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Personalised medicine, genetics and Big Data: the “New Jerusalem” for dementia?
The fact that there are real individuals at the heart of a policy strand summarised as ‘young onset dementia’ is all too easily forgotten, especially by people who prefer to construct “policy by spreadsheet”.
It is relatively uncommon for a dementia to be down to a single gene, but it can happen. And certainly, even if there might not be ‘cure’ for today or tomorrow, identification of precise genetic abnormalities might provide scope for genetic counseling. Markus (2012) argues that many monogenic forms of stroke are untreatable, and therefore, specialised genetic counseling is important before mutation testing. This could be particularly important in asymptomatic individuals, or those with mild disease; for example, potential cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) patients who have migraine but have not yet developed stroke or dementia. Mackenzie and colleagues (Mackenzie et al., 2006) published on a group of families with a clinical diagnosis of tau-negative, ubiquitin-immunoreactive neuronal inclusions (NII). The authors discussed how findings across the literature appeared to suggest that, in this particular condition, NII are a highly sensitive pathological marker for progranulin genetic mutations and their demonstration may be a way of identifying cases and families that should undergo genetic screening.
But is this genomics revolution the beginning of a “New Jerusalem” in dementia, beyond the headlines?
“Big data” refers to information that is too large, varied, or high-speed for traditional methods of storage, processing, and analytics. For example, one application of mining large datasets that has been particularly productive in the research community is the search for genome-wide associations (“Genome-Wide Association Studies (“GWAS”)). GWAS rely on analysis of DNA segments across vast patient populations to search for DNA variants associated with a particular disease. To date, GWAS analyses have identified a handful of promising genetic associations with Alzheimer’s disease, including Apo E4.
This is clearly wonderful if “money does grow on trees”, but the concern for initiatives such as these such work is resource-intensive, and diverts resources from frontline improvements in wellbeing of people living with dementia. Investors also have to be mindful of their financial return compared to the risk of such initiatives. One of the biggest complaints of proponents of “Big Data” is that data tend to be pocketed in a fragmented, piecemeal fashion.
As the McKinsey Centre for Business Technology (2012) state in an interesting document called, “Perspectives on digital business”:
“The US health care sector is dotted by many small companies and individual physicians’ practices. Large hospital chains, national insurers, and drug manufactuers, by contrast, stand to gain substantially through the pooling and more effective analysis of data.”
Vast collections of genomic data obviously represent a goldmine for health providers around the world. Meltzer (2013) reviews correctly that personalized medicine been the subject of increased basic and clinical research interest and funding. Meltzer describes that a knowledge of the genetic and molecular basis of clinical heterogeneity should make it possible to more reliably predict the likely outcomes of alternative approaches to treatment for specific individuals and therefore what course of action is likely to be best for any given patient. Knowledge of personal genetic traits might allow accurate prediction of those invididuals who are most likely to experience adverse events through medication (Markus, 2012).
Both ‘Big Data’ and ‘personalised medicine’, in being couched language of bringing value to operational processes in corporate strategy, tend to lose the precise cost-effectiveness arguments at an accounting level. The new CEO of NHS England, Simon Stevens, will have raised eyebrows with the Guardian piece entitled, “New NHS boss: service must become world leader in personalised medicine” from 4 June 2014 in “The Guardian” newspaper (Campbell, 2014) . Whether the National Health Service of the UK can cope with this, with inevitable transfer of funds from the public funds to private funds, with all the talk of ‘sustainability’, is a different matter. It is difficult to predict what the uptake of personalised medicines will be, even if every patient has access to his or her personal genomic sequence in years to come. All jurisdictions have to consider whether they can justify the sharing of information for public interest overcoming concerns about data privacy and security, and ultimately this is a question of legal proportionality.
The pitch from corporate investors tend to minimise biological practicalities too. For example, it is still yet to be determined what the precise interplay between genetic and environmental factors are, particularly for the young onset dementias. And the assumption that all ‘big’ data are ‘good’ data could be a fallacy. There are 1000 billion neurones in the human brain, and it is well known that not all neuronal connections between them are ‘productive’; in fact a sizeable number are redundant. Heterogeneity in genetic sequences might be meaningful, or utterly spurious, and it could be a costly experiment to wait to find out how, when there are more pressing considerations about both care and cure.
But is this genomics revolution the beginning of a “New Jerusalem” in dementia, beyond the headlines?
