National Catholic Bioethics Center
 

WASHINGTON INSIDER
Winter 2007


 

 

Washington Insider
William L. Saunders, Jr.
Director and Senior Fellow
Center for Human Life and Bioethics
Family Research Council
Washington, D.C.
 

National Developments

President’s Council on Bioethics
 
At the first meeting of the President’s Council on Bioethics on January 17, 2002, I made a public statement suggesting that the council hold its meetings outside Washington, D.C. It was my belief that, in addition to providing guidance to national policy makers, a chief purpose of the council should be to engage in a public conversation with the American people about bioethics issues. I believe that discussions often buried in the Washington media would find an interested audience outside the beltway and in local media. Unless the public is educated on bioethics issues, I do not see how it will be possible to muster the public will to resist unethical research.
 
Consequently, I particularly welcomed the holding, five years later, of the council’s first meeting outside of Washington, when it convened on September 6 and 7 in Chapel Hill, North Carolina. Among items on its agenda was discussion of its draft white paper on the determination of death. The question of when death occurs (and can be measured) is vital for the consideration of end-of-life issues. The commonly accepted criterion is cessation of brain function, or “brain death.” However, there are questions concerning whether this is adequate, particularly when transplantation of a patient’s organs is being contemplated. The council expects to issue the final version of its report in the next few months.
 
The council also devoted substantial time to discussion of “the crisis in the ethics and profession of medicine.” When fashioning, or judging, a health care system, it is important to consider the nature of the doctor’s moral obligation to the patient who has placed his trust in him, as well as the moral obligation of society to the poor and the sick.
 
On its second day, presentations were made by Henk A. M. J. ten Have, M.D., of UNESCO and by Professor Richard Superfine of the University of North Carolina on nanotechnology (which is microscopic engineering that has many potential applications, and raises, in turn, many medical and ethical questions).1
 
Efforts to Overturn Federal Restrictions on Stem Cell Funding
 
Readers will recall from Richard Doerflinger’s last column and mine preceding it that the Congressional effort to overturn the President’s restrictions on federal funding of human embryonic stem cell research was thwarted when the President vetoed a bill making eligible for federal funding research using stem cells taken from embryos in IVF clinics (and destroying the embryos in the process). However, it remains unclear whether the President’s veto can be sustained in Congress. Opponents of the veto want to bring it before the Senate for a vote before it comes before the House. They believe they have sufficient votes (a two-thirds majority) to overturn the veto. They hope that if the Senate so votes, it will bring significant pressure on the House (where the President’s policy is more broadly supported) to do likewise. It is up to the majority party in each chamber of Congress, the Democrats in each case, to set the timing of such votes. To date, the timing has not been announced by the Democratic leadership. Doubtless, that timing will be influenced by considerations surrounding the 2008 Congressional and Presidential elections.
 
Further, Senator Tom Harkin, Democrat from Iowa, has attached an amendment to the appropriations bill to fund the Departments of Labor and of Health and Human Services. The amendment (to section 520 of Title V, General Provisions, of HHS) overturns the President’s restrictions by sleight of hand. While the President’s policy permits no federal funding of embryonic stem cell lines created after August 2001, Senator Harkin’s amendment would simply change that date, to June 2007. Thus, any stem cells lines (created, of course, by destroying embryonic human beings) produced in the past six years would be eligible for funding. As will be discussed below, it is unclear whether the bill to which the amendment is attached will be enacted in this Congress.
 
Effort to Revoke Pro-life Riders
 
As noted in my March column, the new Democratic congressional leadership has been seeking to overturn various pro-life riders that are attached, yearly, to appropriations bills. As this issue goes to press, the fate of such appropriations bills—and their pro-life riders—is uncertain. Congress must enact them by the end of September; otherwise, Congress will be forced to fund the government by “continuing resolutions.” Several of these bills have been amended in the Senate to remove or weaken the pro-life riders, in particular, the Foreign Operations appropriations bill, H.R. 2764, where traditional “Mexico City” restrictions on providing federal funds to organizations that promote or provide abortion are in danger.2 Since bills with stronger pro-life provisions have been passed by the House of Representatives, such Senate bills would have to go to House/Senate conference committees to resolve those differences. It is impossible to predict what might emerge. However, in any case, the President has stated he will veto any bills that remove pro-life riders. In letters to Democratic Congressional leaders, dated May 3, in response to a request from pro-life members of both houses of Congress,3 the President stated:
I am concerned that this year the Congress may consider legislation that could substantially change Federal policies and laws on abortion, and allow taxpayer dollars to be used for the destruction of human life. . . . As you know, current law prohibits Federal funding for abortion, both domestically and internationally, except in cases of rape, incest, or where the life of the mother is endangered. Recent legislative practice has ensured that taxpayer funds do not underwrite organizations that perform or promote abortion as a method of family planning. . . . I will veto any legislation that weakens current Federal policies and laws on abortion, or that encourages the destruction of human life at any stage.4
 
