National Catholic Bioethics Center
 

WASHINGTON INSIDER
Spring 2007


 

 

Richard M. Doerflinger
 
Deputy Director
 
Secretariat for Pro-Life Activities
 
United States Conference of Catholic Bishops
 
Washington, D.C.


 
       At this writing, the 110th Congress has begun its first (2007) session with a new Democratic leadership, and a membership less committed to defending unborn human life. Even with Republicans in the majority in both the House and Senate, however, 2006 featured many impasses and few clear victories on fundamental bioethics issues.
 
       While supporters of human embryo cloning and embryonic stem cell research still failed to demonstrate the utility or clinical benefit of such ethical abuses, their poorly grounded claims of future “miracle cures” wielded great influence in the political sphere, both nationally and in key states. This was illustrated in November by Missouri voters’ narrow approval of Amendment 2, an initiative promoted by an extremely well-funded campaign that centered on the (very unlikely) prospect of “life-saving cures” using embryonic stem cells. The initiative’s actual effect is to create a state constitutional right for researchers to engage in human cloning for purposes of stem cell research.
 
       It seems the political drive for biomedical research without moral limits will continue along this course in 2007, promising miracles while often dismissing or disregarding the actual evidence arising from such research.
 

2006 in Congress:
Impasse and Limited Progress


 
       In 2006, Congress’s most visible bioethics debate was on federal funding for human embryonic stem cell research. Both the Senate and the House approved a bill to fund research using stem cells from newly destroyed “spare” human embryos from fertility clinics (H.R. 810, Stem Cell Research Enhancement Act). President Bush rejected the proposal, wielding the first veto of his career, and the House fell fifty votes short of overriding his veto.
 
       This legislation was considered and approved by the Senate as part of a package of three bills on July 18, 2006. Approved that day by unanimous 100-to-0 votes were a bill to promote alternative ways to derive very versatile or “pluripotent” stem cells without harming human embryos (S. 2754, Alternative Pluripotent Stem Cell Therapies Enhancement Act), and a bill to prevent researchers from deliberately gestating or “farming” unborn children to obtain their stem cells or other tissues (S. 3504, Fetus Farming Prohibition Act). These two bills, supported by the U.S. Conference of Catholic Bishops and other pro-life groups, were considered by the House under a “suspension of the rules” that allows no amendments but requires two-thirds support. The House unanimously approved the fetus farming bill, but its vote of 273 to 154 in favor of the “alternative stem cells” bill fell short of the required margin. This was due to a last-minute attack on the bill by House sponsors of the embryonic stem cell funding bill, who evidently feared competition from research avenues that do not require destroying embryos. I observed then that:
This latest attack on other ways to pursue stem-cell research reveals a new and more intolerant side to the ideology of the embryonic-stem-cell campaign. Now it is not enough to include embryo destruction in the category of acceptable biomedical research—one must wed oneself to embryo destruction, forsaking all other avenues. One must insist that stem-cell research must not move forward to advance knowledge or treat diseases unless it involves destroying human life. This is a dark and narrow vision of science that sets it directly at odds with morality and common sense. In the end, it is as antiscience as it is anti-life.1
       Thus, the only new federal legislation enacted on stem cell research in 2006 (the “fetus farming” prohibition, now Public Law 109-242) was an initiative by the pro-life movement—just as the only such legislation enacted in 2005, establishing a nationwide umbilical cord blood stem cell bank (the Stem Cell Therapeutic and Research Act, now Public Law 109-129), was also strongly supported by the Catholic bishops and other pro-life groups.
 
       Another modest victory for the morally responsible use of biotechnology came at the very end of the year, when Congress approved the Office of National Drug Control Policy Reauthorization Act (H.R. 6344, now Public Law 109-469). This legislation was approved by both House and Senate without significant dissent, and was signed into law by President Bush on December 29. Title VII of the legislation, which gives the U.S. Anti-Doping Agency responsibility for ensuring that U.S. athletes competing in the Olympic Games do not use “performance- enhancing drugs” such as steroids, also requires the agency to help prevent use of “performanceenhancing genetic modifications accomplished through gene-doping.” The agency is further instructed to “permanently include ‘gene doping’ among any list of prohibited substances” that it adopts. The law defines “gene doping” as “the nontherapeutic use of cells, genes, genetic elements, or of the modulation of gene expression, having the capacity to enhance athletic performance.” This may be the first federal legislation ever to require that limits be placed on human germ-line genetic engineering.
 

