are dozens of dodgy alternative medicine journals which are only too keen to print even the most far-fetched nonsense as long as it promotes alternative medicine in some way. Once this paper is published, the proponents of the therapy in question have a comfortable default position to rely on each time someone cites the unfavourable study: “WHAT NOT THAT STUDY AGAIN! THE TREATMENT HAS BEEN SHOWN TO BE ALL WRONG. NOBODY CAN EXPECT GOOD RESULTS FROM A THERAPY THAT WAS NOT CORRECTLY ADMINISTERED. IF YOU DON’T HAVE BETTER STUDIES TO SUPPORT YOUR ARGUMENTS, YOU BETTER SHUT UP.”

There might, in fact, be better studies – but chances are that the ‘other side’ has already documented a ‘fatal flaw’ in them too.

It is usually BIG PHARMA who stands accused of being less than honest with the evidence, particularly when it runs against commercial interests; and the allegations prove to be correct with depressing regularity. In alternative medicine, commercial interests exist too, but there is usually much less money at stake. So, a common assumption is that conflicts of interest are less relevant in alternative medicine. Like so many assumptions in this area, this notion is clearly and demonstrably erroneous.

The sums of money are definitely smaller, but non-commercial conflicts of interest are potentially more important than the commercial ones. I am thinking of the quasi-religious beliefs that are so very prevalent in alternative medicine. Belief can move mountains, they say – it can surely delude people and make them do the most extraordinary things. Belief can transform advocates of alternative medicine into ‘ALCHEMISTS OF ALTERNATIVE EVIDENCE’ who turn negative/unfavourable into positive/favourable evidence.

The alchemists’ ‘tricks of the trade’ are often the same as used by BIG PHARMA; they include:

  • drawing conclusions which are not supported by the data
  • designing studies such that they will inevitably generate a favourable result
  • cherry-picking the evidence
  • hiding unfavourable findings
  • publishing favourable results multiple times
  • submitting data-sets to multiple statistical tests until a positive result emerges
  • defaming scientists who publish unfavourable findings
  • bribing experts
  • prettify data
  • falsifying data

As I said, these methods, albeit despicable, are well-known to pseudoscientists in all fields of inquiry. To assume that they are unknown in alternative medicine is naïve and unrealistic, as many of my previous posts confirm.

In addition to these ubiquitous ‘standard’ methods of scientific misconduct and fraud, there are a few techniques which are more or less unique to and typical for the alchemists of alternative medicine. In the following parts of this series of articles, I will try to explain these methods in more detail.

Steve Scrutton is a UK homeopath on a mission; he seems to want to promote homeopathy at all cost – so much so that he recently ran into trouble with the ASA for breaching CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicines, medical devices, health-related products and beauty products). Scrutton happens to be a Director of the ‘ALLIANCE OF REGISTERED HOMEOPATHS’ (ARH) which represents nearly 700 homeopaths in the UK. On one of his websites, he promotes homeopathy as a treatment and prevention for measles:

Many homeopaths feel that it is better for children, who are otherwise healthy, to contract measles naturally. Homeopathy is less concerned with doing this as it has remedies to treat measles, especially if it persists, or become severe.Other homeopaths will use the measles nosode, Morbillinum, for prevention.Homeopaths have been treating measles for over 200 years with success.

The main remedies used for the condition, according to Scrutton, are the following: Aconite, Belladonna, Gelsemium, Euphrasia, Bryonia, Pulsatilla, Kali Bich, Sulphur, Apis Mel or Arsenicum – depending on the exact set of presenting symptoms.

At the very end of this revealing post, Scrutton makes the following statement: To my knowledge, there have been no RCTs conducted on either the prevention or treatment of Measles with Homeopathy. However, homeopaths have been treating Measles safely and effectively since the early 19th Century, and through many serious epidemics throughout the world.

Why would anyone write such dangerous nonsense, particularly in the position of a director of the ARH? There can, in my view be only one answer: he must be seriously deluded and bar any knowledge what sound medical evidence looks like. One of his articles seems to confirm this suspicion; in 2008, Scrutton wrote: What ‘scientific’ medicine does not like about homeopathy is not the lack of an evidence base – it is the ability to help people get well – and perhaps even more important, we can do it safely.

