It’s seems to be the lot of bloggers, in today’s world of 24 hour churnalism, to do the job that investigative journalists used to do and, so it seems, nowhere more so than when it comes the reporting of health ‘issues’, especially those in which public policy plays both a significant part and finds its under under a concerted attack by hitherto unreported vested interests.
Yesterday, a typically forthright post by Devil’s Kitchen on the subject of the NHS’s policy on co-payments piqued my interest, or should I say that it set my ‘there’s more to this than meets the eye’ bump itching – and sure enough, a bit of fairly straightforward digging later, by way of the blogger’s favourite research tool (Google) a rather different picture of the story that DK’s running with emerges.
Our story starts not with bloggers, who you might say have sold a bit of ‘hospital pass’, but with a national newspaper, The Sunday Times, picked up the story of Collette Mills:
A WOMAN will be denied free National Health Service treatment for breast cancer if she seeks to improve her chances by paying privately for an additional drug.
Colette Mills, a former nurse, has been told that if she attempts to top up her treatment privately, she will have to foot the entire £10,000 bill for her drugs and care. The bizarre threat stems from the refusal by the government to let patients pay for additional drugs that are not prescribed on the NHS.
The story that The Times has to tell is the same in each case. These individuals all have terminal cancer for which there are new treatments available that could prolong their lives, treatments that the NHS does not currently provide on cost grounds. In each case the individual has offered to pay privately for the additional cost of the new treatment over and above the cost of the existing treatments they receive, free of charge, from the NHS, only to be told that NHS policy on co-payments does not permit such a scenario – if they wish to go private they must go fully private and pick up the full tab for all their treatment, including those components that the NHS would other provide for free.
This, as should be obvious, is the cue for a bit of carefully choreographed wailing and gnashing of teeth, not to mention threats of legal action all of which are supported by a campaign/pressure group made up of a reported 1,000 doctors, which calls its ‘Doctor’s for Reform’.
It’s the age old story of the little guy taking on the uncaring, officious and inhuman bureaucracy, and one that none the better for its current iteration than it has been in the past. Such stories are, as a matter of rule, always long on ‘human interest’ reportage and desperately short on material facts, not least of which being those that would cast the whole story in a very different light and expose the many covert interest at play in this scenario.
Let me explain what I mean by way of illustration and by making explicit how each of these ‘stories’ has developed over time, not by way of analysing each in turn but simply by flagging up the elements that a common to all of them, elements that are so common, in fact, that it really makes no difference which of them you choose to look at as they are all present manifestly the same scenario.
So, to begin at the beginning, we have a patient who, for the purposes of this exercise we’ll call John, and John’s story goes something like this:
1. John is neither a well man or a happy one. He has colorectal cancer, for which he has been receiving treatment, and now his doctor has given him the bad news that the cancer has spread to his lymphatic system and to a couple of other organs. The prognosis is not good, John is dying and the doctor’s best guess is that he has a few months to go before he checks into the departure lounge, time enough to put his affairs in order and say his farewells. Nevertheless there’s still one question John has to ask, ‘is the nothing else you can do?’ The doctor’s answer is not what he was hoping for, the clock is ticking and the best the NHS can offer is palliative care. There is to be no reprieve for John, not even a temporary one, but the NHS will doing everything it can to make his final weeks/months as comfortable and as pain-free as possible.
2. For the next few days, John contemplates the inevitability of his fate. He can think of nothing else and what he thinks is that he’s not ready to accept his situation just yet. He know that there are new drugs, new treatments coming on the market all the time. Maybe there’s one out there that will give him a few more week, or months or maybe even a year or two, just that bit more life and that bit more time with his family and friends. Life, he thinks to himself, is too sweet to just give up and let it slip away.
3. John seeks a second opinion from a private practice. Another round of tests and yet another conversation with another doctor. Its starts badly, much as he expected. His prognosis hasn’t changed and the cancer is still there and still spreading. Little by little it eats away at the time he has remaining, at what little remaining life he has left to him. But then the mood changes. This doctor has a silver lining to offer him. Yes, it seems there are a couple of new drug on the markets that might give him a little more time, no more than a temporary stay of execution but more time nonetheless. Why was he not told of this sooner? The doctor explains that these treatments are new. Licensed for use, yes, but expensive, too expensive for the NHS to provide – so it claims.
