JUST CARING: IN DEFENSE OF THE ROLE OF DEMOCRATIC DELIBERATION IN HEALTH CARE RATIONING AND PRIORITY-SETTINGLeonard M. Fleck, Ph.D.

Michigan State University

FIRST, A WORD FROM OUR SPONSOR

NO PAINLESS COST CONTROL

SOME STATISTICS

In 2009 in the US we spent $2.5 trillion on health care, or about 17.3% of GDP.

Compare to 1960 when we spent $26 billion on health care, or about 5.2% of GDP

Project to 2018 when we will spend $4.5 T, or about 20% of projected GDP

Canada, UK, most European nations currently spend 8-10% of GDP on health care.

SOME STATISTICS

In 2009 roughly 35% of total health expenditures were consumed by the 13% of the US population over age 65 (39 million people), or about $850 billion.

In 2012 roughly 15% of our population will be over age 65 and consume $1.2 Trillion in health care

In 2025 roughly 21% of our population will be over age 65, about 76 million individuals.

Medicare spending in the US will go from $500 billion in 2009 to $1 trillion + in 2019.

KEY CLAIMS Significant health reform is an

impossible dream unless: The “Just Caring” problem is explicitly

acknowledged and forthrightly addressed The “Just Caring” problem is addressed

through a very broad, prolonged, fair, and transparent process of rational democratic deliberation.

KEY CLAIMS One major dimension of the “Just

Caring” problem is the “ragged edge” problem. Though Callahan called our attention to it more than 20 years ago, it has been largely ignored. But it is getting more complex and more pervasive. If we fail to address it effectively, health reform will fail.

KEY CLAIMS Another major dimension of the “Just

Caring” problem is the “rough justice” problem. Because of the heterogeneity and complexity of health needs and the complexity and heterogeneity (and uncertainty) of potential therapeutic responses to those needs, we can expect no more than “rough justice” in meeting those needs. Very often every effort to eliminate one pattern of injustices seems to create another pattern.

KEY CLAIMS The moral terrain on which we need to

resolve the “Just Caring” problem is “rugged” because we do not have the shared broad social understandings of what is “just” or “just enough” to generate a productive moral discussion. We want to apply very different understandings of justice in complex moral circumstances.

CASE Dr. Michael DeBakey, age 97, pioneering

heart surgeon, struggling now with a dissecting aortic aneurysm (Jan. 06)

Not sure he wants the surgery necessary to save his life, eventually agrees

Lots of complications following surgery; costs in excess of $1 million for 8-month stay, but glad to be alive in Jan 07.

Would it be unjust to deny him that care?

CASE Mr. Diaz, 69 yrs old (2002) advanced

AD, machine operator, First signs of AD in early 1990s, cared

for by brother, chokes on food in 2002, ends up vent-dependent in hospital on feeding tube

Develops pneumonia and intestinal bleeding in Feb 2003, spends 140 days in the hospital at a cost of $280K

Would it be unjust to deny him that care?

JUSTICE AND COST-EFFECTIVENESS In 2009 we implanted in the US about

200,000 Implantable Cardiac defibrillators [ICDs] at a cost of $40K each. 81% of them never fired in 5 yrs, meaning they made no difference. Consequently, we are often paying as much as $367K per QALY [Quality-Adjusted Life Year]saved.

Is that a just or prudent use of limited health care resources?

ICDS: A RATIONING EXAMPLE A test called the T-wave alternans test

was recently FDA approved. It can identify with 98.8% accuracy who will NOT experience a cardiac arrhythmia in the next five years. This test can reduce the ICD implantation rate by 33%, saving $2-3B per year. But a 1.2 % error rate means that 800 people will die from a fatal arrhythmia per 70,000 denied an ICD.

ICDS: KEY ETHICAL ISSUE Would a society still be just and caring

(not open to moral criticism) if we put in place an ICD rationing protocol that would deny an ICD to anyone who “failed” the T-wave alternans test? In other words we would accept 800 “preventable” deaths in order to save $2-3B per year in medical expenses.

A HEART-STOPPING TITLE Consider the following article in the journal

Circulation, 2010; 121: 208-13. “Operative and Middle-Term Results of Cardiac

Surgery in Nonagenerians: A Bridge Toward Routine Practice.”

