Compassion, care and a fried egg

Three weeks silence has been forced by a repeat visit of acute back problems. Spinal stenosis in the lumbar back was eased last summer by an injection at L4/5. Now the acute focus is at L3/4. The last three weeks have been dominated by morphine induced woolliness and extraordinary gymnastics to achieve simple tasks such as visiting the loo.

The comparison between ten days of hospital care and returning home to the care of my wife Sheelagh, is interesting. In hospital there is no shortage of manpower (sorry personpower) (womanpower really – should I get more PC in my thinking), to help get all these tasks done. There is also a store of equipment and good practice experience. At home the lack of resources is made up for by the familiarity of the surroundings, undistracted love and care, and the provision of food which comes high up my favoutites list. You also feel that you are working together towards a beneficial end. Even though I get “dont even think of trying that” at home, it is delivered with sympathy and the hint of possible negotiation.

There is no negotiation where Sister Helen is concerned. After some four stays on her ward in the last four years Sister Helen has got the measure of me. To be fair her team are superb and I only have praise for Ludlow Ward at the Robert Jones & Agnes Hunt Orthopaedic Hospital at Oswestry, and that includes Mo, who is every bit as formidable (and kind) as her boss. On such wonderful people is the real NHS built.

The hospital has one other call to fame. I have to admit that I have not done any research to estbalish whether RJAH is unique, the first, or one among many, but freshly cooked eggs and bacon for breakfast ! Brown or white toast, warm on the plate ? A pot of real coffee ? Yes this is a hospital breakfast which humbles many hotel breakfasts. I had my first egg and bacon with some trepidation. Long term recall of what hospitals can do to food vanished. It was hard to resist every day thereafter but I had to. The constipatory side-effects of eggs topped up the similar characteristic of morphine and other strong pain-killers. My earlier comment about extrordinary gymnastics has a deep rooted origin.


Addressing the research methodology challenges in rare cancers

The world of rare cancers is a strange one. For patients there is no such thing as rarity – ‘I’ve got this disease and that’s not rare is it?’ For doctors there are specific challenges, mostly around the absence of evidence which gives some certainty to their recommendations and decisions. This is what makes research so important in rare diseases.

At the same time research is difficult. Getting adequate numbers of patients to include in a study which can deliver a level of significance which points to certainty is a challenge. You either need to take a long time over the study or you need to widen the catchment to attract as many patients as you can from as many treatment centres as you can. Both of these issues carry costs, create challenges in consistency of observance of protocols, and maintaining the quality of the data gathered becomes complicated.

It is therefore encouraging to see the article in the latest edition of the European Journal of Cancer addressing the subject. It looks at the practical challenges of trial design in rare cancers from the experience of the International Rare Cancers Initiative. This is a project involving NCI (USA), EORTC (Europe) and Cancer Research UK (with the NIHR Cancer CRN) to develop key studies in very rare diseases.

The lead authors are Jan Bogaerts and Matt Sydes. Jan is the EORTC’s senior methodologist and Matt has a similar role with the MRC’s Clinical Trials Unit. The long list of authors includes the PIs on the various studies and other key trial designers, with Prof Matt Seymour from NCRI/NCRN as final author.

As a description of the decision-making in trial design for rarer cancers it is a masterpiece. The problems and the solutions tested to address them are described in detail (enough for a statisticiain in most cases). This is a recommended read for anyone involved in clinical trial development. It is a free download.

Three of the eight trials developed so far are in sarcomas – two uterine and one for Ewings sarcoma. There are other trials in development and these include one for Desmoplastic Small Round Cell Tumour (DSRCT), a sarcoma of late teenage years. DSRCT affects perhaps 15 patients each year in the UK and there are no treatments with proven efficacy for those who relapse after surgery.