4. John sits at home, surrounded by paperwork. His family’s finances laid bare before him. He can do it. It will be tight, but the children have left home and lives, and families of their own, there’s insurance to pay off the mortgage and just enough in life insurance policies and pension contributions to ensure that his wife will be okay once he’s gone. Not wealthy by any means but comfortable provided she’s careful. He looks at the figures on the paper in front of him, his life savings – it’s just enough to cover the cost of the additional treatment if only the NHS keeps up their end of the bargain he entered into one the day he first started work. Pay your national insurance and we’ll see you right…
5. John meets with his doctor, his NHS doctor. The room is bare, functional and unwelcoming. Pale yellow walls. Plain carpet, A conference table and a few chairs… and the man in the suit who’s name he didn’t quite catch – Mr Not-A-Doctor from Hospital administration. John’s world collapses inwards as the words drift languidly around the room. ‘We’re sorry but that would be against hospital policy. There is nothing we can do…’
It is this last stage is John’s story that both The Times and ‘Doctor for Reform’ would have believe is a matter of public scandal, the point at which his hope for a few more weeks or months of life is cruelly taken away by an uncaring bureaucracy, one that, to use an old aphorism, know the price of everything and the value of nothing. But is that really a true reflection of the scenario I set out above or does the real villain of the piece not turn up a little bit earlier in the story…
Getting back to the real world, the two drugs that feature in the cases highlighted by the Times are Avastin (Bevacizumab), which was sought by Collette Mills and actually obtained by Debbie Hirst, after threats of litigation, as a treatment for secondary cancers arising out of breast cancer, and Cetuximab, which is the drug sought by Jack Hose and which Linda O’Boyle failed to obtain as an additional treatment for secondary cancers arising out of primary colorectal cancer.
Now in that last sentence alone, I have conveyed a piece of information that is critical to our understanding of this whole scenario but which The Times routinely treats as a secondary and, indeed, almost incidental matter.
Neither of these drugs is a ‘cure’ for cancer, indeed neither one of them will even put the cancers they target into remission. Their sole and only purpose is to delay the spread of secondary cancers that will, inevitably, lead to the death of the patient no matter what.
Linda O’Boyle is dead. Collette Mills, Debbie Hirst and Jack Hose are dying. That is a fact that neither of these two drug will change. What they may do, if prescribed, is give these last three individual a bit more time – but how much time exactly and what is the cost?
Looking through the articles in The Times, the figure we find quoted in the case of Collette Mills amount of around £4,000 per month for Avastin out of an all-in cost of £10,000 per month for her full course of treatment – that I would assume includes both the costs of the other drugs she’d be administered alongside Avastin plus all the other medical care that goes with such a course of treatment.
If we refer back to the official NHS guidance, issued by the National Institute of Clinical Excellence, what we find that the estimated cost of a full course of treatment with Avastin – that’s its brand name, by the way, its generic name is Bevacizumab – weighs in a just under £17,000.
Mmm… £4,000 per month and £17,000 for an estimated full course of treatment – so that’s four to four and half months before… what?
Well it turns out that, according to the data from the drug’s clinical trials it’s around four and half months before treatment is terminated with what would general be termed ‘extreme prejudice’, i.e. the death of the patient because four and half months or so is, on average, how much extra life a course of Avastin will deliver… provided, of course, that Avastin is being used as a supplementary treatment for colorectal cancer, which is currently the only purpose for which it has fully been assessed.
So far as breast cancer is concerned, NICE has, as yet, to produce any guidance on the use of Avastin for the simple reason that it use as a treatment for cancers of this kind is still at the trial stage. The drug is licensed for use, in so far as the usual testing process has established that its ‘safe’ for use in humans, inasmuch as clinical trials can ever assert such a thing with a degree of certainty – but as for whether it will provide an effective treatment for secondary cancers of the kind that Mills and Hirst have, right now the only answer any one is ‘who the hell knows?’.
