Inside (The Beltway)
Scoop – Jennifer Zeitzer
The relative quiet that blanketed Capitol Hill this month was disrupted on August 23rd by a Federal District Court ruling barring federal funding for human embryonic stem cell research (see related story below). Given that nearly all members of Congress are outside of Washington at the moment, the reaction to the judicial decision was limited to a few comments from key stem cell supporters, and it is not clear what legislators will do once they return to work the week of September 13th. A
Roll Call story published last week suggested that the House could vote on a stem cell research bill authored by Representatives Diana DeGette (D-CO) and Mike Castle (R-DE). Although the article did identify a specific piece of legislation that may be voted on, one possible option is HR 4808, the
Stem Cell Research Advancement Act of 2009, which would require the Secretary of Health and Human Services (HHS) to conduct and support research that utilizes human stem cells, including embryonic stem cells, as long as they were derived from human embryos donated from in vitro fertilization clinics, created for the purposes of reproductive treatment and in excess of individual needs, and written, informed consent was provided by the donors. The bill language essentially codifies the policy established by the Obama Executive Order on stem cell research that was issued in 2009. Earlier versions of this legislation were passed by Congress and vetoed by President George W. Bush. A spokesman for House Speaker Nancy Pelosi (D-CA) commented that “We are discussing our options,” but offered no additional information.
Representative DeGette subsequently issued a statement stating “Our nation already lost valuable time over the last decade, when we could have been bringing our massive resources and expertise to bear, expanding stem cell research and helping 100 million American patients living with devastating and debilitating diseases.” Other press reports mentioned that a DeGette spokesperson also commented on the pending legislation, noting “She has always known that we must codify the ability to conduct this critical lifesaving research, and the Congresswoman believes that this ruling has now created a greater sense of urgency.” In addition, Representative Michael Castle (R-DE) issued a press statement confirming that he remains committed to supporting stem cell research.
From the other side of the Capitol, Senator Charles Schumer (D-NY) told a New York Times reporter that “I think the public is on our side on stem cell issues and swing voters are on our side. This is very open to a legislative solution.” Senate Labor, Health and Human Services Appropriations Chairman Tom Harkin (D-IA) also announced that a hearing on stem cell funding has been scheduled for September 16th and released a
statement stating that "This ruling should be appealed and I fully believe that it will be overturned. Embryonic stem cell research offers hope to millions of Americans who are suffering from debilitating and life-threatening diseases, and it must be allowed to proceed." FASEB will issue an action alert asking scientists to contact their members of Congress to urge them to approve legislation that will allow continued federal funding for embryonic stem cell research.
The stem cell matter is likely to add additional complexity to the September legislative agenda, which is already crowded with high priority items that will have to be addressed in a very short time frame. Both the House and Senate are expected to recess around October 8th to return to the campaign trail for the final weeks prior to the mid-term elections. Although the Congressional leadership has not announced a specific schedule, lawmakers could address several issues including a small business jobs bill that stalled in the Senate prior to the summer break, an initiative to boost manufacturing efforts in the U.S., a food safety bill, the fiscal year (FY) 2011 defense authorization bill, border security legislation, and a “continuing resolution” to extend funding for government agencies beyond September 30th (the end of the current fiscal year). It is not clear if Congress will attempt to debate any of the FY 2011 spending bills that were passed by the Appropriations Committees earlier this summer.
Legislative issues that are not resolved in September could be addressed later this fall. Senate Majority Leader Harry Reid (D-NV) informed his colleagues in early August that the chamber will return to Washington for a “lame duck” session in November. According to Reid’s office, the Senate will be in session November 15th – 19th, break for Thanksgiving between November 22nd – 26th, and return to the Capitol on November 29th for an unspecified period of time. The House leadership has not released a schedule beyond the previously established October target adjournment date, nor have they indicated if there will be a “lame duck” session after November 2nd.
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Injunction Bars Federal
Funding for Human Embryonic Stem Cell Research
On Monday, August 23rd, Federal District Court for the District of Columbia Judge Royce Lamberth issued a
preliminary injunction barring the Department of Health and Human Services (HHS)
Guidelines for Human Stem Cell Research from taking effect, thereby prohibiting the use of federal funds for human embryonic stem cell research (hESC). In response to the decision, the National Institutes of Health (NIH) ordered an immediate shutdown of hESC research conducted in its intramural program. While extramural research for which funds have already been awarded is currently allowed to proceed, NIH will not review or award any new grants, competing renewals, or continuations involving hESCs. Earlier this week, HHS and NIH
appealed the judge’s decision, filed an emergency
motion to stay the order pending the appeal, and requested that the court rule on the motion to stay by Tuesday, September 7th.
In his decision, Judge Lamberth ruled that the plaintiffs (two adult stem cell researchers) were likely to win their suit contending that hESC research violated the Dickey-Wicker amendment, a provision that has been attached to the annual Labor-HHS appropriations bill every year since 1996. The amendment bars 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 greater than that allowed for research on fetuses
in utero.”
In 1999, HHS determined that the Dickey-Wicker amendment, while prohibiting the derivation of stem cells from embryos, is not applicable to hESC research because such research does not result in the destruction of an embryo. In contrast, Judge Lamberth, in granting the injunction, concluded that “Derivation of ESC from an embryo is an integral step in conducting ESC research…If one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding.”
FASEB immediately issued a
statement condemning the ruling. Federation President William T. Talman, M.D. remarked that “Prohibiting the use of federal funds for human embryonic stem cell research is a major set-back to research that holds promise for future cures. The ruling, if allowed to stand, unnecessarily delays development of new medical treatments and diminishes the hopes of millions of patients suffering from serious illnesses.”
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FASEB President
Discusses NIH Funding For 2012
FASEB President William Talman recently discussed fiscal year 2012 funding for the National Institutes of Health (NIH) with analysts from the White House Office of Management and Budget (OMB). The August 18th meeting was coordinated on behalf of the Steering Committee of the Ad Hoc Group for Medical Research.
The absence of 2011 appropriations bills complicates OMB efforts to construct the 2012 budget. Currently, it seems likely that the NIH discussion will start with the President’s 2011 recommendation of $32 billion (the same number as in the House and Senate mark-up of the 2011 funding bills).
Talman discussed the needs of the biomedical research community, and in particular noted the “cliff scenario” that will occur with the end of the funding from the
American Recovery and Reinvestment Act. Estimating the size, onset and impact of “the cliff” was a clear concern for all parties who participated in the meeting.
In a discussion of budget priorities, FASEB raised concerns about funding for basic research and R01 grants. OMB staff stated that both are important issues. Diminished emphasis in this area was attributed to decisions made by the individual NIH institute and center directors and not priorities in the President’s budget.
OMB staffers expressed strong interest in the community’s estimates and recommendations for fiscal year 2012. They found FASEB’s analyses to be helpful in the past, and noted that they would need this information before October. At the end of the meeting, Talman presented the OMB staff with a copy FASEB’s most recent analysis of trends in
NIH funding and learned that our perspectives had been taken into consideration in creating the FY 2011 budget recommendation.
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