Why it is legal and medical illiteracy to sue your GP over a dementia diagnosis

A recent article in Pulse magazine, entitled “GPs should be sued for ‘late’ dementia diagnoses, says professor”, claimed, “A leading academic has called for patients to sue GPs for failing to diagnose dementia, arguing that ‘the sooner someone sues a GP… the better’. Professor June Andrews, director of the Dementia Services Development Centre at the University of Stirling, made the comments in the Letters section of the London Review of Books, in which she said the ‘sooner someone sues a GP for failure to diagnose as early as possible, the better’.”

The full letter reads as follows:


If a doctor behaves in such a way so as to undermine clearly the medical profession, he could be suspended or struck off at worst by the General Medical Council on the grounds of not “working collaboratively with colleagues” under the code of conduct, “Good medical practice” (domain 3).

The particular subsection is rule 35, “You must work collaboratively with colleagues, respecting their skills and contributions.” June Andrews’ suggestion is offensive as it pits people against professionals in primary care, who are doing their best to practise medicine given the resources available to them.

I strongly commend to you the reply by Dr Margaret McCartney. There are about a hundred different types of dementia, not all presenting with memory problems (though Alzheimer’s disease, typified by problems in short-term learning and memory, in the beginning, is the most common type of dementia globally). Therefore, somebody may present with symptoms which are not easily recognised as a dementia. In the younger age group, the behavioural changes in frontotemporal dementia may be misdiagnosed, with no malintent, as depression or anxiety simply.

The issue that McCartney raises is a very important one. And yet it is reported that Andrews has had difficulty in discussing issues with professional colleagues in a sensible manner. Prof Sube Banerjee emphasised in a recent meeting of the King’s Fund, “Leading change in dementia diagnosis and support”, that dementia diagnoses in primary care had to be of correct quality, and professionals in primary care needed support in making these diagnoses. Banerjee further emphasised the considerable damage which might be done in given an incorrect diagnosis of dementia, to someone who did not have dementia. This has always been a risk with incentivising financially making the diagnosis of dementia as others have correctly pointed out, such as Dr Martin Brunet.

It might be that the symptoms do not progress and do not warrant a diagnosis of dementia in severity. The majority of such people with the diagnosis of “minimal cognitive impairment” do not progress to a full blown dementia, and such patients need to be monitored carefully with time.

Recent evidence on this is noteworthy (source above):

“The most compelling papers that concluded most MCI patients will never develop dementia include what are called “meta-analyses”, that is, they combined and reanalyzed the results from a number of different studies that the researchers considered to meet criteria for being well-designed and -executed.

For example, Mitchell and Shiri-Feshki (2009) analyzed 41 high-quality studies, some done on community populations and some in clinical trials.  They concluded that the annual conversion rate from MCI to a dementia is ~5-10%; and that even after 10 years, more than 60% of MCI patients will not progress to Alzheimer’s or any other dementia.  In fact, a substantial percentage actually revert to normal.  Other meta-analyses of long-term (5-10 years) studies reported even lower annual conversion rates, of 3.3 – 4.2%, and cumulative conversion rates of ~31% over 10 years.”

I have previously blogged myself on how the Wilson and Jungner WHO screening criteria may include case-finding, but the National Screening Committee, as McCartney points out, has consistently advised against screening in dementia for a number of years now (and last upheld in January 2015). The actual issues concerning when patients of the NHS decide to seek help over symptoms of dementia are complicated, and have often been investigated methodically. Such issues indicate the national ‘diagnosis gap’ for dementia is not simply due to General Practitioners ‘under-performing’.

All this raises the question of what the legal claim Andrews has in mind. As such, there is no direct contract between patient and doctor in primary care, for which the contractual term is that the doctor must make an accurate diagnosis of dementia immediately; such a claim would therefore be ‘breach of contract’. The claim, in the alternative, could be in the law of tort for breach of duty of care; this is ‘clinical negligence’. Such claims would have to satisfy the “Bolam” and “Bolitho” tests. They mostly would not, one might reasonably anticipate. In an unlikely case that a claim might be upheld, the civil procedure rules for litigation state clearly that the claimant must pursue other dispute resolution means first. This is according to the “pre action protocols” clearly stated under English law.

And how is the patient meant to fund such a claim? It has been widely reported that there has been no legal aid for medical negligence claims since April 2013. This is pursuant to the Government’s legislation the “Legal aid and sentencing and punishment of offenders Act“. In summary, Prof Andrews’ remark is neither held out by the standards of the legal or medical professions, and arguably should not have been made in a position of power.

All political ideologies, ranging from Edmund Burke or E.P. Thompson, do not condone abuse of power. Burke famously said, “The greater the power, the more dangerous the abuse.” It would thus be helpful if Andrews could withdraw her offensive remark, assuming the LRB have printed her letter correctly.

Public engagement with science must be two-way: that’s why persons with early dementia are so important

I spent some of this afternoon at the Wellcome Trust on Euston Road. Euston Road is of course home of the oldest profession, as well as the General Medical Council too.

I was invited to go there to discuss my plans to bring about a behavioural change in dementia-friendly communities. You see, for people with early dementia, say perhaps people with newly diagnosed dementia and full legal capacity, I feel we should be talking about communities led by people with early dementia.

The last few years for me as a person with two long term conditions, including physical disability, have really given me an urge to speak out on behalf of people who can become too easily trapped by being ‘medicalised’.

I have had endless reports of persons with dementia who have received no details about their dementia from the medical profession on initial diagnosis, and at worst simply given an information pack.

This is not good enough.

How we all make decisions is a fundamental part of life. When a person loses the ability to make decisions, it can be a defining moment – loss of capacity triggers certain legal pathways. Whilst the state of the law on capacity is quite good (through the Mental Capacity Act 2005), it is likely that further welcome refinements in the law on capacity will be seen through the current consultation on the said act.

I have been thinking about applying for a big grant to fund activities in allowing a discussion of decision-making in people with early diagnosis, the science of decisions, and what one might do to influence your decision-making (such as not following the herd).

I’ve also felt that quite substantial amounts of money get pumped into Ivory Tower laboratories on decision-making, but scientists would benefit from learning from people with early dementia regarding what they should research next, as much as informing people with early dementia what the latest findings in decisions neuroscience are.

Also, the medical profession and others are notoriously bad at asking people with dementia what they think about their own decision making. This ‘self reflection’ literature is woefully small, and this gap I feel should be remedied.

I simply don’t think that what scientific funding bodies do has necessarily to interfere with the NHS. I think a motivation to explain and discuss the science of decisions to stimulate a public debate is separable from what the NHS does to encourage people to live well with dementia. This debate can not influence what scientists do, but can influence what lawyers and parliament wish to do about capacity in dementia.

Persons can be encouraged to live well with dementia, and when they become ill they become patients of the NHS. Living well with dementia is for me a philosophy, not a healthcare target. If I can do something to promote my philosophy and help people, I will have achieved where many people in their traditional rôles as medical doctors have gloriously failed as regards dementia.

The G8: when dementia care got personal (well, molecular actually)

Big Data picture

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.