Wednesday, July 14, 2004

The Stem Cell Debate

 Personal Account

Paralysis, Roman Reed, and a ban on stem-cell research

Lancet 2004; 364: 219
Don Reed c/o The Lancet diverdonreed@pacbell.net
Don C Reed is a retired schoolteacher and professional scuba diver. The author of five ocean books is currently working on TAKE A STAND: Roman Reed and the Secret Stem Cell Wars. He is the sponsor of the Roman Reed Spinal Cord Injury Research Act.

What is it like, being paralysed? Try this. Using the insides of your wrists, lift a pencil and write your name. Set the pencil down.

Now imagine picking up (still with your wrists) a flexible rubber tube--and inserting that into your urinary tract--every time you need the rest room. Want to schedule a bowel movement? Allow 2 hours.

Before my son Roman Reed was paralysed in a college football accident, on Sept 10, 1994, I never really thought about people in wheelchairs: about the dangers, hassles, and humiliations they face every day.

Roman considers himself fortunate. He can breathe without a machine; he does not live on charity; his girlfriend (now wife) Terri stood by him. Recovering the partial use of his upper arms, "Rome" can transfer himself from bed to wheelchair. He drives an adapted van, holds down a part-time job, continues his education. Defying doctors' expectations, he became a father. In his wheelchair, he coaches Roman Jr's soccer team. He lives life fiercely.

But I am his father, and I see what he goes through...

The latest issue of the medical journal, The Lancet, is devoted to stem cell research.  Access is free for the editorials and for the personal account excerpted above.  You need a paid subscription to view the original research articles, such as Functional antigen-presenting leucocytes derived from human embryonic stem cells in vitro,  but the editorials are more interesting for the nonspecialist. 

Carol Tauer, Ph.D.One of the editorials is by Dr. Carol Tauer, of the University of Minnesota Center for Bioethics.  Dr. Tauer must be an interesting person; she has degrees in Music, Mathematics, and Philosophy.  She began her career as a teacher in a Catholic high school, currently is an Emeritus Professor of Philosophy at The College of St. Catherine, and is a visiting faculty member at Minnesota.  Her dissertation was: The Moral Status of the Prenatal Human Subject of Research.  A bona fide  Gödel, Escher, Bach - type person. 

The Lancet's synopsis follows:

In late 2003, two international bodies were unable to resolve disagreements that involved bioethical issues. First, the United Nations General Assembly failed to pass a treaty on reproductive cloning because of insistence by some countries that the treaty include a ban on cloning for research. In view of the importance of enacting prohibition of reproductive cloning, the two issues should be separated and each argued on its own merits. Relevant objections to separation of the two issues can be refuted. Second, the European Union (EU) failed to agree on conditions for funding stem-cell research because of the diversity of views and policies of the countries of the EU. Because a stalemate was reached, funding decisions in the next programme cycle will be made on an ad hoc basis. Scientists will not have information they need to plan research programmes, suggesting that clear guidelines, even if restrictive, are preferable to vague unpublicised criteria.

Her editorial illustrates some interesting points about public policy in general, and about stem cell research policy in particular:

In development of public policy on embryonic stem-cell research, an international body or individual state must recognise that many people hold strong views on the moral status of the human embryo. Since a human blastocyst must be destroyed to obtain stem cells, people who believe that the blastocyst is a human being will regard the process as killing. If those who hold this view form a critical mass, public policy probably will not support embryonic stem-cell research. In some political contexts a compromise can be reached: to permit stem-cell extraction only from surplus embryos developed as part of fertility treatment and destined to be destroyed, or to allow research only with embryos or stem-cell lines already in existence at a particular date.

Issues in public policy on cloning overlap somewhat with general stem-cell matters but have additional dimensions. Prohibition of cloning for reproductive reasons is directed at prevention of the birth of children who are genetic copies of already existing individuals. Legislation on cloning for research, however, deals mainly with development of stem-cell lines through somatic cell nuclear transfer (SCNT), thus raising issues about a specific type of stem-cell research.

Right away, it is clear that Dr. Tauer is willing to take a broad-minded approach, yet incisive approach.  Rather than lumping all embryonic stem cell topics into one undifferentiated mass of taboo stuff, she understands that there are many different topics involved.  Only by maintaining clear distinctions, among the sub-topics, is any kind of compromise possible. 

The remainder of her editorial covers some technical details that are essential to the understanding of the various issues.  She also reviews the processes that the UN and the EU went through in failed efforts to develop policies covering embryonic stem cell research.  One of her main points is that there is nearly-universal consensus on the topic of reproductive cloning.  She argues that it would have been possible to enact a ban on that one particular application of embryonic cell research.  This approach was successful in the UK:

By separation of the issue of reproductive cloning from cloning for research, the UK was able to prohibit the former while allowing the latter under regulation and licensing.

