Voices Online Edition
VOICES - Vol. XX No. 3
Christmas 2005 - Epiphany 2006
Ethical and Policy Concerns Regarding Embryonic Stem Cell Research
by Richard Doerflinger
Editor’s Note: In testimony before the Subcommittee on Science, Technology and Space of the US Senate Committee on Commerce, Science and Transportation last year, Richard Doerflinger addressed the ethics of human embryonic stem cell research from a Catholic perspective. Mr. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the US Conference of Catholic Bishops, presented this testimony on September 29, 2004. He does not aim, in this address to a government subcommittee, to present the Church’s moral teaching comprehensively, nor to cover every aspect of the morally treacherous territory that stem cell research presents (such as the proposal to produce stem cells by “Altered Nuclear Transfer and Oocyte Assisted Reprogramming” [ANT/OAR], which was the subject of an article featured in the Michaelmas edition of Voices, “Moral Dilemmas in Stem Cell Research”, available online at www.wf-f.org/05-2-OAR-StemCells.html). Mr. Doerflinger’s address presents an excellent summary of the ethical and moral problems involved in embryonic stem cell research and of Catholic moral teaching on technological manipulation of human life at its earliest beginnings. We believe this will be useful to many readers, and we are grateful to Mr. Doerflinger for permission to publish his testimony here.
I. The Need for Ethical Safeguards in Human Research
The central ethical issue raised by this research is raised whenever proponents of unlimited research freedom complain that ethical restraints get in the way of “progress”. This tension between technical advance and respect for research subjects is at least as old as modern medicine itself. As soon as Western thinkers began to see medicine as a science that could advance and acquire new knowledge, the temptation arose of using human beings as mere means to this end.
When Dr. Claude Bernard sounded an alarm against this temptation in the 19th century, the preferred victims were prisoners convicted of serious crimes. He insisted that the physician must not deliberately do harm to any human being simply to acquire knowledge that may help others:
The principle of medical and surgical morality, therefore, consists in never performing on man an experiment that might be harmful to him to any extent, even though the result might be highly advantageous to science, i.e., to the health of others. But performing experiments and operations exclusively from the point of view of the patient’s own advantage does not prevent their turning out profitably to science.1
In 1865, Dr. Bernard was already making the important distinction between therapeutic and nontherapeutic experimentation. The fact that an experiment may benefit the research subject is only one moral requirement among others; but it is one thing to provide a human being with an experimental treatment whose outcome may also help in treating others in the future, and quite another thing simply to use him or her as a means, imposing significant risk of harm on him or her solely to benefit others.
In the Nuremberg Code, the United States and its allies responded to the horrors of the Nazi war crimes by restating this principle, to ensure that human dignity would not again be trampled on in the pursuit of medical knowledge. Among other things, the Code declared: “No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur...”2
This Code inspired many later declarations, including the “Declaration of Helsinki”, first approved by the World Medical Association in 1964. Here the key principle is:
In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.
The Helsinki declaration noted that this principle must apply to all human beings, and that “some research populations”, including those who cannot give consent for themselves, “need special protection”.3 It seems this principle was intended to encompass the unborn, as the same organization’s statement on the ethics of the practicing physician, the “Declaration of Geneva”, had the physician swear that “I will maintain the utmost respect for human life, from the time of conception”.4
Despite these solemn declarations, American scientists and others dazzled by visions of technical progress have always been tempted to endorse a utilitarian approach to ethics, and to treat helpless or unpopular members of the human race as mere means to their ends.
