Richard Doerflinger - Embryonic Stem Cell Research

Testimony of Richard M. Doerflinger
on behalf of the
U.S. Conference of Catholic Bishops
before the Subcommittee on Science, Technology and Space
Senate Commerce, Science and Transportation Committee
September 29, 2004

Subject: Ethical and Policy Concerns Regarding Embryonic Stem Cell Research

          I am Richard M. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops. On behalf of the bishops' conference I want to thank this Subcommittee for asking us to present our views on the ethics of human embryonic stem cell research.

          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 U.S. 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" onwards.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 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 U.S. 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." See 42 USC §289g. 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 U.S. 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 which 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 over 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 which 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.

          Conclusion

          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.

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