Conclusion: “Although the rate of postoperative complications remains high, cardiac surgery in nonagenarians can achieve functional improvement at the price of considerable operative and follow-up mortality rates.” (at 208) The authors add that such surgery “represents a real challenge in the elderly patients who are more likely to have co-morbid conditions and a complicated/ prolonged hospital course post-operatively.”

QUESTIONS To what extent is a “just” and “caring” society

obligated to provide major life-prolonging surgeries to patients in their eighties and nineties who have many co-morbid conditions? That is, how high a priority ought such surgeries have relative to other unmet health needs?

To what extent is a “just” and “caring” society obligated to provide major life-prolonging interventions to patients with late-stage dementias and many co-morbid conditions? That is, how high a priority ought such interventions have relative to other unmet health needs?

KEY CLAIM The questions in the prior slide cannot be

“justly” addressed through exclusive reliance on any sort of expertise, or on individual physician judgment, or on administrative judgments (as in a managed care plan or hospital), or by allowing ability to pay to determine outcomes.

These are precisely the sort of questions that are best addressed through, fair, inclusive, carefully structured processes of rational democratic deliberation.

KEY CLAIM If the need for health care rationing and

priority-setting is inescapable, and if we need just and legitimate rationing protocols and practices, then BOTH the process that would yield those protocols and practices as well as the protocols and practices themselves must be respectful of our liberal and pluralistic commitments and incorporate our “shared sense of justice.”

BUT, outcomes that are a product of normal interest group politics and relative political power will fail the above test.

WHY HEALTH COSTS INCREASE INEXORABLY Insurance mechanism New medical technologies Extremely fragmented system for

financing health care>>high administrative costs

Competition among health care providers

Increase in burden of chronic illness Social belief in pricelessness of human

life Lack of shared social understanding of

health care justice/ limits on demands

COST-ESCALATING REASONS Advancing Medical Technologies

Beta-interferon for MSStatins Implantable Cardiac DefibrillatorsMRIs/CTs/PET scansTotally Implantable Artificial HeartsPre-Implantation Genetic DiagnosisRenal dialysisFactor VIII for hemophiliacsHerceptin/ Iressa etc---very expensive anti-

cancer drugsRehab for spinal cord injuriesAIDS drugs (triple and quadruple combos)

COST-ESCALATING REASONS “RAGGED EDGES” If there are no bright lines that

establish limits, then an “inchoate jumble of moral intuitions” masquerading as a “public sense of justice” will ignore health care costs and insist that therapies be provided to desperate patients without “preferred” alternatives.

INCHOATE MORAL INTUITIONS Rule of Rescue Urgent needs (related to life-

threatening illness) Last chance therapies Caring for the “medically least well

off” Pricelessness of human life Social visibility of desperate patients

COST-ESCALATING REASONS Chronic conditions are concentrated among

the elderly; the 13% of our population over age 65 consumes 35% of all health dollars (about $850B in 2009)

The 23% of Medicare beneficiaries with five or more chronic conditions consume 68% of Medicare dollars (Anderson, NEJM, 7/21/05)

That outcome is largely a product of our past medical successes, which is why some health policy analysts say we are “doing better and feeling worse.”

PHARMACOGENOMICS: ETHICAL CHALLENGES Key Issue: How should we (citizens and

physicians in a just and caring society) determine the precise characteristics of patients who would have a prima facie just claim to access very expensive drugs that would be more likely to be therapeutically beneficial because of either their genetic characteristics or the genetic characteristics of a cancerous tumor? This question gets raised when what are being bought are extra weeks or extra months of life on average.

Fojo/Grady cancer cost stats.

DRUG---COST---SURVIVAL GAIN Cetuximab (Erbitux) $80 352 1.2 mo

( 1 ) Sorafnib (Nexavar) $90 816 1.5 mo § Bevacizumab (Avastin) $15752 10 d Erlotinib (Tarceva) $34373 2.7 mo

Stats from Fojo/Grady, “How Much is Life Worth: Cetuximab, non-small lung cancer, and the $440 billion question” Journal of the National Cancer Institute June 29, 2009

COMMENT “If we allow a survival advantage of 1.2

months to be worth $80,000, and by extrapolation survival of a year to be valued at $800,000, we would need $440 billion annually to extend by one year the life of the 550,000 Americans who die of cancer annually. And no one would be cured.”

