Dying your way – support the Assisted Dying (No2) Bill

An important moment is coming and everyone needs to think quite hard about it. In just over two weeks time the Assisted Dying (No2) Bill is to have its Second Reading in the House of Commons.

The Bill aims to make medically assisted suicide legal in the UK.

This Bill was originally introduced in the House of Lords by Lord Falconer but it lapsed when Parliament was dissolved for the General Election. It is being revived by Mr Rob Marris MP, who won the lottery for Private Members Bills in the new House of Commons.

The Bill has been very carefully framed and negotiated. Remember that Lord Falconer is a lawyer and former Lord Chancellor. In the Lords there was quite strongly felt debate. It lasted over 9 hours, there were over 100 speakers and two attempts to amend it to worthlessness were resisted, being out-voted by quite substantial margins. It was passed by a majority of two-thirds of those voting.

The Bill is a simple piece of legislation. It has very clear safeguards to prevent misuse of the new provisions. The fear that some elderly people may be exploited and bullied into assisted suicide has been addressed very carefully. Every written application has to be approved by the High Court. Doctors are not obliged to help a patient even to make an application and at every step the patient has the absolute right of withdrawal. Someone seeking to use this as a route to bump off a relative opens the way to life imprisonment.

The Bill’s first real test comes in the House of Commons on Friday 11th September. There will be a debate and a vote. There will, no doubt, be some opposed to the Bill.

There are many cancer patients who would like to see the Bill enacted and to have the option of dying at a time of their own choice. Dying from cancer rarely has much dignity. Even when at home and properly supported by medical and caring staff, extremes of medication are often necessary to control pain and other symptoms. The new NICE Guidance on end-of-life care is explicit about what symptoms might be experienced. It details treatment for agitation, anxiety, breathlessness, nausea and vomiting, “noisy respiratory secretions” and pain. It is not a menu, a list of options from which you make a choice. You might suffer all of them. You will not be in control.

If you would like to see this Bill take its next step through the House of Commons and, hopefully, make its way through Parliament to reach Royal Assent, write to your MP and ask him to join those who will support Rob Marris on September 11th by voting in favour of the Assisted Dying (No2) Bill.

Patient Involvement in Cancer Research – a cause for concern

We are seeing a real shift in patient involvement in healthcare research. It is very encouraging to those of us that have been involved for a decade or more to see how the word is spreading. This is despite the relative disinterest in it shown by the current UK government. Its predecessor was an encourager and ensured that small pots of cash and other resources were made available at crucial moments. The disinterest is perhaps most noticeable in cancer research, for long a leader in the field of patient involvement – not the only leader it must be said but probably the most prominent.

The main organisation in clinical cancer research and the management of late stage trials was the National Cancer Research Network (NCRN). It is the organisation that raised patient accrual into cancer studies from 3.5% of incidence to well over 20% of incidence, a world leader. It is now no more – subsumed into the National Institute for Health Research Clinical Research Network structure.

(For acronym watchers this abbreviates to NIHR CRN. It has a Co-ordinating Centre for which you add CC. I believe it is the current leader in the NHS’s secret competition to adopt the longest acronym.)

There are now 30 speciality areas in healthcare research under the wing of the NIHR CRN. Looking at the list of specialities it is impossible to find one where advances in care informed by high quality research is not desirable. Most have a disease focus, a few such as Critical Care and Public Health have a broad remit across a wide range of diseases. None is as large as cancer in terms of the number of studies underway, or the amount of cash invested, or the range of research funders, or the number of industry funded studies which are accredited for NHS support. However all are shoe-horned into the one over-riding structure.

There are now 15 geographical networks. Cancer research used to have 30 local networks each with a patient ‘partnership’ group. Other diseases had differing numbers of networks, with lots of overlaps and some of them did not have national coverage. This government’s approach to simplifying things has forced everything into one structure, ditching lots of expertise and muddling priorities along the way. Each of these plump ‘no longer local’ networks has a patient involvement strand but because of costs the recruiting tends to be around the geographical centre where the network has its headquarters. There is, of course, no guarantee of any involved patient having the specific disease experience that a researcher might like to call upon.

At a national level patient involvement in cancer research has shifted from NCRN to NCRI. The ‘consumer’ group was always called an NCRI group, even though it was run by NCRN. It has also changed its name to the NCRI Consumer Forum. Membership is largely the same but retirements and the need for continuing recruitment to CSGs means that a high proportion of members have been recruited in the last year. The big problem is that funding from the government has been lost. All credit to NCRI members who have agreed a budget and to NIHR CRN CC, which has contributed. The NCRI has also become incorporated as a charitable organisation, with a board of Trustees which includes a patient and is chaired by the CEO of a patient charity. Its members are its funders, not directly represented by the Trustees.