So that’s the deal that Mills and Hirst are demanding here. They want the NHS to put up £6,000 per month in treatments, which they would have ot have alongside the Avastin for it to have any effect, to enable them to pay out a further £4,000 a month for drug that may or may not extend their lives by a bit, although by how much (on average) no one actually knows for sure although the best guess seems to be a few months, as this 2006 article from the New York Times indicates. Interestingly the same article also shows that even the otherwise notoriously profligate US system is baulking at the cost of Avastin, nevermind that its causing a few squeaky bottoms amongst the NHS’s beancounters.
NICE’s write-up of Cetuximab is equally interesting on a number of points, not least of which being that it appears very much as if NICE are pretty convinced that the drug company with the marketing rights in Europe, Mercx, massaged a few of its figures in an effort to get it through NICE’s approval process.
Costwise, Cetiuximab is a little less expensive that Avastin – NICE estimates around £12,000 for a full course based on the trial data it was given, and of course the $64,000 question is that of just how long is ‘full course’ given that such treatments routinely come to a very natural kind of end, the kind that leads to a funeral.
Working through the data, we find that a combined course of Cetuximab and another drug called Irinetocan gives a figure for median overall survival of 8.6 months against a figure of 6.4 months for Cetuximab alone – provided the treatment works, of course. You see, when you look at NICE’s evaluation of the drug you find a couple of intriguing ‘wrinkles’ that The Times hasn’t bothered to point out, for example…
The Committee was concerned that there were no studies that compared cetuximab with current standard care either in second- or subsequent-line therapy, or with any therapy not including cetuximab. The Committee noted that there were currently no clinical studies available comparing cetuximab with FOLFOX, and therefore the relative clinical effectiveness of cetuximab as a second-line treatment could not as yet be determined.
So, no one has, as yet, got around to comparing Cetuximab with other existing (and less expensive) treatments to see if it does actually prolong patients lives over and above what they might have had anyway. The report then goes on to note…
The Committee heard testimonies from clinical specialists that subsequent to second-line treatment progression-free survival and tumour response would be negligible if further active treatment was not available. Therefore the results seen in the single-arm cetuximab studies for these outcomes could be interpreted as an effect of the drug. It also heard that clinical specialists believed that cetuximab, in this situation, where no other active treatment was available, could prolong survival for a number of months if the disease responded to the drug. The Committee was therefore persuaded that cetuximab in this situation demonstrated some evidence of effectiveness. However, the relative effectiveness against current standard care remains uncertain.
Translated in English that amounts to ‘we’re pretty sure it works but we don’t actually know for sure just how well or whether it really does make a significant difference’ all wrapped around a rather ominous looking ‘if the disease responded to the drug’.
If? Whatever could they mean?
The Committee noted the contradiction that although the UK marketing authorisation stipulates that patients need to be tested for the presence of EGFR, a positive test for the presence of EGFR did not predict response to treatment. The Committee heard from clinical specialists that there is increasing knowledge of the mechanism of action of cetuximab and that it is now thought that the antibody identified through EGFR testing is different from the one targeted by cetuximab. The Committee noted the difficulties in identifying patients who were likely to respond to cetuximab, but was fully aware that decisions about its use in the NHS would have to be based on the current marketing authorisation.
You’re going to love this next bit, because what this passage of report seems to indicate is that the drug doesn’t appear to function in quite the way that the drug company that developed it expected, specifically the type of antibody that they thought it targeted and which they, therefore, tested for in order assess whether the drug might be suitable for a particular patient, now seems to have nothing to do with any of this at all.
In short, for any given potential patient there is no reliable means of assessing whether a course of cetuximab will actually have any effect at all, and even if it does, no way of assessing whether it will actually prolong the patient’s life for any length of time beyond ehat they might otherwise expect from the treatments that the NHs offers them free of charge. In fact, the only thing that can be said with any certainty, according to NICE’s evalution, is that if there is no sign of the treatment working after the first six weeks then you can be pretty sure that you’ve wasted you’re money, which by then will amount to something like £3-3,500 alone just for the cetuximab, never mind the costs of all the other treatment that goes with it which, if the NHS declines to foot the bill, will weigh in at around £6,000 per month.