Source: Fojo/Grady, “How Much is Life Worth: Cetuximab, non-small lung cancer, and the $440 billion question” Journal of the National Cancer Institute June 29, 2

GENOTYPES AND ADVANCED BREAST CA A recent trial of patients with advanced

breast cancer compared their being treated with paclitaxel alone to paclitaxel plus bevacizumab (a targeted biologic). Median survival in those two arms was virtually indistinguishable: 25.2 months vs. 26.7 months. One could say that bevacizumab increased median overall survival by six weeks. However, when specific genotypes were analyzed there were very marked median differences in survival.

B.P. Schneider et al. “Association of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor-2 Genetic Polymorphisms with Outcome in a Trial of Paclitaxel Compared with Paclitaxel Plus Bevacizumab in Advanced Breast Cancer: ECOG 2100,” Journal of Clinical Oncology 26 (2008): 4672-78.

GENOTYPES AND ADVANCED BREAST CA• If the VEGF genotype of an individual was

AA/AA, median survival was 49.7 months (7.6% of the cohort).

• But if their VEGF genotype was AA/GA, median survival dropped to 30.2 months (11.4% of cohort).

• And individuals with a VEGF genotype of CC/GG had a median survival of only 21.7 months (32.9% of the cohort).

BREAST CANCER STATS 44,000 women die of breast cancer each

year in the US If all received pacitaxel and bevacizumab,

aggregate cost for bevacizumab would be $4.4 billion.

If only some were to receive this therapy, what justice-relevant considerations should shape our choice? Last chance therapy? Medically least well off? Pricelessness of human life? Urgency of need?

WHO GETS BEVACIZUMAB? But if we consider cost-effectiveness alone, then the

AA/AA genotype subgroup has the strongest just claim. Each QALY achieved there would cost about $50,000, and aggregate costs would be reduced to about $350 million. Would the AA/GA subgroup have just cause to complain if their access to bevacizumab were not socially underwritten? They would only gain five months in additional life expectancy, which would yield a cost per QALY of about $240,000. Aggregate costs for bevacizumab would then rise to about $1 billion. This concession will hardly break the bank.

How do we know whether the cost of a QALY is reasonable? The reference point used most often is the cost of a year on dialysis, about $67,000 in 2009. In the US we currently sustain about 450,000 individuals on dialysis at that average cost level. The implicit moral argument is that if we regard that as a reasonable purchase for sustaining the lives of patients with end-stage renal disease then we ought to be willing to pay at least that to sustain the lives of patients with other end-stage diseases.

WHO GETS BEVACIZUMAB? However, the next genotype subgroup on the

list, CA/GA, would achieve a median survival of 27.1 months. This group represented 20.9% of that patient cohort and an additional $1 billion in costs. This group would gain on average only two extra months of life above median survival in the paclitaxel alone treatment group, which yields a cost per QALY of $600,000.

WHO GETS BEVACIZUMAB? To many it might seem reasonable and fair to deny

these individuals access to bevacizumab at social expense. However, we can imagine an egalitarian-based argument from those with this last genotype. In brief, if society is willing to spend $100,000 to prolong the lives of each of those AA/GA individuals (same disease as me) for a very modest gain in life expectancy, then society ought to be willing to spend that same $100,000 for each of us with the CA/GA genotype. We too want as much life as possible of acceptable quality, even if it is a bit shorter than someone else’s.

John Harris would make this argument against advocates for the use of cost-effectiveness to determine which lives to save. He writes, “So long as people want to live out the rest of their lives, however long this may be, or looks like being, then they should be given the best chance we can give them of doing so and we should not choose between such people on any other grounds, but treat each as an equal.” The Value of Life (Oxford, UK: Routledge and Kegan Paul, 1985), 110.

COLORECTAL CANCER AND CETUXIMAB The European Medical Agency recently

approved Panitimumab and Cetuximab as first line therapies with chemotherapy for patients with metastatic colorectal cancer “with no mutations in the codon 12 and 13 of the KRAS gene”. Both these drugs are extraordinarily expensive: more than $100,000 for a course of treatment. Neither drug will effect a cure for the cancer.

