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WASHINGTON INSIDER
Autumn 2004
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President's Council on Bioethics:
Reproduction and Responsibility
As reported in the previous installment of this column, the terms of two members
of this federal advisory council were allowed to expire without renewal this
year, and three new members joined the President's Council on Bioethics in March
2004 who might better appreciate ethical arguments against human cloning and
embryo research. Ironically, the council has completed its study of these issues for
the time being, and is turning to issues involving the neurosciences as well as end-oflife
care.
The final report to be voted on by the council's original membership was issued
at the end of March. Titled Reproduction & Responsibility, it discusses ways
in which new technologies applied to human reproduction may endanger the dignity
of human procreation and the well-being of the children who result.1
The report is groundbreaking, in that it provides the first sustained critique of
the largely unregulated U.S. "fertility industry" by any government body since the
first baby conceived by in vitro fertilization (IVF) was born in 1978. While Congress
did enact a federal law in 1992 encouraging some kinds of reporting by clinics
performing IVF, it established only a voluntary registry with no real enforcement or
independent-review mechanism, and it failed to address many areas of concern
altogether.2
Need for Effective Regulation
The need for more effective regulation has become obvious from the growing
evidence of an increased rate of birth defects among children conceived by IVF—
especially among those conceived by intracytoplasmic sperm injection (ICSI), a
procedure which bypasses all the natural safeguards against defective sperm by
injecting a sperm directly into an egg in the laboratory.3 It has also become apparent
that professional associations in this field, such as the American Society for Reproductive
Medicine (ASRM), are unable or unwilling to provide effective policing
against abuses.
On this latter point, damning evidence was provided to the President's Council
by Professor George Annas of Boston University, who testified about his experience
as a member of ASRM's ethics committee when it was chaired by Kenneth
Ryan, M.D., in the 1990s:
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On year three, which I think was around 1995, when we had on the agenda
things like postmenopausal pregnancies, using fetal ova to try to create a pregnancy.
On the committee that's one of the few things the committee said should
never be done, which is great, and disposition of embryos, et cetera. All of these
issues were on our committee.
And before that committee or just as that committee meeting started, I asked
the chairman if I could summarize what I thought the committee's operating
assumptions were, and here's what I said, and I thought this was an insightful
critique. I said: here's our operating assumptions.
Number one, the ethical acceptability of new reproductive technologies is
to be assumed, and the burden of proof is on anyone who would question a new
technology to show how its use is unethical.
Number two, the use of a new technology cannot be declared unethical if
there are any possible ethical applications of that technology no matter how
hypothetical.
Number three, it is assumed that imagined new technologies will ultimately
work and will prove beneficial, and that any imagined harm from the technology
expected can be controlled unless proven otherwise.
And number four, the major values to be taken into account in evaluating
new reproductive technologies are economic—efficiency, supply, and cost—
and not ethical.
Now, I thought this was a critique, and so I was a little surprised when
Chairman Ryan turned to me and said, "George, well, of course that's exactly
right. That is how we operate and are operating. That is our operating assumptions,"
and indeed, they were.4
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The council's own initial recommendations for increased regulation of this
industry were watered down between first draft and final report, due in part to a
lobbying campaign by industry representatives and by advocacy groups representing
fertility patients. Knowing what they knew about the ethical principles guiding
the ASRM, council members should have been embarrassed, not pleased, at the
generally favorable reaction their final report received from this and other industry
groups.5
The final report does call for increased self-regulation by the industry, federally
funded studies of the long-term health of women and children involved in reproductive
technologies, and improvements in the 1992 federal law on reporting by
fertility clinics.
Missing from the council's recommendation regarding the 1992 law is any
requirement that clinics report what percentage of human embryos they conceive
actually survive to live birth. The current law reports "success" in terms of the
percentage of treated reproductive cycles that result in live birth—an approach that
may actually encourage the irresponsible transfer of many embryos to the mother's
womb in each cycle to achieve "success."
The President's Council recommends only that the law be amended to require
that clinics also report what percentage of "patients" achieve success, which fails to
address this problem.6 Here as elsewhere, the council members' failure to agree
that the human embryo has rights or interests of his or her own blocked stronger
conclusions.
Targeted Legislative Measures
The council also recommended "targeted legislative measures" designed to
protect the dignity of the human species, maintain respect for women, preserve the
dignity of procreation, and show some respect for nascent human life. Here, too, the
council proposed some groundbreaking public-policy initiatives, but members' divisions
on the moral status of the embryo also produced disappointments.
