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INSIDE THE ETHICS COMMITTEE

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Programme 3. - Cancer drugs

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RADIO 4

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WEDNESDAY听听听听听听听听听听听听听听听听听听听听听听 07/06/06听听听听听听听听听 2000-2045

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PRESENTER:听听听听听听听听听听听听听听听听听听听听听听 VIVIENNE PARRY

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CONTRIBUTORS:听听听听听听听听听听听听听听 DEBORAH BOWMAN

听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听ANN SLOWTHER

听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听CHARLES FOSTER

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PRODUCER:听听听听听听听听听听听听听听听听听听听听听听听MICHELLE MARTIN

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NOT CHECKED AS BROADCAST

PARRY

Welcome to the final programme of our series.听 Each week our panel, all of whom sit on hospital ethics committees, consider a real life case, highlighting the ethical issues and showing you how they develop their sometimes controversial advice for clinicians.

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Today we discuss the ethical issues surrounding cost of treatment. NHS resources are finite, funding one person's drugs may mean others don't get what they need. Some may even die as a result. 听

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The cost of new treatments has become a major public issue, with high profile cases hitting the headlines every week. Perhaps you feel cost should play no part in ethical decisions or maybe you have other views. If so, you'll have an opportunity to give us your thoughts after the programme, by telephone or on our website and I'll be giving you the details later.

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Our final case then involves Richard, who is in his early 50s.听 He and his wife have three children, all still living at home.听 Last year Richard began getting pains in his abdomen.听 After three weeks he went to his GP who sent him for hospital investigations.听 It wasn't good news.听 His liver was three quarters full of cancerous tumours. Worse, these were secondary growths with the primary cancer discovered in his colon. Things looked very bleak for Richard and his family but there was one gleam of hope on the horizon.听听 His cancer specialist takes up the story.

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ONCOLOGIST

He was then referred to me to consider chemotherapy to try and treat both the cancer in the bowel and the spread of the cancer in the liver.听 We talked at the time about our standard chemotherapy drugs for this particular kind of cancer.听 Richard started on the drug and received one cycle of chemotherapy, he then came back to clinic with information that he'd seen in the press regarding the drug Avastin and we had a long discussion about the pros and cons of this drug and the fact that it's not currently available routinely on the NHS.

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PARRY

Avastin is a new drug which has been developed for those who at first diagnosis are found to have bowel cancer which has already spread to other sites.听 It's a type of medicine called a monoclonal antibody. It targets tumours, and stops them from growing by preventing the formation of new blood vessels.听 It's administered intravenously alongside a specific type of chemotherapy.

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Avastin, which costs eighteen and half thousand pounds per patient, isn't available on the NHS, although the chemotherapy is.

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ONCOLOGIST

We had a discussion about ways in which we may be able to obtain funding for him.听 One was obviously to go completely privately but they didn't have private healthcare insurance.听 The second was for him to pay just for the drug Avastin itself but remain an NHS patient.听 Or thirdly was to approach his primary care trust to see if they would fund the drug for him.

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PARRY

So should the primary care trust pay for this treatment for Richard?听 If he pays for the Avastin, what are the ethics involved in the NHS paying for the rest of his treatment?

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And at that point, let me introduce the panel for today:

Deborah Bowman is senior lecturer in medical ethics at St George's Hospital Medical School.听 Charles Foster is a barrister specialising in medical law who's on the editorial board of the UK Clinical Ethics Network.听 And Ann Slowther is a GP and senior lecturer in clinical ethics at Warwick University's Medical听School.

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So Deborah, what are the main ethical issues in this case?

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BOWMAN

The main ethical issues are first what the NHS can and should fund.听 Secondly, what the ethical issues might be of mixing private and public healthcare.听 And the third are the implications for the doctor/patient relationship as newer drugs are developed that may not be available.

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PARRY

Okay, so let's begin our discussion with that first issue about funding for non NHS drugs by returning to Richard's cancer specialist for some more details on his case.

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ONCOLOGIST

Without any treatment prognosis for bowel cancer that's spread to the liver is below a year.听 With chemotherapy the medium life expectancy would be about 15 months.听 The large study which was published in the New England Journal in 2004 suggests an additional five months increased in survival in patients who received Avastin.听 So from 15 months to 20 months.

