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GOVERNMENT FUNDING VS.
PUBLIC AND PRIVATE FUNDING
FOR STEM CELL RESEARCH
By Ariane N. Davis
QUESTION:
Should stem cell research be funded by the government or through public and/or
   private funding?
History
 Stem cells are cells found in all multi-cellular
  organisms, which includes humans.
 They were first isolated in mice in 1981 and in
  humans in 1988.
Stem Cells Research
 Embryonic cells have the ability to develop into
 virtually any cell in the body, and have the
 potential to treat medical conditions such as
 diabetes and Parkinson’s disease.
Stem Cell Research cont.
 Some have argued that adult stem cells (from bone
 marrow or umbilical cord blood) should be
 pursued instead of embryonic cells because they
 believe the derivation of stem cells from embryos
 is ethically unacceptable.
Stem Cell Research cont.
 Stem cells retain the ability to become some or all
 of the more than 200 different cell types in the
 body, and thereby play a critical role in repairing
 organs and body tissues throughout life.
Stem Cell research cont.
 Embryonic stem cells may have a greater ability to
 become different types of body cells than adult
 stem cells.
Embryonic stem cells from IVF Embryos or
fetal tissue
 Embryonic stem cells were first isolated from
  mouse embryos in 1981 and from primate embryos
  in 1995.
 Animal embryos were the only source for research
  on embryonic stem cells until November 1998.
 The cells were derived from five day old embryos
  produced via in vitro fertilization. (IVF)
Cont.
 This work is controversial because the stem cells
  are located within the embryo and the process of
  removing them destroys the embryo.
 The cells have also been derived from the
  properties from five-to nine week old embryos or
  from fetuses obtained through elective abortion .
Embryonic Stem Cells Obtained via SCNT
(Cloning)

 Another potential source of embryonic stem cells
  is somatic cell nuclear transfer (SCNT), also
  referred to as cloning.
 Stem cells derived from cloned embryos may offer
  the best hope for understanding and treating
  disease.
 The nucleus of the egg is removed and replaced by
  the nucleus from a mature body cell, such as a skin
  cell from a patient.
Stem Cells from Adult Tissue or Umbilical
Cord Blood
 A January 2007 report found cells can be found in
 amniotic fluid.
Potential Applications of Stem Cell Research
 Stem cells provide the opportunity to study the
  growth and differentiation of individual cells in
  tissues. Understanding these processes could
  provide insights into the causes of birth defects,
  genetic abnormalities, and other disease states.
 If normal development were better understood, it
  might be possible to prevent or correct some of
  these conditions.
Cont.
 Stem cells can be used to produce large amounts of
  one cell type, to test new drugs for effectiveness
  and chemicals and toxicity.
 Stem cells might be transplanted into the body
  and treat disease (diabetes, Parkinson’s disease) or
  injury (e.g., spinal cord)
Current Regulations
 The Dickey Amendment
Prior to an August 2001 Bush Administration
 decision, no federal funds had been used to
 support research on stem cells derived from either
 human embryos or fetal tissue.
Cont.
 Under the amendment
 (a) None of the funds made under the Dickey Act
  may be used 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 or discarded, or knowingly
    subjected to risk or injury or death greater than
    that allowed for research on fetuses in utero.
Cont.
 (b) The term ‘embryo or embryos’ includes any
 organism, not protected as a human under 45 CFR
 [the Human Subject Protection regulations} as of
 the date of enactment of this Act, that is derived
 by fertilization, parthenogenesis, cloning or any
 other means from one or more human gametes
 [sperm or egg] or human diploid cells {cells that
 have two sets of chromosomes, such as somatic
 cells]
Peter Griffin visits stem cell research lab
 http://www.youtube.com/watch?feature=player_d
 etailpage&v=TRtlkcQ6brE
Administration Policies
    Clinton Administration Stem                       Bush Adminstration Stem Cell
    cell Policy                                       Policy
     Research in which human stem cells are           On August 9,2001, President Bush
     utilized to create or contribute to a human        announced for the first time federal
     embryo
                                                        funds would be used to support
    Research in which human cells are                  research on embryonic stem
     combined with an animal embryo                     cells, but funding would be limited
    Research in which human stem cells are             to “existing stem cell lines where life
     used for reproductive cloning of a human           and death decisions had already
    Research in which human stem cells are             been made.
     derived using somatic cell nuclear transfer
                                                       (1) with the informed consent of
    Research utilizing human stem cells that           donors
     were derived using somatic cell nuclear
     transfer                                          (2) from excess embryos created
    Research utilizing stem cells that were            solely for reproductive purposes
     derived from human embryos created for
     research purposes, rather than for infertility    (3) without any financial
     treatment.                                         inducements to the donors.
Administration Policies Cont…
 In March of 2009 President Obama signed an
  executive order repealing a Bush-era policy that
  limited federal tax dollars for embryonic stem cell
  research.
 Obama’s repeal overturns an order signed by
  President Bush in 2001 that barred the National
  Institutes of Health from funding research on
  embryonic stem cells beyond using 60 cell lines
  that existed at the time.
Administration Policies cont..
 Obama also signed a presidential memorandum
 establishing greater independence for federal
 science policies and programs.

