Tuesday, July 20, 2004

More Editorials on Embryonic Stem Cell Research

Previously, I wrote about some of the editorials in the medical journal, The Lancet, pertaining to stem cell research.  Almost simultaneously, the New England Journal of Medicine  also published three editorials on the same subject.  Now I have learned (via Eye of the Storm) that a bill (H.R. 4812) has been introduced in the US House of Representatives that would promote stem cell research. 

Two of the editorials were written by members of the President's Council on Bioethics, Dr. Sandel  and Dr. McHugh; the other was written by Dr. Spar, a professor at the Harvard Business School. 

Embryo Ethics — The Moral Logic of Stem-Cell Research
The question is whether the destruction of human embryos in stem-cell research amounts to the killing of human beings. Professor Michael J. Sandel on the stem-cell debate.
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Zygote and "Clonote" — The Ethical Use of Embryonic Stem Cells
The concern that shadows the free use of human stem cells derives from disquiet over their origins. Dr. Paul R. McHugh on the stem-cell debate.
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The Business of Stem Cells
Professor Debora Spar argues that the commercial consequences of U.S. policy are staggering. The future of stem-cell research is likely to be driven as much by markets as by science.
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Dr. Sandel is a professor of Government.  His editorial begins as follows:

At first glance, the case for federal funding of embryonic stem-cell research seems too obvious to need defending. Why should the government refuse to support research that holds promise for the treatment and cure of devastating conditions such as Parkinson's disease, Alzheimer's disease, diabetes, and spinal cord injury? Critics of stem-cell research offer two main objections: some hold that despite its worthy ends, stem-cell research is wrong because it involves the destruction of human embryos; others worry that even if research on embryos is not wrong in itself, it will open the way to a slippery slope of dehumanizing practices, such as embryo farms, cloned babies, the use of fetuses for spare parts, and the commodification of human life.
Neither objection is ultimately persuasive, though each raises
questions that proponents of stem-cell research should take seriously. [...]

Dr. Sandel goes on to argue against the first point:

But this argument is flawed. The fact that every person began life as an embryo does not prove that embryos are persons. Consider an analogy: although every oak tree was once an acorn, it does not follow that acorns are oak trees, or that I should treat the loss of an acorn eaten by a squirrel in my front yard as the same kind of loss as the death of an oak tree felled by a storm. Despite their developmental continuity, acorns and oak trees are different kinds of things. So are human embryos and human beings. Sentient creatures make claims on us that nonsentient ones do not; beings capable of experience and consciousness make higher claims still. Human life develops by degrees.

He points out that all human reproduction involves the loss of embryos.  In fact, it is estimated that half of all embryos created through traditional reproduction either fail to implant, or abort spontaneously. 

[...I]f the embryo loss that accompanies natural procreation were the moral equivalent of infant death, then pregnancy would have to be regarded as a public health crisis of epidemic proportions; alleviating natural embryo loss would be a more urgent moral cause than abortion, in vitro fertilization, and stem-cell research combined. [...]

He addresses the second point -- that of the potential for dehumanization -- as follows:

[...] Those who view embryos as persons often assume that the only alternative is to treat them with moral indifference. But one need not regard the embryo as a full human being in order to accord it a certain respect. To regard an embryo as a mere thing, open to any use we desire or devise, does, it seems to me, miss its significance as potential human life. Few would favor the wanton destruction of embryos or the use of embryos for the purpose of developing a new line of cosmetics. Personhood is not the only warrant for respect. For example, we consider it an act of disrespect when a hiker carves his initials in an ancient sequoia — not because we regard the sequoia as a person, but because we regard it as a natural wonder worthy of appreciation and awe. To respect the old-growth forest does not mean that no tree may ever be felled or harvested for human purposes. Respecting the forest may be consistent with using it. But the purposes should be weighty and appropriate to the wondrous nature of the thing. [...]

Even critics of stem-cell research hesitate to embrace the full implications of the embryo objection. President George W. Bush has prohibited federal funding for research on embryonic stem-cell lines derived after August 9, 2001, but has not sought to ban such research, nor has he called on scientists to desist from it. And as the stem-cell debate heats up in Congress, even outspoken opponents of embryo research have not mounted a national campaign to ban in vitro fertilization or to prohibit fertility clinics from creating and discarding excess embryos. This does not mean that their positions are unprincipled — only that their positions cannot rest on the principle that embryos are inviolable.