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PARRY

This drug isn't life saving, but it will prolong Richard's life by up to five months. However, it would cost around eighteen and a half thousand pounds in addition to the costs of his chemotherapy.听 Richard and his GP applied to the primary health care trust to see if they would fund the drug for him.

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Charles, let's start by just getting some of these terms sorted.听 Avastin's a licensed drug but it's not approved - what does that mean exactly?

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FOSTER

Before the NHS are obliged to prescribe a drug the drug has to jump two hurdles.听 First of all, there's a European level, the European Medicines Agency looks at a drug and decides whether or not it's safe and whether or not it works.听 If it gets European licence it's then looked at by the National Institute for Clinical Excellence in this country.听 There may at the level of that NICE examination be another look at the safety and efficacy of the drug but what NICE will be mainly interested in is value for money.听 NICE will know much more than the European Medicines Agency does about the competing financial priorities for drugs in the UK.听 If a drug gets the endorsement from NICE the NHS is under a duty to prescribe it.听

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PARRY

So this drug then is licensed but not approved, which means people have to go to their PCTs if they want it.听 Ann, you've been involved with PCTs before on this sort of issue, who makes the decision there - is it an ethics committee?

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SLOWTHER

Well it will vary depending on the primary care trust.听 In some situations it may be an individual like the medical director in the trust, in other situations the primary care trust will have a committee that is set up to look specifically at these individual requests for treatment, which is not necessarily an ethics committee.听 And yet other trusts will have a form of ethics committee which is often called a priorities committee or priorities forum which looks at the broader issues of resource allocation from the trust and one of those issues may be individual treatments.

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PARRY

And who represents the patients in trusts?

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SLOWTHER

Well within a committee looking at individual patient treatments or a priorities forum there will be non-executive members of the primary care trust on that committee and they are there to represent the patients.

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PARRY

And is there a specific framework for these discussions?

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SLOWTHER

Most PCTs will not have a specific framework and particularly not one that includes ethical values.听 Most PCTs will be making the decision mainly on issues of effectiveness and cost effectiveness when they make these decisions.听 Although some PCTs have developed specific ethical frameworks for decisions around resource allocation issues.

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PARRY

Deborah, so are these decisions about ethics or about cash?

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BOWMAN

I don't think the two are separate, I don't think you can have ethics that takes place in a utopia where funds are unlimited.听 Resource allocations has been described as the ghost of ethical analysis and I think that's a nice description.听 It's impossible to have an informed ethical discussion without thinking about resource allocation, we have to engage with it.听 I think the issue for me is not whether we engage but how we do that and whether that's transparent and honest and well thought through.听 However, it is not simply about cash and I think cash is not the primary consideration, it is a consideration but it isn't the primary consideration, it is merely the realistic backdrop, if you like, for doing what has to be done.

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PARRY

Because there must be an ethical dimension because if you fund one person then you are having an impact on the ability of others to receive care?

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BOWMAN

Yes absolutely and I think we normally think about individual patients who may or may not be able to make a claim on the NHS but actually the real problem here is how to meet the needs of all patients, both those who are speaking and those who are silent.

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PARRY

And Ann, how were these decisions made?

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SLOWTHER

Well the GP will submit an application to the primary care trust for funding for this particular treatment which is not normally funded.听 And then either the individual medical director or the committee will consider that application.听 They will be asking for the evidence that that drug is effective.听 If it's going to be effective in that particular patient - so does that patient and their condition actually fit with the evidence for this drug or treatment.听 They will also be looking at the cost of the drug, not only the cost effectiveness for this particular patient but the cost implications if they set a precedent by providing the drug for this patient and then there are many other patients in a similar situation who would then say well I would also want the drug provided for me.

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PARRY

Charles, what do the PCTs consider in cases like this and is there a measure of how they gauge a drug's effectiveness?

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FOSTER

Well the classic measure which is used is called a QALY, which is an acronym standing quality adjusted life year.听 And basically it's a measure of how many years of life are bought per pound of NHS money and there's an adjustment for the quality of life which is bought per pound of NHS money.