Intriguingly, the ARH has a code of ethics which states that members must not claim or imply, orally or in writing, to be able to cure any named disease and that they should be aware of the extent and limits of their clinical skills.

Could it be that a director of the ARH violates his own code of ethics?

Cancer patients are bombarded with information about supplements which allegedly are effective for their condition. I estimate that 99.99% of this information is unreliable and much of it is outright dangerous. So, there is an urgent need for trustworthy, objective information. But which source can we trust?

The authors of a recent article in ‘INTEGRATIVE CANCER THARAPIES’ (the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments) review the issue of dietary supplements in the treatment of cancer patients. They claim that the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. This sounds promising, and we might thus trust them to deliver something reliable.

In order to enable doctors and other health care professionals to have such discussion, the authors then report on the work of the ‘Clinical Practice Committee’ of ‘The Society of Integrative Oncology’. This panel undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of supplements that have the best suggestions of benefit was constructed by leading researchers and clinicians who have experience in using these supplements:

  1. curcumin,
  2. glutamine,
  3. vitamin D,
  4. maitake mushrooms,
  5. fish oil,
  6. green tea,
  7. milk thistle,
  8. astragalus,
  9. melatonin,
  10. probiotics.

The authors claim that their review includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would be aware of the supplements and be able to discuss realistic expectations and potential benefits and risks (my emphasis).

At first glance, this task looks ambitious but laudable; however, after studying the paper in some detail, I must admit that I have considerable problems taking it seriously – and here is why.

The first question I ask myself when reading the abstract is: Who are these “leading researchers and clinicians”? Surely such a consensus exercise crucially depends on who is being consulted. The article itself does not reveal who these experts are, merely that they are all members of the ‘Society of Integrative Oncology’. A little research reveals this organisation to be devoted to integrating all sorts of alternative therapies into cancer care. If we assume that the experts are identical with the authors of the review; one should point out that most of them are proponents of alternative medicine. This lack of critical input seems more than a little disconcerting.

My next questions are: How did they identify the 10 supplements and how did they evaluate the evidence for or against them? The article informs us that a 5-step procedure was employed:

1. Each clinician in this project was requested to construct a list of supplements that they tend to use frequently in their practice.

2. An initial list of close to 25 supplements was constructed. This list included supplements that have suggestions of some possible benefit and likely to carry minimal risk in cancer care.

3. From that long list, the group agreed on the 10 leading supplements that have the best suggestions of benefit.

4. Each participant selected 1 to 2 supplements that they have interest and experience in their use and wrote a manuscript related to the selected supplement in a uniformed and agreed format. The agreed format was constructed to provide a base of knowledge, so physicians and other health care providers would be able to discuss realistic expectations and potential benefits and risks with patients and families that seek that kind of information.

5. The revised document was circulated among participants for revisions and comments.

This method might look fine to proponents of alternative medicine, but from a scientific point of view, it is seriously wanting. Essentially, they asked those experts who are in favour of a given supplement to write a report to justify his/her preference. This method is not just open bias, it formally invites bias.

Predictably then, the reviews of the 10 chosen supplements are woefully inadequate. These is no evidence of a systematic approach; the cited evidence is demonstrably cherry-picked; there is a complete lack of critical analysis; for several supplements, clinical data are virtually absent without the authors finding this embarrassing void a reason for concern; dosage recommendations are often vague and naïve, to say the least (for instance, for milk thistle: 200 to 400 mg per day – without indication of what the named weight range refers to, the fresh plant, dried powder, extract…?); safety data are incomplete and nobody seems to mind that supplements are not subject to systematic post-marketing surveillance; the text is full of naïve thinking and contradictions (e.g.”There are no reported side effects of the mushroom extracts or the Maitake D-fraction. As Maitake may lower blood sugar, it should be used with caution in patients with diabetes“); evidence suggesting that a given supplement might reduce the risk of cancer is presented as though this means it is an effective treatment for an existing cancer; cancer is usually treated as though it is one disease entity without any differentiation of different cancer types.

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. But I do wonder, isn’t being in favour of integrating half-baked nonsense into cancer care and being selected for one’s favourable attitude towards certain supplements already a conflict of interest?

