The Stem Cell Controversy
Robbie Majzner, Legislative
Advocacy
Quick Review: What are the
characteristics of a stem cell?
1) POTENCY
• The ability to differentiate into any type of cell in
response to cell signaling
• Pluripotency: This is why stem cells have the potential to
"cure any disease"
2) SELF RENEWAL
o The stem cell can divide over and over and remain in
this undifferentiated state.
o This is why you hear a lot about stem cell "lines."
3) CONTROVERSY
o No matter what, they seem to cause controversy
Types of Stem Cells: Somatic/Adult
• Cells that come from human sources that have some
measure of multipotency (usually less so than embryonic,
but can be made pluripotent)
• Sources include bone marrow, cord blood, teeth (-->
hepatocytes), neural cells, skin, and more
• Used in bone marrow transplant (allogenic or autologous),
tendon/ligament injury in horses, and in 2008, used to
regenerate a section trachea that was transplanted into a
woman
• Used to be without controversy but have now stepped into
the limelight
Embryonic Stem Cells
• Derived from Embryos, thus the controversy of when life
begins
• Harvested from embryos at the blastocyst (day 5) stage
• PLURIPOTENT
• Express transcription factors that suppress differentiation
• Cells that survive growth/harvesting process can become
pluripotent stem cell lines
Embryonic Stem Cell Uses
FANTASY
REALITY
• Spinal Cord Regeneration
• Traumatic Brain Injury
• SC+ Cloning = New livers
for everyone, no risk of
rejection
• Extra limbs
• New islet cells in DM1
• Post MI, heart remodeling
• Replacing SN cells in
Parkinson's
• A single Phase 1 trial of
injecting stem cells into
spinal columns of patients
with acute spinal cord
injury approved in 2009,
but held due to safety
concerns until July 2010
Induced Pluripotent Stem Cells
• In 2006, researchers in Japan successfully inducted mouse
somatic cells to become pluripotent stem cells
o pluripotency depends on transcription factors
o retroviruses used for introduction of these TF's
• First successfully performed in human cells by same group
at University of Wisconsin who first isolated hESC in 2007
and the same group in Japan in 2007
• Possible problems with this cell is retrovirus that randomly
inserts could interrupt tumor suppressor genes
• Current research focusing on using protein only induction
• Promising field as avoids the controversy of embryonic SC
The History of Embryonic Stem Cell
Politics & Research
• 1981: First Embryonic Stem Cells are isolated from mice
(Camridge, UK and UCSF)
• 1995: Accomplished in Primate (Rhesus Monkey) in
Wisconsin
• 1995: NIH Human Embryo Research Panel recommends
federal government fund research using BOTH embryos
left over from IVF and on embryos created for
experimentation
• Bill Clinton, citing ethical concerns, seeks middle ground
and by executive order to HHS/NIH declines to fund
research on embryos created for experimentation
Divided Government, Republicans
Chime in...
Newt Gingrich
Jay Dickey (AK)
The Dickey Amendment, 1995
• Despite Clinton's opinion, Congress intervened and passed
the Dickey Ammendment "banning stem-cell research"
• Passed as a Rider on other legislation, every year since
1997, prohibits HHS/NIH funding for:
(1) the creation of a human embryo or embryos for
research purposes; or
2) research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk
of injury or death...
• Illegal for government to fund, but not for private citizens
to carry out research (some European countries ban all)
Research Continues...(privately)
• In '98, two groups w/private funding successfully harvested
HUMAN EMBRYONIC STEM CELLS (Hopkins, U. Wisconsin)
• Brought to limelight, so Clinton reconsiders his position
• In 1999, the president's National Bioethics Advisory
Commission again recommended that hESC harvested from
embryos discarded after IVF treatments eligible for federal
funding but Dickey stands in his way
Legal Cover
• Chief Counsel for the Department of Health and Human
Services Harriet Rabb (now at Columbia Center for
Bioethics) writes a legal opinion in 1999 that changes the
Clinton Administration opinion and determines US policy
for 10+ year
• Government cannot fund any destruction of embryos but
can fund the research once the stem cells are created
• Creative work around accepted by Clinton Administration
but called "Legal Sophistry" by Republicans at the time
Clinton and NIH Setup to start funding
in 2000/2001, but....
The Bush administration puts a hold on
all NIH funding in January 2001...
• Tommy Thompson, the new head of Health and Human
Services, instructs the NIH to suspend the reviewing of all
grants involving hESC
• President Bush took seven months to issue his decision
regarding stem cell research in a TV speech that was
supposed to be one of the biggest decisions of his term
The Bush Stem Cell Decision, 8/9/01
• Similar to Clinton's decision, the NIH could fund research
on stem cells after they were created (no funding embryo
destruction)
• Unlike Clinton's decision, these funds could only support
research on already established stem cell lines where
o The derivation process was initiated prior 8/9/01
o must have been derived from embryo that was created
for reproductive purposes & was no longer needed.
o Informed consent must have been obtained
• Seen as a compromise by much of the media, but heavily
criticized by liberals and the scientific community
The Stem Cell Lines
• Initially thought to be 77 cell lines available world wide
(from labs in US, S. Korea, India, Sweden, Israel, and more)
• Turned out there were only 21 available
• Some cell lines were contaminated, others had genetic
mutations!