What else could justify restricting federal funding for stem-cell research? It might be the worry, mentioned above, that embryo research will lead down a slippery slope of exploitation and abuse. This objection raises legitimate concerns, but curtailing stem-cell research is the wrong way to address them. Congress can stave off the slippery slope by enacting sensible regulations, beginning with a simple ban on human reproductive cloning. Following the approach adopted by the United Kingdom, Congress might also require that research embryos not be allowed to develop beyond 14 days, restrict the commodification of embryos and gametes, and establish a stem-cell bank to prevent proprietary interests from monopolizing access to stem-cell lines. Regulations such as these could save us from slouching toward a brave new world as we seek to redeem the great biomedical promise of our time. 

I agree with Dr. Sandel's points.  The loss of human embryos is inevitable in human reproduction, and to ban any activity that could result in such loss would be a ban on all human reproduction.  The dehumanization argument is less clear-cut, since dehumanization is a subjective process: it occurs in the mind of the person who is perceiving the action under question.  Dr. Sandel's argument is one of proportionality.  He argues that we should respect human embryos, but not to the extent of sanctifying them. 

Dr. McHugh is a Professor of Psychiatry.  His editorial begins as follows:

Bioethics is a debate without rules about a future dimly apprehended — a debate that is ever in danger of slipping from judicious deliberations into secular sermons. I awoke to these facts soon after I had joined the President's Council on Bioethics, when we began to discuss embryonic stem cells. The discovery of pluripotential, infinitely self-replicating stem cells early in the 1980s had lit up a whole domain of cellular and developmental biology and suggested therapeutic approaches to chronic, debilitating, and incurable diseases such as Parkinson's disease and diabetes mellitus. But for some years, the U.S. government, knowing that harvesting the cells killed the embryos, would not fund research on stem cells that had been derived from human embryos.

On August 9, 2001, President George W. Bush made a thoughtful speech in which he proposed regulations permitting federal funding for research using stem-cell lines from human embryos that had been killed before that date. The National Institutes of Health, proceeding under this compromise, has since made 15 to 20 human stem-cell lines available for federally supported research.

But as might have been expected, few serious participants in the debate were satisfied by this compromise. Most stem-cell specialists reject what they see as an arbitrary limit on their resources and programs — and, among other substantive objections, note that a boundary date for production eliminates the chance of improving the quality of stem cells.1 People who recognize a gift of individual human life in every embryo — an "end" in itself, not to be treated merely as a "means" — recoil at its destruction, no matter when or why it occurs. All the members of the President's Council on Bioethics — whose formation President Bush announced during that same August speech — developed our views on federal funding as we gathered information and exercised (vigorously, I can attest) our human talent for disagreement.

The concern that shadows the free use of human stem cells derives from disquiet over their origins. If a source other than embryos can provide pluripotential stem cells — and harvesting them requires no killing — then this shadow vanishes. Thus, we all celebrate the discovery of stem cells in umbilical-cord blood, bone marrow, and other tissues. [...]

Here, Dr. McHugh is referring to the fact that embryos are not the only source of stem cells.  This is a fact that often is forgotten in public debate on the stem cell issue.  Stem cells from adults, or from umbilical cord blood, do have the potential to be used to create significant medical advances.  However, researchers tell us that they are not the same and do not have the same potential.  This illustrates one of Dr. McHugh's main points:

Know the technical features through and through when working out the rightness or wrongness of a medical procedure. "God is in the details," noted the architect Ludwig Mies van der Rohe. Never has that truth echoed more loudly in the arena of biologic enterprise than it does now. [emphasis added]

Reading through some of the posts on the Blogosphere, it is apparent that some persons see the term "stem cell" and automatically equate all stem cell research with embryonic stem cell research.  This is an error that serious investigators and thoughtful moralists will not make. 

