Ethics and Policy-Making in

Stem Cell Research

Presented by UC Berkeleys STELA:
The Science, Technology, Ethics, and
Law Working Group
March 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 decision

One heart available who should get it?

17-year old girl

40-year-old
school principal

70-year-old
woman

A classic bioethical decision

One heart available who should get it?

17-year old girl

40-year-old
school principal

70-year-old
woman

Basic Bioethics Principles

RESPECT for peoples rights

Autonomy
Dignity

BENEFICENCE: Benefits must be

proportionate to risks

Potential harm = potential good

Basic Bioethics Principles

JUSTICE: The even distribution of

benefits and risks throughout society

NONMALEFICENCE: Do no harm

Experiment must stop if causes harm.

Decision-making organizations

Internal Review Boards (IRBs)

Presidents Council on Bioethics

2001

Independent Citizens Oversight Committee:

Part of California Institute for Regenerative

Medicine (CIRM)

Some recent stem cell policy

President Bush:

August 2001:

Federal funding can only be used for already made

stem cell lines

moral risks > potential benefits

The life and death decision has already been madePresident Bush

The executive order applied only to federallyfunded research

Did not ban new embryonic stem cell research all

together
It may still be funded privately

Some recent stem cell policy

Presidents Council on Bioethics

2002
Human Cloning and Human Dignity
Recommended policy of strict regulation of
embryonic cloning
BUT, opinions varied

Some recent stem cell policy

California 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 policy

U.S. House and Senate, July 2006

Passed a bill to extend funding for research

on NEW embryonic stem cell lines
In response, Bush VETOED
Moral integrity of the embryos
Snowflake babies campaign

Who have been decisionmakers?

Diverse stakeholders have influenced

stem cell research policy
President Bush
Presidents Council on Bioethics
Congress
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 policy

What is an IVF clinic?

Place where a couple can go

after difficulty conceiving a child
Womans eggs extracted; man
contributes sperm
Womans egg fertilized in-vitro
Outside her body
Embryos inserted into her uterus
pregnancy

When stakeholders collide:

Current IVF embryo policy

Left-over embryos

IVF procedure generates many embryos to

increase chances of success
Usually get thrown out or frozen
BUT, stem cells can be derived from these!

When stakeholders collide:

Current IVF embryo policy

President Bush and others object

Potential for embryo adoption

June 2005: 80-100 ever adopted

Which is ethically better?

Total: 400,000
That is 0.02 0.025 %

Throwing out an extra embryo, OR

Saving the embryo for adoption, OR
Using 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 cures

CA now has huge amount of funding

available for stem cell research for
therapies and cures

But 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 diseases

Example: Tay-Sachs Disease

What diseases do we do stem

cell research on first?
Muscular dystrophy
likely to die by age 20

VS.
Spinal cord injuries
paralyzed, but likely to live longer

What diseases do we do stem

cell research on first?

Independent Citizens Oversight Committee (ICOC) includes:

Spinal cord injuries

Alzheimers disease
Type II (adult) diabetes
Multiple sclerosis
Type I (juvenile) diabetes
Heart disease
Cancer
Parkinsons disease
Mental illness
HIV/AIDS

No orphan diseases.

about 35,000 cases in CA

about 470,000 cases in CA
10% of adults (20 and up) have it
in NorCal, 150 in 100,000 people have it
1 in every 400-600 children/adolescents
#1 cause of death in US (12% of adults)
#2 cause of death in US (7.4% of adults)
about 500,000 cases in US
22% of Americans have mental disorders
about 1 million cases of HIV in US

Common concerns in funding

decisions

Number 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 groups

Discuss 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 questions

Spinal cord injuries

about 35,000 cases in CA
Alzheimers disease
about 470,000 cases in CA
Type II (adult) diabetes
10% of adults (20 and up) have it
Multiple sclerosis
in NorCal, 150 in 100,000 people have it
Type I (juvenile) diabetes
1 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 disease
about 500,000 cases in US
Mental illness
22% of Americans have mental disorders
HIV/AIDS
about 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 thoughts

More ethical issues besides, do we

research on embryos?
Todays activity = whats going on now in
California
The future of bioethics needs:

Diverse group of both genders, all racial and

ethnic groups, and from various backgrounds
Goal: Represent interests of all stakeholders

Thank you!