Frontotemporal lobar degeneration (FTLD) is the second most common cause of dementia in individuals younger than 65 years (Ratnavilli et al., 2002). It is a progressive neurodegenerative disorder characteristically defined by behavioural changes, executive dysfunction and language deficits. The behavioural variant of FTLD is characterised in its earliest stages by a progressive, insidious change in behaviour and personality, considered to reflect underlying problems in the ventromedial prefrontal cortex (Rahman et al., 1999). FTLD has a strong genetic background, as supported by positive family history in up to 40% of cases, higher than what reported in other neurodegenerative disorders and by the identification of causative genes related to the disease (Seelaar et al., 2011). The notion that genetic background might affect disease outcomes and rate of survival, modulating the onset and the progression of the pathological process when disease is overt (Premi et al., 2012). Given the consolidated role of genetic loading in FTLD, the likely effect of environment has almost been neglected.
Only recently, it has been reported that modifiable factors, i.e. education and occupation, might act as proxies for reserve capacity in FTLD. Patients with a high level of education and occupation can recruit an alternative neural network to cope better with cognitive functions (e.g. Borroni et al., 2009; Spreng et al., 2011). But the search for treatments for particular types of dementia based on their underlying genes and genetic products is arguably not an unreasonable one. A good example is provided by the Horizon Scanning Centre of the National Institute for Health Research of NHS England in September 2013 (NIHR HSC ID: 8239): leuco-methylthioninium, which is a “tau protein aggregation inhibitor”. It acts by preventing the formation and spread of neurofibrillary tangles, which consist of aberrant tau protein clusters that aggregate within neurons causing toxicity and neuronal cell death in the brain of patients with certain forms of dementia. Leuco-methylthioninium is a stabilised, reduced form of charged methylthioninium chloride. The clinical trials for this are under way. The medication at the time of writing may or may not work safely.
No. This genomics revolution the beginning of a “New Jerusalem” in dementia, especially when social care is on its knees.
References
Borroni B, Premi E, Agosti C, Alberici A, Garibotto V, Bellelli G, Paghera B, Lucchini S, Giubbini R, Perani D, Padovani A. (2009) Revisiting brain reserve hypothesis in frontotemporal dementia: evidence from a brain perfusion study. Dement Geriatr Cogn Disord, 28, pp. 130–135
Campbell, D. (2014) New NHS boss: service must become world leader in personalised medicine, The Guardian, 4 June. http://www.theguardian.com/society/2014/jun/04/nhs-boss-world-leader-personalised-medicine.
Mackenzie, I.R., Baker, M., Pickering-Brown, S., Hsiung, G.Y., Lindholm, C., Dwosh, E., Gass, J., Cannon, A., Rademakers, R., Hutton, M., Feldman, H.H. (2006) The neuropathology of frontotemporal lobar degeneration caused by mutations in the progranulin gene, Brain, 129(Pt 11), pp. 3081-90.
Mendez, M. (2006) The accurate diagnosis of early-onset dementia. Int J Psychiatry Med, 36(4), pp. 401– 12.
McKinsey Centre for Business Technology (2012) Perspectives on digital business.
Rahman, S., Sahakian, B.J., Hodges, J.R., Rogers, R.D., Robbins, T.W. (1999) Specific cognitive deficits in mild frontal variant frontotemporal dementia, 122 (Pt 8), pp. 1469-93.
Ratnavalli E, Brayne C, Dawson K, Hodges JR. (2002) The prevalence of frontotemporal dementia. Neurology, 58(11), pp. 1615-1621.
Spreng, R.N., Drzezga, A., Diehl-Schmid, J., Kurz, A., Levine, B., Perneczky, R. (2011) Relationship between occupation attributes and brain metabolism in frontotemporal dementia, Neuropsychologia, 49, pp. 3699–3703.
Dr Neil Bhatia’s #CareData flow chart
This is Dr Neil Bhatia on Twitter here, @docneilb.
Feel free to contact him over opting out from #CareData.
Here Phil Booth (@MedConfidential) campaigner battling against erosion of valid consent, so essential plank for the medical profession, and Tim Kelsey (@TKelsey1), a guru in big data for the NHS, battle it out.
Flow chart
In “Big Dementia”, who cares about dementia carers?
Without the work of unpaid carers, the formal care system would be likely to collapse. Some feel that the State gets a “very good deal” out of this current system. The ongoing support from unpaid carers will be a particular issue for the care system in the future, as changing demographic patterns, shifts in family composition, labour force participation and increased geographical mobility will affect the availability of the unpaid care workforce. There are also significant issues emerging in care work.
