Thursday, September 18, 2014

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.

Friday, September 12, 2014

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.