In addition to the distinction drawn between adult, umbilical, and embryonic stem cells, Dr. McHugh takes pains to draw a distinction between embryos derived from in-vitro  fertilization and those developed via somatic-cell nuclear transfer (SCNT).  SCNT is what is popularly called cloning.  His explanation of the process follows:

This process, better termed somatic-cell nuclear transfer (SCNT), carries the potential of producing a living replica (clone) of the donor of a somatic-cell nucleus. It involves calling into play the genetic material and mechanisms that are latent in all somatic-cell nuclei, allowing them, under certain conditions, to recapitulate embryonic development and produce stem cells.

Dr. McHugh is not opposed to use of SCNT for the production of cells, although he remains opposed to an attempt to clone an entire human.  In contrast, he views embryos as having only one rightful purpose: to produce babies.  This is a distinction that may surprise some people, since, in theory, an entity produced via SCNT has the potential to develop into a complete human.  This potential does not impress him, in the sense that he does not believe that the potential for a mass of cells to produce an entire human as worthy of sanctity:

[...] I argue that in vitro fertilization entails the begetting of a new human being right from its start as a zygote and that we should use it to produce babies rather than cells or tissues to be harvested for purposes dictated by other human beings. In contrast, SCNT is a biologic manufacturing process that we may use to produce cells but should not use to produce babies.

My distinction rests on the origin of cells in SCNT, not on the process's vaunted potential for producing a living replica (clone) of the donor, as with Dolly the sheep. My confidence in making origins rather than potential the crux of the argument rests first on a reductio ad absurdum: if one used the notion of "potential" to protect cells developed through SCNT because with further manipulation they might become a living clone, then every somatic cell would deserve some protection because it has the potential to follow the same path. [...]

What he means here is that all somatic cells -- all nucleated cells in the body except sperm and eggs -- could be used to grow a complete clone.  In theory, that is: no one has done so with humans.  Clearly, we cannot provide every cell with the same level of protection that we would a complete human.  Indeed, many of our cells are made to be disposable.  The lining of the digestive tract is one example.  Based upon this argument, Dr. McHugh comes out in support of SCNT technology, but with limitations to ensure that it is not used to produce anything other than cells:

I still support the call of the council's small majority for SCNT regulations that will ensure, among other things, that human ova are not wasted like cheap reagents, or women pressed into service in unsafe ovum-production lines. Also, because I see that my argument supporting SCNT as a source of cells might easily justify growing the blastocysts to more advanced stages so as to harvest organs or tissues, I support limiting the existence of the clonote to 14 days. When these regulations are in place, federal funding for biologic research on human stem cells derived through SCNT should proceed.

Thus, he does not support cloning per se, but he does support limited use of cloning technology. 

Dr. Spar is a Professor of Business.  He editorial begins as follows:

On February 12, 2004, a team of Korean scientists made global headlines. Using somatic-cell nuclear transfer (therapeutic cloning), they removed the nucleus of a human egg cell and replaced it with the genetic material from a single adult cell. They then stimulated the newly transformed egg cell and prompted it to begin dividing. Several days later, they had produced a line of human embryonic stem cells — the first ever created in a laboratory.

[...T]he Korean success was greeted with scientific delight and a flurry of accelerated research activity. In Canada, a parliamentary committee voted to legalize the use of excess embryos for stem-cell research. Sweden announced that it would support the cloning of embryos for therapeutic purposes, the United Kingdom authorized a private firm to begin deriving embryonic stem cells, and Singapore forged ahead with plans to spend $300 million on Biopolis, a cutting-edge science park focused on stem-cell technology.

In the United States, by contrast, recent policy has moved sharply in the opposite direction. Following an August 2001 announcement by President George W. Bush, federal funding for stem-cell research has been restricted to roughly 19 stem-cell lines — those created before the President's announcement from embryos donated after in vitro fertilization. No federal funds may be used to investigate other lines or to create new ones. Although federal law remains silent on the topic of therapeutic cloning, the President's Council on Bioethics has recommended a moratorium on the practice.

Dr. Spar goes on to summarize the controversy over cloning research, pointing out that while several advocacy groups clamor for greater federal support of such research, while others declare that the creation, followed by the destruction, of embryonic cells violates "the fundamental sanctity of life."  She explores this controversy:

The argument, therefore, is suspended between extremes. How do we balance existing lives against the purported rights of embryos and the fears of unnatural creation? Under what rules can we sanction using some forms of life to save others? At the moment, the moral debate seems destined to stalemate.