So, your best case scenario for cetuximab seems to be one of dropping £10,000 per patient in total just to find out whether it actually works.
Setting aside the issue of the NHS co-payments policy and the extent to which that’s dictated purely by cost-consideration, it seem to me that there’s rather an interesting set of moral and ethical questions that’s starting to emerge out of the evidence.
Is there not something of a Faustian bargain behind all this?
If we go back to stage 3 in Hypothetical John’s story, is there no a sense in which the second opinion he’s received amounts to one of ‘maybe I can give you an extra four or maybe six months, if it works… now just sign this direct debit mandate and I’ll make all the arrangements?’
On the face of it, I think Mephistopheles probably offered Faust a rather better deal, all things considered… in which case, should the NHS really use taxpayer’s money to facilitate such arrangements?
Personally, this whole thing leaves me feeling rather queasy and certainly wondering quite to what extent this whole scenario differs, in moral and ethical terms, from the practice of showering vulnerable older people with letters telling them that they’ve won a 560,000 euros on the Ruritanian lottery which they can claim if only they’ll sign thins bank mandate and power of attorney.
I’m sure there must be differences but whatever they are the gulf between them and the lottery/419 scammers is nothing like so wide or clear cut as I’d like it to be for personal comfort.
But that’s just my opinion – you may see things very differently.
That’s not to say that we’ve reached the end of the story by any means – and yes, this is one of those long posts of mine.
You see, thus far we’ve only dealt with a few of the main protagonists. The Times, certainly. NICE, check done them. And in somewhat hypothetical terms we’ve also explored the situation of those, like Collette Mills and Jack Hose, who provide this story with the ‘human interest’ element.
All of which leaves us with… Doctors for Reform, the campaign/pressure group of, allegedly, 1,000 doctors who’re currently raising fund to cover the costs of a judicial review of the NHS co-payments system.
Who are they? What is there background and what kind of things motivate them to campaign on this issue.
Well, clearly there is neither the time or space to profile the full 1,000 doctors that the group claims as its membership but what the group’s website does provide are the names of the members of its steering group, so we can look at the group’s leadership and, perhaps, make a few reasonable inferences from there.
Before we get down to the detail, it’s worth noting what The Times had to say about the group in what is pretty much a standard puff-piece published in March this year, from which I’ll note a few ‘highlights’:
Doctors for Reform believes patients should be given the freedom to choose. Its intervention follows a campaign by The Sunday Times highlighting the plight of breast cancer sufferers denied the opportunity to improve their chances by paying privately for drugs…
…Dr Christoph Lees, a steering group member, said: “Doctors are caught in a terrible dilemma: do you tell a patient about a drug that could improve their quality of life, or do you pretend it doesn’t exist?”
So, Doctors for Reform is all about patient choice and informed clinical decision making, right?
Not really, it also about a fair bit of politics, as you’ll quick notice by checking at their own ‘what we believe’ webpage…
We all work in the NHS. We are committed to its values. But we believe the time has come to consider a new way to deliver healthcare in Britain…
The NHS cannot meet public expectations today. It is highly unlikely that it will meet them tomorrow. Future generations will seek rapid access to care, greater choice and more information about their treatment. We need a healthcare system which is equal to rapidly rising costs and demand, and which enables professionals to retain the essential bond of trust with their patients.
The time has come to look at new ways to supply and fund healthcare. We believe that these core principles should underpin reform:
* The fundamental NHS principle of care being universally and equitably available must remain.
* The primacy of the doctor-patient relationship, which politicians have undermined, must be restored.
* Management and administration must be more effective.
* Politicians must be removed from the day-to-day running of the health service.
* Patients must be able to exercise real informed choice about where, how and by whom they are treated.
Now, you’ll notice a couple of interesting points in this – for one thing, this group appears to be subtlety attempting to re-write the founding principles of the NHS such that universal healthcare delivered free at the point of need turned into ‘care being universally and equitably available’.