This is a story of the steady wearing down of patient involvement resources hidden through structural changes and shifting budgets. Getting clinical research into one amorphous structure to the disbenefit of cancer research may appeal to NHS control freaks and the envious. Cancer research is disliked by many in other research areas because it is so large and consumes such large budgets. I have heard the argument that it has been a favoured child for too long. Creating a bland giant in which it has to fight for every bit of territory appeals to some. Allowing nationally funded patient involvement in cancer research to wither away probably pleases those people.

The importance of patient involvement in the development of new studies is now undeniable. Researchers are required by many funders to demonstrate how the user community has influenced their study and patients sit on the award panels of all kinds of research funders. In cancer the peer review process through the NCRI Clinical Studies Groups includes patients and carers, a ready resource immediately available to researchers following that route. However there is no certainty that funding for that immensely important resource will continue.

Independent Cancer Patient Voice (ICPV), a small charity supporting patient involvement in research, responds to a steady stream of researchers wanting different kinds of involvement in research, from looking at initial ideas, reviewing patient information leaflets and providing membership of trial steering groups. Presumably these researchers can no longer find that expertise in the patient groups in their big bland otherwise distracted local research networks – surprise surprise!

The growth in pharmaceutical company interest in having the views of patients is also noticeable. Novartis has undertaken a pan-European project EPALCO to make the company more patient-focussed, although because many of its studies are designed in the USA where patient involvement is almost non-existent, there are still some barriers to overcome. Astra Zeneca and Amgen are two other European pharmaceutical giants with relatively advanced ideas being actively explored. The lesson here is that the pharma companies usually fund this work.

So patient involvement in cancer research is increasing but the resources available are disappearing. ICPV bears a growing burden, at no cost to the research community and its members give their time free of charge. There is a strong core NCRI group which government has stopped funding after twelve years and seems ready to allow to wither away.

This must be a concern for the NCRI Trustees. What a depressing contrast with all the high sounding words from ministers about healthcare being centred on the patient, about sensitivity to patient needs and the importance of research delivering what is of value clinically.

End-of-life care should be an openly discussed topic

End of Life care is not usually regarded as a front page headline topic by the popular press, nor is it a frequent discussion point in cafes, pubs or bars. It is an important topic nonetheless, if only because it is the one area of healthcare which very nearly all of us will experience. Sudden death, from whatever cause, is not the usual way to die.

This lack of debate might be understandable if everyone who died did so in a quiet, caring, and capable environment at home or in hospice. In the right hands the well-evidenced Liverpool Care Pathway (LCP) helped a lot of people cared for by those trained in its use. NICE actually recommended it. However the fact is that hospitals are still the main place where people die and there have been horrific accounts of poor and insensitive care of those dying in hospital.

The abandonment of the Liverpool Care Pathway (LCP) a year ago shows us the nature of that problem. The review into the LCP led by Baroness Julia Neuberger was generally damning of hospital end of life care. A tick-box approach to the LCP de-personalised treatment, they were highly critical of the quality of communications around the dying person, and deeply critical of hospitals’ inability to respond to the needs of families and their loved ones, especially those dying at weekends or in the middle of the night.

“In the wrong hands,” they said, “the Liverpool Care Pathway was an excuse for poor quality care.” They went on “Generic protocols, as the LCP has come to be seen, intended to be applicable for all patients in the last hours or days of their lives, in any setting, are the wrong approach.”

The publication of guidance from the Leadership Alliance for the Care of Dying People followed quickly and set new standards. The Alliance was made up of 21 organisations including the Department of Health, NHS England, NICE, CQC, NIHR and key charities including representation from the Hospice movement. Their guidance is a direct response to the Neuberger review, accepts its recommendations and points to the supporting evidence base to guide local implementation. It confines itself to establishing strategic guiding principles, it does not replace the LCP. No-one following these principles and guidance will reproduce what is bad but they have to make up their own minds about the details of practice and focus that on the individual, not a protocol. The guidance emphasizes the need for individuality of care, giving proper respect to each person and their needs.

The guidance is extensively supported on the NHS Improving Quality website, with direct access to training information, so there is no excuse for any healthcare professional concerned with the care of dying patients not to have referred to it at the very least.

Now NICE is consulting on the draft of new Guidance for care at end of life. This will be authoritative. It is open for comments until the 9th September. At 266 pages its no lightweight and the supporting evidence is a much bigger tome. The group developing the Guidance was chaired by Professor Sam Ahmedzai from Sheffield University, an internationally respected palliative care clinician. If nothing else the list of 67 recommendations is worth reading to take in the breadth and depth involved in creating personalised care at end of life. They also point to four areas of clinical research priority which will hopefully be picked up in the near future.