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PARRY

That doesn't necessarily sound a terribly fair situation, is it fair Charles?

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FOSTER

It depends if you're an unreconstructed utilitarian I suppose.听 QALYs are the high point of utilitarianism and lots of people have criticised the science behind the QALYs, even more people have criticised the ethics behind QALYs, not least how do you value the quality of life.听 It's difficult to think of any obvious alternatives.听 You're replacing something which is obviously ethically and scientifically defective with something which is arguably worse.

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BOWMAN

I think Charles's point is interesting because he actually he raises the question of whether a flawed system is better than no system at all.听 And I'm not sure that QALYs is the only option, it certainly has a seductive simplicity to it but whether or not that is necessarily the only way of approaching it, I'm not sure.听 I think what it enables people to do is scrutinise decision making and it's a way that can be accessible.听 But there may be other ways of approaching problems that have a more robust ethical base.

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PARRY

Would you rather just for instance say this is an exceptional case because for instance there are two small children or there's a family wedding which is terribly important to the person, would you rather do it like that?

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BOWMAN

I think that's very difficult, I think once you start doing that there is always going to be an exceptional case and frankly who is another person to determine what counts in somebody's life?听 For me the more important question is are we concerned with perspective benefit or with need and actually that's seems a fundamental question and is equality the driver that we claim it is in healthcare decision making?

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PARRY

Ann, you're shaking your head.

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SLOWTHER

Well no I agree in general with what Deborah has been saying, I think it's - QALYs are quite useful as a means of comparing different treatments, so you have a standard test that you can use to compare different treatments to try and check that you're not being inconsistent in your decisions.听 However, I would entirely agree with Deborah that there are other things that need to be taking into consideration like a patient's individual feelings about what is important to them and QALYs don't pick up on that at all.

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PARRY

What other circumstances are there, because I mean you can fund drugs in exceptional cases but what does it take to be exceptional, I mean I think most of us would consider that we're all exceptional in those circumstances?

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BOWMAN

Yes absolutely, I think it carries on from what Charles has said that you are starting from a position that not everybody is equal if you accept QALYs and if you accept the notion of exceptional cases.听 The nature of an exceptional case is that it's an individual circumstance, it's very difficult to extrapolate generalisable principle from that.听 However, I think there is a risk that in the effort to make oneself exceptional we are allowing the active or the empowered patient who is better able to plead his or her case, rather than perhaps the silent patient in a Cinderella specialty like care of the elderly.

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PARRY

So, say for example, if someone is a young and attractive woman with two small children who makes a very good media case and who has gone to the media, that sort of person is more likely to get treatment than someone who doesn't have those attributes?

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BOWMAN

I think there's a risk of that, absolutely.听 And I think that's not to diminish the sympathy one feels for the mother with young children but I think if you are looking across the health service there are voices that are not being heard equally.

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PARRY

So at that point let me turn to Charles and talk about an exceptional case that we've read a lot in the media which involved the drug herceptin.听 What was that all about?

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FOSTER

Herceptin is a drug which was licensed only for the treatment of late stage breast cancer.听 A woman called Ann Marie Rogers has early stage breast cancer, she, now famously, wanted to have herceptin prescribed to her.听 Her consultant said that he was prepared to prescribe it and that it might well do her good.听 The Swindon trust said no, we're not paying for it.听 They said that although Ann Marie Rogers fell within the criteria which meant that clinically she might benefit from the drug she wasn't an exceptional case.听 They had said that they weren't going to take funding into consideration in deciding on the prescription of herceptin to any of the patients in their area.听 The issue then went all the way to the Court of Appeal and the trust barrister was pressed - What's an exceptional case and why isn't Ann Marie Rogers an exceptional case?听 And he, frankly, was unable to say what the criteria were which the trust would apply in deciding whether or not anybody was an exceptional case.听 The law in relation to this area is that funding decisions are very difficult to challenge legally, in order to challenge them legally you've got to show that the funder has been frankly irrational in coming to the decision.听 In this case since the trust couldn't say what the exceptional criteria were it was decided that they had acted in an arbitrary and therefore irrational way and they were sent back to redraft their policy about what amounted to exceptional.

