Next Steps for Stem Cell Research and Related Policies: Considerations for the New Administration
Tuesday, January 13, 2009
Posted in Eugenics | Tagged Eugenics
Over the past eight years, public understanding and discussions of embryonic stem cell research have been marked by deep polarization. The new administration has an opportunity to help put this divisive past behind us. It can begin immediately to craft a pro-research stand that simultaneously affirms the need for consistent and enforceable regulation, for hope without hype, and for ensuring that stem cell research and applications accord with principles of equity, social justice and human rights.
This memo recommends new federal policies on embryonic stem cell research; grounds these recommendations in a framework of widely shared social values; and calls attention to related human biotechnology issues that the new administration is likely to confront during its first term. A fuller treatment of these topics, Responsible Federal Oversight of the New Human Biotechnologies: Opportunities for the New Administration, will be available on January 14, 2009 at www.geneticsandsociety.org/Opportunities.
NEW FEDERAL POLICIES ON EMBRYONIC STEM CELL RESEARCH
1. Lift restrictions on federal funding A presidential directive, issued at the earliest opportunity, should lift current restrictions on federal funding
for embryonic stem cell research. It should clearly establish that federal funds will be available for work on stem cell lines that have been derived in accordance with established guidelines. Most important among these are that the stem cell lines be produced using embryos created but not needed for reproductive purposes, and that informed consent for stem cell derivation is given by those whose gametes were used in the creation of the embryos.
2. Ensure comprehensive federal oversight. The new administration should work with Congress on legislation that codifies federal funding for stem cell research along the lines outlined above, and, in broad terms, requires effective regulatory oversight of stem cell research. The Congressional directive should inform regulations to be subsequently developed by the National Institutes of Health. These may be based on the voluntary National Academies guidelines issued in 2005 and amended in 2007 and 2008. Legislation should specify that stem cell research
standards are enforceable rather than voluntary, and that they apply to all research. The Stem Cell Research Oversight (SCRO) committees recommended by the National Academies should be made accountable to a federal oversight authority, as are the Institutional Review Boards that currently oversee human subjects research. Proposals for stem cell research involving somatic cell nuclear transfer should be subject to particular scrutiny, given the special risks involved and the likely availability of induced pluripotent stem cell techniques for deriving disease-specific and patient-specific stem cell lines.
OPPORTUNITIES TO RESHAPE THE DEBATE ON STEM CELL RESEARCH
The new administration can begin to reshape the public debate on stem cell research not just through its policy initiatives, but also through the values in which it grounds them, the messages with which it communicates about them, and the constituencies it brings together to help develop and support them.
1. Encourage deeper understanding of the individual and societal benefits and risks of stem cell research and other human biotechnologies, grounded in widely shared values.
Although Americans may hold differing views about embryo research, they share common ground in the desire to safely and effectively treat disease and alleviate suffering. They are supportive of medical and
scientific advances, but are aware that these can also have unanticipated and undesired social consequences. The majority of Americans support stem cell research using embryos created but not needed for fertility treatments, providing this research is carefully regulated. At the same time, Americans do not support reproductive cloning or inheritable genetic modification, and are wary of many non-medical applications of genetic and biomedical technologies.
As the new administration prepares its stem cell policies, it should continue to emphasize the importance of effective regulatory oversight of research and applications. Special effort must be made to protect the
scientific integrity of stem cell and related medical research by preventing conflicts of interest involving stem cell researchers and commercial ventures. Exaggerated promises about near-term stem cell-based cures must be avoided. The public interest – including equitable access to the benefits of stem cell research – should be a priority value in decisions about broad funding directions, patent policies, and commercialization policies.
2. Engage a wider range of constituencies in public dialogue Public and policy discussions of stem cell research and other human biotechnology issues must involve a wider range of voices than has been heard to date. Debate on these topics has been largely driven by religious conservatives, biomedical researchers, research advocacy groups, and the commercial
biotechnology sector. Additional constituencies, including women’s and children’s health advocates; public health leaders; advocates for civil rights and racial justice; human rights leaders; and representatives of
people with disabilities, need to be represented if the ensuing polices are to have broad support.
RELATED HUMAN BIOTECHNOLOGY ISSUES
1. Prohibit human reproductive cloning
The new administration should work with Congress to quickly enact legislation prohibiting human reproductive cloning. Opposition to reproductive cloning is nearly unanimous among scientists, health
professionals and the general public. As of December 2008, 59 countries have adopted legislation banning it, including those with the most robust biomedical research sectors and every member of the Organization
of Economic Cooperation and Development except the United States. Bills to prohibit reproductive cloning have been introduced by Senators Dianne Feinstein (D-CA), Edward Kennedy (D-MA) and Tom Harkin (DIA), among others. A clear, permanent ban on reproductive cloning, including explicit sanctions for those who seek to violate it, is needed now to help build public confidence in the responsible development of stem cell and other biomedical technologies.