Equitable on what basis, and who’s terms exactly.
I suspect there may a clue or two in the comments of Dr David Wrede, one of the organisation’s steering group members, in this 2006 BBC article:
Mr Wrede and his colleagues want an end to the principle of funding the NHS through tax – and instead a system of insurance company provision, alongside a safety net for the poorest.
He said: “We have got stuck with the idea that the only equitable way to fund healthcare is through taxation, because of the 1948 settlement – regardless of how things have moved in the interim.”
Medical insurance and a ‘safety net’ for the poorest make for an interesting counterpoint to an article about high-cost cancer treatments, which under Wrede’s preferred system wouldn’t even be worth debating when it comes to anyone unfortunate enough to have to rely on the safety net. In fact, this whole piece would be a moot as, for the poorest, not only would £2-4,000 a month drugs like cetuximab be out of the question but most of the rest of the £6,000 a month care package that goes with it as well.
Nevermind, morphine’s nice a cheap and who’s going to miss a few poor people anyway.
Staying with the political, its worth pointing out that another steering group member, Professor Jim Thornton, possesses not only a impressive array of medical and academic qualification but also stood at the last election as the Conservative Party candidate for Nottingham East, not to mention that he’s a member of the Conservative Medical Society. Curiously, the URL from the CMS, which Thornton provides on his webpage give a file not found error but appear to have been hosted, at some point, by a London-based Christian charity called ‘Pecan‘ (???) and digging a little further turns up only a contact address in London on the Tory Party website and a blog, hosted on blogger, which seems to have run out of Avastin (or something) towards the end of last September.
Other than an interest in politics, Thornton and Wrede – who describes himself as a lifelong Lib Dem – share one other common feature which marks them out as somewhat different to the other members of Doctors for Reform’s steering group. They are the only members of that steering group who do not appear to operate a private practice or otherwise have declarable financial interests outside their work in the NHS and their political activities.
As for the other members of the steering group…
Mr Christophe Lees is neither a dentist or a haematologist – let’s get the ‘coo, don’t that sound like Christopher Lee’ gags out the way – is a Consultant in Obstetrics and Fetal-Maternal Medicine at the Rosie Hospital, which the maternity department of Addenbrooke’s NHS Trust in Cambridge, where he also founded Cambridge Fetal Care, which provides…
a private service for pregnancy scanning, invasive testing and counselling
All of which includes…
Viability and early dating scans, nuchal scans combined with blood biochemistry, detailed scans, both amniocentesis and chorion villus sampling with rapid chromosome results, fetal assessments and growth measurements in later pregnancy & both pre- and post-natal counselling.
Dr Paul Charlson is, according to Doctors for Reform, a humble general practitioner, who also has a nice sideline at the Q:ure Skinqure clinic in Hull (as featured on BBC Look North and in the Hull Daily Mail) where he provides the body dismorphic denizons of Prescottville with:
Wrinkle reducing injections (Botox), dermal fillers, skin peels, microdermabrasion, mesotherapy, sclerotherapy, radiolase surgery, lump and bump removal, dematological advice Smart-lipo with aspiration and radiofrequency skin tightening
What, no gastric banding? You’re missing a trick there I can tell you…
If that all seems a bit small potatoes so far, let’s take it up a few notches with Professor Steve Smith who, unless I’m very much mistaken is Professor Stephen K Smith, principle of the Faculty of Medicine of Imperial College London and the Chairman of the Board of London Genetics, which is…
a commercial company, facilitating and managing partnerships between the healthcare industry and a consortium of London centres of excellence in genetics and genomics-based medical research. London Genetics provides access to a consortium of leading London research institutions with an extensive range of facilities and resources.
Now, I don’t about you but I’m starting to sense a bit of a new theme emerging right about now, and that sense gets even stronger when we come to the final two members of the Doctors for Reform steering group…
We’ll start with Dr Maurice Slevin who’s a Consultant Medical Oncologist – that’s a cancer doctor, okay? – and when Dr Slevin is not fulfilling his NHS duties at dear old Barts and the London NHS Trust then I dare say you may run into him at the private London Oncology Centre on Harley Street, where he’s one of the four founding partners and one who, entirely coincidentally, lists amongst his specialisms both Breast and Colorrectal Cancer.