A. Ruzzo et al. “Molecular Predictors of Efficacy to Anti-EGFR Agents in Colorectal Cancer Patients,” Current Cancer Drug Targets 10 (2010): 68-79.

COLORECTAL CANCER AND CETUXIMAB If these drugs are given to everyone with

metastatic colon cancer, then the average gain in life expectancy will be a few weeks. If these drugs are given only to patients lacking the specified mutations, those patients might gain two extra years of life. About 40% of these patients have a KRAS mutation predictive of non-response to these drugs. Another 35%--40% with wild-type KRAS will have an objective response to these drugs.

E. Van Cutsem et al. “Molecular Markers and Biological Targeted Therapies in Metastatic Colorectal Cancer: Expert Opinion and Recommendations Derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009,” Annals of Oncology 21 (Supplement 6) (2010): vi1—vi10.

COLORECTAL CANCER AND CETUXIMAB To put all of this in context, about 55,000

patients in the US will die of colorectal cancer in 2010. If all these patients had access to these drugs at $100,000 for a course of treatment, that would add about $5.5 billion per year to the cost of caring for these patients. In theory, several billion dollars could be saved if access to these drugs was restricted to individuals with a genotype that was most likely to be responsive to these drugs (the 35%--40% with wild-type KRAS). It certainly seems such a limited choice would be both morally and economically reasonable.

COLORECTAL CANCER AND CETUXIMAB However, future research will make this more

morally complicated. Individuals with wild-type KRAS do not all show the same “objective response.” Only some will achieve maximal gains in life expectancy. Others will only gain extra months or a bit more than a year of additional life expectancy. We do not know whether additional genetic factors identified through future research will yield a picture of enhanced median survival comparable to what we described above in connection with advanced breast cancer. Would it be unjust to do the further research that will yield more restrictive access to these expensive drugs for patients with marginally responsive genotypes? What can be said to them, morally speaking, that would justify denying them that desired benefit? What did we say to the patients with advanced breast cancer?

COLORECTAL CANCER AND CETUXIMAB Would it be unjust to deny the whole cohort of

patients access to these drugs at social expense who would only gain extra months of life (less than a year)? This is again Callahan’s “ragged edge”. We are faced with “rugged moral terrain” (not just a bump in the terrain) because this sort of issue will become ubiquitous as the field of pharmacogenetics advances over the next decade. The complexity and uncertainty associated with the science and clinical judgment will allow us to achieve no more than “rough justice.” That in turn raises the question of how rough “rough justice” can be and still be “just enough”.

CRITICAL CHALLENGE Might the argument be made that massive

social expenditures made to forestall individuals becoming the “medically least well off” (reaching the end-stages of HIV, or cancer or heart disease or COPD etc.) would justify reducing our commitment to providing very expensive life-prolonging last chance therapies once individuals had reached the end-stages of a disease process (and could benefit only marginally)?

This assumes we can identify clear sharp criteria for marking this end-stage. [But why should someone be allowed to die when they are “only” at the beginning of the end-stage??? Isn’t the morally right thing to wait until they are at the end of the end-stage?.....more ragged edge!!!]

CHALLENGES OF GENETICS Expect strong pushback from patients denied

very expensive life-prolonging drugs on the basis of genetic tests that predict only marginal gains in life expectancy.

ARG: It is unfair to deny me these life-prolonging treatments on the basis of things I cannot change about myself (my genotype). If anyone should be denied expensive life-prolonging care it is those who are “responsible” for their medical problems.

ENDLESS NEEDS The message from the prior slides (relative to

the “Just Caring” problem) is that needs are endless because we have an unending stream of new (mostly additive) medical technologies and new understandings (limited) of how our bodies react at the molecular level to many therapies.

These technologies dramatically increase the burden of chronic illness

No bright line to separate marginal needs from morally compelling needs----they are all NEEDS!

KEY CLAIMS We need a more just health care system

(practices and policies and institutional structures) if we would want to have more just health outcomes.