• Criticized as not genetically diverse
• Put a lot of money/power in the hands of those that owned
these lines
• Engendered controversy throughout the Bush presidency
and became a big issue in the 2006 and 2008 elections
During Bush, the states speak out...
• Several states put their own money into stem cell research
• 2004: NJ legislators pass a state budget that includes $9.5
million for a newly chartered Stem Cell Institute of New
Jersey
• 2004: California Proposition 17 authorizes the state to
spend $3 billion on embryonic stem-cell research over 10
years, making it a larger funder than the federal govt.
• Efforts also in IL, FL, CT, Iowa and others
Congress considers relaxing the
restrictions...
• After initial victory in 2004, there was significant
weakening of the Republicans and Conservatives in
congress
• Stem Cell research a hot button issue in '06/'08 campaigns
• State funding as well as celebrities like Christopher Reeve
helped bring this issue to the forefront of the media
• 2005 poll, 70% Americans favored loosening the Bush
restrictions (including >50% of conservatives)
But Bush sticks to his guns...
• President Bush used his first ever veto in July 2006 to veto
a bill that would have increased federal funding for other
stem cell lines
• Bush vetoed only 12 bills in his 2 terms as opposed to 44
for Bush 41 in 1 term and 37 for Clinton in 2 terms
• Of those 12 bills, only 7 did not become law
• 3 of those 7 bills were for increased stem cell funding
Democratic Takeover/Obama '09
• Obama campaigned promising to increase Federal Funding
for Stem Cell Research
• In his first 100 days, Obama reversed the Bush restrictions,
but also signed an appropriations bill extending the Dickey
Amendment, thus returning policy to that under the end of
the Clinton Administration
• In the years between Clinton and Obama, many other stem
cell lines were created by private industry, total now ?75
• Obama did not legalize government funding of the
creation of new hESC lines
Sherley v Sebelius, August 2010
• James L. Sherley and Theresa Deisher, two Adult Stem Cell
researchers, brought suit in federal court against HHS to
protest the funding of hESC research over aSC research
• They maintain that original intent of the Dickey
Amendment was to prohibit all research on destroyed
human embryos
• U.S. District Judge Royce Lamberth (DC Appelate) issued a
preliminary injunction on funding hESC research
o If one...piece of research of an ESC research project
results in the destruction of an embryo, the entire
project is precluded from receiving federal funding
• This was a temporary injunction, case not yet decided
The plaintiffs and their backing
• The two scientists were represented by The Alliance
Defense Fund:
"a servant organization that provides the resources
that will keep the door open for the spread of the
Gospel through the legal defense of religious
freedom, the sanctity of life, marriage and the
family."
• Sherley was formerly at MIT; when denied tenure, he went
on a hunger strike and claimed racial bias:
“When I say ‘embryoism,’ I mean discriminating
against human embryos, just like there is
discrimination against people of different culture and
races,” he said."
NIH/HHS Response
• Initially the NIH said they would stop all further funding of
projects until the lawsuit was resolved but current
grantees could continue research
• Appeal to Judge Lamberth for a stay of the injunction was
rejected
• One week later, an appeal to the DC Court of Appeals
granted an administrative stay of this injunction, returning
federal funding to the initial Obama policy
• Now the court is hearing full arguments in Sherley v
Sebelius before determining policy
Future Options...
• Unclear how this case will be decided
o Plantiffs, who claim, irreperable harm not clearly
damaged by this policy
o Policy may not violate law, was accepted by both
Republican and Democratic administrations
o If government loses, would likely mean a stop to all
federal funding of hESC research
• Appeal to US Supreme Court
• Legislative option to repeal or not renew the Dickey
Amendment
• State by State funding
Get Involved
• Embryonic Stem cells, while they have little practical
application today, have the potential to help cure and
understand many congenital and acquired diseases.
• AAP Statement:
Research using human embryos and pluripotent stem
cells is of sufficient scientific important that the NIH
should fund it and...federal oversight is morally
preferable to the currently unregulated private sector
approach.
• Write your senators and congressmen to repeal the Dickey
Amendment
• Be an advocate for scientific research in your own
states, state pressure changes the action of the Federal
govt
Possible Compromises...
• Repealing Dickey would allow for funding of destruction of
embryos by the federal government, which may not be
universally acceptable...Other possibilities:
• Ammend the Dickey Ammendment to reflect the
Clinton/Bush/Obama understanding
• Induced Pluripotent Stem Cells
• Return to Bush era policy with a renewal of the date after
which we can use the stem cell lines to incorporate more
lines