A beautiful, sunny, Saturday morning walk through Glasgow streets with my wife some years ago brought us to the wonderful Kelvingrove Musueum and Art Gallery and something of a surprise.

The ‘Loveseat’ – as shown above – is a Scottish memorial for organ donors. It was established in 2000 and, until April 2014, a silver leaf was attached for every deceased organ donor in Scotland. But with very little space remaining, a new national memorial was created in Edinburgh.

It is a moving tribute which perferctly sums up the relationships and emotions that lie behind organ donation and I thoroughly recommend a visit – and to Kelivingrove as it happens.

This Sunday the Government – after a consultation that prompted 17,000 responses – announced that it will introduce a new opt-out system for organ donation by 2020. Called ‘Max’s’ law, after Max Johnson from Cheshire whose life was saved by a heart transplant, the legislation follows similar moves in Wales and Spain.

I support the introduction of the new law which is currently passing through parliament as a Private Members Bill. But we should see it as a foundation for a wide range of other measures needed if we are to boost the number of registered organ donors and reduce the number of deaths due to lack of donors.

Not as a magic bullet in itself.

As many observers have commented, Wales has not seen the hoped-for rise in organ donors since it changed its law. Spain has a remarkable success story to tell about organ donation. But legislation has been only one part of its tale. This is an excellent article about Spanish approach. Outstanding clinical management and practice, support for families and public awareness seem key features of their world-leading achievements.

Philosophically I have some sympathy with the argument that legislation in this areas is tantamount to the Government declaring ownership over something that only we have a right to decide privately and without intervention from anyone least of all the state.

In fact, when I heard some of the arguments play out over the weekend I cringed with the memory of civil servants who used to tell patients ‘you don’t own your data’ at the the melodramatic height of the debate about patient data. Talk about own goals. Of course they do. All Government’s operate under licence and that licence is public opinion.

So we must be careful. With the national data opt-out and now the organ donation opt-out it is important we do not to step too far towards completely rearranging the social relationships that underpin the provision of health and social care with no debate at all.

There has been much talk about the need for a new social contract in health care and reserach. If so, let’s have a national discussion about what this means. Let’s walk into this new era, together, and with our eyes open.

The memorial at Kelvingrove recognises the extraordinary humanity that is organ donation and brings together those involved – donors, organ recipients, families and loved ones – with a symbol of mutual respect and kindness.

For this reason perhaps we might also think about re-naming the legislation as the ‘Keira and Max’ law to recognise Keira Ball, the nine-year old girl who gave Max his new heart.

One good thing about sleepless nights in this weather is the opportunity to catch up on your reading.

In the wee small hours of this morning I decided to read a report entitled ‘Bursting the Biomedical Bubble’ authored by Richard Jones and James Wilsdon and published by the excellent Nesta just two weeks ago. It has been covered extensively in The Guardian, The Times Higher, and the Lancet among others. It’s the talk of the town so to speak. Well, Whitehall, Westminster and London’s medical mile at least.

The basic argument in the report is that biomedical research funding is out-of-kilter with the nation’s future needs. Funding has been skewed towards a highly medicalised model of health, is concentrated in London, Oxford and Cambridge, and is besotted by things like biotechnology and pharmaceuticals. The authors say the creation of the UK Research and Innovation (UKRI) is a golden opportunity to put things right.

‘Hoorah!’ I hear you say, and well you might. It’s an excellent report. It’s well-written as well.  By two authors who know their stuff and demolish the status quo in biomedical research with some aplomb, marshalling the evidence over the hilltops and into battle like a scene from one of those ‘Lord of the Rings’ films. Anyone who was frustrated if not angered by the smug self-satisfaction of the Life Sciences Industry Strategy and the resurgence of academic self-interest should read this report. There are sensible allies out there.

Yet (there’s always a yet, isn’t there?) there were places where I thought Jones and Wilsdon could have sharpened their pencils just that little bit more. Because while their analysis is powerful, I am not sure their prescription for the future is pointed enough to burst the so-called bubble.