In the Tuskegee syphilis experiment, for example, hundreds of poor black sharecroppers were deliberately left with untreated syphilis for over twenty years to observe the course of their disease. This was no isolated aberration but a sustained, decades-long study conducted with US government support. A report filed by the Public Health Service at the end of the process, in 1953 (years after Nuremberg!), shows no trace of ethical concern -- rather, the authors comment favorably on how subjects were encouraged to comply with the study by the offering of “incentives” -- including the offer of free burial assistance once they died from their untreated syphilis! The authors concluded: “As public health workers accumulate experience and skill in this type of study, not only should the number of such studies increase, but a maximum of information will be gained from the efforts expended”.5
There were indeed more such studies. We need only think of the study at Willowbrook children’s home, where retarded children in the 1960s were deliberately injected with hepatitis virus to study ways of preventing spread of the disease. One justification offered by the researchers was that hepatitis was so common in the institution that these children probably would have been exposed to it anyway -- an argument we now see in the embryo research debate, when researchers insist that the human embryos they destroy probably would have been discarded anyway.6 Or we can look to our government’s Cold War studies on the effects of radiation using unsuspecting military and civilian subjects, conducted from the 1940s to the 1970s -- where the drive to pursue knowledge could claim additional support from the drive for national security.7
The same utilitarian approach drives those who seek to justify harmful experiments on human embryos today. When asked in 1994 whether the National Institutes of Health’s Human Embryo Research Panel should base its conclusions on the principle that “the end justifies the means”, the Panel’s chief ethicist quoted the man known as the father of situation ethics, Joseph Fletcher: “If the end doesn’t justify the means, what does?”8 This ethicist later became the chief ethicist for Advanced Cell Technology, the Massachusetts biotechnology company most prominent in the effort to clone human embryos for research purposes. Interestingly, Fletcher himself claimed that the phrase originally came from Nikolai Lenin, who reportedly used it to justify the killing of countless men, women and children in the Russian revolution of 1917.9
History provides us with little reason to favor utilitarian thinking about human life -- for even judged by its own terms, making moral judgments solely on the basis of consequences has so often had terrible consequences. Because scientists, and the for-profit companies that increasingly support and make use of their research, are always tempted to treat helpless members of the human family as mere means to their ends, the rest of society -- including government -- must supply the urgently needed barrier against unethical exploitation of human beings.
II. The Moral Status of the Human Embryo
Some will object that one-week-old human embryos, uniquely among all classes of living human organisms, deserve no such protection from destructive experiments. They hold that these embryos, “according to science, bear as much resemblance to a human being as a goldfish”.10
But this is simply scientific ignorance. Modern embryology textbooks tell us that the initial one-celled zygote is “the beginning of a new human being”, and define the “embryo” as “the developing human during its early stages of development”.11
The continuity of human development from the very beginning, and the reality of the early embryo as a living organism of the human species, has been underscored by recent biological discoveries. Commenting on these new findings, a major science journal concluded that “developmental biologists will no longer dismiss early mammalian embryos as featureless bundles of cells”.12 Political groups may still attempt to do so, of course, but they cannot claim that science is on their side.
While it makes no sense to say that any of us was once a body cell, or a sperm, or an egg, it makes all the sense in the world to say that each of us was once an embryo. For the embryo is the first stage of my life history, the beginning of my continuous development as a human organism. This claim makes the same kind of sense as the claim that I was once a newborn infant, although I do not have any recollection of cognitive or specifically human “experiences” during that stage of life.
The principle that the embryo deserves recognition and respect as a member of the human family is also already reflected in numerous areas of federal law.13 At every stage of development, the unborn child in the womb is protected by federal homicide laws as a separate victim when there is a violent attack upon his or her mother.14 That same child is recognized in federal health regulations as an eligible patient deserving prenatal care.15 And of course, for the last eight years that same embryo has been protected, in much the same way as other human subjects, from being harmed or killed in federally funded research.16
Catholic moral teaching on this issue is very clear. Every human life, from the first moment of existence until natural death, deserves our respect and protection. Human life has intrinsic dignity, not only a relative or instrumental value; thus every living member of the human species, including the human embryo, must be treated with the respect due to a human person.17 We hold further that attempts to make a principled argument as to why embryos need not be respected as persons end up excluding many other members of the human race from this status as well. Any mental or physical ability or characteristic (aside from simple membership in the human race) that one may propose as the deciding factor for “personhood” will be lacking in some people, or held more by some people than by others.18
Thus Catholic morality regarding respect for human life, and any secular ethic in agreement with its basic premises, rejects all deliberate involvement with the direct killing of human embryos for research or any other purpose. Such killing is gravely and intrinsically wrong, and no promised beneficial consequences can lessen that wrong. This conviction is also held by many American taxpayers, who should not be forced by government to promote with their tax dollars what they recognize as a direct killing of innocent human persons.
But even those who do not hold the human embryo to be a full-fledged human person can conclude that embryonic stem cell research is unethical. Many moral wrongs fall short of the full gravity of homicide but are nonetheless seriously wrong. Setting aside “personhood”, surely no one prefers funding research that requires destroying human life.