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PARRY

But Patricia Hewitt said last year, before the judgement, that cost shouldn't be the only consideration, so where does that leave PCTs and patients?

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FOSTER

Well the Swindon trust in the herceptin case misheard what Patricia Hewitt had said.听 Patricia Hewitt said that herceptin should not be refused simply on the grounds of cost, they read it as saying that costs shouldn't be a consideration and they made it part of their policy that in relation to herceptin funds were irrelevant.听 If they'd said oh well we've got a limited amount of money in our kitty and we prefer to spend our money on mental patients or antenatal care or whatever there wouldn't have been any irrationality about their decision.听 But having taken funding out of their policy as a criterion they were left with precious little else to point to when it came to demonstrating the rationality of their decision making.

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PARRY

Deborah, should politicians get involved in these sort of debates?

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BOWMAN

I think however well intentioned they might be in getting involved and again having a human response to a sympathetic case it is very difficult for the Secretary of State to Health to reconcile her duty to look at the whole of the NHS with a particular involvement in a particular case.听 I also find it quite difficult to imagine that she had sufficient information to make a determination that herceptin should be available in terms that went beyond its licence.

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PARRY

Which really brings us back to our earlier point that people who are able and articulate and who shout the loudest and have the best, if you like, media stories are the ones that are most likely to get treatment, which is not ethical in itself.听 What do you think about that Charles?

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FOSTER

Quite right.听 In the world of medicine and resources, just as everywhere else in the world, big loud people get what they want and little humble ones don't.听 And in the world of NHS resource allocation the poor relatives are classically mental health services, services for the elderly, it's perceived by the politicians that there are relatively few votes in there, lots of votes in breast cancer, hence Patricia Hewitt's statement.

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PARRY

How much does an articulate well informed loud patient sway their PCT's judgements do you thank Ann.

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SLOWTHER

I think implicitly, if not explicitly, that it is bound to have an influence.

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PARRY

Especially if they're going to go to the media.

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SLOWTHER

Exactly.听 Although PCTs and ethics committees may wish not to be influenced by local politicians or the media, in reality if they know that a lot of their time is going to be taken up in dealing with media questions or legal cases then that is going to influence them to make a decision which will avoid that sort of confrontation.

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PARRY

But the bottom line here is that the purse does have a bottom, there are finite resources and presumably Deborah with every one of these new monoclonal antibody drugs coming on there's going to be the same sort of hue and cry?

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BOWMAN

Yes I think there is and certainly the ethical world, for want of a better description, is aware, as is the economic world, that these drugs represent a significant potential threat to the funding that is available in the NHS and to public healthcare services.

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PARRY

The bottom line here though is that the purse is not bottomless, should cost be part of ethics committees' considerations, would you rather consider these cases without a pound sign attached?

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FOSTER

It's got to be considered, there's no way round it.听 It would be nice to think that there was all the money for all the treatments which might produce some benefit but that's not the real world - somebody's got to make these unhappy decisions and the ethics committee sadly has to pick up the challenge.

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SLOWTHER

I think I would entirely agree that ethics committees have to consider costs.听 If you're going to look at justice in terms of allocating resources fairly then costs must come into it within a limited resource budget.听 However, I think the danger is for ethics committees or PCTs is that cost becomes the only ethical consideration and that they have to be quite clear that there are other ethical considerations which need to be taken into account and that they're explicit about how they do that.

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PARRY

So in Richard's case do you think that it's entirely round costs - the ethics?

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SLOWTHER

No I don't think it is in Richard's case.听 I think a key thing in Richard's case is actually the effectiveness of the drug and the risk of harms for that drug.听 And I think one of the issues around this drug, although it has been licensed by the European Union, is that there are only a few trials so the evidence is not very strong.听 Therefore I think the PCT would certainly be looking at how effective this drug was going to be for this person and also in terms of effectiveness - is it going to save life or is it going to prolong life and if so for how long?

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PARRY

You're listening to Inside the Ethics Committee.听 Today we are discussing the case of Richard, who's asked his PCT for a new drug to treat his colon cancer.听 Let's find out from his cancer specialist what happened next.

