"Embryo research was born political."-George Annas (NEJM Oct. 28, 2010)

Introduction


Biotechnological developments and discoveries in stem cell science are happening at a rapid pace. Yet, in no other area of science are the direction and scope of scientific advancement so tightly dictated by ethical consideration and formal sanctions. Since the first stem cells were cultured in 1998, a compelling, and indeed contentious panoply of religious, legal, social, and moral issues have ensued.


Legal matters


For most of the human embryonic stem cell (hESC) research debate, contentious issues have arisen in the arena of administrative policy and federal funding. Different federal administrations with different political leanings have either allowed or curtailed federal support. Meanwhile, research funded through private and state sources has continued. Government and the public have to recognize that stem cell research is currently in its infancy, and there is much work to be done before the promises of stem cell therapy become reality.

The legal battle began in 1973 when the Supreme Court ruled in Roe v. Wade that a fetus in the mother’s uterus is not considered a person with rights under the Fourteenth Amendment (US Supreme Court, Roe V. Wade, 1973). Many assumed that this ruling would extend to embryos outside the mother’s uterus (Wilberforce, Forsythe et al. 2011). In addition, there was an attempt to understand the implications for how states might limit the practice of the destruction of embryos, as they did with abortion, out of an interest in protecting potential life. While indeed, some states have enacted restrictions, the court has yet to issue a ruling on the status of embryos outside the mother’s uterus.

State by State Stem Cell Legislation

For more information on state-by-state legislation concerning restrictions on stem cell research to protect potential life, see this interactive map from the Washington Post.

As restrictions interfere with the very strong desire of scientists to create and develop new stem cell technologies, US federal courts might also seek to encourage and protect stem cell research. If research demonstrates that hESCs could be used as an effective therapy (e.g., to repair spinal cord injury), would federal policy change? The intense debates over the conception and birth in 1978 of the world’s first IVF-generated child, “test tube” baby Louise Brown, soon dissipated as more infertile couples successfully used IVF to produce healthy offspring.

Courts recently entered the debate to address assertions that federal funding of hESC research is in violation of the Dickey-Wicker Amendment.
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Timeline of key legal and political events concerning stem cell research

Key legal and political events

  • 1974: Congress initiated a temporary moratorium on federally-funded clinical research that used human embryos and embryonic tissue, including research on IVF, until national guidelines could be established.
  • 1975: The U.S. Department of Health and Human Services (DHHS) mandated regulations for research on embryos and refused to fund infertility or therapeutic research using human embryos.
  • 1979: The Ethics Advisory Board, created under the Carter administration, recommended that the government should fund research on embryos in an effort to improve IVF.
  • 1981: Embryonic stem cells are first cultured in mice (Evans and Kaufman at Cambridge; Martin at UCSF).
  • January 1996: The Dickey-Wicker Amendment was passed barring "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." (104th Congress 1995-1996)
  • 1998: Human embryonic stem cells were cultured and sustained for several months, thus allowing the cells to undergo self-renewal and differentiation - two fundamental properties of stem cells (J Thomson at University of Wisconsin and JD Gearhart at Johns Hopkins University).
  • January 1999: During the Clinton Administration, the NIH announced that "current law permits federal funds to be used for research using human pluripotent stem cells." This decision was based on the legal opinion of Harriet Rabb, General Counsel to the Department of Health and Human Services (HHS), who argued that since embryonic stem cells are not embryos they are not covered by the federal ban established under the Dickey-Wicker Amendment.
  • August, 2001: In a nationally televised speech, President Bush announced that the NIH will only fund research on human embryonic stem cell lines derived before August 9, 2001. At the time, there were estimated to be 78 cell lines included in the NIH registry, but, of these, only 21 were available for research and of these very few were appropriate for human use as most of the cell lines use mouse feeder cells.
  • 2005-2007: Congress tried twice to overturn the ban on federal funding of research on human embryonic stem cell lines derived after 2001, but President Bush vetoed the bill both times.
  • March 2009: Within two months of his inauguration, President Obama lifted the moratorium on federal funding, issuing an executive order that the NIH "may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law." The expectation is that the NIH will develop guidelines to govern the stem cell research within its institutes.
  • July 7, 2009: New NIH guidelines went into effect, establishing criteria for use of previously derived human embryonic stem cell lines and for lines to be derived thereafter (National Institutes of Health, 2005).
  • August 2009: A group of plaintiffs led by adult stem cell scientists James Sherley and Theresha Deisher filed a lawsuit against the NIH and the US Department of Health and Human Services, arguing that federal funding of the research is in violation of the Dickey-Wicker amendment.
  • October 2009: Chief Judge Royce Lamberth of the US District Court in Washington D.C. dismissed the case, claiming that the plaintiffs are not being affected under the NIH’s current guidelines. The plaintiffs appealed.
  • June 2010: The US Court of Appeals for the District of Columbia Circuit reversed the decision, ordering that the case be sent back to Judge Lamberth.
  • August 23, 2010: Judge Lamberth granted the plaintiffs’ initial request for a preliminary injunction blocking all federal funding of human embryonic stem cell research while the case was being adjudicated. Within a week, the NIH freezed funding for all embryonic stem cell research within its institutes.
  • September 9, 2010: The Washington D.C. Court of Appeals blocked Judge Lamberth’s injunction, allowing funding to continue in the interim.
  • Several interim steps here, most importantly the Court of Appeals overruling Judge Lamberth in April, 2011.
  • July 27, 2011: Judge Lamberth ruleed that the US government can continue to fund embryonic stem cell research and dismissed the 2009 lawsuit by researchers Sherley and Deisher that challenged President Obama’s expansion of funding. Lamberth’s latest decision came almost a year after the Court of Appeals removed his August 2010 preliminary injunction on such grants.