Senate Hearing on Misrepresentations
in Stem Cell Research


 
       The previous “Washington Insider” noted the controversy over an article published online by Nature on August 23.2 In the article and related press releases, Robert Lanza and his colleagues at Advanced Cell Technology in Massachusetts claimed that they had derived human embryonic stem cell lines, using single cells obtained from eight-celled embryos without harming them. It soon came to light that they had misrepresented their study—in fact, they had obtained four to seven cells from each embryo, destroying the embryos, and then cultured all the cells from each embryo closely together to mimic the cell-to-cell interactions that promote healthy growth and differentiation in the intact embryo.3
 
       These facts rebutted early claims that the study would easily lead to the production of stem cell lines using the single, isolated cells sometimes obtained from early embryos for preimplantation genetic diagnosis (PGD). In fact, another study published about the same time, which received far less attention, reported a complete failure to develop cell lines even when two cells are retrieved from each embryo— and these researchers concluded that the cells of early human embryos may be “social” cells that require ongoing interaction with each other to develop normally.4        On September 6, Robert Lanza and his study became the subject of a contentious hearing held by congressional supporters of embryonic stem cell research. Senator Arlen Specter (R-PA), chairman of the Appropriations Subcommittee for Labor, Health and Human Services and Education, and Senator Tom Harkin (D-IA), ranking minority member of the subcommittee, heard testimony from Dr. Lanza as well as his company’s top ethics advisor, Prof. Ronald Green, but “repeatedly interrupted and scolded Lanza” for damaging the reputation of stem cell researchers. Specter said Lanza’s misrepresentations had given the political agenda in favor of embryonic stem cell research “a big black eye,” while Harkin stated more generally that the stem cell field “has been hyped too much. We need to come back to Earth.” 5 Unfortunately, these charges centered chiefly on Lanza’s most recent study, and did not give due attention to the ways in which the entire political drive to destroy embryos for stem cell research has relied on exaggerated and deceptive claims.6 As will be seen, most members of Congress have yet to learn any lasting lessons on this point.
 

Opening Battle of 2007

       The new Democratic leadership of the House of Representatives wasted no time in reopening the stem cell research debate. As part of the House’s first “one hundred hours” of whirlwind legislative activity, Speaker Nancy Pelosi (D-CA) announced that last year’s legislation to expand embryonic stem cell research would be brought up immediately, without committee hearings or an opportunity for amendments. The new bill, introduced as H.R. 3, is identical to last year’s H.R. 810 except that Democrat Diana DeGette (D-CO) took over prime sponsorship from her longtime ally Mike Castle (R-DE). Total co-sponsors increased to 217 (compared to 200 for last year’s bill).
 
       Unexpectedly, however, a scientific study published a few days before the House vote received widespread media attention and enlivened the debate. Researchers at Wake Forest University School of Medicine in North Carolina and Children’s Hospital in Boston announced that they had isolated an easily cultured stem cell in amniotic fluid with “pluripotent” flexibility and therapeutic potential. Especially significant was the cells’ apparent ability to produce a wide variety of functional cell types, without the tendency toward tumor formation that has plagued animal trials using derivatives from embryonic stem cells.7 Thus, they may have the key advantages of embryonic stem cells without the disadvantages that have made those cells too dangerous for human trials.8 In light of the imminent congressional vote, many news reports highlighted the ethical and political implications of this breakthrough. The Los Angeles Times, for example, noted, “The finding points to a promising avenue of research that sidesteps the hurdles facing embryonic stem cell research, which has been hampered by moral objections to the destruction of embryos that occurs when the cells are harvested.” 9
 
       Catholic officials welcomed the study. Calling it “a very significant and ethically admissible advance,” Javier Cardinal Lozano Barragán of the Pontifical Council for Health Pastoral Care commented, “The Church is not obscurantist and is always ready to welcome real scientific progress that neither threatens nor manipulates the sources of life.”10 Speaking for the U.S. Conference of Catholic Bishops, I emphasized that this “is one in a line of studies showing very versatile stem cells can be obtained from a number of different products after live birth—amniotic membrane, amniotic fluid, cord blood, placenta, even umbilical cord tissue.” 11 It is especially ironic that the “frozen embryos,” so eagerly sought by researchers as sources of research material, may not only be more appropriately treated, but may even provide a better source of stem cells if they are simply allowed to be born alive.
 
