Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society Stem Cell Research: Ethics, Translations and Transmissions

Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

Stem Cell Research: Ethics, Translations and

Transmissions

Northwestern UniversityAn NIH Center of Excellence in Stem Cell Research

Center forBioethics Scienceand Society

Laurie Zoloth, Ph.D


Plan of talk Ethical Issues in International Stem Cell Research List of first, second and current ethical concerns Why we must now focus on justice Description of theories of justice Description of historical solutions in resource allocation Proposals for fairness One Critical Note about Veracity as the basis for all

theory (both in science and in philosophy) Gratitude


The First Years of Human Stem Cell Research—a brief review of where we’ve been

Raised three sorts of questions in ethics: Origins : the cells raised issues of moral status of

embryo Process: Donations of eggs and sperm needed

raised issues of informed consent Telos: Long term goals raised issues of the telos

or good ends of the idea itself


The Next Questions concerned Somatic Cell Nuclear Transfer

Raises new issues—cloning Violation of order considered natural or divine Species and boundaries Slippery slope concerns


Core arguments against basic research in human stem cells Slopes are slippery and the future is thus

dangerous Can not use the bodies of others even for good Money and the marketplace are inherently

corrupting Nature is both fixed and sacred DNA is ipsity—once established destroying it

amounts to killing Suffering and finitide defines humanity Women could face particular abuse


That the more we learn about this


The better able we are to relieve human suffering


What have we learned so far? Some questions are not resolvable

Some are merely very difficult to resolve

Some have just not yet been resolved in a temporal sense.


But of all the lessons we learned one thing.

Do not lie

For if you lie about the facts Or hype the results Or hype the fear

Then real discourse cannot happen.


Koreagate: Not too early to tell That lying has had a devastating effect on

the process That international co-operation is made

more difficult That the entire process of bioethics is at

issue That bioethics must make its own demands

What it Means to Have Duties

As in Kantian Moral Imperatives

As in Religious Commands


That is the key question. Isn’t the problem the moral status of the

human embryo?


No.


Stem cell science raises important ethical questions

Even if we cannot decide about moral status

Which we cannot: for it is not a scientific question in its present form and in the present world.


I. 3 interesting Questions in biology and in ethics

What does it mean to be human? What does it mean to be free? What must I do about the suffering of the

other?


II. A Particular history 1970s: ability to deconstruct process of human

reproduction idea that infertility is a disease with a treatment Creation of a genuinely new entity: an unenabled

human embryo In a country with a long history of interest in moral

status issues And Asilomar, which encouraged bioethicists


What policymakers actually need to ask:

Are there reasons in principle why performing the basic research should be impermissible?

What contextual factors should be taken into account an do any of these prevent development and use of the research?

What purposes, techniques or applications would be permissible and under what circumstances?

What procedures, structures, involving what policies, should be used to decide on appropriate techniques and uses?


171 Bills debated in first months of 2005 at the state level in the US

15 on umbilical cord blood banking 156 on committed (“adult”) cells, hES or

cloning 14 enacted into law

A “New Federalism”


Separation Compromise Emerges Election of 2004 Stem Cell Policy, 2005


Stem cells debate draws on classic tropes and borders debates Borders of democracy-> moral status of the other Borders of Nature-> Fixed? Tamed? Normative? Borders of mortality and suffering, contingency Danger -> slopes, precaution, dual use, mistakes Justice-> access, fairness, money and markets A synedoche for modernity—a trigger for

fundamental return(s)


Issues Considered by National Academy of Sciences in the United States1) Recruitment of donors of blastocysts, gametes, or somatic cells

informed consentfinancial incentivesconflicts of interestdonor confidentialityrisks associated with oocyte retrievalhandling of genetic information arising from the research

2) Characterization and standardization of stem cells3) Safe handling and storage of blastocysts and stem cell material 4) Conditions for transfer of such material among laboratories5) Appropriate uses of hES cells in research or therapy 6) Limitations on the use of hES cells7) Safeguards against misuse

Guidelines for Human Embryonic Stem Cell Research


Use local IRBs Use existing BABs Create new oversight groupings at local

level Statewide boards National oversight (raises other risks)


Knowles: “By creating the California Institute for

Regenerative Medicine (CIRM) as a central body to distribute these funds, and within it, the Independent Citizen's Oversight Committee (ICOC) as a governing body to evaluate who receives them, the state has effectively created its own National Institutes of Health. “


The Real NIH is shaken by new forces

Hurricanes Basic flattening before hurricanes Aging population, risk of infectious disease Private model, HSA, and

entrepreneurialism


How to regulate? Despite the appearance of a regulatory vacuum Protections in place include:

federal human-subject research protection FDA protections Health Insurance Portability and Accountability

patient privacy rules. RAC guidelines

Apply to any research supported in whole or in part by federal funds or at institutions that have pledged to follow federal regulations.