And to finish off the list we have Professor Karol Sikora, Professor of Cancer Medicine at the Hammersmith Hospital (NHS) and the proud operator of another Harley Street Clinic, not to mention that he also holds down the position of Medical Director with CancerPartnersUK, which is…
an independent organisation offering a refreshingly different approach to cancer care. We work with the NHS and other providers to create modern cancer centres where the latest technology in radiotherapy and chemotherapy is seamlessly delivered in a comfortable, welcoming environment.
Not mention, of course that is was…
Established by experienced cancer experts…
And that in order to meet its goal of
every patient coming to a CancerPartnersUK centre [being] treated in a way that lets them get on with life.
It’s clinics provide…
a patient-centred holistic service, including chemotherapy, radiotherapy, complementary therapy [that’s placebos and woo, folks] and some diagnostics outside of the traditional hospital setting.
And what kind of organisation is CancerPartnersUK, pray tell?
Company Type: Private Limited Company Nature of Business (SIC(03)): 8511 – Hospital activities
So it’s a private company then, one that doesn’t actually appear to have opened any centres just yet but which, judging by its list of services and other goodies…
* Capital for refurbishment and buildings * Risk sharing for new developments * Speedy building, installation and commissioning * Distributed care networks for both radiotherapy and chemotherapy * New ways of working to increase efficiency
* Distant complex radiotherapy planning * Novel chemotherapy settings * Telephone and web based monitoring * 24/7 call service for patients * Systems to reduce unnecessary emergency hospital admissions * Financial, management and strategic planning expertise * Economies of scale in procurement * Expertise in protocols and care pathways * Consumer focus and patient choice in a competitive marketplace * Agreements with a broad range of suppliers of both hardware and software to ensure that systems are tailor made for each project
…looks a lot like a company trying to make inroads into the PFI business.
Now with these last three members we’re are in rarefied territory in clinical and academic terms – we’re definitely up there with James Robertson Justice rather than languished down amongst the Dirk Bogarde’s and Leslie Phillips’ and I’m sure that each of them is not only a highly regarded physician but a man of integrity and honour…
However it’s certainly also the case that were either Sikora or Slevin to write to the British Medical Journal to offer a comment or two on the case of, say, Collette Mills or any other similar case, let alone on Doctors for Reform’s efforts to drag the whole issue of NHS co-payments before the High Court, then each of them would be required to declare their private practice interests as a matter of routine and in the interests of transparency, for such are the ethical requirements of the BMJ.
Professor Smith’s potential interests are, here, somewhat more tenuous and rather more a matter of potential – as the Chairman of a biotechnology company, albeit on that appears to exist for the purposes of exploiting the potential of research conducted in British academic institutions before they get gazumped by Big Pharma, any ruling which might make it easier, in the long run, to get new and largely unproven high-cost drugs and treatments past NICE and into use within the NHS will have a bottom line that will impact on the business plan/strategy of a company like London Genetics.
Within medical science, R&D is an expensive business not least because the exhaustive clinical trial process that new drugs have to be put though just to establish that they are safe for use. Having overcome that hurdle, any change in NHS policy that then makes its easier for these new, and often expensive drugs, to find a market and start generating revenues is going to be a big plus, even if its going to be a few years before this becomes an issue in which London Genetics has a direct, and declarable, interest.
Now, having read all that, do you still feel the same about this issue as you did when – hopefully – you clicked through the link at the start to see what DK had to say about this issue?
Maybe you do – or maybe I’ve raised a few questions and sewn a few seeds of doubt here as to whether what The Times has been reporting is actually a fair, honest and realistic appraisal of this situation.
And if that’s where you’re at right now, then I’ve done what I set out to do.
Time, I think, for a closing quotation, and who better for this article than Goethe…
Men’s wretchedness in soothe I so deplore, Not even I would plague the sorry creatures more.