Justice, Healthcare and the Trend Towards Predictive Medicine (2004, Brussels)

Conference NotesJustice, Healthcare and the Trend Towards Predictive Medicine 22 & 23 November, 2004.


M-J Simoen Background on Foundation.

Cecille…. Brocher foundation aim to provide place for research, linked to medical and scientific: socio-political implications of progress. Mr and Mrs Brocher interested in links between science and law.

Is medical care a service like any other?

Alex Mauron Scientific and social aspects focus Access to health care should not just be for determining individual predisposition, but social solidarity – linked to justice.

Importance of Europe. Genomic and medical progress – impc placed on difc between individuals and risk profiles and tendency people have to be affected by certain medical conditions – pharmacogenetics.

First analyse from philosophical perspective (first session) – regulatory concepts.

Bernard Baertschi, Uni of Geneva – philosopher of bioethics One of most signif authors in francophone world

Bernard Baertschi Norman Daniels was student of John Rawls

Sustaining a right to health care Norman Daniels, ndaniels@hsph.harvard.edu Harvard School of Public Health

Can (should) t tradl Euro view of health care as a basic, universal right be sustained in t face of t challenges posed by advances in predictive medicine and t emergence of a more diverse Euro Union and Market

I focus on ‘should’ more than ‘can’, though should presupposes can, so cannot escape feasibility

Small Irony

You should sustain right to health care 45million people uninsured in US –  they get care, but get too little too late

mentions Bush prob

Promise from more competition: more efficiency -    US as model – expts in comp at various levels: hospitals, insurer, managed comp o    Early Rand study evidence: cited as main evidence, but negative effects on patient health not given much attention o    Prob with export of US strategies for health care – led to following bad models o    Era of managed comp – 1990s ‘backlash’ o    ‘consumer driven’ health plans in US – newest phase -    Economists: failures to lower unit costs, to lower rates of cost increase are evidence that ideal market conditions not approximated, try harder


Appeal to markets: empirical not principled issue -    not in principe against using market forces – if it could be shown that comp worked to make system yield more value per euro and could be channelled to do so equitably through proper reg, I would embrace integrating marketing mechs -    BUT: US unit prices highest in world, despite more market mechs, no evidence of greater value per doller – indeed contrary evidence, and worst outcomes (return to this later) -    Caution

Promise of Predictive Medicine -    early, low cost predictive profile of health risks – through extensive genetic testing o    assumes low cost, good predictive value for more than straightforward genetic diseases eg. Applicability to high prevalence, chronic conditions o    assume privacy issues addressd -    Promise from (hype from?) genomics, proteonomics,- specifically tailored drugs for safe, effective treatment of indiv depending on genotype -    This technology is a mismatch with existing economic incentives for medicine -    Every drug will become orphan drug – only treat a few people, so why develop o    Many economic and oscila probs before

Predictive Med: two paths -    make syst work better, sustain equity o    idf those at risk o    respond better to identified needs •    indiv medicines? But more orphan drugs o    allocate fairly across competing needs -    divid and conquer: undermine equity o    stratify risk pools •    us v them ideology o    shift costs to those at greater risk (poss to identify those at risk and better respond to needs)

overview of argument -    special moral impc of health o    opp range, capabilities •    connected to Rawls’ theory •    from several philosophical perspectives, if one could devel claim that funl right to protect opp range of indivs (Raels ‘equality of opp’), then argument that way to think about healthcare is protection of opp range… -    obligations of justice to protect health o    obligation to promote fair equality of opp -    use predictive medicine to better protect health, not shift costs or deny coverage -    beware temptations of market – evidence, not ideology -    intergenerational equity/justice and sustainability of transfer schemes o    shrinking working age population makes more difficult to finance health care syst in Europe

FEO Account of moral impc of HC -    disease and disability are epartures from normal function

Justice as Fairness -    hypothetical contract (Orignial posn) -    simplifying assumption o    normal functioning over lifespan -    index of primary social goods -    three principles o    equal basic liberties, fair value of political liberties o    fair equality of opp o    difference principle (restricting range of inequalities permissible in soc)

Extending JAF to healthcare -    JAF simplied to case when there is no disease, disabilityt or premature death -    Open to criticism: - arrow sen, others

Whitehalll study (Marmot and Shipley, 1996) -    all-casue mortality by grade of employment – whitemall men 25 year followup -    socio-economic gradient of health -    not explained by health risk factors we usually talk about (such as lifestyle choices) -    hypothesis

(Justice as fairness) JAF flattens gradient

Compliance with 3 Principles of Rawls -    flatter than

theory extends in surprising way as to why justice is good for health

Accountability fo reasonableness -    four conditions of fair process o    publicity: reasons or rationales for imp decisions and indirect limit-setting structures publicly available o    Relevance: fair minded people (relevant stakeholders) agree rationales are aimed at pursuing appropriate patient care under resource constraint o    Revisability/appeals: fair appeals procedure o    Enforcement/regulation

-    REF: Daniels, Sabin Setting Limits Fairly, OUP 2002 o    Moral disagreements surround many decision, don’t have agreement on moral principles that resolve these disputes, so must fall back on account of fair process that minimises choices that are made

Shifting costs to ill or high risk -    argument for Actuarial Fairness – purchase health security at actuarially fair cost o    US substitute insurance concept for moral concept o    People should buy security that reflects real risks o    It should not apply in health setting -    Actuarial fairness is not fair – if protecting health is social obligation -    Burdens according to ability to pay, not need: principle violated

RAND HIE: SOME NEGATIVES DAVIS, J. HSR 2004, 29: 1219:33. -    Adverse effects on low income and high risk indivs (Rassell, 1995, NEJM) -    Lowincome high BP: better control with free care:; lower risk of death for high risk

