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.
Since that first article, The Times has highlighted a number of similar cases, adding Debbie Hirst, Jack Hose and, most recently Linda O’Boyle, who has sadly succumbed to her illness.
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…
We offer:
* 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 efficiencyOther services:
* 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.Mephistopheles
Excellent post.
Incidentally Dr David Wrede was a Liberal Democrat candidate (Hampstead and Highgate) in the 1992 general election. He may well since have changed his political affiliation.
This is really interesting, but what you don’t do is give any reasons why these people shouldn’t be allowed to pay for these non-approved treatments privately, while receiving approved treatment on the NHS. What’s wrong with co-payment?
I kind of agree with Tom.
Should the NHS also refuse treatment for people who supplement with other things that don’t work such as prayer or “alternative” therapy?
The lack of directly comparable trials with current treatment for the drugs mentioned above is not restricted to them- try any of the new monoclonal antibodies or receptor blockers and you will see that there is a lot of comparison with standard treatment/ placebo but no direct comparison. The actual QALY cost is also always somewhat underestimated! The sheer cost of these new medicines means that there must be a hard look at their efficacy, or we will end paying for what could potentially be a be a lot of smoke and mirrors. However where the evidence is robust and unbiased then of course this medicine should be provided or at least NHS care should not be prejudiced.
Indeed also with Tom and Joe; kinda immaterial whether these people are being sold woo masquerading as science; the accompanying treatment is something they would have been offered along with conventional NICE-approved treatment – they would receive this anyway if they requested it up to (though not in every case) third line treatment, if available. Bringing private money to the pot creates a bigger pot, not just for the person receiving the treatment, but for others as well in the form of drug development, research and grows the NHS. Instead this is, as DK has said, a cost-exercise to kill patients who have seen conventional treatments fail or told they would fail and wish to try something new in the name of making the NHS a more cost effective “enterprise”; it is not – it is a loss leader for the business of society in making it more competitive – it isn’t perfect and there are better alternatives, but what the politicos are no doing to it is destroying even that.
Declaration of interests: none – I am a chemist by trade and have studied in the recent past designer anti-body treatments in therapuetic use; the technology is expensive and is in its infancy but is leading to more effective treatments – all of which a system of liberalised co-payments would help shift along. Yes it allows the rich(er) to purchase a better form of healthcare but better it be the middle classes as the cut-off than the upperclass, the poor and the not so poor rather than the poor and the filthy rich.
It aint fair either way, but then life is rarely fair.
As Tom and Porthos, so long as the patient is fully informed to the best of NICE’s abilities of the efficacy of any proposed additional treatment.
The thing about co-payment is that once it’s in, it’ll spread – remember free education? Most people won’t ever need these drugs, so when the NHS is short next, it’ll be a lot easier to bill more patients than fund it from general taxation (!!Teh income tax!!Ni!Ni!), and so on until not being able to afford treatment becomes a common condition, as it is in the co-paytastic USA.
It is much more important to hold the line on free at the point of use, which accounts for far more saving of life and reduction of suffering than this sort of boutique medicine ever will. Even the majority of cancer patients won’t require this – the prime treatment for cancer is surgery, whose success is strongly associated with early diagnosis. The religion of socialism is the language of priorities.
haha I’ve been digging on these jokers too.
Karol Sikora is also big in the Taxpayer’s Alliance, he wrote the foreword to a particularly dumb report by them about how the NHS is all a bit five minutes ago and found no evidence of benefit for extra spending (probably because it used ordinary least squares to fit a line through rate data instead of eg poisson regression, am i the most interesting man you know?).
The TPA are notable for being exceptionally good at getting in the papers, these chaps too.
Have to say I’ve not come across this blog before, probably won’t again. While some of what you say is correct – the difference these drugs make is limited to a few months, they are very expensive, and the evidence is variable in quality. I got bored with the last bit on Doctors for Reform – I can guess that there will be conflicts of interest galore there.