It can be argued that some carers in dementia, whether unpaid carers or paid care workers, are perceived rather unfairly by society, and this is a matter of real national concern. The issue of researching personalised medicines, and pooling clinical drug trial data, across a number of different jurisdictions, is a curiously international phenomena. It feeds into the ‘big is better’ narrative, which is of course a key aspect of why large multinational companies like ‘Big Data’. But converting our response to dementia to a solution for Big Pharma is not solely the answer. The answer is not simply ‘Big Dementia’, much as that might be attractive for the corporates. It is just as crucial to consider who cares about dementia carers. The two are not necessarily mutually exclusive of course. In an ideal world, we should like to offer the best care for people with dementia, as well as effective symptomatic treatment as well as a cure. However, it’d be a disaster if we could hold our hands up, and say that we could in all reality offer neither. As the international economies recover after the global financial crash, caused by the effects of poor global regulation of securitised mortgage products, it might seem fitting that the international landscape can be tweaked to make dementia profitable for Big Pharma. However, it is clear that our own national parliament, in the recent ‘dementia care and services’ debate on 7 January 2014, wishes to have a frank and sincere debate about who cares for the carers. As a society, this is dependent on economics within our control. If people need to talk about about the ‘cost’ of dementia relentlessly, there might be an equal and opposite need to talk about the value of carers; and this needs to be a national debate.
The usual tired mantra from politicians would of course be trotted out, particularly from those of a certain political inclination, that as the economy improves our living standards will improve. But it has been a concern of all main political parties that living standards for the many are not expected to rise as the economy recovers. In this jurisdiction, there’s a particular phenomenon of how the very wealthy seem to have been relatively immune from the global financial crash. This ‘cost of living crisis’ has been partly attributed to big corporates colluding legally to maintain prices to promote shareholder dividend rather than customer value. In England, the Health and Social Care Act (2012) was legislated by the current government to promote a quasi-market in the NHS in England. The aim was to introduce competition, bolster an economic market regulator, and to produce a mechanism for fast managed decline of ‘failing’ NHS Foundation Trusts. Clinical commissioning groups (CCGs) and health and wellbeing boards were also introduced new parts of the NHS in England. CCGs plan and buy local health services, while health and wellbeing boards influence the local decisions that shape health, public health and social care. In this new political and socio-economic landscape, it has been particularly striking, but encouraging, that the shared vision of the “Dementia Action Alliance” is of an England and Wales where the health and wellbeing of carer of a person with dementia are of equal priority to those of the person for whom they care. Ideally, for competition to thrive, it should not be in the hands of a few corporates and corporate-like charities, but all stakeholders should be given a fair slice of the action.
The wellbeing of carers of dementia in England is related to both its national economy and law, and this is something which is not within the powers of the G8 arena. In keeping with previous Conservative governments, George Osborne has warned that “self-defeating” increases to the minimum wage could “cost jobs”, and John Major, the Prime Minister 1990-7 had argued strongly the dangers of the national minimum wage. Many of the same arguments are likely to resurface as the UK Labour Party will undoubtedly raise the importance of the “living wage”, prior to the general election to be held on May 7th 2015. Cabinet ministers including Business Secretary Vince Cable and Work and Pensions Secretary Iain Duncan Smith are reportedly pressing, currently, for an “above-inflation rise” of 50p or more. Mr Osborne said he too wanted to see the £6.31 hourly minimum wage rise, but he said it should be left to the Low Pay Commission to set the appropriate level.
As Norman Lamb said in the parliamentary debate the other day, “We ask carers to do some of the most difficult work that one can ever imagine but the rewards and the training and support they get is minimal.”
An emerging political consensus has promisingly emerged that “we can never get good care on the back of exploiting very low-paid workers”, as Lamb put it. It turns out that carers are currently paid the national minimum wage if they are lucky. That is, of course, a breach of the minimum wage legislation. According to an authoritative study Dr Shereen Hussein, of King’s College London, estimates that there are between 150,000 and 220,000 care workers in this position. And this is using conservative assumptions – the real number could be higher. The flouting of national minimum wage has, however, become alarmingly widespread. There are a variety of employment practices that result in the minimum wage being circumvented, the most common of which is when councils sign contracts with private providers who recruit staff to provide short slivers of care in the home. A quarter of an hour can be all that a care worker gets to wash, change, feed and talk to someone with dementia. Dignity for the client is often the first casualty: a variety of groups representing the vulnerable, as well as some of the more scrupulous employers, fear that rushed care contracted by the minute often means inadequate care. Previous findings suggest almost half of councils still set 15 minutes as their minimum time slot.