Risk Stratification: other costs -    culture is created by institutions, instits can encourage or discourage and reduce mutual support – what’s in it for me, rather than us’ spreads like cancer -    stratifying insurance schemes not only shifts costs to ill but undermines more gen concerns for social justice -    not only will access and burden be modified, but content and quality of benefits will stratify

In Europe, 50 yrs of sharing and caring, in US has promoted division and self-interest. Contributory factor to recent US election as well as others. In US until now, one of good thiungs has been universal health care provision for elderly – not sure whether will continue

Use predictive power to improve health for all – other parth -    respects social obligation, equity -    estab priorities using accountability for reasonableness -    improved preditctive power may have efficiency gains -    evidence based improvements, compatible with market

Challenge to sustainability -    societal aging, changing worker to elderly ratios o    China most rapidly aging popn in world o    Dramatic societal aging in Several Euro countries – shrinking workforce in Italy, elsewhere threat to pay as you go financing of universal health care -    Technological cost drivers – medicine is not what it used to be, costs more everywhere

Challenge not from predictive medicine, but promoted as challenge, by rise of aging popn and reduction of ratio.

Jean-Francois Mattel University of Nice

Devel of health care since mediaeval system intended to take careof needy – workers -    was a social issue, now political

hospitals previously funded by charity -    now funded through solidarity

why is there a philosophical issue? -    defn of man, solidarity -    moral prob on defining human and fair sharing in terms of human dignity -    different to compare health care systems around world o    instruments used o    current used indicators are infant mortality and life expectancy – which relies more on social conditions -    health care system o    defn: range of techniques/practices intended to produce health in same way as we produce wealth o    metaphysical/ontological: what is health? •    Material asset or something different

Can health be seen as industrial product – something that can be traded

Syst wich distribs health – hc systm –more different to control, since has many parts and increasingly economic, indl, and financial components -    which is wher political comes into play

central Q: equality of access for patients and legality of assumption of HC costs

perhaps 3 main axes: liberal (US egaltarian / Euro), inegalitarian

tendency in Europe to think syst is preferable to US, since has concept of solidarity that underpins it -    link to historical idea of charity

society has moved HC into social space, rather than religious space -    social spaces collective, whereas religious spaces are individual

Durkheim – collective concept of solidarity

How can justify solidarity and influ in HC?

Imp in HC since calls into q, social prof and human dimension, but also biological and physical concept of human.

For first time in history, biology become social concept in terms of how society assumes costs of HC

Can bring demands of health into HC and move beyond idea of HC as idea of solely doctor to patient. Horison of perfect health – Utopian society – everyone perfectly attended to. – to allow maximum of solidarity

Increased medical component of science and way that HC incly based on technology, gives new way of analysing human and providing HC.

Belief in indiv dimnison that is absolute – human dignity

Need some distance – philosophical q

Requirement for human dignity and solidarity is devel of human beings over 300 hrs.

Anthrop sense – modernity – (not go into postmod) – converging processes -    new kind of socialised human being -    First charact: progressive secularisation of religious concepts o    eg. Religion based on Judaism or Greece, man only perceived of own existence through religion. No right to health care. -    Second charca: de Toqueville – inc socialisation of man, led to tensions between social and moral requirements. Political arena where they are reconciled -    Third charc: social reqs of today, express on individual needs, rel between individual and social sphere – social demand as collective -    Fourth charac: technical development leading society. We ask sci and tech to solve social and medical problems

Change to modern sense of man

Second of these claims is that concept of man incly reduced – focus on body reduced – what the body requires

Think philosophically, but also consider human dignity and relationship to body

Does a dead body have dignity or is there a higher concept in play here?

Here we talk about dignity of socialised man

Tension between ethical concept of dignity which, to some extent, has metahistorical/metaphysical concept and need for using body, which means that it naturally comes to disappear

Need medical correctness as equal distrib of care to whole of body or to whole of society

Problem: right to medical care nothing more than political right

Rawls: Demand for right is political demand

In 21st century, law is social demand

Mankind today and societies are trying to provide medicality

2 rights: medicality and sociality

people seem to want a perfect health or life

to have this is to put of death entirely

best to have perfect qualities as human being and to have medical care as close to perfection as possible

producing health as producing products

want a body that will never break down

cannot have perfect mental states, but people want perfect physicality – beauty (ME: not easy)

WHO defined health as ideal health -    state of complete well-being physical. -    Can we attain perfect well-being?

Corpus sanum, not necessarily linked to mens sana

Demands of society a great deal.

Body as product

Product of medicine – from birth onwards, medicine acts on body With GM goes beyond that

Locke distinc between ‘property in’ – obligation to respect people and ‘property on’ – material goods

This health is material property in Locke’s terms – not an inalienable right, like freedom, more like commercial article – privileged to have

But cannot say that a body is good or bad in pure ethical terms

Is it better to die as soon as possible after born to avoid suffering, or the contrary

Our societies are no longer tragic societies, but rational

Philosophical question: can we eliminate all tragedy from human life? -    only way out is death

need to avoid tragic dimension to life

we want perfect mental health and bodily health

we want to look death in the face

and look tragedy of life in death

Aristotelian problem: act of living..

Can we have a happy life in which we aim towards living together in a society, moving forward as society?

In third millennium societies, we are trying to make the challenge of taking biological life and giv it good life in Aristotelian terms -    begins with the body and medicalisation of body

socialisation of medicine is medicalisation of the body

man’s body is locus for application of our technologies

economic dimension as healthcare costs

politics makes final decision on this

fact that man becoming instrument, not just medical or social problem, but a moral problem

if man no longer thinks of self as divine create or natural product or man, but part of social mechanism, how is he then to have a body that no longer belongs to natural world?

The body is more and more a technical object. It is something mediated through the technology.  So man becoming something that technology acts upon. Benson: man is constructing himself nowadays and constructing new way of making himself. The body is something we build. Try to give it perfect life/health.