In any case, the review is in my view not of sufficient rigor to form the basis for well-informed discussions with patients. The authors of the review cite a guideline by the ‘Society of Integrative Oncology’ for the use of supplements in cancer care which states: For cancer patients who wish to use nutritional supplements, including botanicals for purported antitumor effects, it is recommended that they consult a trained professional. During the consultation, the professional should provide support, discuss realistic expectations, and explore potential benefits and risks. It is recommended that use of those agents occur only in the context of clinical trials, recognized nutritional guidelines, clinical evaluation of the risk/benefit ratio based on available evidence, and close monitoring of adverse effects. It seems to me that, with this review, the authors have not adhered to their own guideline.

Criticising the work of others is perhaps not very difficult, however, doing a better job usually is. So, can I offer anything that is better than the above criticised review? The answer is YES. Our initiative ‘CAM cancer’ provides up-to-date, concise and evidence-based systematic reviews of many supplements and other alternative treatments that cancer patients are likely to hear about. Their conclusions are not nearly as uncritically positive as those of the article in ‘INTEGRATIVE CANCER THERAPIES’.

I happen to believe that it is important for cancer patients to have access to reliable information and that it is unethical to mislead them with biased accounts about the value of any treatment.

I am sure, we have all heard it hundreds of times: THERE ARE IMPORTANT LINKS BETWEEN OUR DIET AND CERTAIN CANCERS. The evidence for this statement seems fairly compelling. Yet it also is complex and often confusing.

A recent review, for instance, suggested that fruits (particularly citrus) and vegetable consumption may be beneficial in the primary prevention of pancreatic cancer, the consumption of whole grains has been shown to reduce the risk and fortification of whole grains with folate may confer further protection. Red meat, cooked at high temperatures, should be avoided, and replaced with poultry or fish. Total fat should be reduced. The use of curcumin and other flavonoids should be encouraged in the diet. Another equally recent review, however, indicated that there is no conclusive evidence as an independent risk factor for isolated nutrients versus adoption of dietary patterns for cancer risk. Cancer colon risk derived from meat intake is influenced by both total intake and its frequency. The interaction of phenolic compounds on metabolic and signalling pathways seems to exert an inhibitory effect on cell proliferation and tumor metastasis and induces apoptosis in various types of cancer cells, including colon, lung, prostate, hepatocellular or breast cancer. A third recent review concluded that cruciferous vegetable intake protects against cancer of the colon, while a forth review suggested that the Mediterranean dietary pattern and diets composed largely of vegetables, fruit, fish, and soy are associated with a decreased risk of breast cancer. There was no evidence of an association between traditional dietary patterns and risk of breast cancer.

Not least based on these mixed messages from the scientific literature, an entire industry has developed selling uncounted alternative cancer-diets and dietary supplements to desperate patients and consumers. They promise much more than just cancer prevention, in fact, leave little doubt about the notion that cancer might be curable by diet. Here are just a few quotes from the thousands of websites promoting alternative cancer diets:

  • The Ketogenic Diet is believed capable of starving cancer cells to death, and thus capable of restricting tumour development.
  • a more alkaline body makes it difficult for tumors to grow.
  • Budwig diet: This diet was developed by Dr. Johanna Budwig who was nominated for the noble Prize sixth times. The diet is intended as a preventative as well as an alternative cancer treatment.
  • the Gerson Therapy naturally reactivates your body’s magnificent ability to heal itself – with no damaging side effects. This a powerful, natural treatment boosts the body’s own immune system to heal cancer, arthritis, heart disease, allergies, and many other degenerative diseases. Dr. Max Gerson developed the Gerson Therapy in the 1930s, initially as a treatment for his own debilitating migraines, and eventually as a treatment for degenerative diseases such as skin tuberculosis, diabetes and, most famously, cancer.
  • the concept of macrobiotics is much more than an alternative diet for cancer, or any other illness, but rather the ancient Chinese belief that all life, indeed the whole universe, is a balance of two opposing forces Yin and Yang.

Confused? Yes, I do worry how many cancer patients listen to these claims and pin their hopes on one of these diets. But what exactly does the evidence tell us about them?

