Why it’s Time for Congress to Write New Stem Cell Legislation
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Angelo Bouselli
Aug 30, 2010, 11:03:22 AM8/30/10
to TRAIN Central Station
By Margaret Anderson
Executive Director, FasterCures
We need policy that allows the research to proceed, with federal
dollars and with appropriate oversight.
On August 23, a federal judge blocked NIH from funding human embryonic
stem cell research, ruling that the support violates the rider (the
Dickey Wicker amendment) of the Health and Human Services
appropriations bill written by Congress in 1996. The rider prohibits
the use of taxpayer money for research “in which a human embryo or
embryos are destroyed, discarded, or knowingly subjected to risk of
injury or death greater than that allowed for research on fetuses in
utero.”
In 1999, the Department of Health and Human Services General Counsel
determined that this law does not prevent NIH from supporting research
that uses embryonic stem cells derived—using private funds—from
embryos destined to be destroyed by those no longer needing them for
infertility treatment. That ruling was expectedly controversial but it
set the wheels in motion for U.S. scientists to explore how these most
versatile of human cells could be used to safely test new drugs,
restore worn and torn tissue, and replace diseased cells with healthy
cells.
In 2001, President Bush halted research on all but a few embryonic
stem cell lines. Last year, President Obama lifted some restrictions,
but only after a clear and publicly vetted set of guidelines was in
place for proceeding with scientific work.
Although the private sector is always free to conduct this type of
research, most agree that we need the rigor, stature, and transparency
of federal funding for the field to move forward.
At the bench, there are many ways to read the intent of Congress.
Judge Lamberth read the intent of Congress in a way that would
prohibit federal funding for such research.
If you visit the NIH’s Stem Cell information page today you will read
that:
“Pursuant to a court order issued August 23, 2010, NIH is not
accepting submissions of information about human embryonic stem cell
lines for NIH review. All review of human embryonic stem cell lines
under the NIH Guidelines is suspended. The February 23, 2010, proposal
to revise the Guidelines is also suspended.”
The impact of this decision cannot be understated. Millions of
research dollars and the grant review process have been frozen.
Policymakers on both sides of the aisle have spoken out in support of
this area of research, given that specific safeguards are in place.
The public opinion on pursuing this research is clear. The scientific
need to pursue these avenues is clear. If, as the judge in this case
asserts, the 1996 amendment is in the way, then it needs to be
reexamined.
A June 2008 Time magazine poll conducted by the SBRI research group
found that 73 percent of Americans support embryonic stem cell
research using cells derived from embryos about to be discarded by
couples after infertility treatment. A majority of Americans support
embryonic stem cell research as long as there are strict guidelines
and systems of oversight in place, which there are.
In addition to extensive ethics review at NIH, every institution
receiving federal funding for this research—that could mean the
academic medical center down the street from you—has several
committees in place to review this area of research to ensure it is
conducted ethically and with only the highest scientific
justification. Citizens sit on these committees, as well as
scientists, physicians, lawyers, and ethicists.
The solution now is for Congress to craft a new policy that allows the
research to proceed, with federal dollars and with appropriate
oversight. In the absence of a legislative change, the lawyers will
continue to battle, which will take valuable time, while patients and
their families sit by helplessly, waiting for a political miracle.
Executive Director, FasterCures
We need policy that allows the research to proceed, with federal
dollars and with appropriate oversight.
On August 23, a federal judge blocked NIH from funding human embryonic
stem cell research, ruling that the support violates the rider (the
Dickey Wicker amendment) of the Health and Human Services
appropriations bill written by Congress in 1996. The rider prohibits
the use of taxpayer money for research “in which a human embryo or
embryos are destroyed, discarded, or knowingly subjected to risk of
injury or death greater than that allowed for research on fetuses in
utero.”
In 1999, the Department of Health and Human Services General Counsel
determined that this law does not prevent NIH from supporting research
that uses embryonic stem cells derived—using private funds—from
embryos destined to be destroyed by those no longer needing them for
infertility treatment. That ruling was expectedly controversial but it
set the wheels in motion for U.S. scientists to explore how these most
versatile of human cells could be used to safely test new drugs,
restore worn and torn tissue, and replace diseased cells with healthy
cells.
In 2001, President Bush halted research on all but a few embryonic
stem cell lines. Last year, President Obama lifted some restrictions,
but only after a clear and publicly vetted set of guidelines was in
place for proceeding with scientific work.
Although the private sector is always free to conduct this type of
research, most agree that we need the rigor, stature, and transparency
of federal funding for the field to move forward.
At the bench, there are many ways to read the intent of Congress.
Judge Lamberth read the intent of Congress in a way that would
prohibit federal funding for such research.
If you visit the NIH’s Stem Cell information page today you will read
that:
“Pursuant to a court order issued August 23, 2010, NIH is not
accepting submissions of information about human embryonic stem cell
lines for NIH review. All review of human embryonic stem cell lines
under the NIH Guidelines is suspended. The February 23, 2010, proposal
to revise the Guidelines is also suspended.”
The impact of this decision cannot be understated. Millions of
research dollars and the grant review process have been frozen.
Policymakers on both sides of the aisle have spoken out in support of
this area of research, given that specific safeguards are in place.
The public opinion on pursuing this research is clear. The scientific
need to pursue these avenues is clear. If, as the judge in this case
asserts, the 1996 amendment is in the way, then it needs to be
reexamined.
A June 2008 Time magazine poll conducted by the SBRI research group
found that 73 percent of Americans support embryonic stem cell
research using cells derived from embryos about to be discarded by
couples after infertility treatment. A majority of Americans support
embryonic stem cell research as long as there are strict guidelines
and systems of oversight in place, which there are.
In addition to extensive ethics review at NIH, every institution
receiving federal funding for this research—that could mean the
academic medical center down the street from you—has several
committees in place to review this area of research to ensure it is
conducted ethically and with only the highest scientific
justification. Citizens sit on these committees, as well as
scientists, physicians, lawyers, and ethicists.
The solution now is for Congress to craft a new policy that allows the
research to proceed, with federal dollars and with appropriate
oversight. In the absence of a legislative change, the lawyers will
continue to battle, which will take valuable time, while patients and
their families sit by helplessly, waiting for a political miracle.
Joyce
Aug 30, 2010, 6:07:00 PM8/30/10
to TRAIN Central Station
Congressman Kennedy (MA) dropped in on an NINDS epilepsy workshop I
attended last week. He was highly supportive of revising stem cell
rules to allow US researchers to move forward in this important area.
Count on him as an ally who carries on the vigor of his father, the
late Sen Ted kennedy.
Joyce Cramer
President
Epilepsy Therapy Project
On Aug 30, 10:03 am, Angelo Bouselli <angelo.bouse...@gmail.com>
wrote:
attended last week. He was highly supportive of revising stem cell
rules to allow US researchers to move forward in this important area.
Count on him as an ally who carries on the vigor of his father, the
late Sen Ted kennedy.
Joyce Cramer
President
Epilepsy Therapy Project
On Aug 30, 10:03 am, Angelo Bouselli <angelo.bouse...@gmail.com>
wrote:
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