Furthermore, many paid care workers are on zero-hours contracts. Unison’s ethical care charter aims to put an end to poor pay and working conditions in home care services. Under the charter, for example, Islington council has agreed to implement the charter’s main principles of getting rid of zero hour contracts, ensuring travel time is counted in employees’ paid hours and implementing the London living wage, as well as setting up occupational sickness schemes. Islington, alongside Southwark council, has been an early adopter of the recommendations put forward by Unison in the their report into home care. Published in 2012, the report found that good carers were being lost to “easier jobs that pay more, like in supermarkets” after finding themselves unable to support their family on an inadequate and unreliable salary.
Many paid care workers also do not get paid for travelling between the appointments they undertake, but clearly care workers must be paid when they are travelling from one home to another. Furthermore it is common for remuneration systems to pay only pay per minute actually spent with clients, not the travel time between them. Dozens of these work-related journeys could be made each week as it’s a core part of the job. Not being paid for this time means those who care don’t get paid for a full day’s work.
It is also important for councils commissioning care work to be absolutely clear with those they contract with that they expect total compliance with the law. If a council is commissioning in a way which almost becomes complicit in a breach of the law, that is completely unacceptable. On the other hand, NHS Wiltshire has commissioned an “outcomes based continuing healthcare service” designed to improve quality, reduce cost and link up with social care – but which completely restricts patient choice. The “Help to Live at Home” service has been commissioned jointly with Wiltshire Council. Contracts for the £23m service. The provider a patient receives will depend on where in the county they live. All health and social care services will be delivered by that provider and payment will depend on achieving a set of agreed outcomes.
There is a big difference between “care workers” and “unpaid carers”. A phenomenon worth keeping an eye on is that of “family caregiving” which has been on an upward trend in various jurisdictions, in part due to the economic recession. Some families lack the financial capabilities to pay professional caregivers. In fact, a huge group of carers comprise the “unsalaried family caregivers”. Family caregivers of people with dementia, often called the “invisible second patients”, are critical for people living with dementia. The effects of being a family caregiver, can be both positive and negative, with high rates of burden and psychological morbidity as well as social isolation, physical ill-health, and financial hardship. Indeed, it is mooted that comprehensive care of a person with dementia can include building a partnership between all health professionals and family caregivers. Many family caregivers of people with dementia might also employed, of whom many have reported that they missed work; a proportion may have even that turned down promotion opportunities or given up work to attend to caregiving responsibilities. There is furthermore no doubt that the benefit system is confusing, and it had been hoped that universal credit would be a method of simplying that. If you care for someone with dementia, you are normally advised to check that you are both getting all the benefits and tax credits you are entitled to. For example, you may be able to claim Personal Independence Payment or Attendance Allowance for the person with dementia, and Carer’s Allowance for the carer. You, or the person you look after, may be entitled to a discount on your council tax. Again, the situation can be complicated, and many people get simply put off from applying for the benefits for which they could be entitled due to sheer complexity and/or lack of guidance.
So, how will we eventually know when carers are being looked after? We will hear that carers of people with dementia are confident that their own health and wellbeing needs and requirements are recognised and supported, so that no carer feels alone, and are given regular breaks. This is in keeping with how local and national guidance for working time should be implemented anyway. Carers of people with dementia are also recognised as essential partners in care, assuming an approach which could be best called “coproduction”. Furthermore, carers of people with dementia would also have access to expertise in dementia care for information, advice, support and co-ordination of care. The “Dementia Action Alliance” has been the coming together of over 800 organisations to deliver the National Dementia Declaration; a common set of seven outcomes informed by people with dementia and their family carers. The Declaration provides an ambitious and achievable vision of how people with dementia and their families can be supported by society to live well with the condition
It would be incredibly valuable to have carers have a voice on CCGs and health and wellbeing boards, especially since commissioners are supposed to be promoting wellbeing pursuant to the Care Bill currently being discussed in the House of Commons and the House of Lords. The demands of caring for someone with dementia are great and many carers say they feel totally unsupported. How to include unpaid care workers in this commissioning debate is undoubtedly a difficult issue, but one which simply cannot be ultimately parked for convenience.
“Big Dementia” may not provide all of the answer, unless care is combined with cure.
Does it matter the public was completely misled about the real motives of the G8 dementia summit?
You can argue that the general public were not in fact misled over anything.
The Department of Health had a live stream for the entire day, and the communique and declaration were made available at the end of the day.
It can be argued that the scale of the issue of prevalence of cases of dementia is significant. The media, however, did such a fantastic job in using words such as ‘time bomb’ in scaring the public across all media outlets that Prof Alistair Burns was put in a difficult position as to why dementia policy had appeared to ‘fail’. Burns explained with immaculate civility that the prevalence of dementia had appeared to be falling in recent years to a quiet adversarial but polite Emily Maitlis.