 Obama’s order directs the NIH to develop revised
 guidelines on federal funding for embryonic stem
 cell research within 120 days of the original
 memorandum.

 The federal Courts upheld Obama’s actions.
Federal Funds
 Federal Funds would not be used for:
 (1) the derivation or use of stem cell lines derived
  from newly destroyed embryos.
 (2) the creation of any human embryos for
  research purposes
 (3) the cloning of human embryos for any purpose.
Regulation of Stem Cell Research
                                                 NIH Research funding and
    FDA Regulation                               Stem Cell Registry.
 The FDA defines “xenotransplantation” as
  any procedure that involves the
  tranpltation, implantation, or infusion into
  a human recipient of either
 (a) live cells, tissues, or organs from a
  nonhuman source
 (b) human body fluids, cells, tissues or
  organs that have had ex vivo contact with
  nonhuman animal cells, tissues or organs.
 Under FDA guidelines, transplantation
  therapy involving Bush approved stem cell
  lines, which have all been exposed to
  mouse feeder cells, would constitute
  xenotransplantation.
Private vs. Public Funding
Public Funding                Private Funding

 Public funding can           An advantage of private
 contribute to sound            funding is that it allows
 policy by increasing the       research to proceed even
 probability that the           if it’s a politically touchy
                                issue.
 results of stem cell
                               (In the US, only private
 research will reflect
                                funded companies are
 social priorities that may
                                allowed to perform
 not inform research in         research on embryonic
 the private sector.            or fetal stem cells)
Private vs. Public Funding cont.
Public Funding                  Private Funding
 Many Americans including       The private sector can
 children are excluded from
 the U.S. health care            compensate for
 system. Public funding          fluctuations in
 offer s the best hope of
 fostering public                government
 consideration for common        spending, and more
 good, rather than
 marketplace concerns, and       importantly, and can
 of expanding access to the      move forward without
 fruits of stem cell research
 for a large number of           any federal funding.
 Americans.
Private vs. Public Funding cont.
Public Funding                  Private Funding
 Stem cell research is more     Privately funded
  likely to advance if
  canonical genetic stokes of    lavatories have made
  ES cells are made available    large technical
  to the scientific
  community. Public              advancement s in stem
  funding under the auspices     cell research.
  of federal agencies is the
  only effective means for
  ensuring equal access by
  scientists to standardized
  ES cell lines
Federal Funding
 The federal government is the only realistic source
  for such an infusion of funds.
 The government can strictly monitor the practices
  of public research through federal funding.
 The commitment of federal funds also offer a basis
  for public review, approval and, in monitoring
  through well established procedures that will
  promise the public’s interest in ensuring that stem
  cell research is conducted in a way that is both
  scientifically rigorous and ethically proper.
Recommendations

 Recommendation (1)
 Federal funding for stem cell research is necessary
 in order to promote investment in this promising
 line of research, to encourage sound public policy,
 and to foster public confidence in the conduct of
 such research.
   Realizing the potential health benefits of stem cell
    technology will require a large and sustained
    investment in research. The federal government is the
    only realistic source for such infusion of funds.
 Recommendation (2)
 Public funding should be provided for embryonic stem cell
  research, but not at this time for activities involved in the
  isolation of embryonic stem cells, for which there remains
  continuing debate. This approach will allow publically-
  funded researchers to move more quickly toward
  discoveries that will lead to alleviating the suffering caused
  by human disease.
   Although the derivation of human stem cells can be done in an
    ethical manner, there is enough objection to the process of
    deriving stem cells in a ethical manner, to recommend against
    its public funding. Further for the foreseeable future there will
    be sufficient material isolated by researchers not using public
    funding that this exclusion will not have a negative impact on
    research.
 Recommendation (3)
 The formation of company-based independent ethics
 advisory boards should be encouraged in the private
 sector.
   Private sector research has played a crucial part in the
    advancement of research on stem cells. The leadership
    exhibited by the company that has sponsored all of the
    published human embryonic and germ cell research to
    date in establishing an external Ethics Advisory Board to
    develop guidelines for ethical conduct of such research is
    positive. While these private sector boards are not a
    substitute for public oversight and guidance, they can be a
    positive influence on the way that industry-funded stem
    cell research proceeds.