ASRM guidelines


New Phase Begins: Establishment of Banks for hES lines

Earlier Questions marked by contention Largely issues of faith Issues of significant disagreement with low

likelihood of solution Search for determinate answers for largely

indeterminate problems (see Nature, Oct 16)


Moving from theory to praxis Will create immediate justice issues Need for a UNOS or lottery system


Justice is prior to freedom Levinas’s claim Need I mention once again that truth is a

prerequisite to justice


The Question of Justice How does a society decide what is just? In a world of scarcity, how ought a society justly

distribute scarce goods and services? In light of the particular and poignant crisis of

health care what would be the language of such choices,

How can state can be accountable for justice How can an international community reflect on

justice?


Statement of problem How can we set in place a fair and just

system of access to the good ends of medicine?

Using a fair and just process that protects donors and recipients?

And aiming for fair and just goals for humanity?


Standard candidates for material principles of distribution

numerical equality need individual effort social contribution merit or desert


Theories come from material principles Different theories of justice placed different

emphasis on these material principles, Can accept combinations of material

principles Understanding a particular theory of justice

began by critically examining the theoretical justification of the selection of material principles


And from principles of liberal democracy All liberal theories shared in common the

presuppositions of the liberal tradition, all rested on the assurance of the primacy of the

individual the individual person, with liberty, rights, duties, and the ability to engage in voluntary consent, existed prior to the social contract itself.

the social contract that is entered into by rational free agents operating from an original position that was either historical or hypothetical, that created the liberal state


Libertarian theory liberty, private property, and entitlement. the problem of ownership the rights of each individual to own his or her own resources. According to the classic Lockean theory, the labor power of

the individual, his actual work, was "mixed" with the natural resources, land, and water to create wealth that the individual then owned.

The ownership of the harvested crops was brought into being by virtue of the individual's creation of this commodity where none existed before.


Problems Are free first holdings really free? What of physical or genetic injustice? Does the end not really not matter---could

one accumulate nearly all the resources if done fairly?


Utilitarianism “All action is for the sake of some end, and

rules of action, it seems natural to suppose, must take their whole character and color from the end to which they are subservient. . . . When we are engaged in a pursuit, a clear and precise conception of what we are pursuing would seem to be the first thing we need, instead of the last we are to look forward to”

John Stuart Mill


Based in Consequences Greatest happiness for greatest number

pleasure and the freedom from pain, are the only things desirable as ends; and that all desirable things (which are as numerous in the utilitarian as in any other schemes) are desirable either for the pleasure inherent in themselves, or as a means to the promotion of pleasure and the prevention of pain.


Not rights based liberty was not a right unless it was justified

by its utility to a society that was secure. Claims of merit, claims of prior social

contract, conflicting appeals, and material principles of justice were ultimately subjective and hence did not give a consistent account of justice.


Problems Majority v minority What is good? Evil Fate of individual


Deontology: Duties There is a world of others to whom promises are made and

to whom duties are owed. And underlying norms and presumptions, Duties create the means of being In the context of relationships With attendant obligations that guide our acts. For some deontologists there were certain acts (truth telling,

promise keeping) that contained moral worth distinct from their impact on consequences--independent of the net happiness, pleasure, or difficulties the fulfillment of the obligation would bring.


Kant “nothing is left but the conformity of actions

to universal law as such and this alone must serve the will as its principle. That is to say, I ought never to act except in such a way that I can also will that my maxim should become a universal law.”


Social Contract Theory Based on equality of shares as in John Rawls

“Each person possesses an inviolability founded on justice that even the welfare of society as a whole cannot override.

justice denies that the loss of freedom for some is made right by a greater good shared by others.

Therefore in a just society the liberties of equal citizenship are taken as settled; the rights secured by justice are not subject to political bargaining or to the calculus of social interests.”


First Principle: Each person is to have an equal right to the most extensive total system of equal basic liberties compatible with a similar system of liberty for all


Second Principle: social and economic inequalities are to be arranged so that they are both: a. to the greatest benefit of the least advantaged, b. attached to positions open to all under

conditions of fair equality of opportunity


Egalitarian Theories of Justice each of us had inescapable and essential rights and

obligations toward one another that could not be ignored rights, obligations, duties, and needs arose from

something we shared as persons, common to all must be respected by all. commitment to equality ability to make rational choices that honored this

equality were at the heart of this theory of justice.


First among these duties was the notion that justice was rooted in equality, an equality due on the basis of shared human embodiment and participation in a mutually consensual human

society.


A basic decent minimum. This basic decent minimum was an

assessment of a quantifiable human necessity constituted the share to which all persons were

entitled by virtue of their personhood alone not because of merit or desert.