Four major advisory groups recommending federal policies on human embryo research over the past 23 years have agreed that the destruction of human life is exactly what is at stake in research that involves destroying human embryos. For example, the Ethics Advisory Board to the Department of Health, Education and Welfare concluded in 1979 that the early human embryo deserves “profound respect” as a form of developing human life (though not necessarily “the full legal and moral rights attributed to persons”).19 The NIH Human Embryo Research Panel agreed in 1994 that “the preimplantation human embryo warrants serious moral consideration as a developing form of human life”.20 In 1999, the National Bioethics Advisory Commission (NBAC) cited broad agreement in our society that “human embryos deserve respect as a form of human life”.21 And in 2002, the National Academy of Sciences acknowledged that “in medical terms”, the embryo is a “developing human from fertilization” onward.22
What does this respect mean, if it does not mean full and active protection from harm of the kind we extend to human persons? At a minimum, doesn’t it mean that we will not use public funds to promote such harm? It is absurd to treat a human life solely as a source of spare parts for other people, and to claim that this demonstrates your “respect” for that life. It is equally absurd to fund stem cell research that encourages researchers to destroy human embryos for their cells, and claim that one is not promoting disrespect for the lives of those embryos.23
It does not help this argument to claim that the only embryos to be destroyed for research are those who “would have been discarded anyway”. The mere fact that some parents discard “excess” embryos creates no argument that the federal government should intervene to assist in their destruction -- any more than the fact that many abortions are performed in the US creates an argument that Congress must use its funding power to promote such killing. In fact, Congress has for many years rejected arguments that it can fund harmful experiments on unborn children slated for abortion because “they will die soon anyway”.
The claim that humans who may soon die automatically become fodder for lethal experiments also has ominous implications for condemned prisoners and terminally ill patients. In the final analysis, all of us will die anyway, but that gives no one a right to kill us.
Even on its own amoral terms, that argument also misunderstands the informed consent process for “disposition” of frozen embryos in US fertility clinics. When these clinics produce more embryos in a given cycle than parents need for their immediate reproductive goals, they do indeed freeze the “excess” embryos and ask the parents what should be done with them after a given time.
Most clinics offer the options of continuing to preserve the embryos, using them for further reproductive efforts by the couple, donating them to another couple for reproduction, discarding them, or donating them for research. But these are mutually exclusive options. For example, it would violate the professional code of the fertility industry to take embryos “to be discarded” and use them for research instead. And among embryos donated for research, no researcher or government official can tell which embryos “would have been discarded” if this option had not been offered.24
The problem with past federal advisory panels is that they have generally failed to give any real content to the notion of “respect” or “serious moral consideration” for the embryonic human. The NIH Human Embryo Research Panel failed miserably in this task. Since the Panel approved a wide array of lethal experiments on human embryos -- including some that required specially creating embryos solely to destroy them -- even the Panel’s own members publicly observed that it had come to use the word “respect” merely as a “slogan” with no moral force.25
In the end, the Panel’s report was rejected in part by President Clinton (who denied funding for experiments involving the creation of embryos for research), and rejected in its entirety by Congress (which enacted the appropriations rider against funding harmful embryo research that remains in law to this day).
Five years later, the National Bioethics Advisory Commission tried to give more definition to what “respect” for the embryo might mean in the research context:
In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research.26
While this standard does not fully respect the embryo as a person with inviolable rights, it creates a presumption against research that requires killing embryos: Such research was to be a last resort, pursued only after it is found that research benefits cannot be pursued in any other way. However, the Commission then evaded the implications of this standard, by ignoring the emerging evidence about the promise of adult stem cells and other alternatives. But the Commission admitted that its factual claim on this point must be reevaluated as scientific knowledge advanced.