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Government funding

  • 1. GOVERNMENT FUNDING VS. PUBLIC AND PRIVATE FUNDING FOR STEM CELL RESEARCH By Ariane N. Davis
  • 2. QUESTION: Should stem cell research be funded by the government or through public and/or private funding?
  • 3. History  Stem cells are cells found in all multi-cellular organisms, which includes humans.  They were first isolated in mice in 1981 and in humans in 1988.
  • 4. Stem Cells Research  Embryonic cells have the ability to develop into virtually any cell in the body, and have the potential to treat medical conditions such as diabetes and Parkinson’s disease.
  • 5. Stem Cell Research cont.  Some have argued that adult stem cells (from bone marrow or umbilical cord blood) should be pursued instead of embryonic cells because they believe the derivation of stem cells from embryos is ethically unacceptable.
  • 6. Stem Cell Research cont.  Stem cells retain the ability to become some or all of the more than 200 different cell types in the body, and thereby play a critical role in repairing organs and body tissues throughout life.
  • 7. Stem Cell research cont.  Embryonic stem cells may have a greater ability to become different types of body cells than adult stem cells.
  • 8. Embryonic stem cells from IVF Embryos or fetal tissue  Embryonic stem cells were first isolated from mouse embryos in 1981 and from primate embryos in 1995.  Animal embryos were the only source for research on embryonic stem cells until November 1998.  The cells were derived from five day old embryos produced via in vitro fertilization. (IVF)
  • 9. Cont.  This work is controversial because the stem cells are located within the embryo and the process of removing them destroys the embryo.  The cells have also been derived from the properties from five-to nine week old embryos or from fetuses obtained through elective abortion .
  • 10. Embryonic Stem Cells Obtained via SCNT (Cloning)  Another potential source of embryonic stem cells is somatic cell nuclear transfer (SCNT), also referred to as cloning.  Stem cells derived from cloned embryos may offer the best hope for understanding and treating disease.  The nucleus of the egg is removed and replaced by the nucleus from a mature body cell, such as a skin cell from a patient.
  • 11. Stem Cells from Adult Tissue or Umbilical Cord Blood  A January 2007 report found cells can be found in amniotic fluid.
  • 12. Potential Applications of Stem Cell Research  Stem cells provide the opportunity to study the growth and differentiation of individual cells in tissues. Understanding these processes could provide insights into the causes of birth defects, genetic abnormalities, and other disease states.  If normal development were better understood, it might be possible to prevent or correct some of these conditions.
  • 13. Cont.  Stem cells can be used to produce large amounts of one cell type, to test new drugs for effectiveness and chemicals and toxicity.  Stem cells might be transplanted into the body and treat disease (diabetes, Parkinson’s disease) or injury (e.g., spinal cord)
  • 14. Current Regulations  The Dickey Amendment Prior to an August 2001 Bush Administration decision, no federal funds had been used to support research on stem cells derived from either human embryos or fetal tissue.
  • 15. Cont.  Under the amendment  (a) None of the funds made under the Dickey Act may be used 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 or discarded, or knowingly subjected to risk or injury or death greater than that allowed for research on fetuses in utero.
  • 16. Cont.  (b) The term ‘embryo or embryos’ includes any organism, not protected as a human under 45 CFR [the Human Subject Protection regulations} as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning or any other means from one or more human gametes [sperm or egg] or human diploid cells {cells that have two sets of chromosomes, such as somatic cells]
  • 17. Peter Griffin visits stem cell research lab  http://www.youtube.com/watch?feature=player_d etailpage&v=TRtlkcQ6brE
  • 18. Administration Policies Clinton Administration Stem Bush Adminstration Stem Cell cell Policy Policy  Research in which human stem cells are  On August 9,2001, President Bush utilized to create or contribute to a human announced for the first time federal embryo funds would be used to support  Research in which human cells are research on embryonic stem combined with an animal embryo cells, but funding would be limited  Research in which human stem cells are to “existing stem cell lines where life used for reproductive cloning of a human and death decisions had already  Research in which human stem cells are been made. derived using somatic cell nuclear transfer  (1) with the informed consent of  Research utilizing human stem cells that donors were derived using somatic cell nuclear transfer  (2) from excess embryos created  Research utilizing stem cells that were solely for reproductive purposes derived from human embryos created for research purposes, rather than for infertility  (3) without any financial treatment. inducements to the donors.