The consensus recommendations include legislative bans on transferring a
human embryo into the body of any member of a nonhuman species, on producing
human-animal hybrid embryos by combining human and animal gametes, on transferring
a laboratory-produced human embryo to a woman's womb for any purpose
other than an attempt at live birth, and on buying, selling, or patenting human embryos.7
Some of these proposals are especially timely. For example, a federal ban on
patenting human embryos was passed by Congress last year as an amendment to
the annual Commerce/Justice/State appropriations bill and will soon be debated again.
And the ban on transferring a human embryo to a woman's womb for purposes
other than a live birth would effectively prohibit "farming" unborn children for their
spare parts, a gruesome prospect invited by the state cloning law recently enacted in
New Jersey.8
Recommendation on Cloning
Two other recommendations are more problematic. The first is a recommended
prohibition on "conceiving a child" by various bizarre means—by means other than
the union of egg and sperm (e.g., cloning), by use of gametes from a human fetus or
human embryonic stem cells, or by fusing blastomeres from two or more embryos.
The problem lies in the council's definition of the phrase "conceiving a child": "the
creation ex vivo of any such human embryo with the intent to transfer it to a
woman's body to initiate a pregnancy."9
William Cardinal Keeler, chairman of the U.S. Conference of Catholic Bishops'
Committee for Pro-Life Activities, has commented on the drawbacks in this
proposal:
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A cloning ban based on what a researcher may "intend" to do with an embryo
after cloning occurs is, first of all, unenforceable. More importantly, it misstates
where the wrong lies in such procedures. Human cloning is wrong because it
treats human life as an object of manufacture—not because a researcher, having
created the embryonic human, may "intend" to allow him or her to survive.
These procedures should simply be banned.10
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Pro-life members of the council nonetheless had supported this proposal, reasoning
that it would prevent an evil (cloning for babymaking) while remaining silent on the
issue of cloning embryos for research. They argued that because the proposal bans
not the act of letting a cloned embryo survive in a womb, but the act of creating the
cloned embryo in the first place (albeit with the additional intent of letting the embryo
survive in a womb), such a law would not actually mandate the destruction or
discarding of any cloned embryo.11
The idea of banning the cloning procedure only if done with the "intent" to
produce a baby has been discussed in Congress before. In 2001, Rep. James Greenwood
(R-PA) offered this approach, openly declaring his goal of protecting the use
of the cloning procedure to make embryos for research.12 In hearings on the bill,
however, several witnesses and fellow members of Congress pointed out that such
a ban could easily be evaded—for example, a researcher could ostensibly create
the embryo for research, but then change his mind when he saw what a healthy
embryo he had created this time; or different persons could perform the act of
creating the embryo and the act of transferring it to a womb. Bioethics expert Leon
Kass, Ph.D., later to become chairman of the President's Council, was among these
critics.13 In any case, whether one has performed one act with the intent to perform
a second act is only visible to the law if one is engaging in the second act—so in
practice, it is difficult to see how this language (if it is to be enforceable at all) would
not reduce to a prohibition on the second act. And that is what pro-life council
members wanted to avoid on moral grounds, because it means allowing the act of
cloning while prohibiting the act of allowing a cloned human to survive.
For their part, ignoring the fact that this "intent" approach was tried and rejected
three years ago, council members who support human cloning for research
purposes seized on the council's proposal as a new and creative way to break the
current policy impasse on cloning. They brushed aside statements by Chairman
Kass and other members that the council's older report on human cloning, in which
a council majority proposed at least a four-year moratorium on human cloning for
research purposes, is still in effect. Almost immediately, the "intent" proposal began
to be offered in state legislatures as a unanimous council recommendation, to be
substituted for pending complete bans on human cloning that were labeled "absolutist"
and divisive by comparison.14
The Ten-to-Fourteen-Day Time Limit
The council's second problematic recommendation was to "prohibit the use of
human embryos in research beyond a designated stage in their development
(between ten and fourteen days after fertilization)."15 Pro-life members supported this
proposal with an argument that was clear and, in principle, valid: Since there are
now no federal restraints whatever on privately funded embryo research, and support
does not exist for a complete ban, some legal limit on such research is better
than none. These members favored a complete ban themselves, but as a prudential
matter, they could accept a time limit—perhaps seven days, or ten—beyond which
this research could not be pursued, and in so doing, they were not accepting or
endorsing research before that point.16
Council members who support destructive embryo research explained this
recommendation very differently, however. They cited it as recognizing a significant
difference in moral status between embryos prior to fourteen days of development
and embryos after that point—and they cited it as paving the way for expanded
federal funding for destructive human embryo research within such "ethical standards."