Related Presidential Acts
 
Two other actions of President Bush are particularly worthy of mention. First, in accordance with existing law permitting the withholding of funds from organizations involved in coercive abortion policies overseas (the “Kemp-Kasten amendment”), the President instructed the State Department to inform Congress that he would decline to spend the $34 million it had appropriated for the United Nations’ population fund, the UNFPA.5 Prior investigations had disclosed UNFPA’s involvement in coercive population control activities in China. This was the sixth successive year that the President refused to provide federal funds to UNFPA. Second, on September 7, the President proclaimed that September 24 would be National Family Day. His statement read in part, “Families are the cornerstone of our Nation. On Family Day, we underscore our dedication to strengthening America’s families and recognize the importance that the bonds between parents and children hold for the future of our country.”6
 
Alternatives to Embryo-Destructive Research—NIH Plan
 
On September 18, the National Institutes of Health announced its plan to implement the President’s executive order of June 20, 2007, on stem cell research.7 The plan will ask for grant applications proposing research on human pluripotent stem cells derived from non-embryonic sources, such as somatic cells or cells found in amniotic fluid. The plan also calls for aggressively pursuing an assessment of the feasibility of alternative sources (non-embryonic) of pluripotent stem cells, such as altered nuclear transfer, single-cell embryo biopsy, and dedifferentiation of somatic (body) cells. (See my column in the fall of 2006 for a discussion of these alternatives.) Under the plan, NIH will rename its stem cell registry the Human Pluripotent Stem Cell Registry.
 
State Developments

 
Missouri
As I reported in my last column, an important ballot initiative was defeated in Missouri last fall in a very close vote. Amendment 2, or the “Stem Cell Initiative,” as it was called, claimed to ban cloning while actually anchoring the right to clone human beings in the Missouri state constitution.
 
Also as I noted, Missourians who want to ban human cloning are determined to find ways to reverse Amendment 2. Many of them recently introduced a new initiative for a state constitutional amendment.8
 
The new amendment has not been without problems. In its first iteration a month ago, it defined a human being as one with forty-six chromosomes, inadvertently leaving persons with Down syndrome and other conditions without coverage and triggering a wave of criticism. It has been amended to avoid that mistake, and now bans attempts to clone “a human embryo at any stage, from the one-cell state onward.”
 
The new initiative is being criticized by some because it does not ban all human embryonic stem cell research.9 However, supporters of the initiative point out that it is not addressed to all stem-cell-related issues, but is, instead, focused on one particular issue (and the heart of Amendment 2)—human cloning. In order for the new amendment to be placed on next year’s ballot, supporters must gather signatures of 8 percent of voters in two-thirds of the state’s congressional districts.
 
California
 
California’s Institute for Regenerative Medicine appointed Alan Trounson, a scientist from Australia, to be its new president.10 The Institute was founded in 2004 as part of proposition 71, which amended the California constitution to provide funding for human embryonic stem cell research in response to the limitation placed by President George Bush on federal funding of such research. Although founded in 2004, the agency has been mired in controversy, in-fighting between staff and board, and litigation.11 It finally awarded its first grants this year. It is unlikely that the appointment of Trounson will still the controversy surrounding the institute. First, one of the companies Trounson founded, Embryonic Stem Cell International in Singapore, recently announced it was halting work on embryonic stem cell therapies because such research was not promising—“the likelihood of having products in the clinic in the short term was vanishingly small.”12 Second, Trounson is infamous for claiming to have successfully treated paralyzed rats with embryonic stem cells, enabling them to walk, when, in fact, the treatment had been with fetal stem cells.
 
In the face of all the problems surrounding the institute, some private foundations have stepped in to fund human embryonic stem cell research in California. For instance, the Eli and Edythe L. Broad Foundation announced a $20 million donation to UCLA for its stem cell research institute.13
 
In a potentially important development related to stem cell research in California, Shinya Yamanaka of Kyoto University is opening a laboratory at the J. David Gladstone Institutes, a nonprofit facility in Mission Bay, California, and an affiliate of the University of California–San Francisco.14 Dr. Yamanaka made international headlines when he published a paper in Nature in June showing how to “dedifferentiate” somatic cells of mice.15 (Note that dedifferentiation will be investigated under the new NIH plan; see above.) Upon the insertion of four genes, the cells reverted to the embryonic (pluripotent) state.
 