A German team of researchers evaluated the following alternative cancer-diets: raw vegetables and fruits, alkaline diet, macrobiotics, Gerson’s regime, Budwig’s and low carbohydrate or ketogenic diet. Their extensive searches of the published literature failed to find clinical evidence supporting any of the diets. Furthermore, case reports and pre-clinical data pointed to the potential harm of some of these diets. The authors concluded that considering the lack of evidence of benefits from cancer diets and potential harm by malnutrition, oncologists should engage more in counselling cancer patients on such diets.

In other words, alternative cancer diets – and I mean not just the ones mentioned above, but all of them – are not supported by good evidence for efficacy as a treatment or prevention of any type of cancer. In addition, they might also cause harm.

What follows is obvious: cancer patients should take sound nutritional advice and adopt a healthy general life-style. But they should run a mile as soon as anyone suggests an alternative dietary cure for their disease.

Chiropractors are notorious for their overuse and misuse of x-rays for non-specific back and neck pain as well as other conditions. A recent study from the US has shown that the rate of spine radiographs within 5 days of an initial patient visit to a chiropractor is 204 per 1000 new patient examinations. Considering that X-rays are not usually necessary for patients with non-specific back pain, such rates are far too high. Therefore, a team of US/Canadian researchers conducted a study to evaluate the impact of web-based dissemination of a diagnostic imaging guideline discouraging the use of spine x-rays among chiropractors.

They disseminated an imaging guideline online in April 2008. Administrative claims data were extracted between January 2006 and December 2010. Segmented regression analysis with autoregressive error was used to estimate the impact of guideline recommendations on the rate of spine x-rays. Sensitivity analysis considered the effect of two additional quality improvement strategies, a policy change and an education intervention.

The results show a significant change in the level of spine x-ray ordering weeks after introduction of the guidelines (-0.01; 95% confidence interval=-0.01, -0.002; p=.01), but no change in trend of the regression lines. The monthly mean rate of spine x-rays within 5 days of initial visit per new patient exams decreased by 10 per 1000, a 5.26% relative decrease after guideline dissemination.

The authors concluded that Web-based guideline dissemination was associated with an immediate reduction in spine x-ray claims. Sensitivity analysis suggests our results are robust. This passive strategy is likely cost-effective in a chiropractic network setting.

These findings are encouraging because they suggest that at least some chiropractors are capable of learning, even if this means altering their practice against their financial interests – after all, there is money to be earned with x-ray investigations! At the same time, the results indicate that, despite sound evidence, chiropractors still order far too many x-rays for non-specific back pain. I am not aware of any recent UK data on chiropractic x-ray usage, but judging from old evidence, it might be very high.

It would be interesting to know why chiropractors order spinal x-rays for patients with non-specific back pain or other conditions. A likely answer is that they need them for the diagnosis of spinal ‘subluxations’. To cite just one of thousands of chiropractors with the same opinion: spinography is a necessary part of the chiropractic examination. Detailed analysis of spinographic film and motion x-ray studies helps facilitate a specific and timely correction of vertebral subluxation by the Doctor of Chiropractic. The correction of a vertebral subluxation is called: Adjustment.

This, of course, merely highlights the futility of this practice: despite the fact that the concept is still deeply engrained in the teaching of chiropractic, ‘subluxation’ is a mystical entity or dogma which “is similar to the Santa Claus construct”, characterised by a “significant lack of evidence to fulfil the basic criteria of causation”. But even if chiropractic ‘subluxation’ were real, it would not be diagnosable with spinal x-ray investigations.

The inescapable conclusion from all this, I believe, is that the sooner chiropractors abandon their over-use of x-ray studies, the better for us all.

I have written about this subject before, and I probably will do so again. The reason for my insistence is simple: some homeopathy-fans’ attitude towards and advice about immunizations is, in my view, nothing short of a scandal. Here are excerpts from two articles published in the current issue of ‘HOMEOPATHY 4 EVERYONE’ which amply explain what I mean.

