Four Es: Eggs, Embryos, Embryonic Stem Cells, and Ethics

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Four Es Eggs, Embryos, Embryonic Stem Cells,
and Ethics

• Carol Warner
• Department of Biology
• Northeastern University
• February 15, 2007

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General Overview

• Part IEggs and Embryos
• Scientific Background
• Ethical Considerations
• Part IIEmbryonic Stem Cells
• Scientific Background
• Ethical and Religious Views
• The Law

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Scientific Background

• Part I-Eggs and Embryos

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Eggs, Embryos, and Embryonic Stem Cells
8-cell
2-cell
Zygote ? Oocyte
Morula (16-cell)
Embryonic Stem (ES) Cells
Bone
Blastocyst
Neurons
Cardiac muscle
Blood
Skin
Other
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Brief History of IVF1661 - Omne vivum ex ovo.
Everything living comes from the egg.William
Harvey, discoverer of the circulation of blood.

• 1978 First IVF baby born in England
• (Edwards and Steptoe)
• 1981 First IVF baby born in USA
• (Jones and Jones)
• 2004 CDC Statistics for USA ( 400 IVF clinics)
• 128,000 IVF cycles performed
• 37,000 Live birth deliveries
• 49,000 Live infants (1 of 4 million USA
  births)
• 2002 One millionth IVF baby born (world-wide)
• 2006 Three millionth IVF baby born (world-wide)

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Ethics

• Individual Rights vs. Societys Rights
• Should we be doing IVF at all in an
  over-populated world?

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Recent and Projected World Population Growth
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Recent and Projected United States Population
Growth (U.S. Census Bureau)
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Examples of Other Ethical Issues About Human
Reproduction

• Selective abortion of females has led to an
  excess of 40 million males in India and 30
  million males in China. What should be done?
• Should preimplantation genetic diagnosis (PGD) in
  IVF be used for sex selection or only for disease
  screening?
• Should post-menopausal women be allowed to have
  children using IVF? (In 2006 a 67 year old
  Spanish woman delivered IVF twins. She lied
  about her age to a US clinic.)

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Wal-Martization of Embryos

• Op-ed article by Osagie Obasogie Center for
  Genetics and Society Oakland, CA
  (www.genetics-and-society.org)
• Boston Globe
• February 1, 2007

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Scientific Background

• Part II-Embryonic Stem Cells (ESC)

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Eggs, Embryos, and Embryonic Stem Cells
8-cell
2-cell
Zygote ? Oocyte
Morula (16-cell)
Embryonic Stem (ES) Cells
Bone
Blastocyst
Neurons
Cardiac muscle
Blood
Skin
Other
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Scientific Debate
Are hESC necessary?
www.stemcellresearch.org
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Scientific Options
Surplus IVF
Other Techniques
Created by IVF for Research
Created by SCNT for Research
Adult Stem Cells ONLY
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Somatic Cell Nuclear Transfer (SCNT) (Therapeutic
cloning vs. Reproductive Cloning)
avoids immunoreactivity can correct genetic
defects
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Debate A hESC Bank or Individual SCNT Stem Cells?

• Estimate is that 150,000 hESC lines would be
  needed to get a good tissue match for 99 of the
  population.
• SCNT to produce hESCs has not yet been
  accomplished. (Huang fraud in South Korea2005)

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Ethical and Religious Views
What is the moral status of the embryo?
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Ethical Questions Raised

• Does the embryo or fetus have intrinsic value?
• Should we consider differences between embryos
  created for research vs. spare embryos from IVF?
• Can the embryo or stem cell debate be separated
  from the abortion debate?
• Can we separate the concepts of therapeutic
  (SCNT) and reproductive cloning?
• What should be banned or made illegal?
• Should states be allowed to make their own rules?

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Religious Points of View

• Judaism
• Islam
• Buddhism
• Hinduism
• Taoism
• Catholicism
• Other Christian

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Judaism
Embryo is like water during first 40 days
Mandate to save lives takes precedence over early
embryo
However, no unanimous authority
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Islam
No unanimous view or authority
Majority of Muslim legal commentators accept
abortion through 40th day
Singapore Fatwa Committee ruled that embryos
younger than 14 days may be used to make stem
cells
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Buddhism
No unanimous view or authority
Singapore Permissibility depends on the
intent Against cloning (not clear on therapeutic
SCNT)
Damien Keown (Buddhist Scholar) Against hESC
creation Principles of ahimsa (non-harming)
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Hinduism
Abortion condemned except if life of mother
threatened
Use of preimplantation embryos for ES cells is
ethically justified
Taoism
Unethical to use embryos for research
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Catholicism
Vatican view Life begins at conception
Declaration of the Pontifical Academy for Life-
August 25, 2000
Dissenting opinions by US theologians
Previous Catholic position viewed life beginning
with quickening
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Other Christian
Southern Baptist United Methodist
Oppose hESC Research
Presbyterian Unitarian
Support hESC Research
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Legal and Political Issues
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May 2005 Report by Presidents Council (USA)
White Paper
Debates 4 Possible Alternative Sources of hESC