We need a more just approach to health care rationing and priority-setting

We need to address the “ragged edge” problem explicitly and thoughtfully.

We have to become morally comfortable with rough justice.

Just health care rationing must be public, visible, publicly legitimated, and self-imposed

(MORE) KEY CLAIMS Health care rationing does not have to pit

one group against another Each of us (for lots of reasons) is internally

conflicted about rationing [I don’t want to pay for expensive marginally beneficial life-prolonging health care for a stranger……. So why should a stranger pay for such care when I want it?] We are a society of strangers to one another.

KEY CLAIM I argue that it is through a well-designed

process of rational democratic deliberation that we can collectively, fairly, impartially identify and impose upon our future selves fair health care rationing protocols (though no one should be misled to think such deliberative processes are easy to create or maintain.)

CONCEPTIONS OF JUSTICE Libertarian/ desert based (ability to

pay) Utilitarian: greatest good for greatest

number/ aim should be to purchase the greatest amount of health possible for a fixed sum of dollars

Moderately egalitarianFavor “least well off”Protect fair equality of opportunity

Strict egalitarian PROBLEM: We do not have a shared

conception of health care justice.

KEY CLAIM I contend that none of these conceptions of

justice is capable of addressing all the complexities and instantiations of the problem of health care rationing.

Part of the role of rational democratic deliberation is to determine the circumstances in which these different conceptions of justice are reasonably applied in addressing rationing issues.

Non-ideally just outcomes are the best we can reasonably hope for.

WHY DELIBERATION? Empirical complexities and uncertainties of

contemporary medicine Burdens of judgment: how can the empirical

and moral complexity be managed to yield practical conclusions?

Lots of possible rationing options/ trade-offs in any particular circumstance, no one of which is unequivocally morally superior

Need a socially legitimated decision to avoid arbitrary choices at the clinical level

VIRTUES OF DELIBERATION What we want in any society as the core of

justice is reciprocity and fair terms of cooperation. This is what we seek to articulate in detail through a broad deliberative process about health care rationing.

If I would deny to an 80-yr old (stranger to me) with end-stage AD an ICD because it yielded only small benefits at high cost, then I ought to deny that to my future self as well in end-stage AD.

This is what public, self-imposed rationing is.

MY VIEW: KEY ELEMENTS We must be satisfied with non-ideal

deliberative outcomes We must articulate constitutional principles

of health care justice, and then we must engage in the long term task of balancing these principles in relation to each other and in relation to the concrete rationing problems they must govern.

We must recognize a complex pluralistic conception of health care justice

We must accept limits of moral theorizing, what Rawls calls burdens of judgment

MY VIEW: KEY ELEMENTS We must accept Rawls’ notion of an

overlapping consensus as a tool of democratic stability in making health care rationing/ priority-setting judgments

We must use wide reflective equilibrium as a tool for disciplining (to a degree) democratic deliberations and the constitutional principles of health care justice.

Conclusion: We can construct a democratic deliberative process that is morally robust and congruent with our liberal pluralistic moral and political commitments

GOOD DEMOCRATIC DELIBERATION A deliberative democratic procedure is

morally robust when its outcomes are:

Sufficiently stableSufficiently fair/ reciprocalSufficiently reasonableSufficiently consistentSufficiently liberally legitimateSufficiently determinate

GOOD DEMOCRATIC DELIBERATION A deliberative procedure is morally

robust when its procedure is:Sufficiently inclusive of diverse

voices/perspectivesSufficiently transparentSufficiently impartial/ unbiasedSufficiently objective/ inclusive of

accurate scientific information

IF NOT RDD, WHAT?

Experts? Which experts? [Many disciplinary perspectives would be relevant to the health care rationing problem……..would both physicians and economists see things the same way faced with specific rationing challenges, such as our ICD problem?]

NOTE: Expertise of whatever sort will not resolve the challenge of conflicting values and balancing values in concrete rationing contexts.

IF NOT RDD, WHAT? Individual physicians at the bedside? The risk here is that of seriously compromising

either medical integrity/ patient trust or justice (given that it is a common pool of resources used to pay for medical care that comes from patients).