2. Establish comprehensive federal oversight of other human biotechnologies. The new human biotechnologies have potential for both great good and great harm. If properly used, they could lead to advances in medical knowledge and new ways of treating disease. If misused, however, they could harm research subjects and patients and reinforce societal inequities, discriminatory beliefs and practices, and inequality. During the next few years the administration will likely be called on to address increasingly controversial human biotechnology issues, including the prospect of athletic “gene doping,” the rapid expansion of commercial genetic testing and of commercial trade in reproductive tissues and services, the development of powerful neuro-pharmaceuticals for altering cognitive functions, the creation of animalhuman chimeras for research, the expansion of DNA forensic databases, embryo screening to select the sex and other non-medical traits of future children, and more.
Many countries, including the United Kingdom, Canada, France and Germany, have established comprehensive national policies that allow valuable medical research and applications to proceed while proscribing others. The new administration should begin a review of new and controversial biotechnologies, with an eye towards the development of appropriate federal oversight policies for the United States.
ABOUT THE CENTER FOR GENETICS AND SOCIETY
The Center for Genetics and Society is a nonprofit public affairs organization working to encourage responsible uses and effective societal governance of the new human biotechnologies. The Center works in a context of support for the equitable provision of health technologies domestically and internationally; for women’s health and reproductive rights; for the protection of our children; for the rights of the disabled; and for precaution in the use of powerful new technologies. For information on this memorandum, please contact CGS Associate
Director Dr. Marcy Darnovsky at mdarnovsky@geneticsandsociety.org or 510-625-0819 x 305.
Center for Genetics and Society www.geneticsandsociety.org
436 14th Street, Suite 700 www.YouTube.com/user/geneticsandsociety
Oakland, CA 94122 www.BioPoliticalTimes.org
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Human Embryonic Stem Cell Research Frequently Asked Questions and Fact Sheet Stem Cell Science Basics
What are stem cells?
Stem cells are naturally occurring cells that are not yet fully differentiated. In
contrast, once an “ordinary” cell has become specialized into a particular tissue
type, such as skin or blood, it can only divide into more cells of that type.
(However, see “How do the new methods to derive stem cells change the field?,”
below.) Another key characteristic of stem cells is that they can be maintained and
grown in a laboratory for quite some time. Thus, a stem cell “line” can be
established, characterized, and shared much like bakers or brewers maintain and
share a line of yeast.
Why are scientists interested in stem cells?
Scientists are developing ways to use stem cells to better test drugs before trying
them in humans. Others are creating stem cell lines that have all the genes that
contribute to a particular disease, allowing them to study a “disease in a dish.”
Scientists also believe they can learn to use stem cells to regenerate damaged
body tissues. Many conditions which result from damaged tissues, such as
diabetes, spinal cord injury, and some types of blindness, may be able to be
treated through such cell therapies.
Are all stem cells the same?
No. Stem cells derived from different sources have different characteristics. Some
stem cells are pluripotent: they can turn into any cell type. Others are multipotent:
they can turn into some, but not all, cell types.
“Adult stem cells,” which can be isolated from various organs or from placentas
or umbilical cords, are generally multipotent, although new “cell reprogramming”
techniques have created pluripotent stem cells from adult body tissue. (See “How
do the new methods to derive stem cells change the field?,” below.) Stem cells
derived from embryos are generally pluripotent. Most embryonic stem cell
research uses “leftover” embryos that were created but not used in assisted
reproduction clinics, which generally create more embryos than are needed. A
few researchers are trying to create human embryos via cloning from which they
wish to derive stem cells. (See “How does cloning fit into stem cell research?,”
below.)
How far along is stem cell research towards therapies?
Several adult stem cell therapies are already part of medical practice, and more
are being tested in clinical trials. Procedures using human embryonic stem cells
are not yet being tested on people, although clinical trials are likely to begin soon.
The routine availability of any therapies based on embryonic stem cells is many
years away. Stem cells from clonal embryos have not been successfully isolated.
(See “How does cloning fit into stem cell research?,” below.)
Stem Cell Policy Basics
Why is human embryonic stem cell research controversial?
Deriving stem cells from human embryos requires the destruction of embryos,
which some view as morally equivalent to taking the life of a child or adult.
Supporters of the research point out that the embryos scientists use consist of
about 100 undifferentiated cells, and that these embryos are being stored by
fertility clinics and will eventually be destroyed anyway.
Controversy about the moral status of human embryos led to a hotly contested
partisan divide over embryonic stem cell research, with both sides prone to
exaggeration and distortion. As a result, little attention has been given to social
and ethical issues unrelated to the embryo. These include the need for responsible
representations about the potential of the research, consistent and enforceable
regulation and oversight, the risks to women entailed by the requirement for large
numbers of human eggs in cloning-based stem cell research, and the need for
federal policy to prevent reproductive cloning and other objectionable forms of
human genetic manipulation that embryonic stem cell research may help enable.
What did President Bush’s policy do?