17 These members even gave advance statements to the news media so
their "spin" on the council recommendations would be announced as fact before the
report itself was public.18
In his statement noted earlier, Cardinal Keeler acknowledged these two very
different perspectives on the idea of a time limit and commented: "The decisive fact
is that human life is a continuum from the one-celled stage onward. Any cutoff point
after this event is arbitrary—providing no principled reason not to extend the time
limit for destructive research, once the precedent is established. We should not start
down this road, but explore ways to discourage research that attacks any human
life."19
As a practical matter, which policy impact is the time-limit proposal likely to
have at this time? Consider that a federal ban (or time limit) on privately funded
embryo research, particularly research involving so-called "spare" embryos from
fertility clinics, is not politically possible at this time. Moreover, it seems technically
impossible to sustain a newly conceived human embryo outside the womb past
fourteen days in any case—so that the positive goal of the proposal may, at present,
be sufficiently addressed by the council's separate recommendation to ban placing
human embryos in wombs for purposes other than a live birth. By contrast, the
proposal's negative impact—its misuse as a "compromise" to legitimize unprecedented
federal funding for destructive research on human embryos up to the fourteenth
day of development—seems real and immediate. Perhaps by design, efforts
in Congress to end current limits on federal funding of embryonic stem-cell research
were renewed simultaneously with the publication of the council report.
Renewed Debate on Federal Funding of
Embryonic Stem-Cell Research
In late March and early April, three mutually supporting events occurred in
such close proximity that it is difficult not to see them as parts of a coordinated plan:
- First, on March 25, the New England Journal of Medicine published an
article announcing that Harvard researchers had created seventeen new
embryonic stem-cell (ESC) lines that they would make freely available to
researchers. Accompanying editorials deplored the fact that research using
these cell lines could not be supported by federal funds, due to President
Bush's policy of funding only the use of cells derived from embryos by
August 9, 2001.20
- Second, the new report by the President's Council at the end of March was
hailed by some council members as paving the way for ethically responsible
federal funding of human embryo research (see above).
- Third, in early April, the Juvenile Diabetes Research Foundation began an
intense campaign to obtain the signatures of members of Congress on a
letter urging President Bush to expand his policy on funding ESC research.
The JDRF letter was released on April 28, signed by 204 voting members
of the House of Representatives. A Senate version was circulated by Senators
Arlen Specter (R-PA) and Tom Harkin (D-IA) on May 6 and was
ultimately released on June 7 with the signatures of fifty-eight Senators.
The central arguments of this new campaign for expanded federal funding of
ESC research were simple: the cell lines eligible for funding under the Bush policy are
inadequate in number and "contaminated" by the mouse feeder cells used to culture
them; new cell lines like those at Harvard, and the "more than 400,000 IVF embryos"
now frozen that "will likely be discarded" if not used for research, must not be allowed
to go to waste; and current policy limitations stifle progress in this field and lead the
best U.S. scientists to move overseas to pursue lifesaving ESC research.
These arguments ignore the claimed moral basis of the Bush policy. As noted
in a May 14 letter to the House signers from NIH Director Elias Zerhouni, M.D.,
President Bush framed his policy in August 2001 to "explore the promise and potential
of stem-cell research without crossing a fundamental moral line." By funding
research only on cells derived from embryos before the time of his policy announcement,
he wanted to permit basic research on these cells without allowing the prospect
of federal funding to encourage further destruction of human embryos. Those
who destroyed more embryos to create the new cell lines are already using these
lines to press for expanded funding, and any policy change now would reward that
activity and encourage much more of the same.
For his part, the president has shown no intention of changing his policy, and at
this writing it is not clear how much effort these members of Congress will put into
a legislative plan to reverse it.
Flawed Factual Basis
It is important to note how precarious is the factual basis for the new campaign.
First, it is not clear that the cell lines now eligible for funding are inadequate for
their intended task—conducting basic research in the advantages and disadvantages
of these cells. Because some of the cells were frozen for later use immediately
after being harvested from embryos, the number of actual cell lines continues
to grow as the cells are thawed and cultured—there were fifteen when the House
members wrote their letter, and nineteen by the time the Senate letter was circulated.
According to Dr. Zerhouni's letter, over four hundred derivatives of these
lines have been shipped to researchers. Some cells remain frozen at this point (and
so could be cultured without the "contamination" of animal feeder cells if necessary),
while thirty-one cell lines are currently unavailable to federally funded researchers
solely because their owners have not yet agreed to share them with other
researchers.