However, as others have said already, why the hell should people not be able to pay their money for extra treatment? THe government’s arguement (and yours?) is that it’s better that everyone should die equal than some might survive a bit longer. It’s clearly nonsense, as has been pointed out elsewhere – if you buy some over the counter paracetamol prior to seeing your GP he will congratulate you on looking after yourself, not kick you out of his surgery!
>Pecan
Stands for “Peckham Evangelicals in Action”; they’ve been known as Pecan since the start. A community organisation supporting its community since 1the late 1980s, as far as I know.
1996 Interview here:
http://findarticles.com/p/articles/mi_m0KZH/is_1_14/ai_30121423
It looks like they work with half-a-dozen local authorities.
On the medical stuff, I’m fascinated why NHS Doctors are allowed to combine private and NHS work, but patients who pay for a more effective private treatment are excluded from treatment. As a minimalist position, I can see no real objection to co-payments for recognised and effective drugs that are not available on prescription – but I can’t find the exact policy. This case raised my eyebrows:
http://www.timesonline.co.uk/tol/life_and_style/health/article4040168.ece
I don’t think you covered it, but I don’t trust them without at least some corroboration (see: Bishops).
Declaring an interest, I have a family member just about to come out of cancer post-op critical care.
NHS has generally been good, although a fair amount politics, lots of burocracy and pillar-to-post passing (multiple delays – some with good reason, some not), and some rather nasty handling of patients in order to meet command and control targets (calling patients in where beds are known not to be available since the ward is being refurbished and was scheduled to be so months before the appointment was sent out – nurses in despair because they know reporting up the chain will change nothing. No idea whether it was local or regional management unwilling to tell the higher-ups to change the targets).
Excellent post, as ever. Good to know there are medics willing to make a shitload of cash from people’s misery. Some things never change.
And that’s the bottom line, whoever has a problem with co-payment. If any of you have worked in healthcare, you’d probably see the problem more clearly. Imagine you have two patients with similar diagnoses. One is part of the affluent middle-class, one has a more working-class background. Both have paid NI all their lives. Both are informed of these random, maybe-effective drugs that could prolong their lives, but only one can afford the treatment. What do you say to the patient who cannot? ‘Tough shit’?
Perhaps another point should be aired following your character assasination of these cancer specialists.
The NHS pays these gentlemen about
OFMN,
You’re a spiteful fool. See my post above if you really think they’re “making money out of misery”. If these guys wanted lots of cash, they’d do orthopaedics or cosmetic surgery, and not have any hassle at all.
Not everyone is like you.
And in your example, currently it would be “tough shit” for both, read the article.
The Government’s logic is flawed.
1. These drugs are not available on the NHS, because they do not provide worthwhile effects for the money.
2. We will not allow you to take these drugs because it will create a 2-tier health service.
If taking these drugs gives me superior healthcare, then they are not as ineffective as suggested.
If the drugs are so ineffective then they are not giving me an advantage that others can’t afford.
The government seems to be believing two mutually inconsistent things at once. This would be amusing if it wasn’t using this thinking to kill people.
A good explanation of why these drugs shouldn’t be paid for from the public purse, but they aren’t paid for by taxpayers anyway so that isn’t the issue. Why shouldn’t individuals be able to decide that the small chance of a few more months that these drugs might give, if added to what they have already paid for to get from the NHS, is worth it for them?
I still don’t see why people should not be allowed to pay themselves for treatments that the NHS doesn’t pay for. A lot of patients go to all kind of alternative medicine. The NHS must make decisions about which treatment wil be available for all, I have no problem with that. Before very expensive cancer treatments with limited effect will be available for all, I would like to have a discussion if we could not spend that money to provide more evidence based treatments in Mental Health. The two tier system already exists, you can better have cancer than a mental illness. But I don’t think that patients should be punished if they pay themselves for extra treatment.