On August 9, 2001, President Bush declared that federal funds could be used to
work with human embryonic stem cell lines that had already been established, but
not with stem cell lines created after that date. In a televised speech, he said that
this would allow important scientific work to proceed, but would rule out federal
funding for any future destruction of embryos.
Some religious conservatives objected to any federal funds at all being spent on
embryonic stem cell research; others were glad that at least some limits had been
applied. Some stem cell scientists were initially pleased that federal funding was
at last available for this research. But it turned out that only 22 lines that were at
all suitable were actually eligible for federal support, and many of these were later
found to be contaminated with animal material. Research with these lines has
received about $40 million annually from the federal government. Congress twice passed bills that would have undone these funding restrictions, but Bush vetoed them both.
What was the impact of the Bush policy?
As time went on, and newer and better stem cell lines were established through
efforts receiving private and state funding, the federal funding restriction created
logistical difficulties for scientists. Some researchers established two sets of
laboratory facilities, one of which would be free of federal funding support and
could be used for a wider range of research. In addition, the number of useful
stem cell lines available for federal funding turned out to be fewer than initially
estimated, leading to more requests that the federal constraints be lifted.
Dissatisfaction with the Bush policy contributed to efforts to fund embryonic stem
cell research in several states. The most visible example is in California, where a
ballot initiative passed in 2004 provided $300 million annually for stem cell work.
Other states have taken similar steps. Additionally, hundreds of millions of dollars
have been provided in private donations. One result is an absence of enforceable
federal regulation and oversight of embryonic stem cell research. (See “Is stem
cell research subject to other federal oversight?,” below.)
What is President Obama expected to do?
One of the Barack Obama’s first acts as president is expected to be the removal of
President Bush’s restrictions on the federal funding of human embryonic stem cell
research. After that, research with stem cell lines derived from “leftover” embryos
in assisted reproduction clinics will be eligible for federal funding. President
Obama is also expected to call for the establishment of regulations and oversight
of stem cell research.
After that, will federal funds be used to derive stem cells from human embryos?
Because stem cell lines can be maintained and shared, research with most human
embryonic stem cell lines, once established, will be eligible for federal support.
The actual derivation of new human embryonic stem cell lines will remain
ineligible for federal funding, as it was during the Clinton administration and
before President Bush announced his funding policy. This is due to the “Dickey
Wicker Amendment,” an annually renewed clause in a federal appropriations bill
that prohibits federal dollars from going towards the destruction of embryos. In
addition, work with stem cell lines that are derived without proper consent or that
are derived from embryos other than those leftover in assisted reproduction clinics
will not be eligible for federal dollars.
Is stem cell research subject to other federal oversight?
Stem cell research is not subject to any federal regulations beyond those that
apply to other biomedical research. During the Bush administration, the federal
government did not develop any such regulations. Although non-governmental
bodies such as the National Academies and the International Society for Stem
Cell Research have established stem cell research guidelines, these are nonbinding.
Congressional bills subsequent to President Obama’s new policy are
likely to request that the National Institutes of Health write regulations for
federally funded stem cell research.
How do the new methods to derive stem cells change the field?
In 2007, two teams of researchers developed methods to reprogram normal body
cells into a state of pluripotency, raising the prospect that embryo destruction may
not be needed for stem cell research and therapies. However, these initial
experiments creating “induced pluripotent stem cells,” or iPS cells, used viral
vectors to genetically modify the cells, methods which will need to be refined or
replaced before the cells are put into humans. Since then, significant steps have
been made towards using better methods of cellular reprogramming. Some
scientists are shifting from using embryonic sources to these reprogrammed cells,
and high-profile cloning researchers including Sir Ian Wilmut, who created Dolly
the cloned sheep, have abandoned cloning-based stem cell research. However,
most believe that investigations using embryonic stem cells are still needed.
How does cloning fit into stem cell research?
The use of cloning techniques to create stem cells was conceived as a way to
address the immune rejection issue that some scientists believe will complicate
therapies based on stem cells from “leftover” embryos. However, the method –
known as somatic cell nuclear transfer (SCNT) or research cloning – has been
largely unsuccessful. The first human clonal embryo was created just last year,
and no stem cells have been derived with this method.
Moreover, the cloning process is socially and ethically problematic. It requires
large numbers of women’s eggs, and obtaining them poses non-trivial risks. It
involves the creation of cloned embryos, raising the risk of their unauthorized in
attempts at reproductive cloning. (The United States is the only major industrial
country that has not prohibited reproductive cloning; many believe that such a law
is urgently needed.) In contrast, the new method of cellular reprogramming (see
above) creates pluripotent stem cell lines with the known genetic characteristics
of a specific disease or an existing person, which was the goal of cloning-based
stem cell research.
For more information, see The Basics: Stem Cells and Public Policy [PDF], a 2006
briefing booklet published by The Century Foundation and authored by CGS’s Richard
Hayes, available at http://www.tcf.org/Publications/HealthCare/Stemcellbasics.pdf.
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