  • For a more comprehensive timeline see: Vogel and Couzin-Frankel 2011


Political battles

To appreciate the political battles over the support of human embryonic stem cell (hESC) research, it is necessary to understand the conflicting beliefs concerning the status of the human embryo on the spectrum of life (Brock 2010).

  • There are those who believe that an embryo is a full human life, and therefore cannot be destroyed wantonly or otherwise. According to this school of thought, embryos should not be actively destroyed regardless of the purpose, and regardless of the source.
  • On the other side are those who believe that an embryo is merely a community of cells with no moral status. According to this viewpoint, the creation of embryos for the sole purpose of conducting research poses no problem.
  • Occupying a middle ground are those who believe in an “intermediate moral status,” for example, as proposed by Dan Brock (2010). This group views embryos as neither an aggregate of cells nor a complete being, but rather as entities with potential for full life, giving them at least partial moral status. According to this perspective, creating embryos to then destroy them would be problematic, but using existing embryos that will otherwise be discarded might be acceptable.


Given that the acceptability of hESC research hinges on the issue of destroying early embryos, the discussion was quickly drawn into the well-rehearsed abortion debates that have long occupied the American conscience (Robertson 2010). As such, political lines were similarly drawn, with the more conservative-minded opposing abortion and hESC research, and the more liberal-minded in favor.
Political and social divisions regarding hESC research and abortion may be rooted more in differences in religious ideologies.
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Embryo research during President William J. Clinton’s administration (1993-2001)


Following Clinton’s Presidential Inauguration in 1993, the administration reevaluated its stance on embryo research. Congress soon authorized the NIH to proceed without the then defunct Ethics Advisory Board’s oversight and actually assembled its own ethics advisory committee in preparation for the commencement of embryo research.

With the midterm elections of 1994, however, Republicans regained control of Congress, and progress toward the start of embryo research was slowed due to pressure from the new conservative majority.

The Dickey-Wicker Amendment (1995) and human embryonic stem cell (hESC) research

In 1995, Congress passed, and President Clinton signed, the Dickey-Wicker Amendment.

In 1996, an additional concept was added in the amendment indicating that all federal funding in support of research with human embryos is illegal. Moreover, the Dickey-Wicker amendment defines embryos as “any organism, not protected as a human subject under 45 CFR 46. The Dickey-Wicker Amendment provides that “no federal funds can be expended by the National Institutes of Health (NIH) 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 risks of injury or death.”

The bill has been renewed by every Congress since the signing of this amendment (1995).