I agree with Tom and others, you have not made a case for the NHS to withdraw treatment if a patient pays for additional drugs not available through the NHS. There might be a case if the NHS treatment had to change in a way that made it significantly more expensive for little, if any, benefit.
However, I also agree with Alex. If co-payment becomes acceptable there will be creep and gradually more and more things will require expensive additional payment.
Unity I agree with much of what you say, and in particular with the fact that many (all?) of the doctors for reform group have significant non NHS commercial healthcare interests which calls into question (to put it politely) their position on many of thee issues.
NICE very much takes your view that the costs of these treatments outweigh their benefits for the average person, and most sensible doctors accept that cost-effectiveness is an important measure to decide what treatments the NHS can afford.
BUT let me give you another case: Jane is a 35 year old mother of 2 children age 4 and 2. She has just been diagnosed with colon cancer which has spread to her liver, but only in a relatively small volume. She wants to be able to spend as much time as possible with her children so that they will remember her when she is gone. Her doctor tells her that with the chemotherapy available 10 years ago (which costs about
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If you don’t know a bargain when you see one, you are the loser.
Interesting article. However:
– You (and, more worryingly, the NICE committee) appear to have confused antibody (the drug) with antigen (the target ie EGF) throughout. Please correct me if I am mistaken.
– You article concentrates more on QALYs, where the principles are of logic and effectiveness of therapies and have been debated to death, than on the issues around co-payment, an apparently phenomenon which I struggle to comprehend.
Apologies: should have read:
“…an apparently new phenomenon…”
Lionel:
My reading of what NICE has to say on cetuximab is that its been found that the drug doesn’t work in quite the manner that its developers predicted – its doing something but not in quite the manner that the company behind it thought it would.
The upshot is, as I read it, that while this doesn’t appear adversely alter the data on the performance of the drug when it works, what it does do is render the test, which the company thought would help identify whether a particular patient is likely to benefit from the drug, largely useless.
The co-payment issue is one I’ve picked up on in a follow-up post but the short version of my position is that I would have no problem with allowing co-payments on a case by case basis for drugs that are licensed for the purpose for which the individual patient is seeking them and where there is sufficient evidence from clinical effectiveness trials to give the patient an honest appraisal of what they might be able to expect in return for their money.
What I would not support is co-payments made in such a way as to facilitate access to unlicensed and/unproven treatments where there is insufficient evidence on clinical effectiveness to permit a patient to make an informed choice, which seems to be the case in all the cases highlighted by The Times but not the case in the example that Mens Sana cites a couple of comments back.
Unity,
My point on the antibody / antigen (target) confusion, and it may be a pedantic on, was that it destroys a lot of confidence in the author: ..”the antibody identified via EGFR testing is different to the one tageted by cetuximab.” makes very little sense given that cetuximab is the antibody (cetuxim(onoclonal)a(nti)b(ody) and EGFR is the target (antigen) to which the antibody binds thereby (in theory…) having its effect. The drafting in the committee quote is quite opaque but that is my interpretation of what they have written. If that’s the case, I am not sure how much faith I have in their assertions in the rather more complex area of assessing the efficacy of a therapy, lack of or otherwise.
You are spot on regarding the co-payment issue: I am slightly bewildered that this is the case and, if it is, I would like to understand why it is the case.
Let me see if I can help.
What the developers believe[d] is that cetuximab works by binding to the extracellular domain of cells which express EGFR (epidermal growth factor receptor).
Now my ‘thing’ is neurobiology and not immunology, so while I can follow some of this I may be a little shaky on the fine detail, but as far as I can make out EGFR is a biochemical receptor that cells produce naturally anyway, but in cancer cells the production mechanism goes into overdrive and produces it in excessive quantities. This causes the body to produce antibodies in response to the oversupply of EGFR.
As such the test regime is analogous to that used in, say, testing for HIV, where you cannot test directly for the presence of the virus, because its too small to find, so what you test for is the presence of antibodies that the body generate to try to counter the virus, test being large enough to spot.