There is also the risk of self-interest, either by physicians (whose income may be reduced from doing less) or by patients importuning their physicians (and ignoring just constraints on their rights to that common pool of resources)

BUT medical expertise must inform rationing protocols and some limited degree of clinical flexibility/judgment is needed in the clinic.

IF NOT RDD, WHAT?

Groups of physicians articulating rationing protocols?

If all of the same specialty (oncologists or cardiologists), then self interest will corrupt fairness or reasonableness of the rationing protocols. Oncologists believe cancer drugs with a cost of $300,000 per QALY are reasonable and ought to be supported with social resources.

If a mix of specialists, then interest group politics prevails along with self-interest; justice and cost control suffer.

IF NOT RDD, WHAT?

Let legislators decide rationing protocols? BUT

Interest group politics prevails Inflammatory rhetoric subverts reason Partisanship subverts the common good Justice becomes irrelevant Cost control gets accomplished only in the form

of invisible rationing hidden from public scrutiny

IF NOT RDD, WHAT?

Let insurers determine rationing protocols? Whose interests are insurers serving? What standards would insurers use to determine

rationing protocols/ priorities? If cost-effectiveness alone is the standard, then

what becomes of justice or rights of the medically least well off? [Think of Gaucher’s patient]

Let consumers decide by letting insurers offer a range of plans with differing rationing protocols and prices But this is really regression to health care access

by ability to pay; no fairness here and minimal cost control

CONCLUSION

Relative to all the prior alternatives, the virtue of a properly structured process of rational democratic deliberation is that it can yield health care rationing protocols and priorities that are self-imposed, that are “just enough,” that are reasonable, that are democratically legitimate, and that are respectful of our liberal, pluralistic fundamental political commitments.

In addition, if the process has been properly structured, no social group will be able to impose its will on weaker groups through government.

THE ‘INDETERMINACY’ OBJECTION How would someone committed to this

or that concept of justice address the problems above…………lots of disagreement. So why would we not expect the same problem in democratic deliberations?

BUT, ordinary folks are not ideologically committed philosophers; they are generally more open-minded, educable

KEY TO DELIBERATIVE SUCCESS Frame a problem that requires public

inquiry from the beginning, that internalizes a certain value conflict WITHIN each deliberative participant.

TIAH example: (1) Rule of rescue; can’t just let people die; create 350,000. (2)But consider cost issue, dropped health insurance by employers; no one gets TIAH; affirm equality of all.

KEY TO DELIBERATIVE SUCCESS (3) But some very young people go

into heart failure…….a just and compassionate society cannot just let them die….produce 100,000. Who sets criteria for judging who gets these?

(4) Should feds require coverage by all insurance companies? Then what other expensive life-prolonging devices must get covered?

CRITICISM Are we not back at our indeterminate

stage? Not exactly, since at least all the proposals considered are justified for liberally legitimate reasons.

Some proposals would not be liberally legitimate…….deny artificial hearts to HIV+ pts on protease inhibitors…this violates ‘equal respect’ constitutional principle (especially if reason for the denial is that HIV is punishment for sin).

A DEMOCRATIC PROPOSAL If you have multiple just enough,

reasonable enough proposals after sustained deliberation, then use two-tiered voting procedure to get determinate outcome.

But how do we know this outcome is just? This is the domain of non-ideal justice, faced with burdens of judgment. Each option requires trade-offs.

A DEMOCRATIC PROPOSAL The outcome of the voting procedure

will be justice-warranted (not ideally just). It will have the virtue of balancing (often) a number of conceptions of justice.

Major virtue of RDD is that rationing decisions are self-imposed. Can those who did not vote for winning option claim any injustice? No….no unjust use of majoritarian power or rights violations.

A DEMOCRATIC PROPOSAL Note how vast majority of participants

in RDD rationing discussion are practically behind a veil of ignorance; it is very hard for me to be reflectively biased toward some set of health interventions to distort deliberative process since there are so many future possible illness/injury states I might endure.

CRITICAL COMMENT Can genetic knowledge corrupt RDD?

Not really. Imagine I am genetically predisposed to heart disease. Do I reduce funding for expensive cancer drugs? Do I push for funding 350,000 artificial hearts? Imagine an approved rationing protocol of 100,000 artificial hearts..age 70 limit.