  • 19. Administration Policies Cont…  In March of 2009 President Obama signed an executive order repealing a Bush-era policy that limited federal tax dollars for embryonic stem cell research.  Obama’s repeal overturns an order signed by President Bush in 2001 that barred the National Institutes of Health from funding research on embryonic stem cells beyond using 60 cell lines that existed at the time.
  • 20. Administration Policies cont..  Obama also signed a presidential memorandum establishing greater independence for federal science policies and programs.  Obama’s order directs the NIH to develop revised guidelines on federal funding for embryonic stem cell research within 120 days of the original memorandum.  The federal Courts upheld Obama’s actions.
  • 21. Federal Funds  Federal Funds would not be used for:  (1) the derivation or use of stem cell lines derived from newly destroyed embryos.  (2) the creation of any human embryos for research purposes  (3) the cloning of human embryos for any purpose.
  • 22. Regulation of Stem Cell Research NIH Research funding and FDA Regulation Stem Cell Registry.  The FDA defines “xenotransplantation” as any procedure that involves the tranpltation, implantation, or infusion into a human recipient of either  (a) live cells, tissues, or organs from a nonhuman source  (b) human body fluids, cells, tissues or organs that have had ex vivo contact with nonhuman animal cells, tissues or organs.  Under FDA guidelines, transplantation therapy involving Bush approved stem cell lines, which have all been exposed to mouse feeder cells, would constitute xenotransplantation.
  • 23. Private vs. Public Funding Public Funding Private Funding  Public funding can  An advantage of private contribute to sound funding is that it allows policy by increasing the research to proceed even probability that the if it’s a politically touchy issue. results of stem cell  (In the US, only private research will reflect funded companies are social priorities that may allowed to perform not inform research in research on embryonic the private sector. or fetal stem cells)
  • 24. Private vs. Public Funding cont. Public Funding Private Funding  Many Americans including  The private sector can children are excluded from the U.S. health care compensate for system. Public funding fluctuations in offer s the best hope of fostering public government consideration for common spending, and more good, rather than marketplace concerns, and importantly, and can of expanding access to the move forward without fruits of stem cell research for a large number of any federal funding. Americans.
  • 25. Private vs. Public Funding cont. Public Funding Private Funding  Stem cell research is more  Privately funded likely to advance if canonical genetic stokes of lavatories have made ES cells are made available large technical to the scientific community. Public advancement s in stem funding under the auspices cell research. of federal agencies is the only effective means for ensuring equal access by scientists to standardized ES cell lines
  • 26. Federal Funding  The federal government is the only realistic source for such an infusion of funds.  The government can strictly monitor the practices of public research through federal funding.  The commitment of federal funds also offer a basis for public review, approval and, in monitoring through well established procedures that will promise the public’s interest in ensuring that stem cell research is conducted in a way that is both scientifically rigorous and ethically proper.
  • 27. Recommendations  Recommendation (1)  Federal funding for stem cell research is necessary in order to promote investment in this promising line of research, to encourage sound public policy, and to foster public confidence in the conduct of such research.  Realizing the potential health benefits of stem cell technology will require a large and sustained investment in research. The federal government is the only realistic source for such infusion of funds.
  • 28.  Recommendation (2)  Public funding should be provided for embryonic stem cell research, but not at this time for activities involved in the isolation of embryonic stem cells, for which there remains continuing debate. This approach will allow publically- funded researchers to move more quickly toward discoveries that will lead to alleviating the suffering caused by human disease.  Although the derivation of human stem cells can be done in an ethical manner, there is enough objection to the process of deriving stem cells in a ethical manner, to recommend against its public funding. Further for the foreseeable future there will be sufficient material isolated by researchers not using public funding that this exclusion will not have a negative impact on research.
  • 29.  Recommendation (3)  The formation of company-based independent ethics advisory boards should be encouraged in the private sector.  Private sector research has played a crucial part in the advancement of research on stem cells. The leadership exhibited by the company that has sponsored all of the published human embryonic and germ cell research to date in establishing an external Ethics Advisory Board to develop guidelines for ethical conduct of such research is positive. While these private sector boards are not a substitute for public oversight and guidance, they can be a positive influence on the way that industry-funded stem cell research proceeds.