The tricky distinction between innovative practice and quackery.

The tricky distinction between innovative practice and quackery.

The evidence-based medicine (EBM) movement has heralded increased emphasis on basing medical practise on the best available clinical evidence, although as Greenhalgh stated recently, there are problems with the implementation of EBM. It would be a false dichotomy to divide medical practice into evidence-based and non-evidence based; the principles of EBM recognize that there are different levels of evidence. 
There are some treatments that are acknowledged as being unproven. All treatments must be unproven at one time, just as all adults were once children. Penicillin and heart transplants were radical new treatments once. It can be argued that in modern medicine, a great deal of work goes into discovering new modalities of treatment, so compounds are not found by the process of trial and error of previous eras. This is not strictly true - although drugs are designed on the basis of known receptors (beta blockers being the first example), new compounds are screened using a number of techniques to assess them for particular effects. Antibiotics are still found by sampling bacteria in various places. So there are still treatments developed where it is not known exactly how they work. Where there is a known mechanism of action, there may be as yet unexplained actions that actually explain the therapeutic effect. For example, statins have an anti-inflammatory effect.
Even where there are logical reasons why a treatment might work, there is still a requirement to demonstrate empirically that it does in fact work. So prior to the completion of definitive trials, all unproven treatment are on an unequal footing.
So how do we distinguish innovative practice from quackery? In some cases, the brand of alternative medicine in question has been investigated extensively and been found to be ineffective. There may be good reasons to suspect that on the basis of the assumptions inherent to the modality or the known science that it will not work. But in the absence of empirical evidence, this cannot be definitive. Although the principles of homeopathy are absurd, nonetheless without good evidence we could not dismiss the possibility that it works. There is good evidence that it doesn't. 
However, where the treatment proposed is new, how can we distinguish quackery from bona fide responsible innovation? Really only on the basis of biological plausibility, with all the problems noted above. Only empirical evidence of lack of effect can really divide quackery from medicine. It cannot divide quackery from innovative practice.

Medical Expert Witnesses and the GMC

Medical Expert Witnesses and the GMC

The thorny issue of shaken baby syndrome has been contested in the courts many times. It is part of the scientific process that there needs to be robust debate over facts and theories. Although police forces and prosecutors may prefer to have settled science to support their prosecutions, often the science involved is not unequivocal. There is a range of legitimate opinion on the subjects of shaken baby syndrome and forensic sleep disorders, among many other bio-medical matters. Nevertheless, sincerely held scientific opinions have resulted in referrals to the GMC - an area which is arguably outside its remit (and certainly outside its field of expertise).
So Waney Squier is before the GMC on the basis of her testimony on shaken baby syndrome. Complaints against her have been made by the National Police Improvement Agency. This followed a report that a British police officer suggested that dissenting expert witnesses should be investigated. (http://www.telegraph.co.uk/health/healthnews/11094379/Shaken-baby-expert-faces-witch-hunt.html)

According to the Medical Practitioner Tribunal Service (who run fitness to practise hearings), the allegations are:

that during these proceedings Dr Squier provided an expert opinion evidence by way of written report and/or oral evidence outside her field of expertise. It is also alleged that Dr Squier failed to discharge her duties as an expert in that she failed to work within the limits of her competence, to be objective and unbiased and to pay due regard to the views of other experts.

It is alleged that Dr Squier’s actions were misleading, deliberately misleading, dishonest and brought the reputation of the medical profession into disrepute.

http://www.mpts-uk.org/calendar/event_details.aspx?ID=29076af4-7fce-44b2-81c3-914d078f1acc

It is regrettable that the decision of Judge Collins in the High Court in Meadow  was overturned. He ruled that the GMC should not invoke disciplinary proceedings unless a trial judge commented on the quality of expert evidence given. The Court of Appeal overturned this ruling, stating that the GMC was able to adjudicate where such issues impacted on fitness to practice. It is unclear when, if ever, a doctor’s expert witness work would impact on their fitness to practice. 

The courts set the standards for expert testimony, and it is the courts that should adjudicate on these matters. If they are concerned, then a GMC referral may be appropriate. Having a party to court proceedings refer expert witnesses to professional bodies is not conducive to the fact finding process.