Back to solidarity – guiding threat.

Justice and solidarity: what are they? No longer religious, even if religion is background to all moral thinking. Morality is articulated through society. No greek term for society. Greek words that come close talk about relationship between people. Our modern world needs more solidarity – and more demand.  This means that individuals often unhappy, when they don’t get what they want.

Is our modern societies, whatever decisions, whether will, in allowing soc to determine way medicine acts on body, whether will regulate that or leave it to the market.

Are we going to see market acting in way that Adam Smith described – hand of market – or hand of politics making sure everyone gets health care.

Remarkable that our society is having to deal with this challenge. Not only recognising everyone’s equality before the law – as political, social terms, - but everyone’s equality in medical/bodily terms.

Can our modern societies, where popn aging, can they give healthcare?

Will Genetic Predictive Testing increase inequalities? The Psychl Theresa Marteau Healthy Psych Section, Guy’s Campus, IoP, KCL

How do people respond to predictive genetic testing Must understand something of context where will be introduced We all know that the rich live longer than the poor. This is likely to increase.

Self-efficacy to stop smoking.

Hall and Marteau, in prep – people of lower education, feel less confident to stop smoking

Genetic Predictive Testing for Heart Disease -    websites sell this, but little available from health service

Anticipated that gen test incorporated into HC syst in 5-20 yrs.

Imp to consider now, how people will respond on impact to justice of implementing tests.

Huge expectation that will impact people Gramling et al. 2003 – Exepcted motivational impact of predictive genetic testing for cancers -    asked what they expected to see in their patients, if they underwent testing -    expected that those with risk would be likely to attend screeing, likely to change diet and stop smoking

Will gen pred test inc inequal? -    depends on social patterning of uptake and motivn to change behav o    uptake 1: hypothesis: t difference in uptake between those who are leadst and those who are most deprived is larger for gen predictive test than other pred test (given preexisting socially patenting of expectations and need for informed choice with gen testing) o    hypothesis 2: motivn to change behhav following testing will be lower in those who are most deprived (due to pre-existing socially patterning of fatalism)

role of media in creating hype -    Dobias et al 2001 – womens magazines – mammography messages in women’s magazines aimed at different education levels o    In magazines asso with low education, more likely to be persuasive and less likely to discuss uncertainties

Domenighetti et al 2000 – impact of info on willingness to accept screening -    more we talk about people of uncertainty, less interest they havein attending screening -    when discussing gen screening, emphasis on informed -    those most deprived, less interested

Schwartz et al. 1999 -    mammography ptake in women at high risk for breast cancer (US based study) -    randomly allocated women who were high risk for breast cancer, to receive counselling session or Control o    found that high educated, risk counselling had no impact, but for low level of education, learning in detail mammography rates went down.

Will gen pred test inc inequal? -    hyp1 o    Evidence to support •    Expectations of t benefits of screening higher in those who are more socially deprived -    Hyp 2

Cartoon caption: “Because my genetic programming prevents me from stopping to ask directions – that’s why!”

Perceived controlover causes of illnesses -    Shiloh, Rashuk-Rosenthal and Benyamini, 2002 -    People feel can control, if perceived behavioural and progresses lower to enviro and finally genetic

For chronic gen conditions, gen part only one aspect

Multi-factorial condition emphasse gen component

Senior, Marteau and Peters, 1999 -    parents perceived casues of raised cholestoral in their newborn babies, deterred during screening -    where parents thought was genetic problem, far more fatalistic about the problem -    whereas when not perceived as genetic, felt that was something not of concern


For Norman Daniels -    2 complexes of ethical principles: Rawls justice and 4 conditions of fair processes -    are they separate?

Answer: -    work of philosophers in 1990s, unsolved problem of rationing, how much to give to specific groups? -    When should we trade best outcomes in the use of a resource, in favour for just outcome? -    Do not have philosophical framework of consensus -    Need to suplemetn gen framing of problem of distributive justice with fair process -    Gen framework of fair process

Question: Alex Mauro -    for Norman Daniels -    in view of B Baertschi, process is to flatten gradient, but process is tricky since, if some screening is efficient and if implemented in context of gradient, then expected to steepen. It is as if good quality screening is especially prone to being egalitarian. How can we bring in a correcting factor in name of flattening gradient?

Answer: -    gen law in HC research that medical technology are taken up in proportion to socio-economic status -    Marteau argued that predictive testing might be even worse than established knowl -    The response: more institutional effort from within and outside HC syst to educate people about false aspects of genetic determinism. – health literacy programmes -    This would be consistent with view of health as social product, not just as medicalisation of body -    Evidence from social epidemiology is that health in distrib of populations is primarly effect of social determinants and public health measures -    Couple of other comments on prof Mattei’s paper

Marteau -    if you don’t formulate something, then you don’t set out to try to find it. Solutions in many places, but what one wants is an inequality of resource, when setting up programmes o    spend more resource on those who are more deprived -    education is umbrella term. We know self-efficacy much lower in these groups, so need more help.

Daniels -    Prof Martau focus on threat of inequalities -    Much as I am interested in reducing health inequalities, especially when produced by many unjust XXX, always complex normative problem as to how much to give to worse-off peoplee. We do not have social agreement on this. Itself calls for fair process. Supplement gen view that inequalities are bad, because always faced with specific problem with how much benefit you give up for some people to reduce benefits for others

Ruth Chadwick -    for Marteau on evidence on fatalism -    statement ‘if I have familiar hyper….’ How can one distinguish within that between those who think that’s just what it means to have that condition and a fatalistic attitude, which could be quite different

Response: Mareau -    yes, might be a lack of understanding. -    Was not my study! Similar criticism I have -    One would want to have more than one measure, interview people and understand how that statement is ustod. Better defn of fatalism and use range of measures. -    Was only study that measured education.