While considering the challenges of research in rarer cancers a superb analysis of the issues was recently published in Annals of Oncology. This too is well worth the read. The principle authors include Dr Paolo Casali and Prof Jean-Yves Blay. The consensus group working with them on the paper includes a wide range of professionals and patient group representatives.


Quality Standard sets new challenges

The publication of the Quality Standard for Sarcoma by NICE open up a new set of dialogues in how to improve the standards of sarcoma care in England and Wales. The NICE standing committee on quality recruited six members of the sarcoma community to advise it and to be part of the decision structure during the development of the standards so, hopefully, they are rooted in the realities of daily provision of care and treatment. The standards can be found at:

The first standard calls for clear pathways in diagnosis. This is something for the wider NHS to develop, informed and supported by sarcoma MDTs. There was discussion about the value of local diagnostic services and a real example of development work from Yorkshire where DGH ultrasound operators play an important part in the diagnostic pathway. Other areas are also making important steps in improving GP awareness, for example. The hope is that other commissioners and NHS managers will look at how local services can develop, working with their local sarcoma MDT.

The second standard re-affirms the requirement in the NICE IOG that all sarcomas should be treated in consultation with a sarcoma MDT. It does it however in slightly different terms and gives a Sarcoma Advisory Group (the local oversight group in the NHS) the power to determine which treatments for which groups of patients can be managed outside a sarcoma MDT. In the case of children, for example, the decisions will be easy because the current systems work well. In the case of gynaecological sarcomas those in the gynae community who are reluctant to refer their patients (often until it is too late for any benefit to be gained) can be brought into line (we hope).

Statement number three is an important one for the development of the sarcoma treatment network. Sarcoma MDTs must make public their skills and the pathways they observe. Clearly this will be valuable information for patients. It should become obvious that having a multitude of different sarcoma oncologists in different locations all treating a few gynae patients (for example) is not a proper way forward. Every MDT will need to decide what it handles and what it refers on and to whom – very much in the same way that they may diagnose a bone tumour but pass it on to one of the recognized bone centres. I hope we will see development of regional experts in some areas, giving one centre a critical mass on which to develop a specific expertise. This can only help patients in the longer term. It might also be good for some careers. It is important that MDTs recognise their strengths and where they may be weaker and do not try to maintain a “we can do everything” stance. The NHS England Sarcoma CRG will have a role here, alongside SAGs.

The next statement can be linked to the previous one. Retroperitoneal sarcoma patients have their best chance of survival with radical surgery at the first intervention. There is currently a trial underway to see whether radiotherapy may improve that. There have been too many patients treated conservatively, followed by recurrence and decline. Data from international series also show that high volume centres which can develop expertise, offer real benefit. The NICE rules forbade the quality standard from being specific about this but the Quality Statement is an open invitation to professional associations, the NHS England Sarcoma CRG and to commissioners to put in place structures which meet the Quality Standard and improve outcomes.

Statement number five recognises that there may be unplanned resections of sarcomas but once diagnosed patients must be referred for treatment to a sarcoma MDT. Most limb/trunk tumours will be diagnosed and treated by a surgeon who is a core member of an MDT but in other anatonical sites it is not enough for a diagnosis to be made and surgery to go ahead locally. The sarcoma MDT must be brought in to discuss the treatment plan (Statement 2) and for planned surgery in the anatomical specialty the sarcoma MDT must nominate the surgeon as an extended member of the MDT.

The final statement makes it a requirement that there is a nominated key worker for every sarcoma patient. This includes patients whose care and treatment is co-ordinated through a site MDT (such as Upper GI or Gynae). It makes it an imperative that in agreeing that a site MDT can look after a patient this statement is observed by the site MDT. There is also the implication that a single person in a sarcoma MDT is not adequate for this role. Illness, holidays, training all take people away from their duties and it is essential that patients do not lose this kind of contact. So trained cover is a minimum requirement.

