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

neglect

We have previously seen that SCAM-use is associated with shorter survival of cancer patients. A new article now confirms this notion.

The investigators wanted to find out what patient characteristics are associated with use of SCAM for cancer and what is the association of SCAM with treatment adherence and survival. They thus  compared the overall survival between patients with cancer receiving conventional treatments with or without SCAM and the adherence to treatment and characteristics of patients in both groups.

Their retrospective observational study used data from the National Cancer Database on 1 901 815 patients from 1500 Commission on Cancer–accredited centers across the United States who were diagnosed with nonmetastatic breast, prostate, lung, or colorectal cancer between January 1, 2004, and December 31, 2013. Patients were matched on age, clinical group stage, Charlson-Deyo comorbidity score, insurance type, race/ethnicity, year of diagnosis, and cancer type.  Overall survival, adherence to treatment, and patient characteristics were the study endpoints.

The cohort comprised 1 901 815 patients with cancer (258 patients in the SCAM group and 1 901 557 patients in the control group). In the main analyses following matching, 258 patients were in the SCAM group, and 1032 patients were in the control group. Patients who chose SCAM did not have a longer delay to initiation of conventional therapies, but had higher refusal rates of surgery, radiotherapy, and hormone therapy. Use of SCAM was associated with poorer 5-year overall survival compared with no SCAM (82.2% [95% CI, 76.0%-87.0%] vs 86.6% [95% CI, 84.0%-88.9%]; P = .001) and was independently associated with greater risk of death (hazard ratio, 2.08; 95% CI, 1.50-2.90) in a multivariate model that did not include treatment delay or refusal. However, there was no significant association between SCAM and survival once treatment delay or refusal was included in the model.

The authors concluded that patients who received CM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of CCT.

This new evidence confirms previous papers: SCAM-use is associated with shorter survival of cancer patients. As it is based on a large sample size, its results are more compelling. They indicate that it is not SCAM per se, but the attitude of SCAM-users to conventional therapies that is the cause of the effect. As I have said and written hundreds of times: the most serious risk of SCAM is not a direct but an indirect one: the risk of neglecting effective therapies. Essentially, this means that better information targeted at vulnerable patients must be the way forward (one of the main ambitions of this blog, I hasten to add).

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.

It has been reported that, between 1 January 2018 and 31 May 2018, there have been 587 laboratory confirmed measles cases in England. They were reported in most areas with London (213), the South East (128), West Midlands (81), South West (62), and Yorkshire/Humberside (53). Young people and adults who missed out on MMR vaccine when they were younger and some under-vaccinated communities have been particularly affected.

Public Health England (PHE) local health protection teams are working closely with the NHS and local authorities to raise awareness with health professionals and local communities. Anyone who is not sure if they are fully vaccinated should check with their GP practice who can advise them.

Dr Mary Ramsay, Head of Immunisation at PHE, said:

“The measles outbreaks we are currently seeing in England are linked to ongoing large outbreaks in Europe. The majority of cases we are seeing are in teenagers and young adults who missed out on their MMR vaccine when they were children. Anyone who missed out on their MMR vaccine in the past or are unsure if they had 2 doses should contact their GP practice to catch-up. This serves as an important reminder for parents to take up the offer of MMR vaccination for their children at 1 year of age and as a pre-school booster at 3 years and 4 months of age. We’d also encourage people to ensure they are up to date with their MMR vaccine before travelling to countries with ongoing measles outbreaks. The UK recently achieved WHO measles elimination status and so the overall risk of measles to the UK population is low, however, we will continue to see cases in unimmunised individuals and limited onward spread can occur in communities with low MMR coverage and in age groups with very close mixing.”

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And what has this to do with alternative medicine?

More than meets the eye, I fear.

The low vaccination rates are obviously related to Wakefield’s fraudulent notions of a link between MMR-vaccinations and autism. Such notions were keenly lapped up by the SCAM-community and are still being trumpeted into the ears of parents across the UK. As I have discussed many times, lay-homeopaths are at the forefront of this anti-vaccination campaign. But sadly the phenomenon is not confined to homeopaths nor to the UK; many alternative practitioners across the globe are advising their patients against vaccinations, e. g.:

Considering these facts, I wish Dr Mary Ramsay, Head of Immunisation at PHE, would have had the courage to add to her statement: IT IS HIGH TIME THAT ALTERNATIVE PRACTITIONERS DO MORE THAN A MEEK LIP SERVICE TO THE FACT THAT VACCINATIONS SAVE LIVES.

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

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

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

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

This is also not true, I’m afraid.

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

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

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

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

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

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

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

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

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