The spectacle of the G8 dementia was though a deception of the highest order. The emotions you were undoubtedly supposed to feel were that it was your fault that you hadn’t realised that dementia was a significant public policy issue.
One lie led to another unfortunately. There are at least two hundred different types of dementia. Some are completely reversible. Some are easier to treat than others. Therefore it was completely meaningless to talk of a single cure for dementia by 2025. Some senior medic should have stopped these health ministers including Jeremy Hunt making a fool of themselves.
They did not even aspire to promote good care primarily; they did not pledge monies in this direction; they gave a firm commitment to disseminate examples of good care.
There is no doubt that much more can be done in basic research to do with how Alzheimer’s disease comes about, and to examine why after fifteen years there is no consistent narrative about their lack of the slowing of disease progression.
What is though to me still unfathomable is why it has not been reported what this ‘open data’ agenda is about. It is about the sharing of clinical “big data”, including DNA genomics, across jurisdictions for the development of personalised medicine.
Innovations for wellbeing might be profitable, but nothing compared to this new project of Big Pharma. And there isn’t a single thing about it in the media. How did the G8 choreograph with such synchrony such a united response all of a sudden? It’s because it’s known that big data and personalised medicine are “the next big thing” in profitability for Big Data. And crucially the other approaches have failed.
You cannot help but feel physically sick at the outcome of this unique opportunity. It’s not accidental there was hardly a discussion of the caring shortfalls in any jurisdiction. The worst thing about this deception is that the public don’t even know that they have been deceived. As long as they donate money voluntarily for ‘research’ and/or participate in ‘dementia friends’, and so long charities can deliver in return some people contributing to the ‘big data’ sample, everyone’s a winner.
The sheer terror helps.
Everyone’s a winner.
Except the person with dementia.
The G8: when dementia care got personal (well, molecular actually)
At best, the donation of patients’ DNA for free globally in #G8dementia to enhance Pharma shareholder dividend can be sold as ‘coproduction’. It’s easy to underestimate, though, the significance of the G8 summit. It was overwhelming about the ‘magic bullet’, not the complexities of care. It made great promotional copy though for some.
It was not as such health ministers from the world’s most powerful countries coming together to talk about dementia. It was a targeted strike designed to decrease the democratic deficit which could arise between Big Pharma and the public.
Here it’s important to remember what #G8dementia was not about. It was not about what is a safe level of health and social dementia care is around the world. It had a specific aim of introducing the need for a global collaboration in big data and personalised medicine. Researchers whose funding depends on the wealth of Big Pharma also were needed to sing from the same hymn sheet.
For such a cultural change to take effect into this line of thinking, a high profile publicity stunt was needed. Certain politicians and certain charities were clearly big winners. However, with this, it was deemed necessary from somewhere to introduce an element of ‘crisis’ and ‘panic’, hence the terrifying headlines which served only to introduce a further layer of stigma into the dementia debate.
And yet it is crucial to remember what was actually discussed in #G8dementia.
In a way, the big data and personalised medicine agenda represents the molecular version of ‘person-centred care’, and these are academic and practitioners “circles to be squared”, or whatever.
Big data and personalised medicine have been corporate buzz terms for quite some time, but while it’s widely known there are correlations between the two, many are still struggling with how to effectively leverage mass amounts of data in order to improve efficiencies, reduce costs, and advance patient-centric treatments.
Medicine’s new mantra is “the right drug for the right patient at the right time.” In other words, medical treatments are gradually shifting from a “one size fits all” approach to a more personalized one, so that patients can be matched to the best therapy based on their genetic makeup and other predictive factors. This enables doctors to avoid prescribing a medication that is unlikely to be effective or that might cause serious side effects in certain patients.
Personalised drug therapy in its most sophisticated form uses biological indicators, or “biomarkers” – such as variants of DNA sequences, the levels of certain enzymes, or the presence or absence of drug receptors – as an indicator of how patients should be treated and to estimate the likelihood that the intervention will be effective or elicit dangerous side effects. In the case of Alzheimer’s disease, the hunt for a marker in the ‘brain fluid’ (cerebrospinal fluid) has been quite unimpressive. The hunt for those subtle changes in volumes or abnormal protein levels has not been that great. The information about DNA sequences in Alzheimer’s Disease (more correctly a syndrome) is confusing, to say the least. And there at least 100 different types of dementia apart from Alzheimer’s Disease (making the quest for a single cure for dementia even more banal, but a great soundbite for politicians who won’t be in office long anyway.)
