Posted by: beyondtheheadlines24 March 2014
Jeremy Hunt is keen to ‘put patients first’; so keen in fact, that – according to the BBC Health Correspondent Branwen Jeffreys – when confronted by a nurse whingeing about her below-inflation pay rise, he told her: ‘You went into your profession because you care for patients – put them first’.
Of course, the Health Secretary is only encouraging her to follow his lead – has he not this very week shown how dedicated he is to the most vulnerably ill by removing a huge layer of red tape to speed access to life-saving drugs with the new Early Access to Medicines Scheme? In his words: ‘This ground-breaking scheme will provide cutting edge medicines earlier, give hope to patients and their families and save lives.’ So why am I left feeling so uneasy by this announcement? Perhaps it is because whenever this Government announces something that is good for patients, there always seems to be a vested interest hiding in the wings, rubbing its hands in glee – and this development is no exception.
You don’t have to look far to discover that interests other than the clinical care of patients are absolutely central to this scheme – one of the guiding principles set out in the consultation document was that: ‘the UK economy should benefit from the scheme,’ while the Department of Health website states: ‘The scheme is an important addition to the pharmaceutical sector.’ Now I have nothing against the UK economy being given a boost, nor do I have a grudge against the pharmaceutical industry, but it should concern us greatly that these aims have played such a major role when patient safety is at stake.
The reason why medicines take such a long time to be given a licence is not in order to dampen the economy, or to make life difficult for those involved in the manufacture of drugs, but purely for reasons of patient safety. It takes time to gather and analyse sufficient evidence for a new drug before it should be risked outside a clinical trial. No doubt this process could be made more efficient, and time saved without any risk to patients, but this proposal simply slashes through some of the safety checks and exposes patients to drugs before all the checks are in place.
No doubt the Health Secretary would protest that the plan is entirely safe, since it will ‘make innovative and promising drugs available as soon the Medicines and Healthcare Products Regulatory Agency - the UK’s regulator - has signalled that the benefits outweigh the risks following an initial scientific assessment.’ However, can we really trust the regulator to know that benefits outweigh harms at the point at which patients are now to be exposed to these new drugs? Given how many well established drugs have been withdrawn when unexpected harms have come to light only years after they received their licence under the current system, how can we expect the regulator to have sufficient understanding of harms with significantly less information to go on?
For a drug company to make use of the new scheme they will have to convince the regulator that their product is a ‘Promising Innovative Medicine’, which will give it a special status. This means there will be more pressure than ever for the industry to ham up expectation around new drugs in order to achieve such a labe. Mr Hunt claims that this move will ‘bring hope’ – but false hope is worse than no hope at all, and such a powerful motivation to exaggerate potential in this way should concern us. Will the early release of such drugs really save lives, or will it falsely raise the expectations of a cure for people close to the end of their lives, or even shorten their lives due to as yet unidentified harms? A recent study in the BMJ certainly suggests this may be the outcome in cancer care, showing that patients receiving palliative chemotherapy were significantly more likely to die in hospital and on an intensive care unit than those who were not.
I would love to be able to endorse this new scheme, since I know that patient groups have welcomed it, and some excellent charities - like Joining Jack which raises much needed funds for research into Duchenne Muscular Dystrophy - have campaigned for it. I don’t like being this cynical, but I can’t get the idea out of my mind that patients are being exploited here for the benefit of others; nor can I accept that patients are being put first when the primary purpose of the Government’s actions is to make money for someone else.