• Dead Embryos
• Biopsy of Living Embryos
• Altered Nuclear Transfer
• Dedifferentiation of Somatic Cells

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6 Options for Stem Cell Research Kennedy
Institute of Ethics Journal LeRoy Walters (2004)
1. No embryo research permitted.
No research on existing lines. 2. Research
permitted on existing lines. No
research on human embryos. 3.
Research permitted on existing lines AND
on embryos no longer needed (IVF surplus).
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4. Research on surplus embryos AND those
created via IVF for research. 5. Research
on surplus embryos AND those created by
SCNT into human eggs. 6. Research on
surplus embryos AND those created by SCNT
into human eggs AND transfer of human
nuclei into non-human animal eggs.
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What is the law in other countries?
6 Options
Liberal
Conservative
Option 3 Canada Czech R. Denmark Finland Greece
Hungary Netherlands Russia Spain Taiwan
Option 6 China UK?
Options 4/5 Australia Belgium Sweden Israel Singa
pore S. Korea UK
Option 1 Austria Ireland Italy Norway Poland
Option 2 Germany -can work on lines created
outside Germany before 2002
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Specifics
Asia and Pacific Rim
China Most liberal politics- has allowed
transfer of human nuclei into non-human animal
egg, but not for therapeutic treatment of human
diseases. Singapore Allow Opt 4 and 5 when
research cannot be accomplished using surplus IVF
embryos. Japan The Law concerning regulation of
human cloning techniques and other similar
techniques.- Prohibits reproductive cloning and
allows Opt 3 (surplus IVF embryos).
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Specifics
Asia and Pacific Rim (continued)
Taiwan Opt 3- May use leftover embryos, but
donor egg and sperm cannot be used to create new
embryos for research. S. Korea Allow limited
research with SCNT but prohibits reproductive
cloning. Australia Recently approved SCNT(Ops
4/5). India Sept 2001 National Bioethics
Committee Recommended creation of embryos solely
for research purposes should not be undertaken
But surplus embryos OK. Opt 3.
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Specifics
Middle East
Israel Passed Dec. 1998 law permitting research
cloning, but not reproductive cloning (Opt
5). Iran 2003 Scientist at U. Jihad Institute
created a hESC line.
North America
Canada Allows Opt 3. - Established the Assisted
Human Reproduction Agency of Canada Oversees
and monitors infertility services and licensing
for human embryo research. Mexico Banned both
reproductive and research cloning. United States
Later....
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Specifics UK
United Kingdom
1990 Established Human Fertilisation and
Embryology Authority (HFEA)- allowed embryo
research with license, but not SCNT or
reproductive cloning. 2001 Human Reproductive
Cloning Act Prohibits human reproductive
cloning, but supports SCNT and creation of
embryos for research (Opt 5). 2007 HFEA is
debating whether or not to allow Opt 6 (human
nuclei into animal eggs to produce embryonic stem
cells).
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United Nations
Aug 2001 France and Germany propose a ban on
human reproductive cloning. Nov 2001 Vatican
observer argued for an expansion to cover all
human cloning. Feb 2002 USA joins Vatican in
wanting to prohibit the two types of cloning
(reproductive and therapeutic).
Debated for months Sept 2003 USA-Costa
Rica propose ban on human cloning but not
prohibition of nuclear transfer to produce DNA,
organs, plants, tissues, and cells other than
human and embryos other than human. Sept 2003
65 academics from the Interacademy Panel on
International Issues urged the UN Legal Committee
not to include research cloning in the ban.
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United Nations (cont.)
Oct. 2003 Iran suggests a 2 year deferral on
further debate (Passed vote of 80-79). Dec.
2003 A compromise was reached Costa Rica agreed
not to bring the discussion to the floor and the
deferral was dropped to 1 year. March 2005 The
General Assembly passed the UN declaration that
member states adopt All measures necessary to
prohibit all forms of human cloning inasmuch as
they are incompatible with human dignity and the
protection of human life. Note This fails to
define human cloning, human dignity and human
life. - Vote was 84 in favor, 34
against, 37 abstaining
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Rules and Regulations USA