With healthcare costs in the U.S. increasing steadily over the last 20 years to 17% of GDP, and similar scaremongering about ‘sustainability’ from economically illiterate people on this side of the Atlantic too, overall moronic healthcare “experts” are looking for every path possible for “efficiency”, “productivity” and “reform”. Many believe that a long-term source of savings could be the use of big data in healthcare; in fact, the McKinsey Global Institute estimates that applying big data strategies to better inform decision making in U.S. healthcare could generate up to $100 billion in value annually.
Significant advancements in personalised medicine, which includes genomics, is making it easier for practitioners to tailor medical treatments and preventive strategies to the characteristics of each patient — advancements that supporters say will improve care and reduce costs. Private markets have long capitalised on fear, and dementia represents a nirvana for private healthcare. It is potentially a huge ‘market’ for drugs. Yet progress is being slowed by a number of factors, including the limited sharing of patient information. This is why there was so much shouting about the need for relaxed regulation at #G8dementia. And yet ultimately, these stakeholders, important though they are, know they can go nowhere without the license from the public. Patient groups and charities represent ‘farms’ for such projects in medicine, as they do for law firms.
Greater sharing, it is argued, would allow medical institutions that are creating patient databases — some with genomic information — to expand the size of the patient pool, thus making it more likely to identify and treat rare conditions. Such discussions necessarily avoid the contentious issue of who actually owns personal DNA information. What’s more important? That patient’s privacy, or the public interest? Data sharing, it is argued, would also allow patients to personally store and share their data with different practitioners. The day that everyone will have every detail about their personal health on their smartphones isn’t that far off, some hope.
The other component of the data-accessibility issue is how medical researchers should go about building massive databases of patient records. The ultimate application is a big-data program that could analyse a patient’s data against similar patients and generate a course of action for the physician. This is why the #G8dementia want to get seriously ‘global’ about this project.
Data can help practitioners diagnose patients more accurately and quickly, and identify risk factors much earlier.
Edward Abrahams, president of the Personalized Medicine Coalition, has said,
“The tricky part is that the public wants control over information, but as patients they may think differently”.
The creation of this value lies in collecting, combining, and analysing clinical data, claims data, and pharmaceutical R&D data to be able to assess and predict the most efficacious treatment for an individual patient. This might be possible through ‘big data’ and ‘personalised medicine’ in a number of key areas.
Clinical trials are of course necessary for every drug to get to market, and the gold standard is currently a randomised clinical trial backed up by a published paper. Big data approaches are complementary to traditional clinical trials because they provide the ability to analyse population variability and to conduct analytics in real time. I
Secondly, the ability to manage, integrate, and link data across R&D stages in pharma might enable comprehensive data search and mining that identify better leads, related applications, and potential safety issues. The sequence alone is much more useful as it is correlated with phenotypes and other types of data. This has naturally affected the way companies think about data storage and structure, with cloud solutions becoming more popular. The two leaders in next-gen sequencing technologies, Illumina now offers cloud solutions for data storage and analysis to meet this growing need. Hence it was ‘name checked’ in #G8dementia.
Thirdly once R&D data and clinical trial data is indexed for big data analysis, the third piece of the big data puzzle into routine clinical practice. Ultimately personalised medicine is about this correlation of diagnostics and outcomes, but tailored to each and every patient.
While big data has already been used successfully in consumer markets, challenges remain to its implementation in healthcare. The primary challenge in moving to big data approaches is simply the vast amount of data in existing systems that currently don’t “talk” to one another and have data that exists in different file types. Hence there is considerable talk about ‘harmonisation’ of data at the #G8dementia conference. The second challenge for data in the clinical space is how to store and share these large amounts of data while maintaining standards for patient privacy. Achieving better outcomes at lower costs (aka ‘doing more for less’) has become the exhausted strapline for the NHS recently, and big data may seem particular attractive to NHS England in their thirst for ‘efficiency savings’.
However, bridging the “democratic deficit” remains THE fundamental problem. If you though the #G8dementia was like an international corporate trade fair, you may not have been invited to other similar events.
The 16th European Health Forum brought together 550 delegates from 45 countries, to take the pulse of Europe’s healthcare systems five years after the 2008 financial crisis and consider what needs to be done now to build, ‘Resilient and Innovative Health Systems for Europe. The Big Data workshop was organised by EAPM and sponsored by EFPIA, Pfizer, IBM, Vital Transformation, and the Lithuanian Health Forum.
There, key issues to do with ownership, security and trust must be addressed, believed Amelia Andersdotter, MEP: “We have some serious challenges for politicians and industry to preserve citizens’ confidence.”