CRITICAL RESPONSE Pt A genetically vulnerable to heart disease

has heart attack at age 65…..he gets artificial heart, and gets cancer at age 72---treated successfully.

Same pt in Scenario B has heart attack at age 72, dies. No TIAH. Has he been treated unjustly?

Scenario C: Same pt gets ICD at age 67; others denied ICD because of T-wave rationing protocol (and some die). If he dies at 72 from heart failure, then he is following thru on same commitment others made to save his life. Unfortunate outcome but not unjust.

Core element of justice is reciprocity

OBJECTIONS TO RDD Democratic deliberation cannot change

minds; individuals have beliefs integrated into a complex web of beliefs and commitments that are mutually supportive, thereby making it very difficult to give up a major belief (such as a belief related to the value of human life).

For a critical assessment of this view see Gerry Mackie, “Does democratic deliberation change minds?” Politics, Philosophy and Economics 5 (2006): 279-303.

Minds do change; think civil rights and environmental issues; BUT deliberation must be sustained over long periods to be effective on major policy issues. One time conversations will have little effect. Must create internal moral conflict.

OBJECTIONS TO RDD

Cass Sunstein raises the “polarization” objection: What makes us so confident that the deliberative process will yield consensus or compromise? Is there not lots of empirical evidence that opinions harden, take the form of “deliberative enclaves” and move further to the poles?

OBJECTIONS TO RDD

How do you correct for “unjust rationing decisions” that might emerge from the deliberative process?

How do you recognize an unjust decision when you are choosing among “non-ideally just” options to begin with?

OBJECTIONS TO RDD

How do you avoid the creation of coalitions that would dominate or distort the deliberative process? That is, how do you avoid all the faults and failings of interest group politics?

OBJECTIONS TO RDD How can the deliberative process deliver

outcomes [just rationing/ priority-setting judgments] that are morally robust and morally reliable? Zeke Emanuel (1991) will argue there are many reasonable conceptions of justice. If we favor any one of them in the deliberative, then we are not true to our liberal pluralistic commitments. If we favor none, deliberation is interminable.

If we allow the political winds to favor this or that conception of justice at a point in time regarding a concrete rationing decision, then we risk moral inconsistency.

OBJECTIONS TO RDD

Daniels (1993) “democracy objection”: Can the deliberative process yield outcomes that are unjust and that we can recognize as unjust? If so, then there is a substantive conception of health care justice outside the deliberative process that makes the process otiose. On the other hand, if no outside standard of justice, then all outcomes of the deliberative process must be accepted as procedurally just. Neither of these outcomes seems acceptable.

OBJECTIONS TO RDD

Assuming that we have just outcomes from the deliberative process, how is the integrity of that judgment supposed to be protected from the corrupting effects of the normal process of legitimation through legislative bodies, i.e., interest group politics? If the integrity of the outcome cannot be protected, then it would be reasonable to ask what the point of the deliberative process was.

CONCLUDING PRACTICAL PROPOSAL It is probably necessary to bypass normal

legislative processes [Lesson from Oregon] We can imagine large regional insurers in the

US (covering 5 million lives) with representative citizen deliberative boards charged with determining plan-specific rationing protocols and priorities.

This might work if there were an overall national determination of a comprehensive package of health benefits guaranteed to all in our society;

AND a NICE-like entity to do efficient comparative-effectiveness and cost-effectiveness analyses

CONCLUDING PRACTICAL PROPOSAL There could be differences from one regional

insurer to another, but these would be differences about marginally beneficial non-costworthy health services to which no one had a presumptive just claim. Hence, individuals might be treated marginally differently from one plan to another but those are not justice-significant differences

Though this representative body in each plan would have decisional authority, we would still want very broad informed deliberation accessible to all in the plan (and a mechanism for expressing their judgments to the deliberative board).

CONCLUDING PRACTICAL PROPOSAL

I have listed elsewhere fifteen criteria that can be used to assess the quality and legitimacy of any concrete deliberative process, such as I imagine these Boards engaging in.

See my essay “Creating public conversations about behavioral genetics,” in Wrestling with Behavioral Genetics: Science, Ethics, and Public Conversation (Johns Hopkins University Press, 2006), 257-85.