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ONCOLOGIST

So in this case the primary care trust required more information from myself before they considered the case and decided that they would not fund the drug.听 The reason the PCT declined funding was largely on cost but also that they felt that the additional improvement in survival was not going to make a vast difference to outcome in this case.

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PARRY

Richard felt his only hope was to buy the drug himself.听 But it needs to be administered intravenously. Richard wanted the NHS to do this and asked whether it could be delivered at the same time as his chemotherapy, which of course was free. Combining private and public treatment in this way - something called mixed provision - is fraught with ethical dilemmas. Let's hear from the cancer specialist again about what happened in this case.

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ONCOLOGIST

We approached the hospital management and his case went through the ethics committee to discuss whether or not it was appropriate for patients to remain NHS patients but to receive additional drugs and that they were funding themselves.听 And it was felt that that wasn't appropriate.听 The reasoning was largely that if one patient's receiving a drug that's not routinely available, it's not really fair on other patients who are being treated within the same hospital.

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PARRY

So another major blow for Richard.

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Deborah, why is this considered so unfair?

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BOWMAN

It's considered to be a challenge to the fundamental ethos of the NHS, which is that everybody receives the same treatment which is an agreed minimum standard very often, irrespective of income and any other discriminating variable.

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PARRY

But I can think of lots of cases where private and NHS provision mix, I mean infertility patients, for instance, have their babies on the NHS.

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FOSTER

They do and they're likely to have low birth weight babies and they're likely to have multiple births and all those are associated with increased costs but the NHS will provide antenatal care and help at the birth of babies conceived privately.听 Another classic example is the provision of amenity beds, so if as an NHS patient you pay a little more you can have you own private side room.听 If you have a private GP appointment that private GP can refer you for an NHS intervention, so effectively you're jumping the queue.听 So all these examples and many more indicate that this egalitarian principle, which Deborah's talked about, is flouted daily in the NHS.

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PARRY

Deborah, who clinically would find this unfair?

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BOWMAN

I think potentially the nursing staff, I think potentially anybody actually who is on the wards and involved in Richard's care.听 And I think there may be a feeling that one is colluding with unfairness by providing care that is different for one patient - Richard - as opposed to all the other patients on the ward who have the same diagnosis.听 And there might be an argument for saying well actually if there is disparity that needs to be open, that needs to be discussed openly, rather than providing care secretly or otherwise to one individual over the other people on the wards.

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PARRY

But hang on because what we're talking about is we're just talking about giving an extra drug at the same time as something that's already being done on the NHS, so there's not an additional sort of burden in terms of time Ann, where's the problem?

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SLOWTHER

Well I agree, I think in this particular case that Richard would have a strong argument to say well if the only difference to what my normal care would be is that I'm going to be having an extra drug during that treatment, which I am paying for, I'm not disadvantaging anyone else in the NHS.听 I think we have to be clear that it really is just that additional drug being given and that's the only extra cost.听 If, for example, Richard had to have his extra drug given more frequently than his current chemotherapy then that may involve extra resources being used.听 If he had more side effects from this new drug or had to be monitored more frequently because we were unaware of what side effects might occur then that again might mean that he was taking hospital time that other patients with cancer would normally be allocated.

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PARRY

But Charles, going back to your point, I mean if somebody had a very severe side effect from this sort of treatment in the private sector they'd be shipped back to the NHS for intensive care.

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FOSTER

They would be, it's commonplace for surgical accidents which occur in private hospitals to be sorted out at enormous expense on the NHS.

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PARRY

Ann, does mixed provision happen in many other places around the country, is there a standard policy?

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SLOWTHER

I don't think there is a standard policy, I think as Charles has already pointed out, there are all sorts of examples where there is some mixed provision.听 Quite often, for example, the case of someone having a really severe reaction to a drug that's administered privately and is then treated on the NHS that is seen as reacting in an emergency situation to a crisis that has happened then rather than if you like proactively making a decision that you are going to give someone a different treatment within the NHS.

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PARRY

So in your experience Deborah does it vary enormously around the country in terms of what's acceptable as mixed provision and what's not?