Vivienne Parry in #G8dementia had wanted to talk about ‘safe’ data not ‘open’ data. And where did this idea come from?
Ernst Hafen, Institute of Molecular Systems Biology, ETH Zurich, has said, “We all have the same amount of health data.” Applying big data to personalised medicine, “Only works if we are comfortable with [our data] being used. We have to provide a safe and secure place to store it, like a bank,” also accoding Hafen. Tim Kelsey used exactly the same language of banks at a recent event on innovations in London Olympia.
If you think you’ve had enough of PFI, you ain’t seen nothing yet. Public-private partnerships open the way for health data to be shared, and so improve research and translation, according Barbara Kerstiens, Head of Public Sector Health, DG Research, European Commission. The aim was, “To get stakeholders working together on data-sharing and access, and ensure there is a participant-centred approach,” she said.
And how will the law react? Case law is an important means by which we know what is patentable at the European Patent Office (EPO). However, sometimes the EPO’s view of what is patentable in an area changes before the case law does. This can sometimes be detected when Examiners start raising objections they would not have previously done. Meetings between the EPO and the epi (the professional institute for EPO attorneys) are very useful forums for obtaining ‘inside information’ about the EPO’s thinking which is not yet apparent from the case law. The June 2012 issue of epi Information provides a report of such a meeting held on 10 November 2011 between the EPO and the biotech committee of the epi.
Discussion item 8 was reported as follows:
‘8. Inventions in the area of pharmacogenomics
This concerns cases which are based on a genetic marker to treat a disease, for example methylation profiles. It can involve a new patient group defined by an SNP. The EPO said that often the claims can lack novelty, as one patient will have inevitably been treated with the SNP, even if the art does not explicitly say so.’
The EPO’s comments seem to indicate that it is about to change the way it assesses novelty when looking at medical use claims that refer to treatment of a specific patient group.
A “SNP” is a form of genetic marker which varies between individuals. The idea behind the relatively new field of pharmacogenomics is that, if you know which SNP variants a patient possesses, you can personalise the drugs given to a patient in accordance with his genetic makeup. It is now recognised that the genetic makeup of an individual can be very influential as to whether he responds to a drug, and so one application of pharmacogenomics is to only give those drugs to patients who will respond to them.
Presently, suitable biomarkers for personalised medicine are proving difficult to find. So it seems that the sector is going to require a lot of investment. There’s where #G8dementia came in handy. But in investors in biotech do like to see that strong patent protection is available in the relevant sector; hence the upbeat rosy approach from the speaker from JP Morgan at #G8dementia who framed the debate in terms of risks and returns.
Personalised medicines, and in fact diagnostics in general, has been thrown into uncertainty in the US after the Supreme Court’s decision in Mayo v Prometheus which found that a claim referring to steps that determined the level of a drug in a patient was directed to a law of nature and was thus not patentable. It would be unfortunate for personalised medicines to be dealt a further blow by the EPO, making the test for novelty stricter in this area.
So there may be trouble ahead.
The #G8dementia was merely the big players, with the help of this Pharma-friendly community in the UK, dipping their toe in the water. It was really nothing to do with frontline health and social care, and any mention of them was really to make the business case look relevant to society at large.
It was for academics interesting in that it was when person-centred care came ‘up front and personal’. Molecular, really.
Related articles
- The #G8Dementia Summit: a lack of cure for dementia, and tough on the causes of the lack of cure (livingwelldementia.org)
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Time to rate how Doctors are treated in the NHS?
Sir Gus O’Donnell said famously, “If you treasure it, measure it”. This is happening in the medical profession too, with a policy drive that the best people to rate the NHS are the users of the service. These are the patients (or “customers” if you’re that way inclined). The ‘Friends and Family Test’ has come under fierce criticism, not surprising given that it has never been subject to proper analytical rigour, and the criticisms of it have been well rehearsed elsewhere. There is a fundamental difference in assessing your hospital stay, compared to “Trip Advisor”, but it is all part of the information revolution. Information, according to people interested in innovation like me, is not the same as knowledge, and not all information is useful. Whilst the corporates, who introduced their love for Big Data to the rest of the world are fully aware there is a lot of redundant, useless data, and the importance of certain datasets need to be explained carefully, this has completely passed the NHS by. The introduction of the vascular surgery rates was held by some to be a shambles, due to the poor explanation of these data as well as data inaccuracy. Forgetting the fact that certain fields in vascular surgery (e.g. abdominal artery aneurysm repairs for aneurysms diameter > 6.5 cm are considered riskier than sclerosing varicose veins, for example), or that safety is a team activity (though the root cause of a problem can be identified to a single reason), the data explosion is envisaged as empowering patients and persons with ‘choice’.