       The new amniotic stem cell study and other alternative routes to stem cell research featured prominently in the House debate. Supporters of H.R. 3 responded by enlisting scientists to dismiss or belittle the study. The Juvenile Diabetes Research Foundation, which provided funding for the laboratory that conducted this study, even persuaded chief author Anthony Atala to write to the bill’s sponsors assuring them of his support for embryonic stem cell research—and then widely distributed his letter to members of Congress and posted it on the Web site of the Biotechnology Industry Organization without his knowledge or permission.12 Coming forward to declare that amniotic stem cells “may not do as many tricks” as the embryonic variety was none other than Dr. Robert Lanza, whose disregard for accurate reporting in this field earned him such opprobrium from the bill’s supporters only four months before. Another critic of the study was Dr. Lawrence Goldstein, who questioned whether any cell that does not spontaneously create tumors could really be “pluripotent.” 13 His bizarre message seemed to be that embryonic stem cells are uniquely promising for human treatments because they cause tumors.
 
       Three prominent scientists helping H.R. 3’s supporters to dismiss alternative avenues and promote the legislation—Lanza himself, and Kevin Eggan and George Daley of Harvard—also believe that for some purposes, stem cells from so-called “spare” embryos (the subject of H.R. 3) are no substitute for the tailor-made stem cells that may someday be obtained from cloned human embryos. All three are pursuing research to make human cloning possible. The easy slide from the agenda of H.R. 3 to human cloning was dramatized when, as part of a “motion to recommit” (the only procedural option allowed to those wanting to send the bill back to committee for changes), opponents sought to add language to H.R. 3 to prevent its grant money from going to entities that also use stem cells from cloned human embryos. The amendment was denounced by supporters as a threat to especially promising research, and defeated 189 to 238.
 
       The increased attention to new advances in non-embryonic stem cells, while refreshing, seemed to have a limited immediate effect on voting behavior. The House approved H.R. 3 by a vote of 253 to 174—showing more support for the bill than last July, when a veto override attempt failed on a vote of 235 to 193, though still falling twenty-five votes short of the two-thirds majority needed to override the threatened presidential veto. Only eleven changes of votes were attributable to membership changes from the elections, with the rest due to absentees and to a small number of returning members who changed their position. Remarkably, four new Democratic members voted against H.R. 3. It seems the 110th Congress, like the 109th, may see a good deal of gridlock over this issue.
 
       Also reintroduced during the debate on H.R. 3, but not allowed to come up for a vote, was a new version of the Alternative Pluripotent Stem Cell Therapies Enhancement Act discussed above. The sponsors, Reps. Roscoe Bartlett (R-MD) and Phil Gingrey (R-GA), said they would work for congressional passage of this bill, H.R. 322, after President Bush vetoes H.R. 3. At this writing it was also rumored that the President may issue an executive order to promote federal funding of such alternative research.
 

Genetic Nondiscrimination Bill
May See Action


 
       A bioethics measure that has languished in the House for years may well pass in the 110th Congress. This is the Genetic Information Nondiscrimination Act (109th Congress, S. 306 and H.R. 1227), designed to prevent discrimination against individuals and families by employers and health insurance companies based on the results of genetic testing. The bill was approved unanimously by the Senate in 2005 but not taken up in the House (reportedly because of opposition from businesses concerned about increased costs). The bill is widely supported by Democratic members of Congress and may be approved this year.
 
       One very unfortunate and apparently unintentional loophole in the bill has been that it does not seem to address discrimination against families based on the preimplantation or prenatal genetic testing of their child. The bill prevents discrimination against an individual based on the results of genetic testing of the individual or a “family member” of the individual; but “family member” is defined to include “a child who is born to or placed for adoption with the individual,” apparently excluding the child not yet born.14 This is especially frustrating because even groups supporting “abortion rights,” such as the American Civil Liberties Union, when testifying before Congress, had cited an alleged case of such discrimination based on prenatal testing among the examples illustrating the need for such federal legislation.15 When the bill was debated and approved by the Senate in 2005, supporters disclaimed any intention of excluding such situations and promised that the bill’s scope would be clarified in a final conference report.16 However, because of the House’s inaction, that report was never written.
 
       The current dilemma is that a new Congress more likely to take up and address the issue of genetic discrimination may also be more likely to disregard the status of the unborn child as a family member—even if that means allowing unjust discrimination against the parents who want to deliver and raise that child. Those concerned about the use and misuse of rapidly developing genetic technologies should hope that common sense and fairness will prevail.
 

Notes

1 Richard M. Doerflinger, “Anti-Life, Anti-Science: A Castle of Confusion,” National Review Online, July 19, 2006, http://article.nationalreview.com/?q=ZGE1Zjc4YjljY Tc2YjI2ZTQzOGQ4YmI1ZGYzZGE3ZWM=.
 