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BOWMAN

Yes I think it does and I think individual clinicians have discretion as well, certainly different consultants and different clinical teams may have a quite different approach.听 Increasingly trusts are expecting clinicians, if you like, to come into line and scrutinise policies but I think there will always be variants where there's discretion.

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PARRY

And does the opinion of the hospital staff make a difference?

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BOWMAN

I think again it depends on who those staff are and who's doing the listening.听 But certainly in a paper published in the British Medical Journal in 2001 on the specific point the voice of the nursing staff was extremely influential.

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PARRY

Charles, would it be helpful if there was some standard framework or guideline about what's acceptable and what's not?

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FOSTER

It would be unhelpful for the unfortunate people who have to make these decisions.听 I think it would be very, very difficult to draft meaningful guidelines which could apply in an intelligent way to all cases of suggested mixed provision.

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PARRY

And presumably lawyers, like you, would be constantly challenging it?

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FOSTER

Oh we'd love it, yes, but I don't think it's in the public good that there are such guidelines.

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PARRY

Is there an ethical way to do this Deborah?

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BOWMAN

I think there and I think it involves taking a step backwards and thinking what are the underlying principles.听 So one might take a position that is similar to the position adopted by John Rawls, the philosopher, who wrote a treatise on theories of justice in which one protects the weak and the weakest in society and therefore that's much more congruent with the NHS or whether you're going to take a much more libertarian perspective and say well actually choice matters.听 And interestingly that is much more the dominant rhetoric in health policy at the moment.听 And it will be interesting to see how public and private continue to interrelate as the private sector are more and more involved.

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PARRY

But private choice can affect the ability of others to make choice.

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FOSTER

Indeed it can.听 Deborah's right in identifying the two real principles in play here.听 We've got on one side egalitarianism embodied in the original principle of the NHS.听 And we've got on the other side autonomy which is increasingly not only the political rhetoric which governs medical provision but also the legal rhetoric which governs medical provision.

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BOWMAN

I think the issues around guidelines for these sorts of decisions parallel the issues around guidelines for the PCT making decisions to fund treatment in the first place.听 And in fact what needs to be done is to balance the egalitarian approach with the autonomy or the patient choice approach but to be very explicit about how you're doing that when you do it.

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PARRY

And do PCTs like to be explicit?听 I mean I think that many of them prefer to keep their decisions secret.

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BOWMAN

I think PCTs are increasingly becoming more explicit about their decisions but I think that they do have problems in being explicit about the reasoning behind their decisions, partly because they don't have a robust framework for making these decisions.

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PARRY

Well that leaves us with one further ethical dilemma to discuss.听 Let's remind the audience that we're discussing the case of Richard, who asked to be given an expensive drug that would extend his life but which isn't on the NHS.听 Now if these sort of drugs aren't available to patients, except through a long and incredibly tortuous process, should GPs and specialists even tell their patients about them or do they have an obligation to do so?听 Back to the oncologist again.

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ONCOLOGIST

Currently largely due to the media coverage of Avastin and a drug called Tarceva, which is used in lung cancer, I talk to patients about this four or five times a week.听 I think as a clinician it's very difficult to talk to a patient about a drug that may be of benefit to them but that is not available and I don't routinely discuss these drugs with patients unless they actually come with information about the drugs themselves, which again puts you in a difficult position.

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PARRY

Ann, you're a GP, so do you tell your patients about drugs that aren't available on the NHS but which you think might do them so good?

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SLOWTHER

I have a lot of sympathy with the oncologist talking there in that I think it does depend on the individual situation.听 In general I think the principle is that we have to be honest with our patients, we have to provide them with as much information as we can so that they can make choices.听 And we can make mistakes and inadvertently assume someone wouldn't be able to afford to go privately or want to go privately when in fact they could.听 And if we then didn't tell them about a drug that was available we will be restricting their choice to do that.听 On the other hand telling a patient that there is this drug which may be very effective but which is not available or only available if you can pay for it and there's no chance of that patient being able to pay for it then that increases the distress and if you like the harm to that patient.听 So how do I balance my duty of care to benefit my patient and not to harm them but also to ensure that I respect their autonomy in making choices and that can sometimes be a difficult balance.听 I think one of the things that influences those decisions is how effective you think the treatment is - if it's a very new treatment then you may not tell.