Several points should be noted. First, the technique currently has the risk of causing cancer. Twenty percent of the mice in Yamanaka’s study developed cancer. Further, the retrovirus used to transmit the genes remains after transmission and could itself cause cancer. As readers will know, the use of embryonic stem cells not created by dedifferentiation has not infrequently caused cancer in animal trials (the very “plasticity” of embryonic stem cells can cause uncontrollable growth, leading to tumors). That, in turn, points to the fact that this problem with embryonic stem cells has not been observed with adult stem cells, raising cautions about expectations for embryonic stem cell research and therapies. Still, the ethical significance of Yamanaka’s research is that it identifies a method for obtaining embryonic stem cells that does not require injuring or killing a human embryo.
 
Legal Development:
Plan B Litigation
 
 On April 12, 2007, the Family Research Council, Concerned Women for America, and the Association of American Physicians and Surgeons filed suit against the U.S. Food and Drug Administration. The suit argues that the FDA’s approval for the morning-after-pill, Plan B, to be sold both over-the-counter in the United States to women age seventeen and older and as a prescription drug to girls under age seventeen violates its rule-making authority. At present, the litigation is in the preliminary pleading stages, and the substantive arguments in the case have not been addressed by the court.
 
Foreign Developments:
Britain
 
 There have been important developments in Great Britain that should be of interest to readers of The National Catholic Bioethics Quarterly. In November 2006, two different groups of researchers in the United Kingdom applied to receive research licenses from the Human Fertilisation and Embryology Authority (HFEA) in order to undertake somatic cell nuclear transfer (SCNT) (i.e., cloning) experiments using nonhuman animal eggs. The HFEA, established in 1990 by the authority of the Human Fertilisation and Embryology Act, issues licenses for any research involving human embryos or artificial fertility. Although it was not entirely clear at the time whether the HFEA would have jurisdiction over hybrid research, the authority decided in January 2006 that such research fell within its purview, prior to the requests from the scientists.
 
The research in question would use enucleated nonhuman animal eggs as the medium in which to orchestrate human cloning. A problem has existed for scientists engaging in cloning experiments, because of the scarcity of and difficulty in obtaining human ova in light of the great numbers needed to pursue cloning research. The use of animal ova would take away the ethical and financial constraints presented in mass egg procurement from human women. At the same time, the cytoplasm of the egg contains some mitochondrial DNA, and so any SCNT procedure involving nonhuman eggs would result in nonhuman DNA being present in the clone. Proponents of the research claim that this DNA would be negligible, and thus the product would not be a true hybrid, but rather a “cybrid”—a hybrid derived from cytoplasmic genetic amalgamation.
 
The HFEA proceeded to gauge the public and scientific reaction to the possibility of human–animal hybrid research, undertaking a summer-long consultation. The consultation began with an initial report identifying relevant scientific and ethical factors. The HFEA distinguished between five kinds of hybrid research: cytoplasmic hybrid embryo research (the creation of cybrids), hybrid embryo research (the mixing of animal and human gametes), human chimera embryo research (human embryos with animal cells added to them in early development), animal chimera embryo research (animal embryos with human cells added), and transgenic human embryo research (human embryos with animal genes inserted into them during early development). Each form of research has its own inherent legal and regulatory hurdles in the United Kingdom, and the HFEA dealt primarily with the first sort. (Interestingly, there are also some jurisdictional uncertainties in what procedures the HFEA can and should consider for licensing. Animal chimera embryo research, for example, is under the purview of the Home Office pursuant to the Animals Act of 1986.)
 
Nevertheless, in its decision of September 5, the HFEA noted, “Throughout the consultation there was some questioning, mostly by members of the public, of the scientific worth of creating human-animal embryos. However, the scientific community appears to feel confident that the creation of cytoplasmic hybrids is an avenue of research worth exploring and, in particular, it could be a viable alternative to using human eggs, to investigate the mechanisms of creating patient matched embryonic stem cells.”16 The HFEA concluded, “Having looked at all the evidence the Authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research.”17 The result of this is that specific research teams seeking to engage in cybrid research will be allowed to under the supervision of the HFEA.
 