With the first derivation of human embryonic stem cell (hESC) lines in 1998 (toward the end of the Clinton administration), the question became whether funding of research on hESC’s would be in violation of the Dickey-Wicker amendment.

Congressman Jay W. Dickey and Senator Roger F. Wicker


Jay W. Dickey, Jr. (1939 - ), a former U.S. Representative from the Fourth Congressional District of Arkansas, served in Congress from 1993 to 2001. The Dickey-Wicker Amendment -- prohibiting spending of federal funds on research that involves the destruction of a human embryo -- is a bill he sponsored and is named for him. Former Rep. Dickey, known for controversial and conservative positions on many issues despite representing a moderate district, lost his seat to democrat Mike Ross in 2000.


Roger F. Wicker (1951 - ) the 1st term Republican junior senator of Mississippi who was appointed by then- Governor Haley Barbour in 2007 to fill the seat vacated by Trent Lott, the former Senator. In a 2008 special election, Wicker won for the remainder of Lott’s term. Wicker is also known for the appropriations bill, the Dickey-Wicker Amendment, which he co-sponsored while representing Mississippi’s conservative 1st congressional district (1995 to 2007) prior to his Senate post (Congress 2007).



Harriett Rabb, at the time General Counsel to the Department of Health and Human Services, authored a memo to Dr. Harold Varmus, then Director of the NIH, offering two arguments in favor of the funding of human ESC research (Rabb 1999).

The first was to draw a distinction between the creation of hESC lines and research using those lines; she maintained that if the derivation of the lines was privately funded, federal funding of later research would not pose a problem regarding the creation of embryos.

As to the second issue related to the destruction of embryos during the research, she further argued that the Dickey-Wicker amendment specifically referred to the embryos in question as organisms, and embryonic stem cells, in her opinion, were not legally organisms because they cannot develop into viable embryos outside a woman’s uterus or, once cultured as stem cells, even inside the uterus (Marshall 1999; Dunn 2005).

Given the legal opinion of Harriet Rabb that established Clinton Administration policy about funding of hESC research, the NIH then began to develop guidelines to fund research, and was ready to begin issuing grants.

Harriet S. Rabb is a graduate of Barnard College, Columbia University, and a 1966 graduate of the Columbia University School of Law. She became the first female dean in the history of the Law School when she was named Dean for Urban Affairs in 1972 and in 1992, given her significant work in civil rights and public interest law, she was appointed Vice Dean of the Faculty. In 1993, she took a leave of absence to serve as General Counsel for the U.S. Department of Health and Human Services for eight years, under Secretary Donna Shalala. It was during this period that she addressed the stem cell issue. Currently Ms. Rabb is Vice President and General Counsel at The Rockefeller University in New York City. She has served on a number of boards including Human Rights Watch, the Ford Foundation, and The Hastings Center. She also serves on the External Advisory Board of the Columbia University Center for Bioethics.

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Embryo research during President George W. Bush’s administration (2001-2009)


When George W. Bush took office, many members of Congress were not pleased with what they viewed as a legalistic end-run around conservative policies (Fischbach and Fischbach, 2004).

President George W. Bush adopted a more conservative variation of Harriet Rabb’s approach. In his first public address regarding a human embryonic stem cell (hESC) policy, he announced that human ESC research would be allowed to go forward, but only on stem cell lines derived prior to August 9, 2001, the date of his address (Bush 2001). This approach was remarkable, seeming to favor hESC research while at the same time limiting it.

The policy proved to be more restrictive than it initially seemed. While between 60 and 70 lines had been previously derived and were available for use, over the duration of President Bush’s two terms in office, only 21 lines proved viable, greatly reducing access to the basic material needed to conduct stem cell research.

In 2006, in an effort to overturn the funding ban, the Senate passed a bill allowing funding of research on lines derived after 2001, but President Bush vetoed the bill. He vetoed a similar bill the following year in 2007.

While the restriction of federal funding for hESC funding served to limit embryo research because the blastocyst must be destroyed to obtain the stem cells, embryo research actively continued with private and certain state funding (e.g., California). Moreover, despite its intent to limit research, the restriction served as an impetus for researchers to focus their efforts on novel ways to create stem cells using adult cells that did not require destruction of the embryo (Loike and Fischbach 2009).