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PARRY

But also of course there's an assumption that you as the GP have had the time to go into the enormous literature on these new drugs and carefully weigh up all the pros and cons so that you're able to tell your patient.

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SLOWTHER

I think that's a very good point, with some of these new drugs it may be quite difficult to actually find the evidence and assess the evidence.听 And if we are giving patients incorrect information or not very good assessments then we're still not doing them a service for them being able to make a choice about what would be best for them.

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PARRY

Then of course GPs are prey to media hype as much as anyone else is, you've got a lot of information coming from the pharmaceutical companies, so it's not always as easy as people imagine to tell benefit.

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SLOWTHER

Absolutely, there is an awful lot of implicit inference from various sources on GPs making decisions about treatment for their patients.

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PARRY

Charles, what's the legal situation here - are doctors legally obliged to tell patients about drugs that might help them that are not on the NHS?

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FOSTER

The legal situation is extremely fuzzy, likely to become less fuzzy over the next few years.听 But the law recognises that patient choice, which everyone applauds, means nothing unless people have the raw material upon which to base an informed choice.听 These days it's unrealistic to suppose that patients won't find out about even obscure drugs, a moment's google search will probably turn up endless speculative possibilities.听 I don't think that the law will be satisfied with a GP who said oh well I think that that patient wouldn't have been able to afford this treatment because he lives in a small terraced house.听 I mean he might be enormously wealthy, have lots of money under the bed, or win the lottery next day.听 So I think that although it won't be possible in practice for a GP to give detailed information about what the potential use of a new drug is going to be, perhaps they're at least under a duty to say look there may be other treatments, your consultant may be able to tell you more about them, why don't you ask him and if the consultant can find a way of similarly passing the buck to somebody else I'm sure he'd be very happy to do so.

听

PARRY

Lot of buck passing here, Deborah.

听

BOWMAN

I think actually there's a sound ethical principle here that hasn't been mentioned and that's trust actually.听 I think these are patients who need a therapeutic relationship with their team and if one withholds information or isn't honest about the uncertainty, and I think that's something that Ann alluded to, that actually what we all might require is that information is given but that presupposes that information is clear, certain and known and very often we're talking about uncertain benefits and uncertain risks.听 But from all those things trust flows and trust is never more important than when you are vulnerable and you are going to need an ongoing therapeutic relationship with clinicians.

听

PARRY

And is that trust undermined by the sort of high profile cases that we read about in the media where people talk about wonder drugs.听 I mean, for instance, the particular drug that we're talking about today is often presented as being life saving, rather than actually life prolonging, which is a rather different matter?

听

BOWMAN

Well I think as with all dichotomies, it's presented as an empowering thing - information - but actually the flip side of that is that it can be a burden, particularly if information is represented in a way that overstates its case and makes greater claims.听 And frankly I think it can be a burden for both doctor and patient to hear the hyperbole that surrounds some of the newer drugs.

听

PARRY

Is that something you find Ann.

听

SLOWTHER

I think that's very true.听 If patients have heard that a drug is life saving and they are in danger of losing their life then that is what they hear and that is what they see.听 And it can then be quite difficult to say well actually this is not a life saving drug and try to take a step back and explain in a more balanced way the risks and benefits is not always easy to do.听 Can I just pick up on a point that Charles was making about people using the internet to access information?听 I think that again illustrates an inherent unfairness because there are quite a few people in our society who still don't have access to the internet and so maybe it obliges GPs to make sure that we provide the information for those people otherwise it's going to be again the articulate people who access information that get a better deal.

听

PARRY

Charles, do doctors though have a legal duty not to overspend their budget?

听

Ooh I've foxed him on that one.

听

FOSTER

The funding of doctors is complex.听 Trusts have a duty to try to manage the funds in their hands sensibly and if they massively overspend their budgets yes I suppose you could describe that as a breach of duty.听 It's not a breach of duty in any sense analogous to a breach of clinical duty of an individual doctor to a patient.听

听

PARRY

But let's transfer it now down to the individual doctor, rather than to trusts, what about with individual doctors?