The first paper is by Alan Phillips, a leading U.S. vaccine rights attorney and self-declared fan of homeopathy. It goes through the usual arguments suggesting that immunizations are not effective, outright harmful and a vicious ploy to enrich the pharmaceutical industry at the cost of public health. Subsequently, the author gives advice as to how US citizens can avoid mandatory immunizations: 

God bless homeopathy! A particularly wonderful example was in Cuba in the fall of 2008, when homeoprophylaxis was used in place of allopathic immunizations to respond to a leptospirosis outbreak. Two and a half million people were each given 2 doses of a remedy, and the results not only substantially exceeded prior experience with vaccines, it was about 1/15 the cost! And to the best of my knowledge, there are no serious adverse events with homeopathy as there are with virtually any widespread use of vaccines. The failure of our government health agencies to seize upon the Cuban and other homeoprophylaxis successes by aggressively pursuing further research in this area, and the incorporation of homeoprophylaxis into standard infectious disease control strategies, reveals a public health policy driven by something other than the best health interests of the members of our society.

With all of the problems in the allopathic world, and obvious safe and effective alternatives to immunizations that are being systematically ignored, it’s no wonder that a growing number of people are looking for ways to legally avoid immunization mandates. Ironically, vaccines are being required in greater and greater numbers for more and more people. The reason is simple: The federal government subsidizes vaccine research and development; state and federal governments mandate vaccines; state and federal governments purchase vaccines; and state and federal governments compensate those injured or killed by vaccines. So, for those who are able to throw ethics and morality out the window without a second thought, there’s a racket here offering profound profits, and a convenient vehicle for injecting who knows what into literally billions of people worldwide. The multi-billion dollar international vaccine industry is projected to grow at some 10-12% annually for the next several years…

So you’ve done your research, and you’ve decided that you’d like to postpone, or even forego some or all vaccines altogether. Can you do that? How do you do that? Well, it depends on your specific situation… 

Fortunately, everywhere vaccines are mandated in the U.S., one or more exemptions are available…

Medical exemptions can be hard to get. They usually require the support of a medical doctor, and there are usually specific, narrow criteria that must be met to qualify… So, if you’re considering a medical exemption, make sure you find out first what qualifies for the exemption in your specific situation; and if you can get a doctor to support you for a qualifying reason, then pursuing a medical exemption may be an appropriate route to take.

Religious exemptions are probably the most commonly used exemption. What qualifies is a topic too lengthy for an article, but in brief, it doesn’t require membership in an organized religion, and it doesn’t matter what religion you belong to, if you do belong to one…

Philosophical exemptions, when available, are great in that they don’t require you to justify your beliefs or to state reasons. But states have been changing laws to make them harder to get… The long-held notion of a presumed net benefit from vaccines has been slowly undermined by medical science, though the medical authorities, increasingly controlled by the pharmaceutical industry, continue to actively suppress this reality to the best of their ability… However, in those religious exemption situations where you are required to state your beliefs, and where the authorities involved have authority to scrutinize your beliefs, it is highly advisable to seek out professional help from an experienced attorney…

The second article is by Fran Sheffield, a homeopath from NSW, who began her homeopathic studies after “seeing the benefits homeopathy brought to her vaccine-injured child”, and a founding member of ‘The Do No Harm Initiative Inc.’, a lobby group misinforming communities and governments about ‘homeopathic immunisation’:

Homeoprophylaxis has a remarkable record of safety – vaccines less so. From the homeopath’s point of view they are still associated with risks: the dose is too strong, they have toxic additives, and they’re given by inappropriate pathways.

Homeoprophylaxis has avoided these problems. It’s also versatile, inexpensive, quick to produce and easy to distribute.

Keeping these points in mind, I’ll return to Von Behring who went on to say:

“I am touching here upon a subject anathematized till very recently by medical penalty: but if I am to present these problems in historical illumination, dogmatic imprecations must not deter me”…

The same sentiments are true today – dogma and penalty must not be allowed to restrict information on homeoprophylaxis or deprive others of this safe, simple option. The time has come for all of us – governments and individuals – to take a closer look at homeoprophylaxis and how it relieves the burden of disease…

Future posts show what I did with the prophylactic information, why some were offended or upset, the inevitable backlash that followed, attempts at intimidation and suppression, what happens when a matter like this goes to court, what is lost when we don’t speak out about the truth, and what we should do for the future.

I think I will abstain from any comment; if I did, I would be in danger of being libellous. However, I do hope that my readers will post their opinions freely.