As the National Institutes of Health acknowledged in 2001, the burden of proof needed to justify human embryo research by NBAC’s ethical standard has never been met. The NIH’s review of stem cell research concluded that any therapies based on embryonic stem cells were “hypothetical and highly experimental”, and that it could not be determined at that time whether these cells would have any advantages over the less morally problematic alternatives.27
Since that time, in fact, scientific and practical barriers to the medical use of embryonic stem cells have loomed larger than many scientists expected in 1999. Problems of tumor formation, uncontrollability, and genetic instability are now cited among the reasons why embryonic stem cells cannot safely be used in human trials any time in the foreseeable future.28 At the same time, non-embryonic stem cells have moved quickly into promising clinical trials for a wide array of conditions, including spinal cord injury, multiple sclerosis, Parkinson’s disease, heart damage and corneal damage.29
Many researchers and biotechnology companies have responded to this evidence by simply abandoning NBAC’s standard. In short, they are losing the game and have decided to move the goalpost.
What is now often heard is that research using both embryonic and non-embryonic stem cells must be fully funded now, to determine which source is best for various functions. In other words, we must help researchers violate NBAC’s ethical standard now, to determine whether they will ever be able to meet the burden of proof that standard places on them.
But this approach simply reduces “respect” for the embryo to nothing at all. For that is the approach one would take if there were no moral problem whatever -- if the only factor determining our research priorities were relative efficiency at achieving certain goals. “Respect” must mean, at a minimum, that we are willing to give up some ease and efficiency in order to obey important moral norms instead of transgressing them.
At this point, it is not even established that continued pursuit of embryonic stem cell research would increase the ease and efficiency of arriving at any treatments, for it may only divert attention and resources away from alternative approaches that could cure diseases more quickly.
In short, using federal funds to encourage the destruction of embryos for new stem cell lines not only fails the test of a principled “sanctity of life” ethic. Given the lack of clear evidence for any unique or irreplaceable role for embryonic stem cells in the treatment of devastating diseases, it even fails the test offered by proponents of human embryo research when they advised the federal government on this issue five years ago.
III. The Reality of an Ethical Slippery Slope
The campaign for expanded federal support for embryonic stem cell research also ignores the fact that its goal cannot be achieved without violating even more ethical norms. Any agenda that will inevitably require such further violations in order to produce any of its promised results must be held accountable now for justifying those violations. Otherwise our government could waste years of effort and millions of dollars on an approach that must be abandoned in midstream, before producing results -- with devastating consequences for patients now awaiting treatments.
At present, contrary to many misleading comments in the political debate, there are no set limits on the amount of federal funding that may be allocated for embryonic stem cell research. However, current policy is to fund only research using the embryonic stem cells obtained by destroying human embryos prior to August 9, 2001. These cell lines are intended to be adequate only for basic research, to determine whether embryonic stem cells offer uniquely promising benefits without encouraging the destruction of live embryos to obtain the cells for that project.
Some claim the currently eligible cell lines are inadequate in number and “contaminated” by the mouse feeder cells used to culture them. They argue that new cell lines like those recently created with private funds by Harvard researchers, and the “more than 400,000 IVF embryos” now frozen that could be used for research, must not be allowed to go to waste. The implied argument is that if only these additional cell lines, and currently existing “excess” embryos, were offered up for federally funded research, researchers would have all they need to cure terrible diseases.
But even if embryonic stem cells could ever be used to cure serious illnesses -- which at this point is hypothetical -- this argument makes no sense. It is important to understand why.
First, it has not been shown that the cell lines already 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. For example, there were 15 lines when House members wrote to President Bush urging an expanded policy this summer, and 19 by the time the Senate letter was circulated a few weeks later. According to the NIH, over 400 derivatives of these lines have been shipped to researchers as of February 2004. Some cells remain frozen at this point (and so could be cultured without the “contamination” of animal feeder cells if necessary), while more than two dozen eligible cell lines are currently unavailable to federally funded researchers only because their owners have not yet agreed to share them with other researchers.30
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.31 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.32
Third, the Rand study, which concluded that there may be as many as 400,000 frozen embryos in the United States, also found that only 11,000 (less than 3% of the total) are designated by parents for possible use in research. If all these 11,000 frozen embryos 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.33
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 that could be obtained by destroying every available human embryo in frozen storage nationwide.34
Another group of researchers has concluded that in order to reflect the genetic and ethnic diversity of the American population, an embryonic stem cell bank geared toward treating any major disease would have to include cell lines from many embryos created solely in order to be destroyed for those cells -- including a disproportionate number of specially created embryos conceived by black couples and other racial minorities, who are underrepresented among current fertility clinic clients.35 Yet another 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.36
Of course, trying to address this problem with cloning would require specially creating and then destroying many millions of embryos as well -- an estimated hundred embryos per individual patient, potentially requiring the exploitation of many millions of women for their eggs to treat even one major disease.37 Undaunted, the national Biotechnology Industry Organization (BIO), in a statement echoed by many researchers, has testified that the use in humans of the cloning technique that created Dolly the sheep will be “essential” to realizing the promise of embryonic stem cell research.38
BIO’s testimony on this point should help to clarify our minds, for it may be rephrased as follows: Unless you are willing to commit yourself in the future to human cloning and the mass-production of human lives in order to exploit and destroy them, there is no point in promoting federally funded research using so-called “excess” embryos now.