Question: Mattei -    diffc between solidarity and charity -    seemed to imply that religious spaces were individual, but lose out on a lot of judeo-christian trad with God’s relationship with individuals -    misses fundamental idea of church -    interested to hear Prof Daniels response too

Answer: Mattei -    distinction isn’t just a reflection on Christianity, but type of help can give to others. True that Christianity has community dimension – caritas – love for other people. What history has show is that when first establishments set up for needy and sick, did supply solidarity, but based on Christian idea of charity. Did welcome non-christians, but nonetheless something that happened within religious sphere -    social sphere has taken over. In a religious relationship between different groups or person and group, are different relationship to ones they have in impersonal relationship between person and group under solidarity. -    In modern societies, have hundreds or thousands of indivs, different to develop social network. -    Prof. Daniels said that social but also political forces directing what goes on.

Norman Daniels -    Agree that religious traditions have community value. Hebrew for charity ‘sadaca’ – righteousness. But is different. If I don’t give charity to some individual, they don’t necessarily have a claim against me, it is at discretion of charity giver, whereas rights involve reciprocal duties. Domain of justice a little different from charity. -    Framework of rights reveals that where diverse popn, merely as citizens, we owe each other as deserving of basic cares.

Question: -    charity and solidarity – one of imp aspects is that solidarity comes from workers movement. Autonomous action in charity, not in solidarity. -    Moving towards individualist soc and lost some value -    Difference in some charities – Muslim: fundamental value -    Careful of Eurocentric view -    Question for Daniels: mentioned market aspect and solidarity system, question about pharmaceutical market. -    Given that market is maximising profits, down side. Taking an outside regulatory sphere. Not helping to modulate practices for access

Answer: Daniels -    complex problem with pharma -    have hd this issue close on pricingof endoretro viral treatments. -    Pharma made concession by providing generics -    Decided to lower prices. -    What drugs get developed and for who? -    Njeed to be revisited

MATTEI -    would all like to see most egalitarian distribution of justice -    this is something inalienable, cannot talk about justice without fairness. -    Can we have justice really or is it just utopian ideal? -    Is it something we can concretely have? -    Saying that market is selfish, must ask whether is individuals are selfish -    Niave to say we have some magic wand to solve this problem

Question for Marteau -    data suggests that more detail of info, the more it risks to increase t inegality -    to poor people give simple messages, to richer, give sophisticated, which also increases inegality of knowl? How deal with this problem of communication?

Answer -    this is one of tensions in this field -    magazine analysis shows that simplistic messages to lower levels of education -    highlights tension between individual autonomy and realising public health outcomes

Daniels -    what we owe each other, not just what it would be nice to have -    connected to broad and confused defn of WHO on health -    real people in HC don’t worry about that defn, they look at morbidity -    protecting health and not all aspects of human well-being -    I don’t think talking about groups is an abstraction -    Markets are not simply individuals, they are shaped by rules and regulations to ensure they avoid certain failures -    One of problems with pharma is that IP law may be stacked in favour of houw drugs get developed

Access to healthcare, in particular new medical technology

Yvon Englert

Thoas Perneger

Imagine trying to screen for cancer in over 50s, test A = cheap and available to everyone, avoid 1000 deaths; or test B = more sensitive, can only give it to 1 in 2, save 1,100 lives. Which would be preferable? -    thi was asked to doctors in private practice and public and asked how they would choose for test B – eg lottery, or medical orgs, only a minority choosing test B -    Med Decis Making, 2002, 21: 3-8 -    Doctors were prepared to lose 100 lives in order to preserve fairness -    BMJ 2004; 329, 425-8 o    Would you allow XX into intensive care? o    Woman in A&E and feels bad o    Do we do it? o    Might depend on disease o    Only one bed available in intensive care, or only 3 o    Describe personality of patient. o    Whether is anxious or not o    Swiss doctors split down middle o    Asked 200 doctors and 55% said they would send patient to intensive care. If 3 beds available, 59% if 1, 45% o    Somebody who is being brave is twice as likely to be admitted to intensive care as someone who is anxious and depressed

10% of doctors said did not want to answer the question

Telemedicine, virtual reality and robotics, new technologies for an optimised health care. Luc Soler

The First Keyhole surgery course

Is patient clinical case or a person? How teach future surgeons if don’t really have contact with patients? When dealing with patients, you might see inturns who are with head doctor and some consideration not given to patient Reduction of surgical nature of medicine – smaller incisions. Direct contact between surgeon and patient, beginning to diminish Operate using tv screens or robotics New imaging technology – MRI scanner Helps for greater communication with patient Reaching areas where human patient becomes digital data Technological developments -    Virtual Reality for Tumour Analysis -    Take 3d medical image – computer tomography, magnetic resonancing, set up digital clone -    No risk to patient since working on virtual patient -    Prepare surgery on this basis -    Simulation of surgery -    Pre-op phase helps for actual op, since info can be superimposed onto patient. So , through robotics, willl get to point where levels of care will rely on these procedures and can rely on qual of care too Medical Imaging -    from CT-scan or MRI of a patient -    better tools for visual

Using algorithms, can build up representation -    allows 3D model to be visualised -    software name: Cult3D (works with IE)

made poss by advances in video games and computer games -    computers now have 3d imaging cards within them

used for explaining condition to patient WebSurg – www.web-surg.com -    World Electronic book of surgery -    Financed by various people. Only free site -    This software is freeware

ME: v intrereting software. Look into

Capacity to go backwards within a procedure and start again

Being used in Geneva and Zurich for surgery planning

Also exists as network system – can be shared with various experts

Helped for info sharing

Real time force feedback simulation -    probe includes feelings of resistance -    INRIA – link again with computer games – Project EPIDAURE

Intra-operative VR surgery

Interactive Augmented Reality

JAMA November 2004

Superimposes image of surgery procedure so can see that eth is being done correctly