The restrictions on stem cell research also resulted in many scientists changing research direction or going abroad to be able to continue their work. Some states like California and New York allocated substantial state and private funds in order to provide strong opportunities for scientists and to establish their state’s leadership in stem cell science.

The development of induced pluripotent stem (iPS) cells, as well as the use of adult stem cell sources such as cord blood, amniotic fluid, adipose tissue, and bone marrow have led to promising developments. Scientists have been able to do with adult stem cells many of the things they might have done with embryonic stem cells, while avoiding the controversial and divisive destruction of human embryos.

The power of high profile advocacy for stem cell science across the political spectrum



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Ronald and Nancy Reagan (Source: Wikimedia Commons)

Christopher Reeve (pictured above), well-recognized for his role in the popular Superman movies, later became quadriplegic as a result of a horseback riding accident. Subsequently,became an active advocate and spokesperson for embryonic stem cell research in the hopes that it might benefit him, as well as others with spinal cord injury.


Political conservative Nancy Reagan (pictured left with President Reagan) has advocated in favor of embryonic stem cell science to address Alzheimer’s disease, which afflicted her late husband, former President Ronald Reagan.

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Embryo research during President Barack Obama's administration (2009- )


In 2009, just two months into his term, President Barack Obama lifted the ban on federal funding of newly created lines, as long as the embryos used were not created specifically for the purpose of conducting research on them and ethical guidelines developed by the NIH were followed (Obama 2009). Human embryonic stem cell lines produced with non-federal funding, if following strict ethical NIH guidelines, were added to a list of “approved” stem cell lines that could be eligible for federal funding.

President Obama signed an order reversing the Bush administration's strict limits on human embryonic stem cell research.
(See the New York Times Topics - Stem Cells)

In 2009, a few weeks after the new NIH guidelines went into effect, a group of plaintiffs that included two adult stem cell researchers (James Sherley and Theresa Deisher), an embryo adoption agency, and actual embryos, filed a lawsuit against the Department of Health and Human Services and the NIH, insisting that federal funding of human ESC research is in violation of the Dickey-Wicker Amendment (contradicting Harriet Rabb’s interpretation of a decade earlier). The case was initially dismissed by Chief Judge Royce Lamberth, but after an appeal, his ruling was reversed and the case was sent back to him for reconsideration regarding the competitive standing of Sherley and Deisher. (Vogel and Couzin-Frankel 2011).

Judge Lamberth's judicial actions


After reviewing the case in August of 2010, Chief Judge Lamberth instituted a temporary injunction blocking government funding of hESC research, arguing that Rabb’s logic was faulty. This returned the policy to its “status quo” while the case was to be decided in full.

With the Lamberth ruling, the NIH scrambled to put on hold new grants and renewals while struggling to fund all existing human embryonic stem cell research it supported, waiting for the Justice Department to appeal the ruling.

In September of 2010, after having been denied by the court a motion to stay the preliminary injunction, the Department of Justice filed an emergency motion with the Court of Appeals again to stay the injunction (United-States-Court-of-Appeals-for-the-DC-Circuit 2010). The Washington DC Appellate Court then blocked the temporary injunction of Judge Lamberth which has allowed funding of hESC research to continue in the interim, following the guidelines developed by the NIH.
Chief Judge of the US District Court Royce LamberthChief Judge of the US District Court Royce Lamberth


In what may be the final word, at least as of 2011, Judge Lamberth, on July 27th, issued a ruling that the US government can continue funding embryonic stem cell research. This decision threw out the 2009 lawsuit by researchers Sherley and Deisher that had challenged President Obama’s expansion of funding. The Judge’s latest decision came after the D.C. Circuit of Appeals removed his temporary injunction of such grants.

Lamberth stated in his opinion that the Appeals Court decision “constrains this court” which compelled him to dismiss the researchers’ challenge. Importantly, the Judge ruled that allowing federal funding for research using stem cells created using private funds is not a violation of the Dickey-Wicker Amendment because such research is not “research in which a human embryo or embryos are destroyed” (Bohan, 2011).

Click here to download the Lamberth Ruling (via nature.com).