The number one issue I have with report is that it could have more strongly challenge the leadership and governance that has presided over the creation of this biomedical bubble in the first place.  The same voices and interests continue to dominate decision-making in health research. Until they make space for other voices including patients, carers and the public decisions will follow an all too predictable pattern.  Finding itself in the classic situation of over-promising and under-delivering public trust will fade away. A sentiment that will be felt politically and financially.

Few would disagree with the report’s view that the UK is a world-leader in ‘public engagement.’ Nor would they disagree with its sentiment that public engagement is overdue radical reform and needs reinvigorating.  Read the BMJ editorial published this week and authored by Paul Wicks, Fi Godlee, Tessa Richards and me about patient rights and roles that challenge existing research hierarchies.

They pleasingly refer to examples of other nations such as the Netherlands where the science hierarchy has been brave enough to involve citizens in thinking about the research questions of the future.  But, again, I think they could have advocated more strongly for public engagement to be integrated into the whole fabric of how research is conducted. As we have learnt at the NIHR, cultural change only comes about by integrating the public voice in every aspect of an organisation’s/system’s strategic and operational decision-making.

And while a National Institute for People-Powered Research sounds a lot of fun (yes please!) I am not sure it would lead to the scale of change necessary. Just as building a new members-only sports centre in London W1 wouldn’t improve the nation’s fitness levels.

Finally, I hope it’s trust in UKRI to think out of the box and tackle public engagement head on is justified. After all ,UKRI only devoted a couple of pages to it in its strategic prospectus – a fact that doesn’t inspire confidence.

But these are perhaps picky observations. This is a good report that in most respects pulls few punches. It was worth the sleepless night that’s for sure. Perhaps the point is that we all now need to join James and Richard in sharpening our pencils if we are to burst the biomedical bubble for the better.

 

I once went to Las Vegas. It is a long, long time ago now. But I remember it being a very strange experience.

Everything is turned in on itself. Away from the inhospitable heat of the sidewalks. Or, more accurately, everything – from hotel bedrooms to burger joints and cocktail bars – is turned to face into hangar-sized casinos which are open 24/7. Because if you’re in the Las Vegas then all you want to do is gamble, right?

For most – whose resources are frankly limited – this gambling takes the form of slot machines. These are glorified versions of what you’ll find at English seaside amusement arcades. Lights flash everywhere. The air is filled with bleeps and the sound of coins falling into slots. But if you’re rich enough then you can break away from this melee and join exclusive clubs, playing poker and other high stakes games behind closed doors.

I sometimes wonder whether science funding is taking on the airs of a poker game m. There’s our public funders – Government, publicly funded charities – spending their money while everyone looks over their shoulder. Even industry to an increasing extent. And then there’s the philanthropists: Gates and Zuckerberg being the most obvious examples and spending collectively tens of £billions. But with many others joining them – wanting to do good no doubt but in their own inimitable way and with the sort of money that really can move mountains.

And to be honest I really can’t decide whether this is a good thing or a bad thing. On the one hand it means lots more money being spent on research which is great, right? But, on the other, there’s no guarantee it’s being spent in the public interest is there? Because what people forget is that while public funders when invited around any table must always show their hand, philanthropists are under no obligation to reveal any of their cards whatsoever. More over, by the time we get to the sorts of eye-watering sums coming into play with philanthropists most of our charities are well out of the game.

Some time ago I wrote an open letter to Zuckerberg (the founder of Zuckerberg) on this blog. This, after he’d announced his flight of fancy donation to research to cure everything. I asked him to involve people in deciding how it was spent. I never got a reply. Which surprised me because his data geeks probably knew I was writing it before I did. Now I suspect he’s too busy being fined for me to ever have a chance of a reply.

Fact is we have no way of telling whether it’s all in the public interest or not – other than the good news stories they tell us and themselves. And I worry that so entangled are we all becoming across research that we may not ‘call out’ the philanthropist who is not acting with the public interest in mind. Or not until there was pressure from the media and the public which is never a good position to get into. I hope I’m wrong but it is a worry.