At first sight these standards look quite gentle. Close examination shows that there are some big nitty-gritty issues hidden in them, as I am sure you can see, and it will be something of a challenge to attitudes and behaviour to make this work. The sarcoma network in England has been slowly coming together and with the BSG now properly constituted and ready to take some actions and decisions, together with a Sarcoma CRG which is clinically led and has a role with commissioners, we have a structure which could initiate action and deliver new benefit to patients.

Update – a view from the sunshine

The idea of getting away for the worst of the winter has always been very attractive. This year, for the very first time, we have been able to do it and we have gone to the Costa Blanca. The weather here is like an early summer’s day at home. Temperature out of the wind is in the mid-20s, though the wind has a chill to it and the official shade temperature comes down to 17 degrees. Its hard not to gloat, knowing the UK is in the grip of snow and ice with temperatures below zero for most of the day.

Going away however has other dangers. Everything seems to be happening. The Cancer Drugs Fund debacle, Harpal Kumar’s Task Force, at Sarcoma UK we are about to publish our study into gynae sarcoma, and NICE is about to publish (later this week) the Quality Standard for Sarcoma – the first of the rare cancers to have a Quality Standard. We also have the British Sarcoma Group Conference at the end of February. And then there is a General Election in May – although with the intensity of the campaigning which is already underway you’d think it was in early March.

So where do we stand on all these happenings?

Two weeks on from its controversial announcement CDF is revealed as a tawdry beast, built by politicians then deserted by them, taken on by a strong oncology commitment with patient interests at heart, unsupported by mandarins and then dumped by them when the heat built up. CDF will have spent over £1.2bn by the time it is meant to finish in 2016 and it has not gathered a single bit of efficacy data to support its spend. It has distorted the research community as new indications have been funded immediately off-label rather than real evidence being developed in an academic trial – a letter from Professor Matt Seymour of NIHR to Sean Brady, National Clinical Director for Cancer revealed that issue. Above all it is quite clear that the pharmaceutical industry has been benefitting, some companies being exploitative in their approach to it. The one thing it has achieved is to get people thinking evidence, research, new methods in research, and rational approaches to drug regulation.

Harpal Kumar’s Task Force is a welcome development. Not only is he the right person to be undertaking such a sweeping review it is going to be done quickly. The aim is clearly to have something approaching a new Natonal Cancer Plan by the time there is a new government. The new emphasis on early diagnosis will clearly be a key part of whatever comes out of the discussions.

Sarcoma UK”s report on gynae sarcomas deserves close attention. it is sub-titled ‘The Hidden Cancer’. We have long believed these patients are among the worst treated in the whole cancer community and this survey, of over 50 patients, shows just how poorly treated some of them are. There will be attempts to deride this study as too small to be representative. Consider however the sample size and the incidence of the disease. It is equivalent to an 8500 patient study in lung cancer – that would never be ignored, it would get front page treatment. Available on Sarcoma UK’s website from Tuesday.

The NICE Quality Standards programme is something of a treadmill for those involved in it. The process for a standard in sarcoma started in spring 2014, finished before Christmas and is being published at the end of January. The aim is a set of clear statements which define a quality service in the NHS and together with defined measures allow commissioners to assess quickly whether they are getting value for money. The NICE standing committee was supplemented by six people with an interest – two surgeons, an oncologist, a radiologist, a specialist nurse and a patient (me). There was lots of detailed debate, including some passionate episodes from a member or two. We agreed that diagnosis and the pathway to first treatment were the priority so when you read them (published on Friday 29th) do not be put off by the tight focus on the early stages of disease. More on this in due course.

The BSG Conference is from February 25th at the East Midlands Conference Centre in Nottingham. It is the annual educational event of the UK sarcoma community and provides the best all round view of developments from treatment, nursing care, through NHS structure, to regulation and of course sarcoma community affairs. If you are interested see the BSG wesbite at

As for the General Election – I leave that to others.

Silent politicians preside over CDF ‘car crash’.