Scientists involved in embryonic stem cell research applauded Lamberth’s ruling. “We clearly think it’s the right decision,” said Dr. Jonathan Thomas of the California Institute for Regenerative Medicine. “It will now lift the cloud that’s been hanging over researchers around the country” (Bohan, 2011)

The Lamberth ruling is a big relief for many scientists who have been anxious about their NIH funding. For the 2011 fiscal year, the NIH estimated that $358 million of its budget would go toward human non-embryonic stem cell research and $126 million would go toward human embryonic stem cell research (http://www.aaas.org/spp/cstc/briefs/stemcells).

But Dr. David Prentice, a senior fellow for Life Sciences at the conservative Family Research Council, called the Lamberth July 2011 ruling “unfortunate,” saying that it allowed “the flow of taxpayer funds to continue for this unethical, scientifically unworthy embryonic stem cell research.” He added that it was also a “sad day for patients, because it is not embryonic stem cells, but only adult stem cells that are currently treating patients and offering real hope for the future.” (Bohan, 2011)


Informal Online Poll Results (Phillips, 2010)


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Source: biotech.about.com Online Poll



Conclusion

As of July 27, 2011, it seems a final legal decision about federal funding of human embryonic stem cell research has been announced. Before the ruling, researchers, particularly new researchers, had been in legal limbo, unsure of whether to submit grant applications to the NIH using hESC. There now seems to be some stability in hESC federal funding. Some states including Massachusetts, New York, and California that are continuing to support hESC research at high levels, with the election of a more conservative Congress, the future of hESC support on a federal level would once again remain uncertain.

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References

  • Annas G (2010). Resurrection of a stem-cell funding barrier--Dickey-Wicker in court. NEJM Oct 28;363(18):1687-9.
  • Brock, D. W. (2010). "Creating Embryos for Use in Stem Cell Research." The Journal of Law, Medicine & Ethics38(2): 229-237.
  • Bush, G. W. (2001). "Remarks by the President on Stem-Cell Research." On-line], URL:http://www. whitehouse. gov/news/releases/2001/08/20010809-2. html.
  • Bush, P. G. (2001). "President Bush announces funding for limited embryonic stem cell research." (August 9).
  • Congress. (2007). "Roger Wicker.", from http://www.opencongress.org/wiki/Roger_Wicker.
  • Dunn, K. (2005). "Public Broadcasting System " NOVA: The Politics of Stem Cells. Retrieved February 15, 2011, from http://www.pbs.org/wgbh/nova/body/stem-cells-politics.html.
  • Loike, J. and R. Fischbach (2009). "Benefits of the stem cell ban." The ScientistJune 8th 2009.
  • Marshall, E. (1999). "Ruling may free NIH to fund stem cells studies." Science283(5401): 465, 467.
  • Obama, P. B. (2009). "Removing Barriers to Responsible Scientiic Research Involving Human Stem Cells." Ececutive ORder No. 13,535. Federal Register 74. 11 March.
  • Rabb, H. S. (1999). "Federal Funding for Research Involving Human Pluripotent Stem Cells." DEPARTMENT OF HEALTH &. HUMAN SERVICES: The General Counsel.
  • Robertson, J. A. (2010). "Embryo stem cell research: ten years of controversy." The Journal of Law, Medicine & Ethics38(2): 191-203.
  • The-Washington-post. (2005). "Stem Cell Legislation in the US by State." from http://www.washingtonpost.com/wp-dyn/content/custom/2005/08/12/CU2005081200827.html.
  • United-States-Court-of-Appeals-for-the-DC-Circuit. (2010). "Defendants' Emergency Motion to Stay Preliminary Injunction Pending Appeal and Request for Immediate Administrative Stay. 8 Sep.." United States Court of Appeals for the DC Circuit, from http://www.nih.gov/about/director/stemcell/stay_09082010.pdf
  • Vogel, G. and J. Couzin-Frankel (2011). "Science and the law. With stem cells in court, a history primer."
  • Wilberforce, W., C. Forsythe, et al. (2011). "Personhood: Prudential, Political, and legal objections." Personhood: A Pragmatic Guide to Prolife Victory in the 21st Century and the Return to First Principles in Politics: 81.



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