Ethics and Policy-Making in Stem Cell ResearchPresented by UC Berkeleys STELA: The Science, Technology, Ethics, and Law Working GroupMarch 22, 2007

What is ethics?Ethics: the rules of conduct recognized in respect to a particular class of human actions or a particular group, culture

What is Bioethics?Bioethics: a field of study concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments, such as organ transplants, genetic engineering, and care of the terminally ill

A classic bioethical decisionOne heart available who should get it?17-year old girl 40-year-old school principal70-year-old woman

A classic bioethical decisionOne heart available who should get it?17-year old girl 40-year-old school principal70-year-old woman

Basic Bioethics PrinciplesRESPECT for peoples rightsAutonomyDignity

BENEFICENCE: Benefits must be proportionate to risksPotential harm = potential good

Basic Bioethics PrinciplesJUSTICE: The even distribution of benefits and risks throughout society

NONMALEFICENCE: Do no harmExperiment must stop if causes harm.

Decision-making organizationsInternal Review Boards (IRBs)

Presidents Council on Bioethics2001

Independent Citizens Oversight Committee:Part of California Institute for Regenerative Medicine (CIRM)

Some recent stem cell policyPresident Bush:August 2001: moral risks > potential benefitsFederal funding can only be used for already made stem cell linesThe life and death decision has already been made- President BushThe executive order applied only to federally-funded researchDid not ban new embryonic stem cell research all togetherIt may still be funded privately

Some recent stem cell policyPresidents Council on Bioethics 2002 Human Cloning and Human DignityRecommended policy of strict regulation of embryonic cloningBUT, opinions varied

Some recent stem cell policyCalifornia voters:2004, Prop 71

Voted to spend $3 billion over the next ten years to fund stem cell research

PUBLIC money in the form of bonds

Some recent stem cell policyU.S. House and Senate, July 2006Passed a bill to extend funding for research on NEW embryonic stem cell linesIn response, Bush VETOED Moral integrity of the embryosSnowflake babies campaign

Who have been decision-makers?Diverse stakeholders have influenced stem cell research policyPresident BushPresidents Council on BioethicsCongress California voters

Other possible stakeholders?

Lets start tackling some current ethical issues in stem cell research!What were discussing next:

Use of leftover embryos from IVF clinics for embryonic stem cell research

What diseases will be researched? You are the bioethicists!

When stakeholders collide: Current IVF embryo policyWhat is an IVF clinic?Place where a couple can go after difficulty conceiving a childWomans eggs extracted; man contributes spermWomans egg fertilized in-vitro Outside her bodyEmbryos inserted into her uterus pregnancy

When stakeholders collide: Current IVF embryo policyLeft-over embryosIVF procedure generates many embryos to increase chances of success Usually get thrown out or frozenBUT, stem cells can be derived from these!

When stakeholders collide: Current IVF embryo policyPresident Bush and others object Potential for embryo adoptionJune 2005: 80-100 ever adopted Total: 400,000That is 0.02 0.025 %

Which is ethically better? Throwing out an extra embryo, ORSaving the embryo for adoption, ORUsing the embryo for biomedical research?

How do we find a compromise?

The use of IVF embryos is not the only issue stem cell research is currently facing!Some of the other questions policy-makers must tackle in the coming years:

How do we decide which diseases to do research on?

How do we make sure that all citizens receive equal access to the treatments, given that the research is funded with government (public) money?

From stem cell research to therapies and curesCA now has huge amount of funding available for stem cell research for therapies and curesBut which diseases in particular do we do stem cell research on? How do we distribute the funding across the hundreds of diseases?

Proposition 71 The California Institute for Regenerative Medicine

What CIRM does:Decides what research institutions get public money for stem cell research

Research must have the goal of curing or improving major diseases, injuries, and orphan diseasesExample: Tay-Sachs Disease

What diseases do we do stem cell research on first?Muscular dystrophylikely to die by age 20

VS.

Spinal cord injuriesparalyzed, but likely to live longer

What diseases do we do stem cell research on first?Independent Citizens Oversight Committee (ICOC) includes:

Spinal cord injuries about 35,000 cases in CAAlzheimers diseaseabout 470,000 cases in CAType II (adult) diabetes10% of adults (20 and up) have itMultiple sclerosis in NorCal, 150 in 100,000 people have itType I (juvenile) diabetes1 in every 400-600 children/adolescents Heart disease#1 cause of death in US (12% of adults)Cancer#2 cause of death in US (7.4% of adults)Parkinsons diseaseabout 500,000 cases in USMental illness22% of Americans have mental disordersHIV/AIDSabout 1 million cases of HIV in US

No orphan diseases.

Common concerns in funding decisionsNumber of people with the disease.

The groups that suffer from the disease.

Severity of the disease.

Disease mortality.

Average age at death.

Already available therapies or treatments.

Activity: What diseases should we do research on?Divide into small groupsDiscuss the following, referring to the bioethics principles that we discussed yesterday and earlier:Which concerns are most important?Prioritize them, 1 through 6. COMPROMISE!Some bonus questions:Look back at the list of disease groups on the ICOC. Do the diseases on the list meet your criteria? Are there any diseases you think should be added to or removed from the list?Are there any other criteria you think should be considered?

For activity: ICOC diseases and bonus activity questionsSpinal cord injuries about 35,000 cases in CAAlzheimers diseaseabout 470,000 cases in CAType II (adult) diabetes10% of adults (20 and up) have itMultiple sclerosis in NorCal, 150 in 100,000 people have itType I (juvenile) diabetes1 in every 400-600 children/adolescents Heart disease#1 cause of death in US (12% of adults)Cancer#2 cause of death in US (7.4% of adults)Parkinsons diseaseabout 500,000 cases in USMental illness22% of Americans have mental disordersHIV/AIDSabout 1 million cases of HIV in US

Look back at the list of disease groups on the ICOC. Do the diseases on the list meet your criteria? Are there any diseases you think should be added to or removed from the list?Are there any other criteria you think should be considered?

Take-home thoughtsMore ethical issues besides, do we research on embryos?Todays activity = whats going on now in CaliforniaThe future of bioethics needs:Diverse group of both genders, all racial and ethnic groups, and from various backgroundsGoal: Represent interests of all stakeholders

Thank you!