Huge surgical advance

3D image doesn’t move when patient breathes – current limitation being dealt with

fully automated augmented reality

LNCS vol 3150

Robot: Telesurgery -    2 robots, 1 society : intuitive surgical -    Da Vinci and Zeus machines, now merged -    New solutions: Artemis, Hitashi, Sinters… -    Extremely expensive $1m (access issues) -    Surgeon can be decoupled from OS -    Robot controlled by -    Lindbergh Surgery, sept 7, 2001, Nature -    Idea not to replace local surg team, but support -    V expensive, since fibre optic transmission time across atlantic costs a lot, so not really poss at mo

Visual Servoin -    increased automation -    control instrument remotely -    can take into account t breathing of patient -    instrument moves to follows beat of heart -    microrobotics and nanorobotics – Norika3 – swallow a pill that will look at what the body doess -    Toshiba (Japan) 5 cm tube trying to make smaller -    Intelligent Microsystem Center (Korea) - biomimetic

ME: this is a good argument to reject naturalness of human

Future of surgery?

Automated procedure -    mistakes of movement can be re -    Robot for a better control of the surgery -    Under the control of surgeons! -    Cartoon: robot surgeon

Acess to health care: Patients rights as a tool for priority setting in Norway Ole Norheim, Uni of Bergen Part 1: background -    priority setting in practice: experience from Norway -    assessement according to t ideals of deliberative demorcaty o    Norheim OF: Report on Norway in Eds Ham and Robert, Reasonable rationinign, OUP, 2003

Part 2: recent development -    patient rights as a tool for priority setting

A short history of priority setting in Norway -    1987: the Lonning I-commission and waiting list guarantee o    set priorities according to severity of disease -    1990: expert group developing national clinical guidelines for bone marrow transplantion o    practical priority setting o    was emerging new technology, costing a lot o    many patients competing for this scarce resource o    principle of evidence as basis for rationing o    where firm evidence, priority stronger o    received supp from ministry and health council -    The Sandberg case, 1993\ o    System broke down. Said no to a patient, whjo happened to be brother of a TV personality in Norway, led to media storm, decision challenged, and minister for health backed down. Several cases like this in 1990s. -    1993: publication of national guidelines for anti-hypertensive treatment informed by cost-considerations o    arguing that not all prevention of CV disease should be provided – higher threshold, based on cost and personal resources to screen and treat -    1997: controversies encompassing new prescrip drugs o    Aricept for Alzheimers disease o    Forsamax for primary osteoporosis -    1997: The Lonning II-commission o    adjustment of criteria for waiting list guarantee •    severity of disease cannot be main concern •    Rawls difference principle: distribution favour the worse-off – easy to see cannot follow this principle extensively in special cases. Eg. Terminally ill cancer patients should not have high priority. Medical outcomes also considered and balanced against needs. Cost-effectivenesss introduced. o    proposed procedures for defining core services o    based on t principles of Accountability for Reasonableness o    compromise between competing values: severity, cost-effectiveness, medical outcomes. o    Inspired by Norman Daniels work o    Ministry of health did not takeup idea of implementing procedures -    1997:Philosophy Norwgian centre for health technology assessment estab -    1999: Norwegian govl appeal board regarding medical treatement abroad established o    as a result of lobbying minister of health on specific cases -    1999: Patient Rights Act o    specialized care

Evaluation -    what procedures are used to determine whether health technologies should be funded? o    No estab procedures o    Highly specialised interventions centralised o    Diffusion of technologies is the rule

Government isn’t actually regulating things

Fear that new technology is being easily introduced, might replace other important services that our HC syst should provide

What is t role of t different instits in these procedures? -    rationing was almost a non-existing health policy issue -    regulation is centralised, funding is decentralised -    little research from Norway on houw such decrentralised decisions are made -    centre for HTA: evidence based assessment of new technologies -    Norwegian Medicines Control Authority: Reimbursement drugs, evidence from cost-effectiveness studies are required

What knids of evidence do these institutions expec, req, or consider in making funding decisions? -    exptl or investigational treatment vs established treatment -    t evidence hierarchy: evidence from randomised clinical trials, systematic reviews and meta-analyses -    evidence from cost-effectiveness studies seldom cited

What ‘standard of proof’ do t institutions expect to be demonstrated in agreeing funding? -    no govl institutions have explicitly formulated ‘standards of proof’ -    Oncology: two or moroe RCTs before a new treatment modality is regarded as ‘established’ -    This standard was challenged by Matheson case, 1996 o    Woman aged 50, breast cancer with metastasis o    Received high-dose chemo with stem cel support in Sweden o    Evidence: Bezwoda et al 1995 o    Demined reimburesment from National Insurance Adminsitration o    Appealed to Minister of Health, appeal accepted o    But only in this case, not for comparable cases o    Oncologists objected: violation of t principle for equal treatment for equals

What appeals mechs ar avaialbe or reviewing decisions? -    appeals mechs for coverage decisionwihtin con

Eval of pririy setting in Norway –prior to 2003 -    much high level activity – principles well established -    political and admin reluctance to introduced proceduires and institutions with a mandate to make explicit coverage decisions -    Patients Rights Act not really implemented o    Now change in Legal system -    Appeals mech estab -    Technology assessment playing minor role -    Conclusion o    Stronger institutions will inc demand for more and relevant info o    Implementin right to necessary health care, a way forward?