Concurrent with the HFEA consultation, a joint committee of Parliament published a report, in August, on the Human Tissue and Embryos (Draft) Bill, in which, among other things, it investigated the authority of the HFEA to license interspecies research.18 The Human Tissue and Embryos Bill is designed to update the 1990 Human Fertilisation and Embryology Act. The report is intended to guide the parliamentary debate in areas of tissue procurement and embryo research that are on the cutting edge and need to be addressed.
 
The most pressing questions addressed by the report are whether the HFEA and the Human Tissue Authority (HTA) ought to be merged into the Regulatory Authority for Tissue and Embryos (RATE), how both the HFEA and Parliament should respond to the prospect of animal–human hybrid research, the idea of “saviour siblings,” and whether or not the “need for a father” should be a valid criterion in assessing the possibility of assisted reproduction.
 
In terms of structural concerns, the joint committee found “the evidence against establishing RATE overwhelming and convincing and we recommend that the Government abandons the proposals in Part 1 of the draft Bill [merging HTA and HFEA into RATE].” (para. 92). This is a positive development, given that the regulatory union of human tissue and human embryos would prove problematic in its tacit implication that human embryos are comparable to human tissue (a problem addressed in paragraph 72 of the report). Nevertheless, the joint committee rejected the advice of some witnesses (including Professor John Haldane of the University of St. Andrews) that Parliament establish a national bioethics committee, through which to establish the basic ethical substrates necessary for informed regulatory action on the part of the regulatory agencies such as the HTA and HFEA, believing the prerogative of establishing ethical guidelines to fall within the purview of Parliament. (Nevertheless, the joint committee welcomed the formation of a joint bioethics committee in Parliament to advise members in advance of bioethical legislation [para. 48].)
 
After hearing from all sides on the matter of interspecies experimentation—from scientists eager to engage in the practice to representatives of the Church of England, the Roman Catholic bishops of England and Wales, and the Society for the Protection of Unborn Children19—the joint committee determined that the existing government regulations for interspecies experimentation “is misguided and rests on no sound point of principle.” They “recommend that the HFEA should be left to judge which entities may be created, kept and used for research purposes under licence” (para. 161). At issue in particular was the scope of the HFEA’s jurisdiction in interspecies research. It is unclear, for example, whether the HFEA has the power to grant licenses for “true” hybrid (as opposed to cybrid) research—that is, whether true hybrids are covered by the HFE Act of 1990 or the Animals Act of 1986. The joint committee found distinctions between hybrids and cybrids in the licensing authority of the HFEA to be arbitrary. Nevertheless, given the contentious nature of interspecies experimentation, the joint committee concluded that the question should be decided by the representatives of the people (as the question of embryo experimentation was in 1990 with the HFE Act), in a “free vote in both Houses” of Parliament (para.177).
 
The joint committee also considered the question of “saviour siblings.” The process of creating a “saviour sibling” involves creating a number of embryos, and then engaging in preimplantation genetic diagnoses to determine which of them is a sufficient genetic match for an already born child who suffers from a medical condition (such as sickle-cell anemia or various blood cancers). An embryo that proves to be an immunogenic match is then implanted in its mother’s womb and brought to term, with its umbilical cord blood used to treat its older sibling. The non-matching embryos are usually destroyed. The practice is already legal in England, but restricted to “life-threatening conditions.” The HFEA among others have disputed this criterion as “too restrictive,” seeking to allow the creation of savior siblings for “serious conditions.” The joint committee agreed with the HFEA that the standard should be relaxed to the merely “serious” instead of the “life-threatening” (para. 199).
 
Lastly, the joint committee looked at section 13(5) of the 1990 act that refers to the “need for a father” in assisted reproduction. The joint committee advises a free vote by Parliament on the matter, and recommends “amending” the “need for a father” clause with “need for a second parent” language (para. 243). The joint committee argues, “We have found persuasive the evidence presented to us that a loving, supportive family network is more important for a child’s development than the gender of the second parent” (para. 242).
 
The radical nature of this recommendation can be seen in the opposition it has received from the Church of England. The Bishop of Rochester, Rt. Rev. Michael Nazir-Ali has said, “In the past, the Government has itself declared that it is best for a child to have both a father and a mother. Why is it changing its stance now, at the precise moment when we are seeing all too starkly the consequences of fatherless families?”20
 
William L. Saunders, Jr.
Notes

 
1 Meeting transcripts are available at http://www.bioethics.gov/transcripts/transcriptdate. html.
 
2 In a statement, the Bush administration said in part, “The Administration strongly opposes this legislation because it includes provisions that are inconsistent with the Administration’s international family planning policy. . . . If the President were presented a bill such as H.R. 2764 that weakens current Federal policies and laws on abortion, he would veto the bill.” Statement by Executive Office of Management and Budget, September 6, 2007, on file with the author.
 