2 William L. Saunders, Jr., “Washington Insider,” National Catholic Bioethics Quarterly 6.4 (Winter 2006): 629–636.
 
3 I. Klimanskaya et al., “Human Embryonic Stem Cell Lines Derived from Single Blastomeres,” Nature 444.7118 (November 23, 2006): 481–485, www.nature.com/nature/ journal/v444/n7118/abs/nature05142.html. This corrected print version differs markedly from the version originally published online August 23 with much fanfare. The changes are described in an addendum on p. 512, www.nature.com/nature/journal/v444/n7118/full/ nature 05366.html.
 
4 C. Y. Fong, M. Richards, and A. Bongso, “Unsuccessful Derivation of Human Embryonic Stem Cell Lines from Pairs of Human Blastomeres,” Reproductive Biomedicine Online 13.2 (August 2006): 295–300, abstract at http://lib.bioinfo.pl/pmid:16895649.
 
5 Rick Weiss, “Senators Denounce Scientist’s Stem Cell Claims,” Washington Post, September 7, 2006, A4, www.washingtonpost.com/wp-dyn/content/article/2006/09/06/ AR2006090601749.html?nav=rss_technology.
 
6 For a brief overview of this problem, see Richard Doerflinger, “The Problem of Deception in Stem Cell Research,” remarks at the International Congress “Stem Cells: What Future for Therapy?” Rome, September 15, 2006, http://www.usccb.org/prolife/issues/ bioethic/RDRome91506speech.pdf. An older but more fully documented account can be found in Doerflinger, “Human Cloning and Embryonic Stem Cell Research after Seoul: Examining Exploitation, Fraud, and Ethical Problems in Research,” testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources, House Committee on Government Reform, March 7, 2006, www.usccb.org/prolife/issues/ bioethic/cloning/test2006a.shtml; reprinted in National Catholic Bioethics Quarterly 6.2 (Summer 2006): 339–350.
 
7 P. De Coppi et al., “Isolation of Amniotic Stem Cell Lines with Potential for Therapy,” Nature Biotechnology 25.1 (January 2007): 100–106, published online January 7, 2007, www.nature.com/nbt/journal/v25/n1/abs/nbt1274.html.
 
8 See Rick Weiss, “Scientists See Potential in Amniotic Stem Cells,” The Washington Post, January 8, 2007, A1 and A5, www.washingtonpost.com/wp-dyn/content/article/ 2007/01/07/AR2007010700674.html.
 
9 Karen Kaplan, “Stem Cells in Amniotic Fluid Show Promise,” Los Angeles Times, January 8, 2007, www.latimes.com/news/science/la-sci-stemcells8jan08,0,1519192,full .story.
 
10“Vatican Welcomes New Stem Cell Advance,” Reuters News Service, January 9, 2007, http://today.reuters.com/ news/articlenews.aspx?type=topNews&storyID=2007-01- 09T140843Z_01_L0948679_RTRUKOC_0_US-VATICAN-STEMCELLS.xml& WTmodLoc=NewsHome-C1-topNews-9.
 
11 Carl T. Hall, “Amniotic Fluid a Promising Stem Cell Source: Political Resistance to Using Embryos Drives Research,” San Francisco Chronicle, January 8, 2006, A1, www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/01/08/ MNG4PNENI31.DTL.
 
12 See Catherine Clabby, “Stem-cell Pioneer Encourages More Research,” Monterey County Herald, January 13, 2007, www.montereyherald.com/mld/montereyherald/living/ health/16452824.htm.
 
13 Kaplan, “Stem Cells.”
 
14 Genetic Information Nondiscrimination Act, sec. 201(3)(b) (emphasis added).
 
15 “Indeed, consider further the pregnant woman whose fetus tested positive for cystic fibrosis and whose managed-care health plan limited coverage for her pregnancy and future child while offering full coverage should she choose an abortion.” Jeremy Gruber, ACLU Legal Director, “Testimony Presented to the Senate Labor and Human Resources Committee,” May 21, 1998, www.workrights.org/issue_genetic/gd_house_testimony.html.
 
16 Remarks of Senators Mike Enzi (R-WY) and Tom Coburn (R-OK), 109th Cong. 1st sess., Cong. Rec. 151 (February 16, 2005), S1480.
 

6399 Drexel Road, Philadelphia, PA 19151 | TEL: (215) 877-2660 | FAX: (215) 877-2688
ABOUT | NEWS | PUBLICATIONS | MEMBERSHIP | EDUCATION | CONSULTATION | CONTACT | STORE