Part II

Implementing patients rights as tool for priority setting in Norway Experience from Bergen: largest uni hospital Bottom u

Norwegian Patients Rights act 1999 -    obje: ensure pop equal access -    no sepecifiction on right

Financial sanctions -    since Sep 1, 2004, every patient has right, if not patient free to seek service at other hospital or abroad and regional health authorities wil reimburse t expenses

Implementation -    Wstern health region, -    Consensus based guidance for patients rights -    - based on accepted criteria -    Development by specific group -    Output: rough ‘guidelines’ for all relevant patient groups and interventions with recommended max approp waiting time -    Process:

Aim of project -    strengthen provision of well documented and reasonable cost eeffective health services to all patients with serve conditions

Priority setting model -    core services that should be provided -    elective necessary with right

Results so far -    16 guidelines from different specialistes

-    available for all health professionals on intracnet of hospitals

egs. -    rheumatology

next steps

1. evaluation, adjudtement and comparative analysis

1.    severity of diseas 2.    effectivness of technology 3.    reasonablness

2. Hearing process

3. revision 4.  publication: internet (accessible)

Conclusion: -    rights to core services can be defined through delib open process -    requires consider of who is worst off, clinical outcome,s cost-efectiveness, and qual of evidence -    but leaves room for indivd deiscretion -    openand explicit guidelines prov an opp for starting process toward fair and legit priority -    though not yet evaluated

Genes, food and drugs Ruth Chadwick

Outline -    new technologies have led to revisitng of t individual-collective relation in public health -    and to questions of their impact on health inequalities

related to political will and underlying presuppositions and inconsistencies in policy that can affect whether new technology can inc or dec equality

partic ref to individual choice

Issues -    opp costs: what else could we do with the money? -    access and benefit-sharing Choice? -    upholding of choice coincides with new forms of stratification -    no consistency in argument -    examples: nutrigenetics, obesity, and fnl foods

Two white papers (UK two strategies -    “we will learn more about t genetic featuresof common diseases, such as heart disease and diabetes and t way exeternal factors such as diet and smoking interact with our genes to increase t likelihood of developing a given diease” -    “There will then be t option to test peopole for a predisposition to diesae or a higher than normal risk. Trreatment, lifestyle advice and minotriing aimed at diease prevention could then be tailed appropy to suit each iniv, “Our inhertance, our future” -    Choosing health (2004) o    Sets out stratefy for action based on principles of informed choice….identifies how people can be empowered to make health choices. It sets out how health can be supported and improved in jey environments such as restail outlets local

First white paper, might have thought wil get individual advice in continuing to smoke, more rrecent one is to try to prevent them from smooking

Pulblic engagement -    2003 – traces of deficit model in public understanding o    people don’t understand, but if they had, they would be able to make approp choices -    2004 White paper – shaped by public consultation o    so that individual preferences have influenced development of policy document, but still hang on to view that info will empower people to make healthy choices. Though recog that not simple matter of giving people info and then make healthy choices, because of complecity of people’s lifves Key question -    how do these strategies relate -    impact on health inequalities -    what notions of perosnalised health care and choice are at stake -    2004 white paper talks about false dichotomy ‘nanny state’ – ‘freedom’ can imply neglect

Key example -    food and diet -    nutrigenetics -    food labelling -    obesity, diabetes

Nutrigenetics -    study of individual differences at genetic level (SNPs) influencing response to diet (whole genes or part)

Nutrigenomics -    aplic of genomics in nutrition research enabling assocationbw nutrients and genomic factors

info leading to applic -    understand how nutrition influ metabolic pathways -    understand how this goes way in diet -    understand how individual genotypes are influencing factors

Context -    public perceptions of genetics -    novel foods, eg gm -    prevailing ethical paradigms o    individualism and choice

Public health -    will nutrigenomics have signif public health benefits -    different between nutrigenomics and pharmacogenomics o    the other great promise in the 2003 white paper

pharmacogenomics promises individualised presecribing on basis of genotype -    enable avoidance of adverse reactions -    genetically informed prescribing (type of drug and amount -    greater safety and efficacy -    patient stratification -    signif differences to nutrigenomics o    food stuffs have many different effective ingredients, drugs are much greater characterised, acting on particular pathways o    more diffi to predict effect of specific foods o    promises of nutrigenomics more diffi to establish

testing – empowerment? -    single gene disorders (huntingtons) -    suspectiability testing o    idf recessive genes o    idef genetic makeuip which may increase risk of developing common diseases (heart disease and some cancers) -    pharmacogenetics testing o    medicine response test -    nutrigenetic testing (a form of suscpet test) -    empowerment depends on number of factors (partly due to interpretation, options, and whether people want them or not – right not to know)

Screening -    testing versus screening o    testing: of an individual through referral or self-referral o    screening: ascertaining of prevelance of genes in popn -    criteria for introducting screening o    important condition o    acceptable and reliable test o    scope for action

conditions -    PKU for newborns good example o    Phenylketonuria allows diagnosis to be made and if positive, diet can be adjusted o    However, is single gene disorder and nutrigenetics wont offer that sort of info. -    Diabetes o    Better candidtate -    Obesity o    Genetic Factor A – predisposition to obesity with food X o    Case for screening? o    Importance/scope for action?

Individualism and public health -    personal pills and personalised diets? -    More individualised t promise, t more collective action is required

Acquisition of info -    association studies o    popn groups o    specific disorders -    national dietary surveys o    established for many years, but new twist with genetic element, require setting up large genetic databases -    genetic databases

WHO (on genetic datbaseS) -    ‘..t justification for a database is more likely to be grounded in communal value, and less on individual gain….it leads to t question whether t individual can remain of paramount importance in this context’ -    ‘the achievement of optimal advances in t name of t collective good may require a reconsideration…

Alternative in 2004 whitepaper -    ‘environmental’ approach o    healthy choices (encourage people) o    labelling (Clear) o    restrictions on advertising (of junk food) o    children as a special group -    undelyin principle o    informed choice o    two qualifications •    children •    responsibilities to others (smoking) Inequalities? -    how this approach deal with? -    Increase buren of responsibility for health? -    Whose choice and for what?