The other issues I ponder and wonder whether to worry about are more insidious things. First, it’s the degree to which funders seem increasingly intoxicated with risk. And the bigger the risk the better. It’s as if they are saying what’s gone before is done and dusted. We’ve exhausted what’s there and the returns are too small for all the effort. Sounds like the closure of the coal mines in the 1980s.

But we know that there has been terrible waste in science already. Also that one of the reasons for this is that it has not focused on the needs and priorities of patients and carers and the public. Sometimes just sometimes the lurch towards risk feels like the science funding equivalent of chasing the dragon in search of ever greater highs. Boring can be good you know. It can be very very good from a patient perspective if it means attention to pain, fatigue and de-medicalising health.

I also wonder whether a double standard is at play here.

When the Wellcome Trust trumpeted it’s new Leap Fund yesterday with £250M downloaded from its reserves plus a little help from venture capitalists and other risk-takers the announcement was crafted around all the usual messages on innovation, new ideas etc etc. But if you strip all this away it’s really about leaps of faith. And if that is the case, why do funders increasingly resist adequately funding public engagement and involvement on the basis that, well, er, they are leaps of faith. That the evidence base is minimal and we just can’t afford such a punt? Mmmmm. I think that’s crass don’t you?

It’s probably worth pointing out that however good Wellcome Trust’s public engagement programme is – and it is very, very good – as a private charitable trust it is under no obligation to, nor does it, involve the public in setting its research priorities or making funding decisions to any great extent.

I’m sure my fears are unfounded. But if they are not, what to do about it is a conundrum. Can we – patients, carers and the public – ever be the dealer? Probably not. Can we set the rules of the game? Possibly.

It would be good to see philanthropists strongly encouraged to sign up to bodies like AMRC which at least ensure some quality control. Perhaps we could claim PPI refunds on the science that clearly has wasted good money? Or just for once ensure that all research funding decisions – however risky – is informed by patient experience. I’m looking forward to someone setting up the ‘Leap of Faith’ fund for publicly chosen science. Now that would be good,

For, just remember, as the tax-payer pulling on that ‘one-armed’ bandit every day, one way or other you’re going to be footing the bill for an increasingly high stakes game.

There, I’ve shown my hand as ever.

(Warning several spoiler alerts!)

If the sight and sound of research institutions and organisations bellowing about their impact on life and the universe has a familiar ring to it, you’d be right.

The reference point you are looking for – but have understandably mislaid – is ‘Monsters Inc.’ The brilliant 2001 Pixar animation in which a motley crew of loveable and not so loveable monsters seek to outdo each other in making small children scream and cry in the middle of the night. As you’ll remember, their shrieks of terror are captured and turned into electricity to power Monster City.

Yes, the research community is doing its VERY best to tell us VERY loudly about the HUGE/MASSIVE/INCREDIBLE difference it is making to you, me and the world. And this cacophony of noise is likely to reach ‘11’ on the volume button as we head towards the Research Excellence Framework (REF) in 2021. The REF is the name given to the exercise by which the UK decides which institutions are doing the best research. Since 2014 it has included a component which assesses institutions for the impact their research has had on society.

That institutions should care about the difference they are making to society is a good thing. That they should be assessed as to whether this impact is real (or imagined by the Vice Chancellor) is also a good thing. After all, if you roll back the years to before the 2014 REF when ‘impact’ was first assessed, much of the research community was kicking and screaming about the mere notion. So loudly in fact that we could have solved the world’s energy problems for at least a month. I really do wish it was 50% of the REF instead of the current 25% just to see what would happen.

Now that ‘impact’ is part of the laboratory furniture so to speak, thought is turning to how the devil we should define and measure it? What does it look like? Would we know it if we walked into it? How can we reduce the fear?

Last week I attended a very good event about impact hosted by the NIHR Oxford Biomedical Research Centre and the Cochrane Collaboration (#OxfordImpact). Then Chaired the NIHR working group on public involvement impact. Each meeting in its own ways was trying to get to grips with the issues.