And there is yet another moral line to cross beyond this. For the effort to use human embryo cloning for “therapeutic” purposes involves all the practical barriers inherent in embryonic stem cell research in general, plus some additional problems. For example, even cloned embryos with a normal genetic makeup generally suffer from chaotic gene expression, leading to many embryonic and fetal deaths and to increased risks in using any cells from these embryos for future therapies. There is evidence that there may be a later opportunity in fetal development to correct these gene expression problems, if the embryo can survive to that point.39
Perhaps due partly to this phenomenon, the major studies seeking to provide an animal model for “therapeutic” cloning have found it necessary to implant the cloned embryo in a womb and develop it past the embryonic stage to obtain usable cells and tissues.40 Thus the old alleged distinction between “reproductive” cloning (placing cloned embryos in a womb for gestation) and “therapeutic” cloning (destroying cloned embryos for research purposes) is breaking down, as the former increasingly becomes a necessary component of the latter.
BIO has already acted to provide legislative authorization for this approach in humans -- by supporting state laws to allow researchers to clone human embryos and develop them in wombs into the last stages of fetal development, as long as they do not allow a full-term live birth.41 One such law has already been enacted, in New Jersey.42 And the pending California ballot initiative known as Proposition 71, which would force the financially strapped state government to borrow $3 billion to fund embryonic stem cell and human cloning research, would “initially” forbid developing cloned human embryos past 12 days -- but allow indefinite expansion of this limit, by vote of a new Oversight Committee dominated by stem cell advocates.43
In short, no new breakthroughs have shown that embryonic stem cells are ready or almost ready for clinical use. Use of new cell lines from frozen embryos has not been shown to be necessary for current basic research, and would still be completely inadequate for any large-scale clinical research -- suggesting that proposals for expanding the current embryonic stem cell policy are themselves only a transitional step toward mass-producing embryos (by cloning or other means) solely for harmful experimentation. The for-profit biotechnology industry has known this for years, and has begun paving the legislative road toward large-scale human cloning and “fetus farming” in case these prove necessary for technical progress in this field.
Take stock now
Since human embryonic stem cells were isolated and cultured in 1998, initial hyped promises of miracle cures for devastating diseases have collided with reality. More than two decades of research using mouse embryonic stem cells have produced no treatments in mice that are safe or effective enough for anyone to propose in humans. These cells have not helped a single human being, and the practical barriers to their safe and effective use loom larger than ever. Meanwhile, alternative approaches that harm no human being have moved forward to offer realistic hope for patients who many said could be helped only by research that destroys human embryos. Campaigns for increased public funding have grown in inverse proportion to the dwindling hopes of medical benefit, as private funding sources increasingly realize that embryonic stem cell research may not be a wise investment.
We should not succumb to this latest campaign, but reflect on the ethical errors that brought us this far. Even proponents of the research have admitted that it poses an ethical problem, because it involves destroying human lives deserving our respect. Based in part on the actions and statements of proponents, we can see that still further ethical breaches will be required of Congress and society to realize the “promise” of this approach. Already the policy debate has moved from “spare” embryos in fertility clinics, to specially creating embryos for destruction, to mass-production of embryos through cloning, to the gestation of these embryos for “fetus farming” and the harvesting of body parts.
Congress should take stock now and realize that the promise of this approach is too speculative, and the cost too high. That cost includes the early human lives destroyed now and in the future, the required exploitation of women for their eggs and perhaps for their wombs, and the diversion of finite public resources away from research avenues that offer real reasons for hope for patients with terrible diseases. Let’s agree to support avenues to medical progress that we can all live with.