Second, the new Harvard cell lines have the same deficiencies as the currently
eligible cell lines. They are inadequate for any significant clinical use, they
were cultured in mouse feeder cells, and—most interesting of all—they have
already developed serious genetic "abnormalities" in culture.21 A recent study
suggests that all human ESC lines may spontaneously accumulate extra chromosomes
that are typical of human embryonal carcinoma cells from testicular cancer.22
Third, there are not 400,000 frozen embryos available for research, and those
which are designated by parents for research (an estimated 11,000, or 2.8 percent
of the total) are distinct from those which are designated for discarding if not
needed for further reproductive attempts. The claim that embryos requisitioned
for research are those which "would have been discarded anyway" is meaningless
—if parents in a fertility clinic have designated their frozen embryos for use in
research, no one knows what their second choice would have been if the research
option were not offered. (Some, for example, may well have donated the embryos
to another couple for reproduction instead, seeing this as an alternative way to
"get some good" out of the embryos.) In any event, the same study that found as
many as 400,000 frozen embryos in the U.S. also concluded that even if all the
11,000 frozen embryos that are available for research were destroyed for their
stem cells (seen by the authors as a "highly unlikely"scenario), this may produce
a grand total of 275 cell lines—surely inadequate for use in treating any major
disease.23
Last year an opinion piece attacking President Bush's policy cited two prominent
researchers in support of the claim that merely determining the "best options for
research" (to say nothing of clinical use) would require "perhaps 1,000" stem cell
lines—about four times as many as those which could be obtained by destroying every
available human embryo in frozen storage nationwide.24 More recently, a prominent
stem-cell researcher estimated that unless researchers resort to human cloning to
produce genetically matched stem cells for each patient, "millions" of embryos from
fertility clinics may be needed to create cell lines of sufficient genetic diversity for
clinical use.25 (Of course, trying to address this problem with cloning would require
specially creating and then destroying many millions of embryos as well.)
Fourth, there is little evidence that the United States' dominance in biotechnology
and medical research has been damaged by the limits on federal support for
embryonic stem-cell research. ESC research has been a disappointing and laborintensive
segment of the biotechnology field in general, and the states (and foreign
countries) showing the most rapid growth in biotechnology are often those which
prohibit cloning and destructive embryo research.26 Ironically, the Biotechnology
Industry Organization (BIO), an active member of the political coalition insisting on
the need for expanded ESC research, is holding its international convention this
summer with a special focus on Germany as "the leading country for commercial
biotechnology in continental Europe"—and Germany has long had Europe's strongest
laws against human cloning and embryo research.27
In short, members of Congress signing letters against the Bush policy clearly
did not check their facts before joining this political initiative. The current cell lines
are not so useless, or the new cell lines so promising, as they claim. Moreover, the
signers seem to have no idea how massive the destruction of human embryos (and
most likely the creation-for-the sake-of-destruction) would have to be to realize any
"promise" that may someday emerge from ESC research. They are guilty of the
same flaw that some attribute to President Bush's policy in Iraq: Launching a war
(in this case, a one-sided war on nascent human life) without an exit strategy.
Richard M. Doerflinger
Deputy Director
Secretariat for Pro-Life Activities
United States Conference of Catholic Bishops
Washington, D.C.
Notes
1
President's Council on Bioethics, Reproduction and Responsibility: The Regulation
of New Biotechnologies (Washington, D.C.: President's Council on Bioethics, 2004), http://
www.bioethics.gov/reports/reproductionandresponsibility/index.html.
2
Fertility Clinic Success Rate and Certification Act of 1992, 42 U.S. Code §§263a-1 to
263a-7.
3
See Richard M. Doerflinger, "Testimony on Embryo Research and Related Issues,"
National Catholic Bioethics Quarterly 3.4 (Winter 2003): 778 note 32.
4
George J. Annas, in testimony before the President's Council on Bioethics, March 7,
2003, http://www.bioethics.gov/transcripts/march03/session6.html.
5
For example, see "ASRM/SART Statement on ‘Responsibility and Reproduction,'"
press release, March 30, 2004, http://www.asrm.org/Media/Press/responsibility_reprod.html;
and the favorable public comments delivered by industry supporters at the council's April 1,
2004, meeting, http://www.bioethics.gov/transcripts/april04/public1.html.
6
President's Council on Bioethics, Reproduction and Responsibility, 210–211.
7
Ibid., 218–224.
8
See Wesley Smith, "Cloning in New Jersey," Daily Standard (Washington, D.C.) (online
service of The Weekly Standard), December 11, 2003, http://www.weeklystandard.com/Content/
Public/Articles/000/000/003/482iusla.asp. Once this proposal was enacted in January,
the governor began pressing for public funding for such research on cloned human embryos
and fetuses. L. Mansnerus, "New Jersey Forges Ahead On Stem Cells," New York Times,
February 21, 2004, B1.