Autonomy and choice

Identity – Individual autonomy –    utility – responsibility

White paper operates with notin of ‘responsible choice’ -    if people have info, they will b helped to make those choices -    though antoher notion, which does not arise o    choosing one’s identity: the sort of life one wants to live – which might include not wanting not to know genetic info, or choosing particualrl food style or lifestyle

implics for info -    food, body and self -    what sort of person do I want to be? (eg. Vegetarianism)

Fnl foods -    specific health-promoting or enhancing foods -    regulatory appracoh – highlights importance of freedom to market, subject to safety o    allows rejection in euro, if unsafe, though not whether effective (drugs must prove safety and effectiveness) o    problem: fnl foods targeted at partic audience,s but not like drugs prescribed by professionals, are available in shops; can be bought by anyone who might not benefit -    case by case approach o    tf. No mechanism for looking at… -    potential problem identified with fnl foods – target groups and overdosing -    e.g. cholestoral lowering margarines and yogurts – if same ingredients in many foods, poss to overdose – risk assessed on product alone -    cannotbe solved by labelling alone -    plus or minus nutrigenetics? -    For fnl foods, no drive to protect children as sep group -    Fnal food might be GM

Benefit-sharing -    turn towards sharing benefits of genomics (HUGO 2000, 2002) -    what counts as benefit? -    added value? -    Sharing of burdens? -    Return to issues of class

We are seeing, despite explicit ref to informed choice, return to class divisions

Rights and class -    financial times 20-11-4: ultimately, t worldwide reg push against smoking is being driven by a rev not just in rights but in calss… a class syste is solely being reereced on new bassis, brining with it a new and narrowe understand of rights o    by trying to persuade people to give up smoking, is disproportionately targeted against poort. Same can be said about food styles. – less affluent groups are targeted in strategy. o    By looking at extent to which these policy development will inc/dec inequalities, must look at other strategies, which say certain food choices have to be made. o    Not that people will make more informed choices

It widens genomics divide, but need for joined=up thinking in the two polices


Question: Norman Daniels -    to all 3 presenters -    first, Norheim, Matteson case, where min of healh backed down, the Bazooda study was later proven to be a fraudulent manipulation of evidence, and was a case that was reviewed in US, Blue Cross, Blue Shield debate – split decision 8 to 7 (scientists voted against it and managers voted for it) – when one capitulates to public, politically manipulated demand, often have signif harms to popn and huge costs. In this case, survival not increased by bone marrow transplant, but decreased -    hype of nutrigenomics might lead to experimentation on popn based on prospect for benefits -    Soler’s presentation was innovative, but problem of distincc between human subject research (requires clinical review and IRBs) and innovative therapies, which do not. o    The 3D tech does not require procedures -    What is case for ethical review for innovative technology


Ruth Chadwick -    agree: fnl foods introduced on case by case basis and nobody is thinking about overall consq of mass consumption -    for nutrigenomics, willl not have enough added value to deliver and wil become fashion accessory for few, real agenda is to get people to make responsible choices -    pharmacogenomics big demand, so bigger issue

Norheim -    medical truth have a half life of five years: be sceptical of medical evidence. -    High standards of evidence a wise approach

Soler -    already performed some evaluation -    ethics: new technology bringing separation of physician and patient -    cannot forget patient is still there, so must see them

Comment rrom Y Englert: Daniels claim v important, current distinc between pharmacology (strict exptn) and expt of therapies -    in Europe, reimbursement for

Question: fro Y Englert: -    poss risk in strategy of prioritising by structure of health care (for Norheim) -    diffi and dangerous for minister to be the one to decide -    also risk that political decision that places framework

Question: for Norheim -    high standard for evidence, reasonable to prefer benefit with high certainty than low, but assumes that research questions are equitably distributed -    research questions are inequitable -    link between framework and research agenda

Response: -    might have problem -    acknowl different criteria in law would be need to be interepreted differently. -    Acknowled different equal disttrib in funding for research -    Framework of accountability – give reasons (scientific) -    Ethical arguments on severity of disease is another argument

Question: -    context in which people make decisions on food important -    food deserts – areas where no food shops and some less than optimal foods -    option for healthy choices has gone down -    changing the context?

Answer: Ruth -    reliance on labelling totally insufficient -    person that eats, not always person who buys -    gov white paper does recog that labelling not suff -    though not clear how help people to make choices -    bear in mind that eveidence of healthy choices is always years out of date – national dietary surveys – produced 5 a day policy – took place in mid-1990s.

Question: Theresa Marteau -    for norheim -    extent to which there is a tension between informed choice and thinking in those providing health care that there is a right choice -    nobody wants to talk about weaknesses in medicine –s ometimes doesn’t work -    people offered pills and potions, but chances are will not benefit -    if there was more of an informed choice, people less interested in choices people made, might be less demand for things

Response: Norheim -    studies on giving info -    BMJ some years ago on managing market -    Prostheic problems -    Prov info about risks/benefits of different interventions, changed demand for the services

Question: Euopean Commission: Health Technology and Informatics -    we are more and more influ by genomics -    interested in projects on popn data -    Question for Chadwick o    Puzzled by dichotomy o    enviro approach sounds like eastern religions. Don’t go into level of atoms, just believe in holistic truth that there are good and bad foods o    other view that analyse to level of gene o    why are we being put in this dilemma o    we have indogenous and exogenous determiniant s(nature/nurture), need to understand from level of cell and synthesise. We have v different worlds with different ontologies, which are sep: molecular biologist, clinicians, and health care people o    each live in their own worlds o    need vertical integration o    seems like policy based evidence, rather than evidence based policy

Response: Chadwick -    need for joined up thinking -    should not look at these things in isolated way -    these 2 policy documents have done that -    not either or, hwr, in case of nutrition, serious question about whether could get suff added value, by going down that research route, over and above generliased dietary advice -    not an argument against genomics approach per se, but in nutrition much more diffi to be clear about cause and effect

Question: Precise philosophical model being discussed on patients -    autonomous informed indivs, but implies info supplied in good faith and checked by publishers -    closer look at accuracy of that info -    problem not having access to it, but having too much info -    in  NEJM article on access to health care, something Clinton admi had raised – access to Hc discrim -    report rewritten twice by next admin in US and new version said something completely different – political interference -     also market interference on report, not pharma industry, which had right not to publish resultst hat didn’t suit them, rather, where info is a merchandise, new info sells best -    eg. New diets being sold to us -    should be talking about autonomous and correctly informed citizen -    Question: how you manage access to info for citzen and make sure is correct?