Ideological Opposition to the Saatchi Bill

Ideological Opposition to the Saatchi Bill

My presentation about the ideological opposition to the Saatchi Bill was received well at the Postgraduate Bioethics Conference. Although there are concerns about the effect of the Saatchi Bill on patient safety, there are some groups whose objections are not related to patient welfare at all. 

The two groups of ideologues opposed to the very principle of permitting wider use of innovative treatments are 1) the evidence-based medicine fanatics and 2) so-called “skeptics”.  The self-described “skeptics” appear to be a group of humanists/atheists committed to fighting alternative medicine, most of whom have no scientific qualifications whatsoever, having graduated in history, IT or other non-scientific fields. Both these groups have articulated their concerns that the bill is a “quack’s charter”.

Both these groups suffer from ethical blindness. They fail to appreciate that bad science can be good ethics. Similarly good science can be bad ethics, as the medical experiments of Nazi Germany demonstrate all too well (experiments which have driven the current framework for research governance). 

It would be blinkered thinking to consider that lack of research evidence prohibits the use of a treatment. The pioneer of the PRCT, Austin Bradford Hill, stated

‘All scientific work is incomplete - whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. This does not confer on us a freedom to ignore the knowledge we already have, or to postpone the action it appears to demand at a given time.’

He also stated that

‘Any belief that the controlled trial is the only way (to study therapeutic efficacy) would mean that not only that the pendulum had swung too far but that it has swung right off the hook.'

Ethical illiteracy is worse than scientific illiteracy in this context. Ironically, the humanists seem to have lost sight of their humanity.

Proof that Evidence-Based Medicine can make you a bit loony?

Proof that Evidence-Based Medicine can make you a bit loony?

I have discussed the strange mentality that EBM can incubate in certain individuals previously in this blog. The so-called skeptics would probably approve heartily of the latest pronouncement from an evolutionary biologist that use of unproven treatments for the deadly disease Ebola is unethical outside of a prospective randomised controlled trial:

http://scientiasalon.wordpress.com/2014/08/14/on-the-science-and-ethics-of-ebola-treatments/

The same bug-eyed loonies 


that find the notion of a terminal cancer patient getting some hope through trying an innovative treatment quite awful, will probably be horrified at the prospect of someone with Ebola, which in the current outbreak has a mortality of 55%, trying an untested treatment in the hope that it may benefit them. It is an indictment of their inflexible thinking that they cannot see the difference between this situation and experimental treatment of more common but less lethal diseases. 

It's also proof that scientists by and large shouldn't stray into the field of ethics. A bit like another famous evolutionary biologist (and his followers) should keep out of religious debates. 

Neurolaw in the UK

Neurolaw in the UK

Neuroscientific evidence will continue to increase in importance in criminal trials. The biggest danger is the potential failure to properly test such evidence, and it is important that judges and lawyers understand the limitations of much neuroscientific evidence. What educational resources are available in the UK?

The Royal Society's Brainwaves project looked at developments in neuroscience and their implications for society and public policy. One module looked at neuroscience and the law. The medical Royal Colleges and the Royal Society of Medicine hold seminars on medico-legal matters, for example the RSM is holding a series of events on Sleep and the Law (the first meeting is on Sep 30th). A medico-legal seminar was held at Keele in 2013 on automatism which was expressly aimed at both medical experts and lawyers. There are a number of events organized for lawyers on neurolaw in the United States. Most of the universities known for neurolaw are in the USA. 

British universities do offer modules in this area, for example the University of Kent offer a module on "Neuroscience in Law: Forensic, Medical and Ethical Aspects". Much of the expertise in this area is in the field of forensic psychiatry, and indeed there is a dedicated Forensic Psychiatry Chambers, as well as many forensic psychiatrists working in high and medium secure units throughout the country. There are related disciplines such as neuroethics which inform discussion about the use of neuroscience in the law. 

There are a number of academics with a special interest in neurolaw in the UK - Lisa Claydon, Paul Catley, and Robin Mackenzie. There is a European body for neurolaw, the European Association for Neuroscience and Law (EANL). There certainly appears to be much academic activity on the continent. It would be a useful resource for the UK to have an established centre for neurolaw to aid education of the legal profession and the judiciary. Neuroscience has great potential to aid legal decision-making, but there also needs to be appropriate skills in handling expert evidence in neuroscience.  Neurolaw may still be in its infancy, but we need to be proactive rather than reactive. 