听

FOSTER

Individual doctors have a duty to watch their balance sheet and they also have a duty to individual patients, which may well conflict with their duty to their balance sheet, to make sure that they get the care which they need.听 Where those two principles are in conflict the welfare of the patient has to take precedence and those conflicts between what the accountants want and where the best interests of the patients lie are precisely the things which cause ethics committees to scratch their heads in the way we've been discussing just now.

听

PARRY

And for you Ann as a practising GP it's a hard call isn't it?

听

SLOWTHER

It can be a very hard call and it can be a day to day problem in general practice.听 One of the problems for doctors, particularly general practitioners, is that they have a duty of care to the individual patient in front of them to provide the best for them but they also have a duty of care to their other patients.听 So there is always an awareness that if I spent a huge amount of money on this patient then if the next patient who comes along who also has a great need and there is no money left then that patient would be disadvantaged.听 It is easier for individual doctors in cases where the PCT say is not funding particular treatment because at least then you can say to the patient I think this would be the best for you but I can't do anything about that because the PCT is not funding it.

听

PARRY

But isn't that a cop out?

听

SLOWTHER

I think it is a cop out to a certain extent.听 But on the other hand I think there is an advantage to individual doctors still being seen as an advocate for their patients and this ties into the issue of trust that Deborah was talking about before.

听

PARRY

Okay. So today we've considered the case of Richard who has colon cancer and who wants to be given a drug that isn't available on the NHS.听 More and more of these highly specific expensive new drugs are coming to market, so this case has a wide resonance for the future of cancer treatment in particular.听 Let's now turn to our panel for their final thoughts.听 Deborah.

听

BOWMAN

I think for me this case highlights so many tensions in the way in which we run the NHS and that there are different people making claims to have authoritative voices inconsistently.听 Consistency may not be necessary but I would like people to step back from trying to provide pragmatic solutions and perhaps scrutinise the questions and the underlying principles a little more vigorously.听 Only by doing that I think will we have an honest debate, an open debate that engages people who aren't ethicists, who aren't lawyers, who aren't necessarily relatives or families that actually have a vested interest in how we allocate resources.

听

PARRY

Charles.

听

FOSTER

It seems to me that there are two ethical principles in play here.听 The principle of egalitarianism, which it is said is fundamental to the NHS.听 On the other hand there's the principle of autonomy, Richard's autonomy in this case.听 So far as the egalitarian ethos of the NHS is concerned we've given examples to show that nobody can say with a straight face that those principles are consistently honoured.听 So what damage would be done to that egalitarian ethos if Richard were to receive mixed treatment?听 Not much I think.听 On the other hand the benefit to him would be potentially huge.听 That's the conflict as it appears to me.听 And so far as the law is concerned, is there anything irrational and therefore unlawful about providing this treatment?听 I don't think so.听 Is there anything irrational and unlawful about failing to provide this treatment?听 I don't think so.

听

PARRY

Ann.

听

SLOWTHER

I think like Deborah that this case raises wider issues for the NHS and for how people make decisions within the NHS.听 And I think it highlights the fact that we need to be more clear about the underlying values that we are using to make some of these decisions both at the individual patient level and at the PCT level.听 And I really do think that some ethical frameworks or some more explicit values need to be inherent in GP and PCT decision making.

听

PARRY

Now clearly if this had been discussed in a genuine ethics committee it would have been at much greater length, but I hope nevertheless that we've covered some of the main points and thank you very much to all our panel.

听

And if you'd like to have your say, or find out more information about the topics covered in this programme then go to bbc.co.uk/radio4 and follow the links to Inside the Ethics Committee, where you can leave your comments. Or you can call the Radio 4 Action Line on 0800 044 044.

听

And now let's return to real life.听 What happened in this case?

听

Richard didn't receive the drug he wanted. Initially he responded well to the standard chemotherapy, but began suffering increasing pain. He was admitted to hospital for surgery to remove the primary tumour that was obstructing his colon and is now at home recovering. However, the cancer in his liver remains and is not curable.

听

ENDS