All these theories share these qualities:

Must be applicable: Any theory, to be ultimately credible, must address certain social imperatives: cultural norms, economic limits, and the power of the state.

Rooted in mortality and rooted in scarcity Theory for rational beings


All faced challenges in the late 20th century

Feminist in North America Liberation Theology in Latin America Post- Modernist in Europe


But were the basis for many health care dilemmas

3 Classic lifeboat problems in all technological advances First use will be risky and dangerous Will quickly be available to a small elite Will move from desire to need to entitlement


No Formal Rationing Plan until Medicine becomes a Public Act

Prior idea was individuals tending to individuals

Family based care Hospices of the Knights Templar Village healers First come, first served


American Civil War Whitman notes first come, first served

model Some use of rank Occasional compassionate attention to

child soldiers


“Triage” in Crimean War, WWI French surgeons

Florence Nightingale

Technology (in this case of killing) forced treatment changes


Idea is that scarcity is made transparent

Rational planning and order is based on logical theory

System planned in advance Choices based on clinical assessment


Priorities vary In War: need for activities to resume as

quickly as possible— First attention to most lightly wounded Least resources on most critical, likely to die, or

complex


Historical Rationing of PenicillinWWII

Introduction in wartime framed the first use Triage was based on ability to restore ill to

battle Syphilis before battle infection Not routinely given in life threatening cases


Kidney Hemodialysis Machines First use monitored by Ethics Boards

(“leading citizens”) Difficult and class based results Ended up funding everyone


Lottery systems for rare drug protocols

All patients considered equally at risk Main consideration was appearance of utter

fairness


United National Organ Sharing:UNOS

Developed for a ranking system for solid tissue cadaveric organs

Has expanded for living organ donors Based on medical need Geography a factor Must first be able to be listed

Able to pay in some fashion Able to care for self in the eyes of the boards


HeLa cells—how pure research distributes

Mrs. Henrietta Lane’s tumor removed in cancer surgery

No consent or knowledge to family Pure transformation to commodity as cell

line Free use in all labs


Flu vaccine systems set in place by the CDC in 2004-2005

Idea of ‘high risk’ category Likely to die if aquired upper respiratory illness

and pnuemonia Or likely to affect fetus Or in historical life boat catagory


Statement of problem How can we set in place a fair and just

system of access to the good ends of medicine?

Using a fair and just process that protects donors and recipients?

And aiming for fair and just goals for humanity?


When we live in an unjust world?


Stem Cell Libraries (note: not “banking”)

Theory is a source for most MHC (HLA) lines in a given population

Need justice in how donations (not deposits) are made

In how withdraw fairly


Four problems How to make donation fair and just from

egg donors? How to distribute lines to researchers so

research is just? How to do clinical trials justly? How to distribute or trade fairly when

therapies are discovered and verified?


A theory of donation Stem cells reveal certain veracities

Humans are pluripotent at the cellular level Healing is a complex and self organizing system Abundance is structured into nature People have an abundance of gametes—more

than they could even possibly need as individuals


Organ donation remind us of an ontology: the neighbor is the self

That the self may be (literally) for the other Which is the bases for much of ethics and

religious morality Note: Emmanuel Levinas—”the very skin of

the self if needed.” A theory of hospitality grounds our duty


Egg donations may offer another chance to know this

Egg donation as altrusim Hence, not as a commodity but a gift And, in the sense of the Hebrew Scripture,

a justice making act (tzedakah)


Philosophic problems in giving Are women really free moral agents? Can the state compel altruism? What about free markets? How to avoid coercion?

Hard coercion as in prostitution (cash for use of body)

Soft coercion as in family pressure or desperation (love/approval for use of body)


Cannot avoid coercion In fact, it may be a constraint on all human

existence And this is a good thing! However we can support compassionate

donation, and avoid payment


New NU research toward egg maturation in cancer survivors

Northwestern University (“Joseph Project”) NuBorn NuAge


Philosophic problems in receiving Need a system of triage Based on prior UNOS system Should follow from an international discussion

within stem cell community Investigators Patients

Need to research how economies of fair trade can be supported with experimental economics


What is new or distinctive about hES lines?—unsolved challenges!

First use risky but desperately needed? Demand outweighs supply? Distribution in a world with uneven access

to basic decent minimum of other social and health care needs

Americans face a unique problem in developed world (uninsured)


Like penicillin, offers hope for cure and not treatment

Net savings if successful in millions of cases of chronic disability

Technology may allow for wide distribution without expensive treatment centers

Spinal cord injury as first target Offers the chance to be both a donor and

recipient


New philosophical opportunities Rational creatures allow systems of justice Plasticity of the creature allows systems of

justice as well a duty of reversibility a duty to heal

Human duties movement


Should always be reviewed by an Institutional Review Board

Should be governed by informed consent of all donors

Separation of decision to donate from all clinical decisions

No payments to donors beyond reimbursement

of direct expenses

No purchase or sale of donated materials

Protection of donor privacy

Guidelines for Human Embryonic Stem Cell Research

NAS Guidelines: Donations of blastocysts, oocytes, sperm and somatic cells


NAS Recommendations for Oversight of Human Embryonic Stem (hES) Cell Research

Local oversight - each institution should establish an Embryonic Stem Cell Research Oversight (ESCRO) committee to review and monitor all proposals to conduct hES cell research.