Enter the market. Jeremy Hunt continues to dodge completely the question why private sector entities under freedom of information legislation introduced by a Labour government are not under obligation to disclose data because of their ‘commercial interest’. As they are not public bodies, they are not amenable to judicial review either. Moving swiftly on, choice is supposed to empower the patient with information. How is that possible, that a patient will be equally fluent as a Doctor of about 7 years’ standing who has achieved registration with the General Medical Council? Very good question. Is it the case that vascular surgeons have a need to improve their mortality data because they are now operating (quite literally) in a free (pseudo)market? No, categorically not. The Royal Colleges of Surgeons and the General Medical Council are responsible for general professional training and higher specialist training standards in surgery. Doctors are increasingly seen as employees in a business case, with Trusts salami-slicing how much they want to spend on staff to achieve their efficiency savings as mandated by Sir David Nicholson and the Department of Health. They are that respect no more essential than an import of horsemeat for lasagna to improve the profitability of a venture capital investment. Registered Doctors are professionals though, and legal.
It has been noted that trust in GPs has plummeted from 70% to 30% since the implementation of the Health and Social Care Act (2012)? I, for one, would quite like to rate how management consultants conducted this important strategic implementation. This £3bn reorganisation had a critical piece of legislation, the “section 75 regulations”, which produced competitive tendering as the default option. The first set of Regulations were so bad they had to be withdrawn. The Medical Royal Colleges, the BMA and RCN all say the Act won’t work. The first rule of strategic implementation is that you involve all the stakeholders and engage in a realistic conversation about what is intended to be achieved, how, why, or when. None of this happened. That is why I award the Department of Health, despite what can be best described as “shuttle diplomacy” by Earl Howe, a big fat result thus:
And why has trust in GPs plummeted? Is it anything to do with the fact the media and politicians have been force-feeding the public with stories that GPs opted out of out-of-hours some time ago, and they got a deal which was quite lucrative? Or is it because there are now anecdotal reports of GPs having to advise non-NHS care to their patients in the hope that they can jump a lengthy NHS queue? It is very hard to tell. But certainly it is true that GPs have become first in the firing line for the NHS reforms. They in fact opposed the reforms, with clear leadership by Prof Clare Gerada, Chair of the Royal College of General Practitioners. The Government PR went into overdrive that “GPs are at the heart of commissioning”, the ‘clinical commissioning groups’, but this was obviously never the intention. CCGs are merely a vehicle for holding funds and assessing risk in a pooled population, in a manner of ‘statutory insurance schemes’. This has always been the case, and always will be. For all the talk of ‘entrepreneurial GPs’, the public do not appear to warm to the idea of GPs as businessmen (and GPs do not particularly wish to represented as businessmen). Germane to this is the “dual agent” problem, very well known in insurance markets. That is the idea that no person can have “two masters”, without a significant conflict of interest: this might be for example a GP’s professional duty to his or her patient, and his or her duty to the people who ultimately provide the funding. This issue of trust is possibly bound to get worse, as ‘scandals’ are drip fed to the media of a system in distress. The reason this score is nothing to do with Prof Gerada is because Prof Gerada, as the new “NHS SOS” book explains (edited by Dr Jacky Davis and Prof Ray Tallis), was one of the few NHS leaders to have a clear vision and have the charisma to set this out in confidence, a textbook example of a “charismatic leader”, who deservedly was one of the hundred most influential individuals in health. And, very clearly, she appeared to be representing patients as well as GPs.
Anyone who wishes to defend the NHS is accused of protecting a ‘national religion’. And yet the NHS is accused of being ‘monolithic’, ‘inefficient’, ‘dangerous’, ‘expensive’, and every negative adjective under the sun. Politicians are responsible for this deprofessionalisation of key non-managerial workers in the NHS, with talk of ‘it doesn’t matter who provides my care as long as it is the…’ (a saying which in the legal and medical sectors has increasingly been completed with the word “cheapest”). Every conceivable thing is blamed for the pressures under which the NHS functions; such as the “burden of the ageing population” and the equally pathetic and untrue myth that high-quality healthcare is dependent on expensive equipment. Tell that to the cardiologist who can discern an early diastolic murmur with a pulmonary hypertensive ‘heave’ due to a crappy £20 stethoscope, not a £5000 portable digital echocardiogram machine. The number of lies in the drive to make the NHS attractive financially to outsourcers and privatisers has been breath-taking. In view of this, isn’t it time perhaps we either rate how Doctors are actually treated in the NHS, or time to turn the tables and rate our NHS management and politicians?