 

Cancer patients are understandably desperate and leave no stone unturned to improve their prognosis. Thus they become easy prey of charlatans who claim that this or that alternative therapy will cure them or improve their outlook. One of the most popular alternative cancer therapies is mistletoe, a treatment dreamt up by Rudolf Steiner on the basis of the ‘like cures like’ principle: the mistletoe plant grows on a host tree like a cancer in the human body. One of many websites on this subject, for instance, states:

Mistletoe therapy

  • integrates with conventional cancer treatments
  • can be used for a wide range of cancers
  • may be started at any stage of the illness….

potential benefits…include:

  • Improved quality of life
  • generally feeling better
  • increased appetite and weight
  • less tired/more energy
  • reduced pain
  • better sleep pattern
  • felling more hopeful and motivated
  • reduced adverse effects from chemo and radiotherapy
  • reduced risk of cancer spread and recurrence
  • increased life expectancy.

Mistletoe extracts have been shown in studies to:

  • stimulate the immune system
  • cause cancer cell death
  • protect healthy cells against harmful effects of radiation and chemotherapy.

In fact, the debate about the efficacy of mistletoe either as a cancer cure, a supportive therapy, or a palliative measure is often less than rational and seems never-ending.

The latest contribution to this saga comes from US oncologists who published a phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC). The trial was aimed at evaluating: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM.

A total of 44 study participants were enrolled; 20 were treated in stage I (mistletoe dose escalation phase) and 24 in stage II (gemcitabine dose escalation phase). All patients had stage IV disease; the majority had received previous chemo-, hormonal, immunological, or radiation therapy, and 23% were chemotherapy-naïve.

Patients were treated with increasing doses of a mistletoe-extract (HELIXOR Apis (A), growing on fir trees) plus a fixed GEM dose in stage I, and with increasing doses of GEM plus a fixed dose of mistletoe in stage II. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery.

The results show that dose-limiting toxicities were neutropenia, thrombocytopenia, acute renal failure, and cellulitis, attributed to mistletoe. GEM 1380 mg/m2 and mistletoe 250 mg combined were the MTD. Of the 44 patients, 24 developed non-neutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation.

6% of patients showed a partial response, and 42% had stable disease. Of the 44 study participants, three died during the study, 10 participants requested to terminate the study, 23 participants progressed while on study, one terminated the study due to a dose limiting toxicity, 6 left due to complicating disease issues which may be tied to progression, and one voluntarily withdrew.

An attempt was made to follow study subjects once they terminated study treatment until death. At the last attempt to contact former participants, three were still alive and five others were lost to follow-up. The median time to death of any cause was approximately 200 days. Compliance with mistletoe injections was high.

The authors explain that a partial response rate of 6% is comparable to what would be expected from single agent gemcitabine in this population of patients with advanced, mostly heavily pretreated carcinomas. The median survival from study enrollment of about 200 days is within the range of what would be expected from single agent gemcitabine.

The authors concluded that GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response  is similar to GEM alone.

These results are hardly encouraging but they originate from just one (not particularly rigorous) study and might thus not be reliable. So, what does the totality of the reliable evidence tell us? Our 2003 systematic review of 10 RCTs found that none of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

Will this stop the highly lucrative trade in mistletoe extracts? will it prevent desperate cancer patients being misled about the value of mistletoe treatment? I fear not.

Continuing on the theme from my previous post, a website of a homeopath (and member of the UK ‘Society of Homeopaths’) caught my attention. In in it, Neil Spence makes a wide range of far-reaching statements. Because they seem rather typical of the claims made by homeopaths, I intent to scrutinize them in this post. For clarity, I put the (unaltered and unabbreviated) text from Neil Spence’s site in italics, while my own comments are in Roman print.

The holistic model of health says all disease comes from a disturbance in the vitality (life force) of the body. The energetic disturbance creates symptoms in the mind, the emotions and the physical body. Each patient has their own store of how this disturbance in vitality came about and each person has individual symptoms.

What is a ‘holistic model of health’, I wonder? Holism in health care means to treat patients as whole individuals which is a hallmark of any good health care; this means that all good medicine is holistic.