There is another lens through which to view the stem-cell controversy, however — a less obvious but also a less controversial one. And that is the lens of the market, a lens through which stem cells are seen not as life-or-death projects but rather as the basis for a set of highly promising but still unproven technologies. They are technologies that — like satellite television in the 1980s or Web browsers in the 1990s — seem to be standing on the cusp of history, eliciting a complicated mix of commercial interest and social concern. They are technologies, moreover, whose evolution will be shaped by business as well as science — by the markets they create, in other words, and the people who clamor for their goods.

Dr. Spar seems to believe that market forces will prevail, ultimately:

Currently, the market for stem cells is distinctly immature. Only 10 private firms in the United States were actively involved in embryonic stem-cell research in 2003, spending a total of just $70 million. Over time, however, this still-small business is likely to expand dramatically, following along the well-trod path of similar breakthrough technologies. The economics here are simple. Already, there is a widespread, deep-seated demand for the products that stem cells may eventually provide — treatments for diabetes, regenerative medicine, and customized therapies. As the science matures, there will also be firms with the capacity to supply these very same products. And once demand and supply exist together, they will naturally create a market. Governments can try to prohibit or constrain this market; they can push the market abroad or underground. But history suggests that such prohibitions will inevitably be short-lived, because if demand is intense enough and supply available, then would-be buyers and sellers will eventually constitute a market of their own, either by circumventing the law or by pushing the state to relax its restrictions.

Based upon this line of reasoning, she concludes:

Government restrictions cannot prevent this transition from occurring. They can, however, exert a powerful influence on how and where the stem-cell industry develops.

At first, it may seem that she is abandoning ethical principles in the service of pure pragmatism.  As is often the case, you have to get to the end of her essay to see her point:

To be sure, only the most ardent capitalist would endorse giving the market free reign over stem cells. The moral issues involved are simply too important, and the social debates too intense. At the same time, though, approaching stem-cell technologies purely from the viewpoint of science or ethics robs the debate of a critical dimension, because over the long run, stem cells — like books, radios, and birth-control pills — are likely to evolve into less contentious, more commercial forms.

[...] Venture capitalists will fund research into the most acceptable offshoots of stem-cell science, driving a market that runs in accordance with the wishes of society and not against them. Firms, in other words, will cluster not at the scary edges of scientific potential but, rather, where rules are transparent, and where states are essentially accepting. 

Dr. Spar's conclusion is consistent with that expressed in the editorial by Dr. Tauer in The Lancet,  discussed in a previous post  here.  That is, governments should act quickly to establish clear, if conservative, regulations.  The lack of clarity is an impediment to progress.  Although there may be a temptation in government circles to wait until a comprehensive set of guidelines can be developed, that is unlikely to be feasible.  As the announcement from South Korea demonstrates, science develops faster than governments can act.  Therefore, if government waits until the implications of a line of research are known fully, then tries to write comprehensive guidelines, the guidelines will be outdated by the time they are enacted.  The correct governmental approach, then, is to establish policies that clarify positions on the more fundamental aspects of a line of research, and allow the policies to evolve as the science progresses. 

This may seem distasteful, event intolerable, to moral absolutists.  But guidelines in bioethics are not fundamentally different from other areas of government regulation where human safety is involved. 

For example, look at airline regulations.  Not as glamorous as biotech, to be sure, but still a matter of life and death.  If a new aeronautical technology is developed, it is tested.  If it seems safe, the new technology is permitted.  If a plane crashes and people die, that is a serious matter.  Then we go back and revise the regulations.  Governments deal with this level of risk all the time.  Now we know that we should not route wiring through fuel tanks in airplanes.  If anyone built such a plane today, that would be unethical.  But no one is going out and clamoring for all airplanes to be grounded, claiming that some of them might have been built in a manner that later will be found to have been unethical. 

This is not a perfect analogy, but it illustrates the point: as we strive for higher levels of achievement, we cannot allow all of our worries about possible future ethical problems to block our progress completely.  Nor do we rush headlong into strange new worlds without prudence.  We seek to find an appropriate balance.  In doing so, we should heed Dr. McHugh's advice, and remember that we must know the technical details through and through, as we seek the appropriate balance. 

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