The test is not for EGFR itself but for the level of naturally produced EGFR antibodies, from which it can be determined as to whether or not the cancer that patient had is of a type suitable for treatment using cetuximab. If levels of EGFR antibodies are abnormally high then you have a winner and can move on to the next stage and start the treatment.
This is all well and good if the drug works exactly as expected, but what NICE appear to be indicating is that it doesn’t and that what it interacts with is not the EGFR receptors that the developer expected but some other relevant biochemical receptor. This doesn’t necessarily mean the drug is useless but it does mean that testing for EGFR antibodies ceases to be reliable means of identifying whether the drug is likely to prove to be effective for a particular individual.
The drafting of the committee may seem opaque but, to be honest, I suspect that that’s much more a function of the complexity of immunology than any fault on the part of the committee.
It may not quite fit in with your notion of what constitutes the clinical hierarchy of complexity, but compared to the immune system the biochemistry of the brain is relatively straightforward.
Mens Sana:
If ever a comment deserved a response then your does…
As I’ve already noted I think you patient’s situation is qualitatively different from those that The Times has been featuring. Avastin is licensed for use as a treatment for colorectal cancer and as I’m assuming here that their test results show them to have a form of cancer that would respond to the treatment and that you’ve given them the full rundown in terms of costs, possible benefits and chances of success/failure then your patient is in a position to make an informed decision about whether or not to take the option.
In that situation, were I her doctor, I would be going in to bat for her and doing everything I can to help her gain access to the treatment if that is genuine what she wishes.
So far as priorities go, survival is number one, so she should take what the NHS has to offer regardless of whether she intends to push the issue on Avastin. If I’m reading the guidance correctly then, in clinical terms, accepting the NHS package at this stage does not rule out having another go with Avastin a bit further down the line although, depending on how her condition progresses, delaying the Avastin treatment might have some effect on her quality of life.
The number two priority would be to get her into a cancer support group and make damn sure that no matter what else happens she has a chance to make the most of the time she has left.
After that’s sorted, then it time to look at what might be done to challenge the co-payments issue and or bring the cost of treatment down to a more affordable level, which means a two-pronged attack.
One strand would be to get on to the relevant NHS trust and appeal the policy on grounds of exceptional circumstances. All trusts will have noted the adverse publicity these issues generate and yours may not be for the fight and minded to exercise a bit of discretion on the budgets provided its all done quietly and without getting the press involved.
I would also follow what some doctors have done in the US and make a bit a noise about the cost of this treatment and pose a question or two about whether it can be justified. In my experience, there’s as much of a good story in a tale of Big Pharma screwing the little guy as there is the government doing the same thing and they can be just as sensitive about the effect of bad press on their share price as politicos can be about the effect they might get at the ballot box.
I’d also suggest that she cast around for a lawyer who might take on her case on a pro bono basis but I would not advise her to join in any litigation taken forward by Doctors for Reform if that is going to be based on cases in which the drug that being sought isn’t yet fully licensed or evaluated. She has a better case for Avastin being licensed and evaluated for her condition than any of the others that The Times have raised and, I think, quite a strong argument as the courts generally do not like arbitrary decisions.
That said, anyone who thinks that a judicial review will actually force the NHS to accept co-payments doesn’t understand how judicial reviews work as the most anyone will get is a ruling that sets aside the use of a blanket policy in favour of requiring NHS trusts to consider co-payments on a case-by-case basis, in which case the trust is still in a position to consider each case on its merits and then turn it down anyway.
Best case scenario for most people would, I suspect, be a ruling that the NHS cannot withdraw or ask for payment for ancillary/palliative care but whether a court would rule it must provide the chemotherapy that runs in conjunction with Avastin is another matter entirely and one I couldn’t call at this time.
A very well thought out, detailed and researched article. However I do have some problems with it.