The committee should include representatives of the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research.


A national panel should be established to assess

periodically the adequacy of the guidelines and to

provide a forum for a continuing discussion of issues involved in hES cell research.

politically independent and without conflicts of interest respected in the lay and scientific communities able to call on suitable expertise to support this effort.


International System needs international forum

UN? Council of Stem Cell Centers?


Conclusions Unique opportunity for new theory of justice

based on: Classic theologies: shared stewardship of land Actual physiologies of plasticity The gift relationship that also grounds society The principle of Hospitality even with moral

strangers


Conclusions: All science is political and is thus like free

speech (with permission and limits) for: Basic medical research is always about the other understood as

the self— And carries both an overt text and a covert text that “pokes holes

in the fabric of what we know.” Science advances are ontological, and hence, allow for a new

self-social interaction (Thomas Jefferson) Hence, research—even if on the molecules of the cells of the

body will be understood as a social act.


Public Science creates a Moral Economy

Public Funding will be key, for only if there is public funding can there be frank and open oversight and regulation

Need to allow for public access to all cures All citizens need to reflect on the ethical

choices science raises And science and the public are both moral

witness to how the future will be shared


Not a “Bank” but a “Grange” Co-op model based on fair trade Storehouse with shares based on

stewardship Neighbors in need versus customers


Not a “Bank” but a “Library” Language will be important


The ethical question of stem cell research also is a deontological question

If I have a duty to heal the suffering other, Then how should I judge things or persons

that block that duty or moral action? Is it warranted to block the moral action of

healing to avoid the destruction of a blastocyst?


But please remember that it is not the key question Because the debate about stem cells is often seems to

turn around the debate about abortion This is a conceptual error (sorry) but a probable one Takes us away from justice, the poor, or actual women,

but has been important And it is a fundamental theological dispute This being the case—is there anything more to say

about moral status? Hence: The search for agreement-aka “the third way.”


Is this controversy sufficient to stop a moral agent from her duty? No: because it is the (valid and unassailable)

problem of one religious group—separation principle

No: because of justice consideration on where to spend research social goods

No: because the power of this duty grounds medicine

No: because several other civic compromises exist (including Bush’s plan)


Final Premise: Practical Matters Matter Long held tradition (religions) and practice

(clinical) offer far clearer models for discursive community praxis.

Basic science should proceed in all directions. Funding for particular projects about faith

communities should be supported by these communities.

Therapies and basic research ought not wait for social consensus.


How to respond? : One Idea from One Moral Philosopher Healing is at the Moral Center of the Universe

it is the core of most religions and the call of prophets consider our duty

it is the core of what stem cells do in the human body

It is good for the country Freedom of research is an enabling idea in

democracies


Now: Can we please ask the question of Justice?

Stem cell research will proceed (new lines, new methods, emergence of clinical trials protocols, etc)

The deeper questions are ones of justice and access: like all health care, an unfinished project


A Commercial for Bioethics You must always tell the truth and be prepared to

verify it with repeatable data Our trust in you requires transparency and

veracity. A note about absolute veracity in Jewish Law:

while it is permitted to tell the bride she is beautiful, science and ethics is a different matter.

“Tell the truth and stand up for all humanity” Sydney Brenner, Science , 2004.


acknowledgments From Northwestern

Teresa Woodruff: Cancer Genetics John Kessler: Stem Cell Research NIH Center

of Excellence Mary Hendrix, CMH and Northwestern Rex Chisholm, Genetic Medicine Lynne Keasling, Kelloge School and

Economics Kelly Mayo, Biology

Jonathon Moreno University of Virginia and NAS Richard Hayes, MIT and NAS Len Zon, Harvard University, HHMI Doug Melton, Harvard University, HHMI Irv Weisman, Stanford University Ronald McKay, NIH Nissim Benvenisty Hebrew University, Jerusalem Rudolph Jaenisch, MIT Suzanne Holland, University of Puget Sound Karen Lebacqz, Pacific School of Religion, emertius Roger Pederson, Cambridge Knowledge Research Center Woo-Suk Hwang, Seoul National University, Gerald Schatten, University of Pittsburg

Documents

Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society Stem Cell Research: Ethics, Translations and Transmissions