1 Claude Bernard, An Introduction to the Study of Experimental Medicine (1865), quoted in Stephen Post, Inquiries in Bioethics (Georgetown University Press 1993), at 145.
2 See “The Nuremberg Code (1947)” (www.cirp.org/library/ethics/nuremberg/). The Code acknowledges one possible exception to this norm, which if taken absolutely would itself be problematic: “those experiments where the experimental physicians also serve as subjects.” Researchers have a moral responsibility to take due care of their own lives as well.
3 World Medical Association, “Declaration of Helsinki” (www.wma.net/e/policy/b3.htm).
4 World Medical Association, “Declaration of Geneva”, reprinted in Reiser, Dyck and Curran (eds.), Ethics in Medicine (The MIT Press 1977), at 37. In the Declaration’s 1994 revision, this phrase was amended to “human life from its beginning” (www.wma.net/e/policy/b3.htm).
5 Eunice Rivers et al., “Twenty Years of Follow-Up Experience in a Long-Range Medical Study”, 68 Public Health Reports 391-5 (April 1953).
6 See the source materials in J. Katz, Experimentation with Human Beings (New York: Russell Sage Foundation 1972) at 1007-8.
7 See A. Skolnick, “Advisory Committee Report Recommends That U.S. Make Amends for Human Radiation Experiments”, 274 Journal of the American Medical Association 933 (Sept. 27, 1995).
8 Ronald Green, in Transcript of the NIH Human Embryo Research Panel (National Institutes of Health: Rockville, MD 1994), Monday, April 11, 1994, at 92.
9 J. Fletcher, Situation Ethics: The New Morality (Philadelphia: Westminster Press 1966) at 120-21.
10 Mary Tyler Moore, Testimony on behalf of the Juvenile Diabetes Foundation before the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education, September 14, 2000.
11 K. Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology, 7th edition (Saunders: Philadelphia 2003), at 2, 3. For similar statements from other textbooks see USCCB Secretariat for Pro-Life Activities, “What is an Embryo?”, at www.usccb.org/prolife/ issues/bioethic/fact298.htm.
12 H. Pearson, “Your destiny, from day one”, 418 Nature 14-15 (4 July 2002) at 15. For an overview of the recent findings see the Appendix to our June 2003 testimony to the President’s Council on Bioethics, reprinted as R.M. Doerflinger, “Testimony on Embryo Research and Related Issues”, 3 National Catholic Bioethics Quarterly 767-86 (Winter 2003) at 783-6.
13 This is even generally true in the context of abortion, wherever Supreme Court decisions have allowed the legislative branch to make policy choices (as with federal funding of abortion). In any event, the Supreme Court has allowed legislatures to respect unborn human beings and recognize them as human persons, in contexts other than abortion. Webster v. Reproductive Health Services, 492 U.S. 490, 506-07 (1989). Because the human embryo in the laboratory is not encompassed by any reproductive liberty or “privacy” defined in the Court’s abortion decisions, there is no constitutional barrier to the laws passed by several states against destroying embryos in the laboratory. The research that some members of Congress want to subsidize with federal funds would be a felony in their own home states. See USCCB Secretariat for Pro-Life Activities, “Current State Laws Against Human Embryo Research”, www.usccb.org/prolife/issues/bioethic/states701.htm, and “Current State Laws on Human Cloning,” www.usccb.org/prolife/issues/bioethic/ statelaw.htm.
14 Laci and Conner’s Law, signed into law April 1, 2004 (Pub. L. 108-212).
15 Final Rule: State Children’s Health Insurance Program; Eligibility for Prenatal Care and Other Health Services for Unborn Children, 67 Fed.Reg. 61956-74 (Oct. 2, 2002) at 61974 (definition of “child” includes “the period from conception to birth”).
16 The version currently in effect is Section 510 of Division E of the Consolidated Appropriations Act of 2004 (Pub. L. 108-199).
