Looking for evidence, I looked in the BMJ and in an article published in 1996 a rather tongue in cheek comment suggested that it was a ‘dangerous innovation perpetrated by the arrogant to serve cost cutters and suppress clinical freedom’.
Well I have sat in meetings – even in the hallowed grounds of NICE and felt that this is absolutely true. I have rigorously defended NICE in removing the word ‘affordability’ from a definition of evidence. I have listened to colleagues who add the word ‘evidence’ to the end of every sentence, perhaps hoping that it will give them some importance. I have been staggered by the arrogance of some who contend that everything is in the clinical paper and they gain nothing more from dialogue with the industry and other experts. And I have witnessed the suppression of innovative new medicines because of ‘cost’ and the shrinking of the investment in the UK.
Is EBM safe in the hands of medicines management – hell no! Will it be safe in the hands of medicines optimisation experts – only time will tell.
Wikipedia – that font of accurate knowledge actually helps – it defines it as – ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’.
There are important parts to this – ‘current knowledge’ clearly suggests that knowledge is a continuum and we are just at a single point in this. This is actually important when we consider the development of medicines and the registration process. The EMA and the FDA are usually involved in the process of trial design and agreement of end-points. I am currently working on the most amazing case where both the EMA and FDA asked for different endpoints from those developed by the company. Hence there is absolutely loads of primary and secondary endpoints and I am scratching my head – was that an original one, a FDA one or an EMA one. Fortunately the medicine seems to have hit every one – that’s a relief!
And then it mentions ‘the care of the individual patient’. Interesting that it doesn’t say the population! Committees should remember this point and consider which ‘individuals’ the medicine will give benefit to.
And then it is the ‘conscious, explicit and judicious use’. So obviously ingraining EBM in everything that we do. But what does judicious mean here? Yes it is all about judgement, wisdom, good-sense and discretion.
So here is a view on this. I ask for three things – the three kings of EBM
Should it – the science – I would because I am also a pharmacologist and I like to know the basis of things.
Does it – the clinical trial evidence – so when put in a contrived and controlled situation does it perform and hit endpoints that might be applicable to the patient in front of me
Did it – the experience of others who have used the medicine in a similar situation
Naturally for every situation there are risks and benefits, but patients come in all sorts of shapes and sizes and the risk benefit conundrum is down to agreement in which both the patient and the prescribing clinician are happy
I have seen treatments blocked – and when I say blocked I mean ‘not to be prescribed under any circumstance’ by evidence based boffins’ for a whole host of implausible and inaccurate reasons. This is medicines management.
Medicines management is dead – long live medicines optimisation.
And finally, in the words of Sir David Nicholson, we need to be a little less risk averse. We need to use evidence, support experience and drive change.