One issue which affects research is that there is no clinical priority for end of life care research in the NIHR Clinical Research Network. It is a topic which is ignored in the way the Network has been structured. The 30 speciality topics mostly have a disease theme. In all probability the four end-of-life research priorities (and others which arise) will get researched through the cancer theme. The NCRI seems to be alone in clinical research in recognising Palliative Care with its own Clinical Studies Group (chaired by Professor Ahmedzai).

In addition to the clinical issues there is a need to better understand why so many people die in hospital when research shows they wish to die in their own homes. There have been numerous small studies, mostly focussed on one institution. There is no reason to doubt one conclusion that the communications problems and mechanics of transferring uninterrupted active care from a hospital to a GP, who relies on the support of multi-agency resources in the community, are dominant but there is a very real need to find ways of making it better.

There is also a need to find out what are the key measures which can evaluate performance. This may sound a bit callous. Maybe it is one of the characteristics of this topic that there are aspects which feel a bit insensitive. But it does affect all of us and I know that, when it comes to my time, I want to know that I am getting the best care there is.


Richmond Pharmacology and the HRA – what was it about ?

Something quite extraordinary has happened in the last couple of weeks which has barely attracted any attention in the media.

I am sure that many of you, like me, were very confused by the High Court action taken by Richmond Pharmacology Ltd against the Health Research Authority (HRA).

It seemed to go on for months (it did), the issues in contention were not clear (they kept changing), and the outcome appeared to be that Richmond won, although the Judge has yet to decide on what actions to recommend.

What was at stake was the transparency of clinical trials. The openness of everything from registration to results. Richmond appeared to have set itself up as a voice for the pharmaceutical industry. However the industry effectively disowned it and made it quite clear that Richmond was on its own.

The Judge made a declaration that the HRA has acted unlawfully because material on its website is “ambiguous and potentially misleading.”

The Judge was heavily critical of Richmond Pharmacology for not being clear about what they were arguing for until their very final submission to Court. He criticized them for introducing new arguments at a very late stage.  There were many broad points that were dismissed in 5 months of intense legal argument, in a process that cost hundreds of thousands of pounds. There were continual challenges to the standards which have been developed to create clinical trial transparency.

The main argument Richmond (at the last minute) had asked the Court to rule on was that the HRA is acting unlawfully by asserting that there is an overarching legal requirement for everyone running every clinical trial to register it. The Judge is clear that the HRA never claimed there was such an overarching legal requirement. Phase 1 trials, which is the area where Richmond Pharmacology works, are exempted at present, although EU law may change.

Richmond has ended up with an order which says that the HRA’s website had some ambiguous wording.

Richmond had claimed during the five months of argument that high regulatory standards on trials are making the UK a less competitive place to do research. There are growing concerns about unreliable data from clinical trials, especially when trials are run at low cost in countries with weaker standards. The one thing the UK can compete on is quality and integrity. The Judge’s decision supports that position. We are not in a race to see how far we can compromise standards.

The HRA’s position has been made stronger by the judgement. The Judge says it has a clear legal right to check researchers’ compliance with ethical and legal requirements to register and publish clinical trials. It has a mandate to continue its work raising awareness of researcher’s requirements to register trials and to check researchers’ compliance with those requirements.

Similarly the judge made it clear that people conducting trials have ethical obligations, as well as legal ones. He said the HRA is entitled to apply sanctions where ethical requirements have been breached, as long as it is clear about what those requirements are and what the sanction would be.

Richmond Pharmacology has said little about this case themselves, although their lawyers have inevitably crowed over winning the case on their website. So where were they coming from ? Who are they ?

Richmond Pharmacology Ltd is one of the largest clinical research organizations (CRO) in the UK. They are a commercial provider of the facilities and expertise for Phase 1 clinical trials. They have no investigator led research, their clients are largely pharmaceutical companies. Their facilities are in south London at St George’s University Hospital (Tooting) and Croydon University Hospital. They are therefore a tenant of the NHS and pay substantial fees for the facilities they use.

The Directors of the company own the company and are the doctors who lead the clinical teams, so it is a hands on operation. They turnover about £10m a year and like any small privately owned company have been through ups and downs and have learned how to survive. So what brought about this extraordinary legal case ?

I have never before seen a small company set itself up as the champion for a multi-billion dollar industry, only to find itself dis-owned by that industry. Richmond Pharmacology had nothing to gain from winning any part of the case at all. Misguided altruism? Surely not. What they have won is so easily sorted that it could be called trivial.

Until they actually say something it will remain a mystery. No openness at all, perhaps that’s no surprise. What is no mystery though is that the HRA has massively drawn on public funds to defend itself. An explanation for why that was necessary is the least the public deserves.

Can we, the public, exert any pressure to ensure that happens? Perhaps we should discourage people thinking of joining a Richmond clinical trial.