‘It might lengthen the patients life and cost the NHS more’. Well – Duh. Isn’t lengthening the patients life the point?
‘It might not be effective’. So what – its not your money. If someone want to spend their last
Slight edit to previous post
‘It might not be effective
If someone want to spend their last
Thank you, Unity.
Very few bloggers would the time to provide the context of a quote: thanks again.
Provide, of course, that they
Because even if one allows for the largesse accorded to purveyors of woo, if someone tried to charge 4 grand for ‘light crystals infused with moonbeams harminised with the lifegiving energy from nature’ then I strongly suspect that their local Trading Standards Department might have a few things to say about it.
Not to mention that giving patients the information necessary to make an informed choice is not an option but a matter of professional ethics.
What it has to do with the NHS withdrawing certain treatments is that it would be unethical for the NHS to act in a manner which facilitated access to an unlicensed and/or unproven treatment using taxpayers money.
I am getting more and more confused with the reasoning presented but here goes again.
“Not to mention that giving patients the information necessary to make an informed choice is not an option but a matter of professional ethics.”
Yes. Agreed…..And? What does that have to do with forcing a patient to pay for all of their treatment if they to pay for something extra? I do not understand how a matter of professional ethics adds up to forcing a patient to pay for all of their NHS treatment if they want to pay extra for additional treatment.
“What it has to do with the NHS withdrawing certain treatments is that it would be unethical for the NHS to act in a manner which facilitated access to an unlicensed and/or unproven treatment using taxpayers money.”
Who was taking about using taxpayers money? Look through the previous comments. No-one is talking about trying to get the NHS to pay for dubious, unlicensed or ineffective treatment. It is about withdrawing NHS treatment because someone what to pay for an additional treatment using THEIR OWN MONEY.
I can only repeat it again to make it crystal clear. The discussion is not about funding dubious, unlicensed or ineffective treatment through the NHS or forcing Doctors to go against their professional ethics. It is about forcing a patient to pay for their NHS treatment if they want to pay extra for additional treatment with THEIR OWN MONEY. I really do not understand why there is confusion on this point.
I can see I’m going to have to take this a little more slowly.
Thus far The Times has highlight four specific cases in the course of its campaign.
Two of them, Collette Mills and Debbie Hirst wanted Avastin as a treatment for secondary cancer following breast cancer and at the time they wanted this Avastin was not licensed for that purpose either here or in the US.
It has since been licensed for that purpose in the US (April 2008) but only on appeal after it was initial turned down by the FDA’s panel on a 5-4 vote against and only because the lack of solid evidence for its clinical effectiveness in this context was pretty much disregarded.
The other two case, Jack Hose and Linda O’Boyle wanted cetuximab to treat colorectal cancer. Cetuximab is licensed for that purpose but, as yet, there is no sound clinical effectiveness data and its been found that the pre-treatment test that is used to identify suitable candidates is unreliably because the drug doesn’t function as expected.
The ONLY specific case where a patient is considering treatment for one of these drugs (Avastin) for a condition for which it is both licensed and has sufficient clinical effectiveness data to allow for properly informed to choice to made is that of Jane, which Mens Sana raised in comments.
Now in order to avail yourself of this treatment you need a care package that comes in what is effectively three parts.
There is the ancillary care which includes assessments, nursing care and palliative care. It’s not at all clear from anything in the press whether this is part of what the NHS is withdrawing if people go private but if it is then they shouldn’t be doing it in my view.
There is, of course, the Avastin or cetuximab, which the NHS doesn’t provide because its not cost-effective and because, depending on type of cancer were dealing with the drugs may still be at the trial stage for clinical effectiveness.
And then there’s the course of chemotherapy that needs to be administered along with the Avastin/cetuximab in order to get the full benefit of the drug.
Now that is the component that the NHS is, in my view, quite justified in withdrawing from patients if they wish to use unlicensed and/or unproven treatments, which is the case for Mills, Hirst, Hose and O’Boyle but not the case for ‘Jane’.