A week of gathering protest has passed and rather weak support for the Cancer Drugs Fund has been given by NHS England through National Clinical Director for Cancer, Sean Duffy, and CDF Chairman Professor Peter Clark. There are times when a holiday seems irrelevant.

From the (relatively) warm shores of Spain CDF is looking more and more like a car crash. It has long been an accident waiting to happen, now it is unfolding in slow motion, and the repercussions are becoming clearer. The political moves to dampen down the news story about it are already underway but a contrary momentum is also building.

The underlying truth is that the NHS is proposing to deny treatment to patients based on arbitrary judgements by an unnamed panel using secret criteria and answerable to no-one identifiable. The result is that people will die earlier than they might otherwise have done. In the field of law this practice went out in mediaeval times, although the identifiable responsibility lay with the King.

What makes it more interesting is that the CDF initiative was a personal one by David Cameron made before he became ‘king’. In April 2010 he promised, I use this word carefully, that all cancer patients should have access to the treatment their doctor wants them to have. It was an unconditional promise.

He remains silent.
As does his Secretary of State for Health, Jeremy Hunt.
As do the higher staff echelons of NHS England.
And so do the NHS England Board – which includes lay people.

Remember, all they have to do is stay silent and the problem will go away. Or so they think. But people get hurt in car crashes and want to know why it happened.

Are we harking back to the days of the self appointed passing judgement on ordinary people in secret, accountable only to the King?

In the meantime today’s Daily Telegraph carries a letter from a group of cancer charities. While regretting the actions being taken over CDF the letter makes it clear that replacing the failed system is a priority and the charities are willing to be part of the debate, starting now. They are waiting for the invitation.

However, there is as yet no invitation and no debate. The silent lords and masters are hoping the problem will go away.

UPDATE on Tuesday

The NHS England team responsible for the review have now come clean to cancer charities on their methodology and the people involved in the review. There were dark hints about things moving in the background to make things better in the future, but no details. There was also the blunt admission that the process discriminated against rare cancers where getting ‘acceptable’ levels of evidence can be impossible and where off-label (ie unlicensed) treatments can be a lifesaver.

Still no comment by politicians. So much for Prime Ministerial promises.

Cast into oblivion

Among the cancer drugs refused continuing funding through the revised Cancer Drugs Fund are three treatments for sarcoma, one of the groups of rare cancers.

Sarcoma patients are used to discrimination through rarity – they have suffered for decades. When a drug company decides to test its new treatments in sarcoma it is welcomed, but few drugs survive the trials process. When one does survive, showing benefit to patients, it is fair to expect it to be accepted by funding bodies such as the NHS.

Two recent drugs that have come through this process are pazopanib (Votrient) for advanced soft tissue sarcoma and regorafenib (Stivarga) for 3rd line use with GIST. Another drug, pegylated doxorubicin (Caelyx) had shown real value for the treatment of cardiac sarcoma patients.

The first two have been refused appraisals by NICE because it is judged they are applicable to so few patients that the costs would be disproportionate. The third will never be appraised by NICE because it is an off-label treatment for which a licensed indication is unlikely when only a handful of patients are treated each year.

All have now been refused funding by the Cancer Drugs Fund. I estimate that they account for between £1 to £2m of the CDF budget and more than 10% of the refused drugs.

They have no other route to NHS approval. They represent half of the new generation drugs licensed for sarcoma. Patients have been benefiting but now, using criteria valid for commoner cancers but not for rare situations, they have been de-listed.

This is blatant discrimination against rarity.

Early diagnosis – shame about the politics

Some people might suggest that its unfair to say this but the timing of the NHS England announcement of a cancer early diagnosis initiative, while welcome, has all the markings of being politically driven.

In 2007 the Cancer Reform Strategy announced NAEDI – the National Awareness and Early Diagnosis Initiative. After the change of government the group kept meeting, Cancer Research UK kept putting up funding for research into practical issues and Macmillan did its best to make people aware of the importance of early diagnosis.