The debate about impact has given me more highs and lows in the last 12 months than watching the England football team over the last 50 years. One minute I’m running round my kitchen shouting ‘I’ve solved it.’ The next minute I’m sobbing at my desk, inconsolable amidst the piles of screwed up bits of paper pleading ‘why, why, why?’ The point being – and here’s my lightbulb moment of the last week (spoiler moment, I am actually quite dim) – this is an issue which has no solution. Rather it’s a question that can only be answered by asking lots of other questions. Which lead to further questions etc. And so slowly we will form a picture. But it will never be perfect I suspect. Where would the fun be in that?

I have distant memories of a similar ‘impact’ frenzy gripping the charity sector many moons ago. It sparked very similar behaviour. Screaming. Hand-wringing. People with ‘Impact’ in their job title (some of my best friends are impact experts). Overpaid consultants. An industry of…well, an industry. Frameworks you wouldn’t hang your washing on. Etc etc. And eventually it has all settled somewhere sensible where people do their best to say what difference they have made. A place where there is more art than science in all truth.

I suppose where I am for the moment is believing passionately that research impact is in the eye of the beholder. And that, in respect of health research, no conversation about impact can get very far without understanding how our publics see it. What difference do they think health research should be making to them and their family and neighbours? Our public, our citizens, can provide the ‘moral narrative’ as it was called in Oxford that can get this debate off on the right foot. Hence the NIHR impact working group will try to tackle this first. With the help of many others.

If you don’t believe me then just watch Monsters Inc. As you’ll know the story ends with our heroic monsters Sullivan and Mike Wazowski exposing the corrupt factory managers for what they are and discovering that its children’s laughter that creates the greatest energy. And they all live happily ever after.

There’s really no need to make us scream.

Have a great evening.

I was delighted to see that Billy Caldwell had been discharged from hospital yesterday. This, after the Home Office granted a 20-day licence for the cannabis oil that alleviates the seizures associated with his epilepsy.

The substance had been confiscated on his arrival in the UK from Canada with his mother, Charlotte, last week. Shortly after which he was admitted to hospital in a life-threatening condition following a series of seizures.  The outrage has been justified. The decision taken yesterday, the right one.

We can only hope the license is more than a temporary reprieve. That the Government has at last managed to untie the knot it has got itself into. Yesterday there seemed conflicting messages from within Whitehall as to what will happen next. But we do know that a committee of expert clinicians is to be set up to look at ‘individual cases’ and that this will be chaired by the Chief Medical Officer, Professor Dame Sally Davies.

Today’s media are full of opinion and analysis about cannabis oil. Some have chosen to open up the discussion even wider and look at the legalisation of cannabis.  Inevitably others are wading in. The unfolding debate is perhaps shrouding some deeper questions that Billy’s case raises, not about cannabis but about patient experience.

The first time Billy’s plight came to my attention was hearing Charlotte being interviewed on BBC Radio 4’s Today Programme. She was up against a very senior academic whose name escapes me I am afraid. The two-way interview concluded with the latter commenting that – and I paraphrase – ‘ we have to look at the evidence and can’t do things on the basis of anecdote.’

This turn of phrase was interesting to me. For me, anecdotes are stories often told in the third person and with some implied distance from the subject or event. Charlotte and Billy’s story was not an anecdote. They were relaying their lived – and current – experience. The professor’s statement seemed an unnecessary public dismissal. I thought at the time that overcoming this perception would be the biggest hurdle for the family.

Yet this frequent rubbishing – and it is rubbishing – of patient experience as being without value, of not being believable and of relegating it to the bottom of the ‘evidence’ pile is something that will not be new to many patients.  Not only does it put patients and their families at an immediate disadvantage in their own care, it also seems an entirely unambitious and inflexible way for health and research to look at the world: who knows what promising lines of inquiry might be raised by Billy’s experiences? Shouldn’t we be embracing it rather than decrying it?

The other interesting observation about how this whole episode has unfolded – apart from the usual accusations about bureaucracy and the shoddy state of our Home Office – is that it shows how inept the system is at responding to and managing patient expectations. Having spent decades creating a culture of expectation around medicines and treatments – cure versus care – health organisations, research institutions and regulators have thought little about what this might mean for them.  They respond in the only way they know – according to rules and regulations. Rather than operating to any discernible values or principles which might guide more effective and timely decision-making.