So even if the system did allow for co-payments, only Jane should, in my view, get the full NHS care package, with the chemotherapy, free of charge while the others should pay for the chemo but not the ancillary care component because it would be unethical for the NHS to provide the chemotherapy element as this would amount to aiding and abetting patients in their efforts to obtain unlicensed, unproven treatments.
Money is not the issue here, for me, behaving ethically and taking reasonable measures at least try to protect vulnerable individuals from exploitation is.
Does that sort out the confusion?
Unity thanks for the response, and for the interesting post. You will be pleased to hear that most of what you suggest is already done. I am always very reluctant to advise patients to go to law as in my experience the issue tends to become a burning obsession which takes a lot of the energy people should or could devote to living. In her case, actually I am hopeful the PCT may agree to fund the drug.
wrt your other comments.
Cetuximab is an antibody to the EGF receptor. This receptor is “overexpressed” in a high proportion of colorectal cancer cases. The drug is licensed for use “in colorectal cancers expressing the EGFR” ie in whom it can be detected by testing their tumours. The drug works-no question. Although as stated above for avastin, only in a small minority of cases. HOWEVER, research has shown that the expression of the receptor is not necessary for the drug to be effective. In fact I think this says more about the diagnostic test than the drug. If I haven’t bored you sufficiently then I could tell you that there is a test for a protein called KRAS which if abnormal does predict non-response (but not response) to cetuximab. This fact supports the biological hypothesis for the mode of action of cetuximab through inhibiting the EGF pathway as KRAS is “downstream” of the EGFR
NICE does not dispute the effectiveness, only the cost-effectiveness. Cetuximab when combined with chemotherapy is approximately twice as effective as when used alone.
Avastin in breast cancer (and indeed all drugs in breast cancer) is another issue entirely. It is to my mind definitely the case that drugs for breast cancer are fast tracked for approval, and are often approved with limited evidence for efficacy. This is partly because J Hoffmann LaRoche is a very effective marketing and lobbying company, but also because of the power of the breast cancer lobby. No health secretary likes to be attacked by hordes of pink-ribbon wearing articulate middle class women (cf Mrs Hewitt and Herceptin).
Yes it is a long post, but for the benefit of my understanding, and in the interests of getting to the point, I gather that your points were:
1. The Press often do not tell the whole story – especially human interest stories.
2. Cetuximab and Bevacizumab limited effectiveness in a small (as yet poorly characterised) group of people.
3. Despite this there are patients who are willing to clutch at straws (and doctors who will encourage them).
4. NICE has reasonably decided that the economic cost of subsidising these treatments is not justified.
5. Hospitals / the NHS are not willing to subsidise (even in part) the cost of these treatments, and as a disincentive is not willing to provide any subsidised services for patients who pay privately for these treatments.
6. The reason for this disincentive is the policy that NHS health care is free, and that a most excellent series of committees have decided what is statistically best for all patients and is implementing this without exception. If you or your doctor disagree then you must go fully private.
7. Doctors for reform thinks that point number 6 is Bunkum (they might be right, they might be wrong).
8. Doctors for Reform and its steering committee members have not fully disclosed their political or non-clinical interests in this issue
9. Doctors for Reform members have deliberately used DfR to push for a change in the principles of the NHS which is commercially advantageous to them, without full disclosure.
5. You disagree with DfR’s position on co-payments, and the concept of a safety net with a larger private insurance system, as well as their lack of disclosure.
Is that a fair summary of what you are trying to say?
To Unity.
“…..only Jane should, in my view, get the full NHS care package, with the chemotherapy, free of charge while the others should pay for the chemo but not the ancillary care component because it would be unethical for the NHS to provide the chemotherapy element as this would amount to aiding and abetting patients in their efforts to obtain unlicensed, unproven treatments”.