Holism and vitalism are two separate things entirely. Vitalism is the obsolete notion of a vital force or energy that determines our health. ‘Disturbances in vitality’ are not the cause of illness.

We will attempt, as far as possible, to treat the whole person and to change the conditions that created your susceptibility to cancer.

Much of the susceptibility to cancer is genetically determined and cannot be altered homeopathically.

Using Homeopathy to treat people with cancer

Homeopathic treatment can help someone with cancer. It can also be helpful for people who have a history of cancer in their family or have cared for a relative or friend with cancer. There are a number of methods of using homeopathic remedies to help people with cancer.

There is no good evidence that homeopathic remedies are effective for cancer patients or their carers.

Constitutional treatment: Treat the person who suffers the illness. A constitutional homeopathic remedy suits your nature as a person and its symptom picture reflects the unique expression of your symptoms. It can arouse the bodyʼs natural ability to heal itself and this can have profound benefits. It is appropriate if your vitality is strong.

There is no evidence that constitutional homeopathic treatments increase the body’s self-healing ability.

Stimulate the immune system to fight cancer: Remedies can be used to help the body fight the cancer, using specific homeopathic remedies called nosodes. A second treatment may be used to support the weakened organ. This method is most useful for people who are not using chemotherapy or radiotherapy.

There is no evidence that nosodes or other homeopathic remedies have any effect on the immune system ( – if they did, they would be contra-indicated for people suffering from auto-immune diseases).

Support the failing organs and the functions of the body that are not working: Remedies can be used to support weakened organs; to help with appetite; to help sleep and to treat sleep disturbances; to reduce the toxic symptoms; to help the body eliminate toxins. These treatments are helpful to people undergoing chemotherapy or radiotherapy.

For none of these claims is there good evidence; they are pure fantasy. The notion that homeopathy can help eliminate toxins is so wide-spread that it merits a further comment. It would be easy to measure such a detoxifying effect, but there is no evidence that it exists. Moreover, I would question whether, in the particular situation of a cancer patient on chemotherapy, a hastened elimination of the toxin (= chemotherapeutic agent) would be desirable; it would merely diminish the efficacy of the chemotherapy and reduce the chances of a cure.

Treat the pain: Homeopathic remedies can be very effective in aiding pain control. Remedies such as calendula can be effective in situations of intractable pain. If the cancer is at the terminal stage, remedies can be used to increase the quality of life. These remedies are palliative and can assist the patient keep mentally and emotionally alert so they can have quality time with loved ones.

Where is the evidence? Pain can obviously be a serious problem for cancer patients, and the notion that calendula in homeopathic dilutions reduces pain such that it significantly improves quality of life is laughable. Conventional medicine has powerful drugs to alleviate cancer pain but even they sometimes do not suffice to make patients pain-free.

Homeopathy in conjunction with other therapies

When a patient chooses to use chemotherapy or radiotherapy to treat their cancer the homeopath will prescribe remedies to support the body and ease the side-effects. Remedies can also be very useful after surgery to encourage the body to heal and allow greater mobility at an early stage.

Again no good evidence exists to support these claims – pure fantasy.

Other therapies can complement homeopathy but the homeopath will advise that you do not use every therapy just because they are available. It may be better to choose two or perhaps three main approaches to improving your health and ensure each one has positive effects that suit you very well.

Is he saying that cancer patients are best advised to listen to a homeopath rather than to their oncology-team? Is he encouraging them to not use all possible mainstream options available? If so, he is most irresponsible.

Each person will have different needs. It is always appropriate to change your diet. Nutritional and dietary advice is of the utmost importance to support the bodyʼs healing process. Cancer has many symptoms of disturbed metabolism and a poor diet has often contributed to the disturbance in the body that allowed the cancer to flourish. It is essential to remedy this situation. Nutritional advice puts you back in charge of your body; with good homeopathic treatments this provides the basis for improving your health.

Dietary advice can be useful and is therefore routinely provided by professionals who understand this subject much better than the average homeopath.

CONCLUSION

The thought that some cancer patients might be following such recommendations is most disturbing. Advice of this nature has doubtlessly the potential to significantly shorten the life and decrease the well-being of cancer patients. People who recommend treatments that clearly harm vulnerable patients are charlatans who should not be allowed to treat patients.

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