9
President's Council on Bioethics, Reproduction and Responsibility, 222, original
emphasis.
10
USCCB, Office of Communications, "Cardinal Keeler Critiques Report of Bioethics
Council," April 1, 2004, http://www.usccb.org/comm/archives/2004/04-061.htm.
11
President's Council on Bioethics, Reproduction and Responsibility, 240–241.
12
See 107th Congress, H.R. 2172, the Cloning Prohibition Act of 2001. As introduced
on June 14, 2001, the act would have made it unlawful "to use or attempt to use human somatic-
cell nuclear-transfer technology with the intent to initiate a pregnancy."
13
Remarks of Dr. Claude Allen, in The Human Cloning Prohibition Act of 2001 and the
Cloning Prohibition Act of 2001, hearing before the Subcommittee on Health of the Committee
on Energy and Commerce, House of Representatives on H.R. 1644 and H.R. 2172 (June
20, 2001), Serial No. 107-41 (Washington, D.C.: U.S. Government Printing Office, 2001), 35, 38;
remarks of Dr. Leon Kass, 51–52 and 98; remarks of Mr. Richard Doerflinger, 79; exchange
between Rep. Joseph Pitts and Dr. Thomas Okarma, 105; comment by Rep. Greenwood that
he concurs with these criticisms and intends to "tighten that up," 106.
14
President's Council on Bioethics, Reproduction and Responsibility, 233. In Nebraska,
which had been considering a complete ban on human cloning, legislators opposed to the
ban immediately introduced a substitute based on the council's recommendations, and the
chairman of the state coalition promoting cloning for research purposes wrote in the state's
largest newspaper that the council's "common-sense advice" should replace "an unachievable
absolutist position against human embryonic stem-cell research and therapeutic cloning."
See S. Goodman, "President's Council Plots a Good Course on Stem-Cell Research," Omaha
World-Herald, April 6, 2004, 7B.
15
President's Council on Bioethics, Reproduction and Responsibility, 223.
16
Ibid., 241 and 243–244.
17
Ibid., 234; and statement of Michael Sandel at meeting of the President's Council on
Bioethics, April 1, 2004, http://www.bioethics.gov/transcripts/april04/session1.html.
18
See S. Hall, "U.S. Panel About to Weigh In On Rules for Assisted Fertility," New York
Times, March 30, 2004, F1.
19
USCCB, Office of Communications, "Cardinal Keeler Critiques Report."
20
C. Cowan, Ph.D., et al., "Derivation of Embryonic Stem-Cell Lines from Human Blastocysts,"
New England Journal of Medicine 350.13 (March 25, 2004): 1353–1356; J. Gearhart,
Ph.D., "New Human Embryonic Stem-Cell Lines—More is Better" (ibid., 1275–1276); E.
Phimister, Ph.D., and J. Drazen, M.D., "Two Fillips for Human Embryonic Stem Cells" (ibid.,1351–1352).
21
The abnormal cells have a "proliferative advantage" over the remaining normal cells
in the culture, suggesting that these cell lines may soon consist largely of abnormal cells.
Cowan, "Derivation of Embryonic Stem-Cell Lines," 1355.
22
J. Draper et al., "Recurrent Gain of Chromosomes 17q and 12 in Cultured Human
Embryonic Stem Cells," Nature Biotechnology 22.1 (January 2003): 53–54.
23
D. Hoffman, M.D., et al., "Cryopreserved Embryos in the United States and Their
Availability for Research," Fertility and Sterility 79.5 (May 2003): 1068.
24
S. Hall, "Bush's Political Science," New York Times, June 12, 2003, A33.
25
R. Lanza and N. Rosenthal, "The Stem Cell Challenge," Scientific American 290.6
(June 2004), 94. Another recent study, while noting that other solutions to the immune rejection
problem might be found, agrees that the creation of a sufficiently diverse bank of embryonic
stem-cell lines is "almost impossible." M. Drukker and N. Benvenisty, "The Immunogenicity
of Human Embryonic Stem-Derived Cells," TRENDS in Biotechnology 22.3 (March 2004): 138.
26
See USCCB Secretariat for Pro-Life Activities, "Human Cloning and Embryo Research:
No Road to Biotechnology Growth," http://www.usccb.org/prolife/issues/bioethic/embryo/growth11404.htm.
27
See Web site for the German pavilion, http://www.german-pavilion.com; see also "BIO
2004–Annual International Convention," http://62.27.89.247/biosan/home/index.cfm.
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