The limits of the adversarial system

The limits of the adversarial system

A recent action against barrister Lawrence McNulty emphasized that despite what some lay people might believe, there are limits in the adversarial system to the tactics counsel can employ at trial. In fact, although lawyers are retained by their clients, they are nonetheless "officers to the court". This is why a lawyer cannot argue that if his client is innocent if he knows otherwise. He may argue that the case against him has not been proven beyond a reasonable doubt, but he may not argue for this innocence.

Lawrence McNulty is appealing the decision. The disciplinary tribunal found that he had contravened professional ethics in several ways. He had argued a defence of entrapment without the necessary notice. The allegations of entrapment “were completely unfounded and his conduct had the potential to undermine public confidence in the legal profession and the administration of justice”. Further, he made a "deliberate and misguided attempt to undermine the authority of the judge and to neutralise his summing-up", and had also attacked police witnesses without giving them the opportunity of reply. 

It must be emphasized that such behaviour and resulting disciplinary action is notable for its rarity, and no one has suggested that the barrister in question is not normally conscientious and ethical. Nonetheless, it is an important reminder that the courts are interested in justice, and although the adversarial system may seem like a bun fight to the layperson, there are consequences if counsel stray across certain boundaries when representing their client. 

The Evolution of the Insanity Defence in England and Wales

The Evolution of the Insanity Defence in England and Wales

The insanity defence in English law is typically pleaded in the crown court, where the statutory special verdict applies. This dates back to the Criminal Lunatics Act 1800. Prior to this, only the common law insanity defence applied, which resulted in a plain acquittal (although often civil detention occurred given the profound degree of impairment required to persuade a lay jury of insanity before medical experts were permitted in court, the first case being in 1760). This still applies when the insanity defence is successful in the magistrates court. It results in a verdict of not guilty by reason of insanity, although between 1883 and 1964 the verdict was 'guilty of the act but insane at the time' (introduced by the Trial of Lunatics Act 1883, with the original wording restored by the Criminal Procedure (Insanity) Act 1964). This outcome was unacceptable to monarch and parliament for the man who attempted to assassinate King George III, Hadfield, and so emergency legislation was passed to enable his detention.

Hadfield was a veteran of the First War of the Coalition, and had been part of the bodyguard of the Duke of York at the battle of Lincelles, where he received a serious head wound from a sabre. It was clear that prior to the injury he had been a loyal and brave subject. It was likely that the visible head injury (counsel invited the jury “to inspect the membranes of the brain itself”) and his previous loyal service helped persuade the jury that this behaviour was contrary to his pre-morbid character. This was the first case where the concept of partial insanity was accepted as the basis of an acquittal. Hadfield’s counsel, Erskine, argued that delusion “unaccompanied by frenzy or raving madness [was] the true character of insanity”. Hadfield’s delusion was that he must die to save the world, but he could not die by his own hand. Thus he contrived to be killed in the course of an assassination attempt. 

The statutory special verdict allowed for only one disposal until recently - detention at Her Majesty's Pleasure. Once the death penalty was abolished and the defence of diminished responsibility was introduced for homicide, the insanity defence became less and less attractive given the prospect of indefinite detention. The insanity defence became virtually obsolete. However the Criminal Procedure (Insanity and Fitness to Plead) Act 1991 gave judges the choice of four disposal options, later reduced to these three:

1) A hospital order with or without a restriction order (mandatory for homicide where there is a mental condition)

2) Supervision order

3) Absolute discharge

Mackay found that this legislation resulted in increasing numbers of successful insanity defences. 

So rather than being motivated by compassion, the statutory special verdict was a regressive step. During the 19th century it was widely considered that the insane were still capable of being deterred, and so the detention of the insane had a punitive element to it. Indefinite detention very often did amount to detention for life, and the conditions in the asylums of the time were appalling by modern standards. Prime Minister Gladstone considered the special verdict 

"an inducement...to morbid minds for the commission of crime by an apparent declaration of innocence in the teeth of the facts."

This perception led to the substitution of the original verdict of 'not guilty by reason of insanity' with 'guilty of the act but insane at the time', as noted above.