Thanks for clearing up the confusion by explaining your position fully. From your statement quoted, we now agree that patients paying for additional treatment should not be forced to pay for (standard) NHS treatment. Funny there was that confusion, as that was exactly my point. I must have not have made myself clear enough!
I really enjoyed reading this post: Great coverage of the issues, well researched and couched in such a way as is accessible for all. In particular, the section on Doctors for reform sets out what appear to be obvious conflicts of interest, and a barely concealed motivation for insurance-based healthcare provision to supplant Aneurin Bevan’s founding principle of healthcare free at the point of use. However, there are some areas on which I cannot entirely agree:
1) You lump together unlicensed and unproven drugs, but there is an important distinction to be made. The primary consideration with any new drug must always be one of safety rather than efficacy. If evidence of safety (to the extent that this can be ever considered proof) cannot be provided through a phase 1 trial, then the NHS MIGHT be considered justified in not offering treatment related to drug related toxicity – although I cannot imagine many doctors turning away a critically ill patient regardless of the cause.
Unproven drugs (and by that I mean those which NICE has not approved for NHS use) is an entirely different matter. To see why, consider the constant state of flux of cancer research; New drugs and novel targets are being discovered at an impressive rate (for an example, read some of the papers and poster presentations at the recent annual meeting of the American Society of Clinical Oncology). In order to authorise NHS usage of a particular drug, NICE must run some fairly abstruse econometric models, which are predicated on a number of assumptions (which clearly can alter the outcome). The implications of this are twofold. Firstly, it will take time for most drugs to be sanctioned irrespective of the efficacy data, and this is a commodity many patients do not have. Secondly, whilst it is correct that we defer to expertise to make the objective judgements which help decide which drugs are available for free provision for all, this should not preclude individual patients from picking up the tab for that drug if they so desire to do that with their money. There is a vital distinction (made by mens sans) between cost-effectiveness and effectiveness. The failure of NICE to recommend a new treatment, does not rule out the possibility that it could help a particular patient (For example, consider the use of Aricept for mild Alzheimers disease). It might, it might not – but where is the harm in letting them try if they pick up the cost?
Indeed, as you rightly conclude, many of the cancer drugs remain at the trial stage for clinical effectiveness for treatment of a specific cancer. They are are therefore, by their very nature, “unproven” in the sense of statistically significant results in a large sample. Nevertheless, a patient might wish to try a drug off-trial, if it has shown promising results in smaller samples. Once again, if they are willing to pay the cost of the drug, why not?
You might argue that the patient does not pay for any complications related to new drug use if we were to allow for co-payment of this sort, but the NHS covers the side-effects of more pernicious lifestyle choices such as smoking, drinking and illegal drug-use.
2)I am inclined to agree that if standard chemotherapy is required alongside the new drug in order to make it effective, then the patient should pay for their entire drug combination (IF they would not be having one without the other). My real concern is that everything will be withdrawn from the patient (correct me if I am wrong here). As far as I understand it, Cancer patients who try new drugs will have to pay for all their treatment thenceforth including doctor consultations, nurse care, blood tests, scans etc and for Cancer patients this is a considerable amount of care and by extension would not be cheap. For this to be the only factor which precludes an individual from trying to extend their life, and for it to be an active policy of the NHS seems cruel and inhumane.
A well drafted bill in parliament could put in place the necessary safeguards to stop the ‘creep’ of privatisation into the NHS, which so many of this issue’s opponents fear. If the bill stated unambiguously that patients can pay for a treatment regime (including associated chemo) if and only if their disease is refractory to all available NHS treatment modalities, then this would strictly rule out any shrinkage of the NHS for ailments which can be cured or effectively managed and treated. Indeed, if managed correctly it could serve as an opportunity to restate the importance of the NHS for the general population as a whole, but provide new treatment opportunities for patients with recalcitrant disease.
If these safeguards can be put in place, then such a move may provide hope for patients who have none. That is surely reason enough.