17 See Pope John Paul II, Evangelium vitae (The Gospel of Life) (1995), nos. 60-63.
18 Thus human life must be respected as having intrinsic dignity before birth, or it will not have such dignity even after birth. This is recognized by many ethicists favoring human embryo research, most famously by Peter Singer of Princeton University. Ronald Green, cited above for his role in the embryo research debate, holds that there is nothing objective in human beings that demands our recognition of that human as a “person” -- rather, society may judge in given cases that born humans, as well, have qualities making them more valuable dead than alive. Ronald M. Green, “Toward a Copernican Revolution In Our Thinking About Life’s Beginning and Life’s End”, 66 Soundings 152 (1983) at 159-160. If one attempts to develop and apply objective criteria for personhood, based for example on cognitive abilities, says Green, then “it seems to be true that if the fetus is not a person, neither is the newborn or young infant”. Id. at 156.
19 “Report of the Ethics Advisory Board”, 44 Fed. Reg. 35033-58 (June 18, 1979) at 35056.
20 National Institutes of Health (NIH), Report of the Human Embryo Research Panel (September 1994), at 2.
21 National Bioethics Advisory Commission (NBAC), Ethical Issues in Human Stem Cell Research (Rockville, Maryland: September 1999), Vol. I at ii; cf. 2.
22 National Academy of Sciences (NAS), Scientific and Medical Aspects of Human Reproductive Cloning (National Academy Press 2002), 262.
23 Says ethicist Glenn McGee, who supports embryo research: “Pretending that the scientists who do stem cell research are in no way complicit in the destruction of embryos is just wrong, a smoke and mirrors game on the part of the NIH. It would be much better to take the issue on directly by making the argument that destroying embryos in this way is morally justified -- is, in effect, a just sacrifice to make”. Quoted in J. Spanogle, “Transforming Life”, The Baylor Line (Winter 2000) at 30.
24 In its 1999 report, NBAC recommended that clinics first offer parents the option of having their embryonic children destroyed, and only then offer a choice between discarding and destructive research as the two ways of destroying them. NBAC, note 21 supra at 53. Such a policy might provide a factual basis for determining that embryos slated for research would have been destroyed anyway. But as far as anyone can determine, no fertility clinic has taken this approach. The number of frozen embryos in the United States now designated for research, that one can determine would only have been “discarded anyway”, is zero.
25 Transcript, note 8 supra, April 11, 1994, at 40 (remarks by Dr. Bernard Lo).
26 NBAC, note 21 supra, at 53.
27 NIH, Stem Cells: Scientific Progress and Future Research Directions (Dept. of Health and Human Services, June 2001), at 17; also see 63 (any possible advantages of embryonic cells remain to be determined), 102 (not known whether these cells are better suited for gene therapy).
28 See the sources cited in USCCB Secretariat for Pro-Life Activities, “Practical Problems with Embryonic Stem Cells”, www.usccb.org/prolife/issues/bioethic/stemcell/obstacles51004.htm.
29 See: the sources cited in USCCB Secretariat for Pro-Life Activities, “Scientific Experts Agree: Embryonic Stem Cells are Unnecessary for Medical Progress”, www.usccb.org/prolife/issues/bioethic/fact401.htm; Testimony of Susan Fajt, Laura Dominguez, and Dennis Turner before this Subcommittee, July 14, 2004, at www.stemcellresearch.org/testimony/index.html; and the constantly updated reports of therapeutic advances at www.stemcellresearch.org.
30 See A. Robeznieks, “The politics of progress: How to continue stem cell research despite limitations”, American Medical News, August 9, 2004, www.ama-assn.org/amednews/2004/08/09/prsa0809.htm#s1. (available only to AMA Members and subscribers to AMNews.)
31 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. C. Cowan et al., “Derivation of Embryonic Stem-Cell Lines from Human Blastocysts”, 350(13) New England Journal of Medicine 1353-6 (March 25, 2004) at 1355.
32 J. Draper et al., “Recurrent gain of chromosomes 17q and 12 in cultured human embryonic stem cells”, 22 Nature Biotechnology 53-4 (2003).
33 D. Hoffman et al., “Cryopreserved embryos in the United States and their availability for research”, in 79 Fertility and Sterility 1063-9 (2003) at 1068.
34 S. Hall, “Bush’s Political Science”, in The New York Times, June 12, 2003, A33.
35 R. Faden et al., “Public Stem Cell Banks: Considerations of Justice in Stem Cell Research and Therapy”, in Hastings Center Report, November-December 2003, 13-27.
36 R. Lanza and N. Rosenthal, “The Stem Cell Challenge”, Scientific American (May 2004), 93-99 at 94. Another 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”, 22(3) TRENDS in Biotechnology 136-141 (March 2004) at 138.