The new government picked off some headlines but otherwise did nothing for over four years.

Now its election time again and guess what – new money, new priorities, new targets. This time though the government has nothing to do with it. Of course its all in the hands of the (quasi)-autonomous NHS England. Who are they kidding?

However it is very welcome.

One person deserves the greatest credit that we can give for getting it this far. Harpal Kumar is the CEO of Cancer Research UK. His personal commitment to creating change on this issue is undoubted. It dates from 2007 when Prof Sir Mike Richards asked him to chair NAEDI and he has seen it through to today. He continues in charge, it is in safe hands, things will happen.

Thank you Harpal.

Cancer Drugs Fund – inevitable signal for wider change

If I remember correctly the Cancer Drugs Fund was set up at the same time as the Government announced it was to establish a value-added base to NICE drug appraisal which could support and reward innovation. NICE was left to consult on it, which it diligently did. However it became apparent that without an agreed definition of ‘value’ and without agreed means and methods of measuring and quantifying ‘value’ this was a fruitless task. The current Secretary of State has made no comment on this issue and his dis-interest in value/pricing has left the Cancer Drugs Fund exposed in an unsustainable way that means that the Government just has to keep putting more money in.

The re-working of the Cancer Drugs Fund, now underway, is long overdue. Professor Peter Clark, the well respected oncologist who chairs it, has been left with the difficult task. One can argue that he has been left with the problem when the politicians who created the fund, and NHS England, which now owns it, don’t want that profile. Sadly for him, I don’t know of anyone better equipped for the task. He is, however, going to field a lot of criticism and it is going to echo into the l;eval system and the political arena.

The Fund was set up to ensure that people with a rarer cancer got an equal chance at new technology drugs as those with more common cancers. It was also aimed at treatment which had been refused NICE approval. Among rare cancers are drugs which have applicability to 50 or 60 patients a year and which are never going to be appraised by NICE because the cost of doing so is unreasonable. These should get funded. At the other end of the scale it is questionable whether a drug which NICE has rejected on the grounds of cost effectiveness should receive funding. However such drugs quite often already have an applicability outside the strict indication for which they were appraised by NICE. It is a factor of timing as much as anything else and these new indications can carry a badge of rarity because they are off the standard track of treatment.

The CDF budget has inevitably burgeoned and the focus on drugs is also threatening to distort the evolving balance of treatment opportunity as new technologies in radiotherapy and new therapy methods employing techniques such as sound and light, appear.

The review was inevitable, the squeaks of complaint from pharmaceutical companies are inevitable and the protest of patient groups is inevitable.

What is the answer?

There is no easy answer but if we look at the longer term history, which provides the context for the CDF, we can perhaps see a way through. The answer is in NICE which has consistently failed to recognise cancer as anything different from other disease/treatments areas. It uses a generic means of assessing the quality of benefit achieved by a treatment in isolation from the whole patient context in which that treatment takes place. Its former chairman, Professor Sir Michael Rawlins, instructed committee chairs to be ready to use their judgement. However the whole NICE appraisal process is quite rigorously focussed on the new drug and its immediate treatment purpose, not the value a drug can offer in the widest patient sense. The cost per QALY* benchmark has not altered in 18 years, not even to reflect inflation, and bandages put over the process such as “end of life” criteria are just that, bandages.

Peter Clark and his team are not trying to be another NICE but they are trying to identify criteria which allow them, openly, to refuse funding for a drug which offers little or no value. Let us hope they don’t try to evaluate drugs for rare cancers with the same sriteria as those for common cancers.

Rather than wingeing the pharmaceutical industry should be taking steps to illustrate indisputable value in their new agents. The current clinical trials model which industry (and to be fair regulators too) are wedded to does not do that. It’s a broken system. The patient community is not short of ideas on how to change things. The medical oncology community is also beginning to question the endless ‘me too’ drugs, treating yet another tumour pathway and offering another month of life with yet more side effects but only in common cancers of course**. Schemes like Cancer Research UK’s Stratified Medicine programme are welcome developments which will help change the shape of treatment and of drug regulation. Bring ‘em on.