(As an aside I wonder whether we should be investing more money in exploring public expectations of health and research rather than the typical ‘public understanding’ agenda which has always been a loaded question in my mind)

The final point is that, were we to have such principles then ‘openness’ would surely be fundamental to how the system operated: transparency over how decisions are reached, who is responsible, what information is used to reach them? If patients are to be able to contest or challenge decisions then this sort of knowledge seems essential. Fighting the smoke and mirrors that are usually put in people’s way is exhausting if not insulting.

So the new expert committee must think about how it takes on board patient experience alongside the clinical evidence, how it will involve relevant parties and communicate its decisions. But it can only ever be a short-term fix for some fundamental issues that need addressing.

Hats off to the National Institute for Health Research (NIHR) Clinical Research Networks who published the latest data on patient experience in research this week. They have now been tracking patient views on participation for three years and with each report we gain a more informed picture of what matters to them. And with the sample now rising to nearly 5000 people, it’s become an extremely credible exercise.

The high positive ratings on overall experience (80+ %) are consistent with every survey I’ve seen in this field. But the report includes a neat synopsis of the recurrent themes in the data about what’s high on the priority list for patients including: motivation; research staff (constantly over-looked in public engagement efforts around health research); time; information; access issues. It will be interesting to see if and how these are highlighted in the PRIORITY Priority Setting Partnership looking at retention issues in trials.

What’s really clever about the report is that the authors – Mana Golsorkhi and Roger Steel – have then taken the findings and translated them into a series of recommendations for how issues might be addressed, charting these against different stages in the research pathway and then which organisations have responsibility for making it happen. In such a way they have shone a light on some of the weaker areas where further work is needed.

They also make some more pointed recommendations for each of the main issues identified above. I was taken with the proposal that each site (hospital, surgery etc). taking part in a clinical trial should carry out an ‘access audit’ which takes into account physical access, parking, time to travel etc. It’s a good idea. But i think it could be widened to a more general audit that is integral to assessing site feasibility.

Personally I would like to see all Clinical Trials Units and trial sites have Standard Operating Procedures (SOP) to cover public involvement and patient experience.

Great report. A good way to end the week.

I have written a fair bit about Academic Health Sciences Networks (AHSNs) in the past. Not always favourably I’ll admit. But that was then and this is now.

I am pleased to report that, as of May, the 15 AHSN have been re-licensed/re-designated/re-booted (select as necessary) for another five years with NHS Chief Executive, Simon Stevens, describing them as a catalyst for change in the innovation landscape.

They have also produced a rather nifty booklet entitled ‘Guide to the AHSN Network 2018: Our collective impact and future plans.’ It was launched at the NHS Confederation today and includes some great examples of innovation that AHSNs have had a role in developing. From medicines safety to cerebral palsy. I encourage you to take a look.

I was pleased to see Mike Hannay, Chair of the AHSN Network and managing director of the East Midlands AHSN, use his blog on the NHS Confederation website today to call out the important role of public involvement and engagement in this success to date. Mike Hannay describes this as one of the ‘untold stories’ and I would agree.

The role of public involvement and engagement in the AHSNs continues to be under-stated. Individually and collectively they have done some great work. This booklet ‘Exploring Patient and Public Involvement in a Digital Age’ is an exemplar.  Where there has been a lack of definition it is perhaps only natural given their stage of development. But with some careful thought they could be the cutting edge of public involvement in some key areas of weakness for our community such as innovation adoption.  The sorts of areas which would enhance the UK’s attractiveness on the global stage.

So the re-licensing gives them an opportunity to work with patients, carers and the public and think creatively and ambitiously about the future, to chart  in coherent terms the role that involvement and engagement will have. Key criteria for success will include: clarity of mission, strong leadership from top to bottom, appropriate resourcing including people, the setting of clear expectations with partners and a willingness to partner with patient organisations locally and nationally.

I understand that we will hear more about the AHSNs future programme and plans over the summer. Let’s hope the next chapter is an even better one.