Response: Chadwick -    serious problem -    diet: one week red wine is good for you, next week it is not -    channels of info need to be examined -    issue about scientific responsib in communicating with public 0 increasingly addressed -    media responsibility -    different for citizen to know where to turn

Question: -    for Ruth -    issue about return of class -    what kind of class is this -    have mentioned various sorts of social stratification -    eg daniels – if genetic diversity is treated only through an actruarial model, might have unwanted genetic stratification. Marteau described social stratification in atts to genetic testing -    so what dimension of class is particuarlly concerned about?

Response: -    different interventions could impact on this in different ways -    social stratify: policy is reinforcing social stratify, since health behavious are those associated with poorer groups of soc -    problem with this is that, if you take this approach, - voting against lifestyle choices – sits uneasily with purported unholding of individual choice assoc with genetic testing, since suggests that indivdiualised medicine approach willl not be to support particular choices -    both strategies wil reinforce social stratify, though one explicitly claims to allow individual choice

Response Norheim -    ban on smoking in restaurants and bars since Jan and argument was about workplace rights -    this might also be a classist debate

Response Ruth -    this argument also used in UK debate, but proposal is that will still be allowed in private clubs, so employees in private clubs not protected

Response Norman Daniels -    availability of info -    Ministerial sumit in Mexico, WHO health systems research -    One of proposals is interenational registryo fo all clinical trials and public assurance of acess to all clinical trials -    Could not have propriety management over info – couldnot manipulate clinical trial info -    Establish a public goods environment for management of these Its.

Response: Englert -    Registry of medicines to provide all data available -    Cannot be some parts left out for negative result -    Transparency issues about study itself and decisions taken over results orientation -    These are difficult to monitor

Question thereas Mareau -    changes in UK trying to improve, where might be divisive -    partly a semantic issue -    choice socially patterned and behaviour socially patterned -    just because people are engaging in behaves doesn’t mean is a choice -    in UK at any one time 70% of smokers would like to stop smoking. While engaging in behaves, perhaps would like to stop.

Response: Ruth -    worth some consideration, but main concern is not reasons why people make certain choices, but view that policy has about what choices people ought to make -    must look at what policy makers mean when they mean choice and upholding choice

Protection of medical and genetic data Heidi Diggelmann Olivier Guillod

Dilemma of Predictive Medicine Y Englert

Medicine evolve to predictive and to collective Move from single gene to multi gene Pre-clinical diagnosing been around for decade or so, since being able to detect for unborn child More complex when trying to deal with diagnosis of illness, which hasn’t yet appeared, but feared by patient or family

If we look at diseases that come later on, more difficult Access to jobs, insurance and social organisation

Pre-clinical screening as starting point, must first consider whether test straightaway and influence of that. Often no symptoms.

Poss of testing raises number of people who want test by 50%. If poss during pregnancy, number raises to 98%. Thus, predictive medicine provides reassurance, rather than distress

For someone with Duchenne syndrome, can avoid no of tragedies

Importance of genetic counselling before test, but not enough – need info for everybody – education programmes. Avoid stigmatisation of people

Not much use for employment purposes

Insurance implications clear

Key issue is data protection

Most sensitive of all data, because of predictive power and shared in specific group of individuals

Goes beyond individualistic approach

Can be used exclusively for identification purposes


Who owns genetic info?

Council of Europ recommendation 97.5 -

Stefano Rodota

Legit of tests only for health or research Therapeutic model Conference Review: Justice, healthcare and the Trend Towards Predictive Medicine For British Medical Journal

Thus week, Brussels held a symposium on the future of health care, which aimed to bring young and senior scholars to question the ends of current trends in medicine. In particular, the symposium focused on ‘predictive medicine’ and the emerging opportunities for working towards a more just healthcare system. The symposium was supported through the Brocher Foundation, a research foundation interested in questions concerning the socio-political context of science and medicine. It was a relatively small meeting, though the kinds of guests reflected key authors and speakers in bioethics.

The symposium began with a lecture from Norman Daniels, whose work on XXX

Norman Daniels drew attention to the inadequacies of the US model and the worry of exporting its medical models to other countries. His Rawlsian approach to healthcare justice reflected the social obligation to provide socially just …. He also spoke about the challenges faced by the emergence of predictive medicine as a moment of opportunity for requestioning how medicine takes place. Acknowledging that predictive medicine will raise challenging economic realities for the medical industries, Daniels argued that this can be seen as a chance to provide greater justice in healthcare, or it can be used to exacerbate the needs and lack of the most vulnerable people.

Rawlsian ideas were taken up in the subsequent presentation byXX. However, the focus was significantly different, raising questions about the body-as-product both commercially and ideologically. XXX addressed the challenge of Utopian medicine, the prospect of which seems wholly inadequate even in best-case scenarios. The acceptance of tragedy in life is considered indicative of the human condition and the rejection of this circumstance can be seen as socially divisive. It is not that people should not seek to optimise their health, but that the process towards realising that will be to the detriment of those who have the most need.

Neither of the speakers fully addressed the difficulty with limiting individual desires to pursue health at all costs. Indeed, there was lmite