*Quality Adjusted Life Year – a statistically derived measure of patient benefit built on factors which are so opaque you need a degree in Health Economics to argue them.

**Because that’s where you get the quickest payback.

Love, morphine and whisky

Dr Richard Smith, the former editor of BMJ, raised a storm last week with his blog about dying. He drew broad comparisons between different pathways to death and made the statement that death from cancer can be more acceptable than a death from a lingering disease like dementia.

Maybe his wording was a bit careless and he has acknowledged that in his latest addition to the blog. He certainly attracted a large number of reactions to what he said. Most were highly critical, going way beyond the point of understanding what he was actually saying. There were intensely personal and very painful stories of death from cancer, focussing on an individual, usually in the family of the writer.

Richard was addressing an important issue – we all have to die of something. This is not something that is part of general conversation and culturally it is a topic avoided like the plague. Sudden death, or peaceful death in ones sleep, are the preferred pathways when people do talk about it. Sudden death leaves goodbyes unsaid. Dementia leaves goodbyes behind hanging meaningless in the air. Dying of cancer gives us some time, occasionally it is not very much time, to get things into order, to make our peace with everyone who matters to us, and to accept the inevitable. I liked his line about love morphine and whisky. I am still trying to decide which whisky !

We need to look at whole contexts. Science is currently driving us down a route to scavenging a few weeks and months of life at a high cost in the ambition, maybe hopeless but we don’t know that, that along the way the magic cure to cancer will be found. One of his points was that the more we spend on cancer research the more likely it is that more people will die of dementia. That is the worst death on his list of pathways to dying.

There are no easy answers, there may be no answers at all. What Richard Smith has done is, hopefully, to open the debate up a bit wider than it has been. The list of doctors doing that is growing, now we need the patients and carers clamouring to add to that debate, not with emotion, but with a considered view recognising realities, however harsh they may be.

The rod and staff

Being diagnosed with a potentially terminal illness is a shock. Education does not prepare us and culturally it is not a conversation topic. The message can come when you least expect it, sometimes at an age when lifestyle changes are bringing a whole new vista of life’s opportunity into focus.

This situation is a huge challenge over and above the physical demands which come with treatment, or with deteriorating health. This is the valley of the shadow of death, so poetically defined by the writer of the 23rd Psalm – the poem of praise and of comfort made more familiar by the much-loved hymn ‘The Lord is my Shepherd’.

Psalm 23 has a particular resonance as a focus for mindfulness and meditation. You find words of comfort that go far deeper than you might expect. There is a call to your spirit which is conjured up by the images the writer’s words describe. Familiar pictures offer themselves to those who are distressed and upset, firstly as reassurance and then as spiritual comfort.

Increasingly healthcare professionals recognise that physical and spiritual co-exist and comfort can be gained from words. By reaching out to your mind the spiritual can be brought into play. This is not a new idea but it is not always one we think of first when health problems arise. In cancer care the value of spiritual wellbeing has long been recognised though how to support it remains a question.

The psalm assumes our natural goodness. Just reaching out to the shepherd is enough to start the process of healing and help.  There is just the one condition. You can only get help by reaching out to the shepherd with your heart and in your mind. This opens the way to the comforts of green pastures, still waters and the support from the rod and staff. It translates into spiritual strength.

But this is no shepherd carrying a brand or badge which denotes a specific religion. This is the spiritual shepherd of all mankind. The route by which the shepherd is reached can be religious but it can also be a route travelled alone, even in anxiety and fear. There is the certainty in the Psalm “Yea, though I walk through the valley of the shadow of death,
 I will fear no evil;
 for You are with me”.