37 “Optimistically, ~100 human oocytes would be required to generate customized ntES cell [nuclear transfer embryonic stem cell] lines for a single individual … human oocytes must be harvested from superovulated volunteers, who are reimbursed for their participation. Add to this the complexity of the clinical procedure, and the cost of a human oocyte is ~$1,000-2,000 in the U.S. Thus, to generate a set of customized ntES cell lines for an individual, the budget for the human oocyte material alone would be ~$100,000-200,000. This is a prohibitively high sum that will impede the widespread application of this technology in its present form.” P. Mombaerts, “Therapeutic cloning in the mouse”, 100 Proceedings of the National Academy of Sciences 11924-5 (September 30, 2003) at 11925.
38 “Somatic cell nuclear transfer research is essential if we are to achieve our goals in regenerative medicine.” Testimony of Thomas Okarma on behalf of BIO before the House Energy and Commerce Subcommittee on Health, June 20, 2001, http://energycommerce.house.gov/107/hearings/06202001Hearing291/Okarma450.htm. During the question session Dr. Okarma made it clear he meant the use of this technology to create genetically tailored human embryos for research, including stem cell research.
39 J. Fulka et al., “Do cloned mammals skip a reprogramming step?”, 22(1) Nature Biotechnology 25-6 (January 2004).
40 In the first study, mice derived from cloning had to be brought to live birth to harvest their adult bone marrow stem cells. W. Rideout III et al., “Correction of a Genetic Defect by Nuclear Transplantation and Combined Cell and Gene Therapy”, 109 Cell (April 5, 2002), 17-27. For a critique see Americans to Ban Cloning, “Why the ‘Successful’ Mouse ‘Therapeutic’ Cloning Really Didn’t Work”, www.cloninginformation.org/info/unsuccessful_mouse_therapy.htm. A second study required placing cloned cow embryos in wombs to develop them to the fetal stage, then aborting them for their kidney tissue. R. Lanza et al., “Generation of histocompatible tissues using nuclear transplantation”, 20(7) Nature Biotechnology 689-696 (July 2002). The authors wrote: “Because the cloned cells were derived from early-stage fetuses, this approach is not an example of therapeutic cloning and would not be undertaken in humans.” Id. at 689. But these same authors published a new study this year, in which cloned mouse embryos had to be developed to 11 to 13 days of gestation (the equivalent of the fifth to sixth month in humans) and then aborted to obtain usable cardiac cells. R. Lanza et al., “Regeneration of the Infarcted Heart With Stem Cells Derived by Nuclear Transplantation”, 94 Circulation Research 820-7 (April 2, 2004). This time there were no disclaimers. Instead the lead author declared that this is “an important new paradigm” for human “therapeutic cloning”. See Advanced Cell Technology, “Cloned Stem Cells Regenerate Heart Muscle Following a Heart Attack”, February 10, 2004, http://salesandmarketingnetwork.com/news_release.php?ID= 14109.
41 See Americans to Ban Cloning, “Report: State Bills on Human Cloning”, March 26, 2003, www.cloninginformation.org/info/ABC-State-Laws.htm.
42 See: W. Smith, “Cloning in New Jersey”, in The Daily Standard (online service of The Weekly Standard), December 11, 2003, www.weeklystandard.com/Content/Public/Articles/000/ 000/003/482iusla.asp [broken link 12/3/2007]; News Article, “A safe haven for human cloning?”, The Monitor (Newspaper of the Diocese of Trenton, NJ), December 19, 2003, http://www.dioceseoftrenton.org/department/ news_detail.asp? newsid=850.
43 The “California Stem Cell Research and Cures Act”, stated that the “initial” time limit on the age of embryos to be destroyed for their stem cells (8 to 12 days) can be changed by the Oversight Committee (Id. at 11), whose chairperson must have a “documented history in successful stem cell research advocacy” (Id. at 6). The initiative places a “high priority” on stem cell research not eligible for federal funding, ensuring that the funds will be used primarily for embryonic stem cell and human cloning research (Id. at 16). (Note: this was on web site of the Attorney General of California: http://www.caag.state.ca.us/initiatives/pdf/ sa2003rf0055amdt1_ns.pdf. However the link was not active as of December 2005.)
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