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

malpractice

The fact that many SCAM-practitioners are latent or even overt anti-vaxxers has often been addressed on this blog. The fact that the anti-vaccination guru, Andrew Wakefield, has his fingers deep in the SCAM-pie is less well appreciated.

In case you forgot who Wakefield is, let me remind you. As a gastroenterologist at the London Royal Free Hospital, he published evidence in the Lancet (1998) suggesting that the MMR vaccination was a cause of autism. It was discovered to be fraudulent. In 2010, a statutory tribunal of the GMC found three dozen charges proved, including 4 counts of dishonesty and 12 counts involving the abuse of developmentally delayed children. Consequently, he was struck off the register and lives in the US ever since where he, amongst many other things, enjoys lecturing to homeopaths and chiropractors about the dangers of vaccination.

Since Trump, who seems to share Wakefield’s anti-vaxx stance, has become president of the US, Wakefield has managed to creep back in the limelight. The Guardian recently reported: At one of President Trump’s inaugural balls in January last year, he was quoted as contemplating the overthrow of the (pro-vaccine) US medical establishment in words that brought to mind Trump himself. “What we need now is a huge shakeup at the Centers for Disease Control and Prevention (CDC) – a huge shakeup. We need that to change dramatically.”

In the US, Wakefield also founded the ‘Autism Media Channel’ which makes videos alleging a causal link between autism and the MMR vaccine. The film ‘Vaxxed’ was thus directed by Wakefield. It was put forward to premiere at the 2016 Tribeca film festival by Robert De Niro, the father of an autistic child. It alleges a cover-up of the alleged link between MMR and autism by the CDC – the institute Wakefield said needed a shake-up at the Trump inaugural ball. After much discussion, De Niro fortunately withdrew the film.

Wakefield’s private life has also seem significant changes. He is reported to have recently left his wife who had supported him throughout the debacle in the UK and is now ‘deliciously in love’ with the super-model and entrepreneur Elle Macpherson . Brian Burrowes, 48, who edited ‘Vaxxed’ was reported stating that he and Macpherson had begun dating after they were both guests at the ‘Doctors Who Rock‘ Awards in November last year. This event was to honour alternative medicine practitioners, with Macpherson handing out an award and Wakefield receiving one. Other awardees included Del Bigtree and Billy DeMoss DC.

Wakefield’s legacy in Europe is the recurrence of measles due to persistent doubts in vaccination safety. This regrettable phenomenon is fuelled by Wakefield’s multiple activities, including face-book, twitter and you-tube. Social media has provided an alternative to the “failings of mainstream media”, Wakefield was quoted in the Guardian saying – another phrase that could have come from a tweet by the US president himself. “In this country, it’s become so polarised now … No one knows quite what to believe,” Wakefield said. “So, people are turning increasingly to social media.”

And this is what I said about this strategy in today’s Times: “Such anti-vaccination propaganda is hugely harmful. It prompts many families to shun immunisations which means firstly they are unprotected, and secondly we as a people might lose herd immunity. The result is what we currently see throughout Europe: epidemics are threatening the lives of millions. It is in my view irresponsible for any institution to get involved in the anti-vaxx cult, particularly for universities who really should know better.”

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.

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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.

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 literature on malpractice in medicine is huge: more than 33 000 articles listed in Medline. By contrast, the literature on malpractice in alternative medicine hardly exists. An exception is this recent article. I therefore thought I share it with you and provide a few comments:

START OF QUOTE

According to the (US) National Practitioner Data Bank, between September 1, 1990 and January 29, 2012, a total of 5,796 chiropractic medical malpractice reports were filed. Lawsuits with the highest payouts in any medical field are related to misdiagnosis, failure to diagnose and delayed diagnosis of a severe medical condition.

Common reasons for chiropractic malpractice lawsuits:

Chiropractor causes stroke: Numerous cases have been documented in which a patient suffers a stroke after getting his or her neck manipulated, or adjusted. Especially forceful rotation of the neck from side to side can overextend an artery that runs along the spine, which can result in a blockage of blood flow to the brain. Strokes are among the most serious medical conditions caused by chiropractic treatment, and can result in temporary or permanent paralysis, and even death.

Herniated disc following adjustment: Although many patients seek the medical attention of a chiropractor after they have experienced a herniated disc, chiropractors can actually be the cause of the problem. Usually a herniated disc is caused by wear and tear, but a sudden heavy strain, increased pressure to the lower back or twisting motions can cause a sudden herniated disc. The stress that chiropractors exercise in their adjustments have been known to be the root cause of some herniated discs.

Sexual misconduct: The American Chiropractic Association has assembled a code of ethics “based upon the acknowledgement that the social contract dictates the profession’s responsibilities to the patient, the public and the profession.” Sexual misconduct is among the top ten reasons that patients file lawsuits against chiropractors. Often, chiropractic practices are unfamiliar to many new patients and can be misinterpreted as inappropriate even though they are absolutely normal, so it is important that patients familiarize themselves with common chiropractic methods of healing.

END OF QUOTE

In this context, a study of chiropractic from Canada might be interesting. It highlights the conclusions from Canadian courts: informed consent is an ongoing process that cannot be entirely delegated to office personnel… A further study showed that valid consent procedures are either poorly understood or selectively implemented by chiropractors. Arguably, not obtaining informed consent amounts to malpractice.

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

I fear that, if we were to count the lack of informed consent by chiropractors (and other alternative practitioners) as malpractice, the numbers would be astronomical. Or, to put it differently, the often-cited relatively low malpractice rate in chiropractic is due to the omission of the vast majority of malpractice cases.

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