StemCell Therapy

The legal battle began in 1973 when the Supreme Court ruled in Roe v. Wade that a fetus in the mothers 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 mothers 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 mothers uterus.

Courts recently entered the debate to address assertions that federal funding of hESC research is in violation of the Dickey-Wicker Amendment. Return to Top

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. Return to Top

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.

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:

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 hESCs would be in violation of the Dickey-Wicker amendment.

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 Lotts term. Wicker is also known for the appropriations bill, the Dickey-Wicker Amendment, which he co-sponsored while representing Mississippis conservative 1st congressional district (1995 to 2007) prior to his Senate post (Congress 2007).

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 womans 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.

President George W. Bush adopted a more conservative variation of Harriet Rabbs 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 Bushs 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 states 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.

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

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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 Rabbs 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).

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.

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 Obamas expansion of funding. The Judges 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 Lamberths ruling. We clearly think its the right decision, said Dr. Jonathan Thomas of the California Institute for Regenerative Medicine. It will now lift the cloud thats 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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stemcellbioethics - Legal and Political History of Stem ...

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