• Embryos
• No prohibitive regulations on mouse
• Private may be used for human
• Stem Cells Adult
• No prohibitive regulations
• Stem Cells Human Embryonic
• August, 9 2001 NIH funding for 74 existing
  lines
• January, 2006 21 lines currently available
  (contaminated)
• Private may be used for any hESC research
• State to state legislation regarding cloning
  (SCNT) and funding

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USA-National Laws-2007(There are None)

• House of Representatives- H.R.3 (reintroduction
  of bill HR.810- previously vetoed)
• Stem Cell Research Enhancement Act of
  2007
• Passed January 11, 2007
• (NOT veto-proof)
• Senate-S.5
• Will be debated shortly

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United States

• There are no federal laws regulating hESCs (or
  IVF).
• All regulations are at the state level.

Some States Encourage hESC Research
California (3 billion, 2005-15) Connecticut
(100 million, 2005-15) Illinois (15 million,
2006-07) New Jersey (270 million, 2006) Maryland
(15 million, 2007) Massachusetts (1 million,
2005) Wisconsin (1 million, 2006)no law
State Bans on hESC Research
South Dakota
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Massachusetts Law-Legalization of hES Cell
Research-2005
Bill passed in the senate by a vote of
35-2. Bill passed in the House of
Representatives by a vote of 117- 37 (76 in
favor). Bill vetoed by Governor Mitt
Romney. Veto over-riddenJune 2005 35-2
Senate, 112-42 House

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Massacusetts Law-2005
Sections 1 and 2 Importance, Definitions Section
3 Makes it legal to work on Human embryonic
stem cells Human adult SC from any source
SCNT Umbilical cord blood stem cells Placental
stem cells Parthenotes -Establishment of
Institution Review Boards (IRB) -Prior written
approval from IRB
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Massachusetts Law-2005 (cont.)
Section 4 -IVF providers shall provide
information on storing/donating unused
preimplantation embryos - Info on procedure and
health impacts of egg retrieval - Informed
consent and info pamphlet necessary Section
5 -University of Mass Medical School, Worcester,
to collect and store umbilical cord blood and
placental tissue -Educate maternity patients on
cord blood banking
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Massacusetts Law-2005 (cont.)
Section 6 -Institutional Review Board (U Mass
Worcester) Section 7 -No employee shall be
required to work with preimplantation embryos to
create stem cells if in conflict with personal
beliefs -Employee protection
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Massachusetts Law-2005 (cont.)
Section 8 - Reproductive cloning banned
(Punishable by 5 year minimum jail sentence, 1
million fine) - Cannot fertilize an egg solely
for research - Cannot sell/transfer embryos or
gametes for research Section 9 -Biomedical
research advisory council Section
10 -Enforcement
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The Massachusetts law is a great start!The
problem is that no state money was allocated!!

• The problem is that very little state money was
  allocated!
• (Harvard University has allocated 100 million
  for hESC research.)
• (Columbia has allocated 50 million for hESC
  research.)

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Northeastern Universitys Position on Human
Embryonic Stem Cell Research

• There will be no human embryonic stem cell
  research at Northeastern University.

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Science Needs More Money!
2007 Federal Budget
Total Expenditures 2.8 Trillion Total
Revenues 2.4 Trillion Deficit for 2007 0.4
Trillion
Discretionary
Mandatory
Numbers are in billions of dollars
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References

• CDC Statistics on Assisted Reproductive
  Technologies (including IVF), 2004
• Walters, L. Human Embryonic Stem Cell Research
  An Intercultural Perspective. Kennedy Institute
  of Ethics Journal Vol 14 No 1 p 3-38, 2004
• Gareth Cook Boston Globe Articles on Embryonic
  Stem Cells, 2005 (Pulitzer Prize Winner)
• Kiessling and Anderson. Human Embryonic Stem
  Cells, 2nd edition, Jones and Bartlett, 2007
• Presidents Council on Bioethics Website
  www.bioethics.gov
• Mooney, C. The Republican War on Science,
  Basic Books, 2005
• National Conference of State Legislatures State
  Embryonic and Fetal Research Laws,
  www.ncsl.org/prgrams.health.genetics/embfet.htm
• Daley, G.Q. et al. ISSCR Guidelines for the
  Conduct of Human Embryonic Stem Cell Research,
  Science, 315, 603-604, 2007