2010-09-17
There has been tremendous activity over the past several
weeks, both legislatively and in the courts, in response to the August 23
federal court ruling
prohibiting federal funding of human embryonic stem cell (hESC) research.
The lawsuit responsible for all of
the recent activity (Sherley et al. v. Sebelius) is continuing to make its way
through the federal court system. On September 9, the U.S. Court of Appeals for
the District of Columbia lifted
a temporary injunction barring the federal government from funding hESC
research. As part of its ruling, the court indicated that the Obama Administration
could resume funding the research pending a full appeal of the case and the
National Institutes of Health (NIH) has, at least temporarily, resumed both its
intramural hESC research and its normal extramural application and grant
processes.
Both sides involved in the lawsuit
will be providing additional responses to the court as the appeals process
continues. The Coalition for the Advancement of Medical Research (CAMR), of
which ASH is a member, filed an amicus
brief in support of the federal government’s appeal. The brief filed by
CAMR addresses two of the four factors relevant to evaluating the emergency
stay motion: the public interest and the likelihood of harm to other parties.
CAMR asked for the stay to be granted, stating that “…the preliminary
injunction will, if not stayed, radically disrupt, and perhaps permanently
cripple, ongoing and planned human embryonic stem cell research.” CAMR will
file another, more complete brief, when the merits of the case are heard.
Meanwhile, the U.S. House of Representatives and Senate have
begun to consider legislative means to ensure ability of the federal government
to fund hESC research. At this point, it remains unclear precisely how Congress
will proceed, although several legislative remedies have been discussed.
In the U.S. House of
Representatives, Representatives Diana DeGette (D-CO) and Michael Castle
(R-DE), have indicated they have gained support for legislation they have
introduced which would codify President Obama’s March 2009 Executive
Order expanding federally funded embryonic stem cell research. The Stem
Cell Research Advancement Act (HR
4808) would “ensure a lasting ethical framework" for human stem cell
research at NIH and would authorize the Department of Health and Human Services
(HHS) to conduct and support research on human stem cells, including embryonic
stem cells. The legislation would also require NIH to maintain guidelines on
human stem cell research conducted or supported by HHS, to review the
guidelines at least every three years and update them as warranted. ASH supports
this legislative proposal and Representatives DeGette and Castle have indicated
that they hope the House may consider the legislation prior to adjourning for
the mid-term elections in early October.
In the Senate, a chief proponent of
hESC research, Senator Arlen Specter (D-PA), has introduced legislation (S
3766) that would address the August 23 court ruling by updating the
guidelines for federal funding for embryonic stem cell research as laid out in
President Obama’s 2009 Executive
Order. Specifically, his bill would set guidelines to ensure that
federally-funded research is conducted only on stem cells from embryos that
would otherwise be discarded and are in excess of clinical need, clarifying for
the court Congress’ intent for funding hESC.
Following a September 16 hearing on hESC
research, Senator Tom Harkin (D-IA), Chair of both the Senate Health,
Education, Labor and Pensions (HELP) Committee and the Senate Labor-Health and
Human Services Appropriations Subcommittee, as well as a leading Senate
proponent of hESC research, indicated that the Senate would not consider
legislation dealing with hESC research prior to the Senate’s adjournment for
the November elections. Senator Harkin indicated that any Senate action on the
issue would have to wait until December and could even move into next year.
Senator Harkin has also indicated that
the HELP Committee is looking to lift the funding freeze by modifying the
language of a 1995 law known as the Dickey-Wicker amendment, which prohibits
the use of federal funds for research that destroys human embryos. Amending the
Dickey-Wicker amendment will be challenging, as the new legislation will have
to be very specific to satisfy Judge Lamberth’s concerns about its
interpretation. Previously, HHS had concluded NIH support of human embryonic
stem cell research did not violate the amendment if the funds were used only
for research involving the cells – not to procure them. The court ruling,
however, rejected that distinction, citing the “unambiguous intent of Congress
to enact a broad prohibition of funding...all research in which an embryo is
destroyed, not just the piece of research in which the embryo is destroyed.”
Despite the temporary stay on the ban, it is
important for Congress to act by passing legislation to permanently allow
hESC research to continue. Given the potential of the midterm elections to
change the Democrats majority in the Congress, it is particularly important
that Congress act soon. It is critical
that Members of Congress hear from the scientific community today that
prohibiting the use of federal funds for hESC research is a major set-back for
the potential development of new medical treatments. All ASH members are
encouraged to visit the ASH Advocacy Center
to join ASH’s campaign and send a letter to their
Representative and Senators urging passage of legislation ensuring the
continued availability of federal funding for hESC research.
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