3 Letter from House members, dated March 30, 2007, stated in part, “As you know, there is a long-standing tradition of including language in appropriations bills to prevent taxpayer money from being used to fund things objectionable to pro-life Americans. . . . We believe that this tradition should be continued and urge you to commit publicly to veto any appropriations bill that weakens taxpayer protections in his regard. We will vote to sustain any such veto.” The Senate letter, dated February 1, was to the same effect. Both letters on file with the author.
 
4 Letters on file with the author; also available at http://www.nrlc.org/press_releases_new/ Release050307.html.
 
5 “U.S., Citing Abortion in China, Again Withholds Funding from U.N. Group,” Associated Press, September 7, 2007.
 
6 Statement on file with the author; also available at http://www.whitehouse.gov/news/ releases/2007/09/20070920-6.html.
 
7 The statement is available at http://stemcells.nih.gov/policy/091907eo.htm, and the plan itself is available at http://stemcells.nih.gov/staticresources/policy/eo13435.pdf.
 
8 Kit Wagar, “Hope Rises for Rollback of Stem-Cell Research Initiative,” Kansas City Star, September 14, 2007, http://www.kansascity.com/news/politics/story/276125.html.
 
9 Matt Franck, “Stem Cell Foes Dual over the Definition of ‘Human Life,’” on Political Fix blog, entry posted August 27, 2007, www.stltoday.com/blogs/news-politicalfix/2007/08/ stem-cell-foes-dual-over-the-definition-of-human-life/.
 
10 Paul Elias, “California’s $3 Billion Stem Cell Agency Names New Chief,” Associated Press, September 14, 2007, http://www.nytimes.com/2007/09/15/health/15stem.html.
 
11 Jacob Goldstein, “Billion-Dollar Stem Cell Institute Can’t Find a Chief,” Wall Street Journal, August 9, 2007.
 
12 Dennis Normile, “Singapore Firm Abandons Plans for Stem Cell Therapies,” Science 317.5836 (July 20, 2007): 305.
 
13 Gretchen Vogel and Constance Holden, “Stem Cell Funding Plans,” Science 317.5844 (September 14, 2007): 1483.
 
14 Mary Anne Ostrom, “S.F. Lab for Stem-Cell Pioneer,” San Jose Mercury News, August 17, 2007, http://www.mercurynews.com/business/ci_6646957.
 
15 K. Okita, T. Ichisaka, S. Yamanaka, “Generation of Germline-Competent Induced Pluripotent Stem Cells,” Nature 448.7151 (July 19, 2007: 313–317.
 
16 Helen Coath, “Hybrids and Chimeras: Findings of the Consultation,” Human Fertilisation and Embryology Authority (HFEA, U.K.), September 5, 2007, para. 7.3, http://www.hfea.gov.uk/ docs/2007-09-05_Authority_Paper_Hybrids_and_Chimeras__Findings_of_the_Consultation_ 396.pdf.
 
17 “HFEA Statement on Its Decision regarding Hybrid Embryos,” HFEA press release, September 5, 2007, http://www.hfea.gov.uk/en/1581.html.
 
18 House of Lords / House of Commons (U.K.), “Joint Committee on the Human Tissue and Embryos (Draft) Bill—First Report,” Session 2006–2007 (London: U.K. Department of Health, May 17, 2007), http://www.publications.parliament.uk/pa/jt200607/jtselect/jtembryos/169/ 16902.htm.
 
19 The Catholic bishops stated in part, “At the very least, embryos with a preponderance of human genes should be assumed to be embryonic human beings, and should be treated accordingly. In particular, it should not be a crime to transfer them, or other human embryos, to the body of the woman providing the ovum, in cases where a human ovum has been used to create them.” See Jonathan Petre, “Chimera Embryos Have Right to Life, Say Bishops,” Daily Telegraph (U.K.), June 27, 2007, http://www.telegraph.co.uk/news/main.jhtml?xml=/ news/2007/06/26/nchimera126.xml.
 
20 Laura Donnelly, “Fathers ‘No Longer Needed for IVF,’” Daily Telegraph (U.K.), September 10, 2007, http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/09/ nivf109.xml.
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