Apparent, though, some parties to the UN and EU negotiations insisted on lumping everything together, thus creating an impasse.  In the EU, there have been consequences:

When the EU is faced with decisions about funding research these varied interpretations can clash. In December, 2003, an 18-month process for development of guidelines on funding stem-cell research within the Sixth Framework Programme collapsed. A 1-year moratorium in 2003 had allowed funding only for research on embryonic stem cells that had been derived before the end of 2002. During 2003 the European Parliament and Council of Ministers were to develop rules about whether additional stem-cell lines could be derived, studied, or both with EU funding. In November, 2003, the European Parliament approved permissive regulations, endorsing stem-cell research and eliminating any cutoff dates. However, the research ministers of the European Council had the final say and on Dec 3, 2003, they failed to reach agreement. Thus, the European Commission will have to make decisions about funding of stem-cell proposals on a case-by-case basis.18,19

[...]  Some observers believe that limitations on EU funding are not important. In the first round of applications for funding under the Sixth Framework Programme, only 126 of more than 12 000 proposals focused on stem cells and only one of those dealt with human embryonic stem cells.19 Researchers, however, argue that to plan research and develop proposals is difficult when uncertainty exists about what the rules are.

Writing proposals is a major effort for any researcher: a source of great angst.  A serious investment of time and emotional effort is necessary to write a good proposal.  Lacking clarity, there is a risk that researchers could waste a lot of time and effort, trying to establish projects that are doomed before they even get started.  This is not a trivial problem.   We, as a society, need these talented individuals to be as productive as possible. 

Dr. Tauer goes on to discuss the situation in the USA:

[...] But even when the rules are clear, as in the USA, severe restrictions on the funding of stem-cell research might have curtailed interest in the field. The number of applications for federal funding under the current guidelines is small, and Elias Zerhouni, Director of the National Institutes of Health, has lamented the scarcity of research scientists with expertise in stem-cell research.21

Her conclusion:

It is appropriate for the US government and the EU to distinguish "between permitting or tolerating an activity . . . and actively promoting it through governmental funding".22 Many reasons exist why a public body might decide not to fund a particular activity, and in view of the fact that public resources are not boundless, it can fund only some of the projects that are proposed. Yet decisions not to fund stem-cell research, or some categories of stem-cell work, are ordinarily based on deeper considerations than simply prioritising the allocation of limited resources. These decisions become a matter of principle based on the moral objections of (some of) the citizens of a country or certain member states of the EU.

A country or group of countries can legitimately not fund certain controversial types of scientific or biomedical research. But a decision is preferable to a stalemate. Scientists who do not know what types of research proposals can be considered for funding are likely to shy away from a particular area of investigation. In this respect, the US rules, while restrictive, might have some advantages over the EU's lack of agreement on rules. If clear rules exist about what can and cannot be publicly funded then scientists can plan and seek private funding if necessary. The EU needs to break its stalemate and agree on funding policies, if not within the Sixth Framework Programme then at least by the time of the next programme cycle.

At the conclusion of the editorial, The Lancet notes:

Conflict of interest statement

CT is a member of the ethics advisory board of Advanced Cell Technology, a for-profit company in Worcester, MA, USA, engaged in stem-cell research.

So here we have a former Catholic school teacher, who picked up Ph.D.'s in Mathematics and Philosophy, now advising a for-profit biotech company about bioethics.  I was not able to detect any obvious bias in her editorial.  Clearly, she does not stick to the religious party line; nor does she blatantly advocate for more funding that could benefit Advanced Cell Technology.  Instead, she argues for clear guidelines that would assist researchers in using their time and other resources most effectively.  How...pragmatic!

Another article by Dr. Tauer is available here  (small PDF file).  Children as Research Subjects: Guinea Pigs or Therapeutic Orphans?  Addresses issues pertaining to pharmaceutical research in children.  In it, she again argues for greater clarity in guidelines, rather than promoting either a carte blanche,  or any kind of blanket restriction on such research. 

In contrast, another editorial,  It is time for scientists to make the case for stem-cell research, is more open in actively advocating embryonic stem cell research.  Their conclusion:

A catalyst for the change in medicine has been the increasing ease of access to patient-friendly information through the internet. But in science there is little incentive for individuals to seek out the information behind the headlines. Kerry's pledge to make stem cells an election issue provides part of the solution to this dilemma. Perhaps if more scientific issues were forced into country-wide debate, then the public's trust could be more easily won.

But convincing critics of the value of embryonic stem cells poses especially difficult problems. Few other scientific advances have challenged such fundamental human values or posed such ethical dilemmas. The field is also unique in that the science has caught the public's imagination at a much earlier stage than previous developments, due in part to overly optimistic reporting of preliminary findings. The attention focused on stem-cell research unfortunately comes at a moment when there are few tangible clinical benefits to report, although, as many of the papers in this weeks' issue show, the field is advancing at such velocity that this evidence may not be far off. Stem-cell researchers and other proponents are faced with a challenge: how to win back support for this important work with only promises to bargain with?

The case for stem-cell research cannot be left to patient advocates alone. While the stories of Don Reed, and the profile of campaigners such as the actor Christopher Reeve, are important in galvanising public interest, scientists are even better placed to lead a public debate about the potential benefits--and costs--of working with stem cells. It is time for these scientists to step forward.  * The Lancet.

For a contrasting view, see Dan McChonchie's   recent article  in The Illinois Leader.  In it, he argues that, so far, there is little evidence that embryonic stem cell research holds greater promise than research carried out using adult stem cells.  This is true, but of course the limitation in funding for embryonic research hardly creates a level playing field. 

Is rational, informed debate possible?  In a book review in The Lancet,  the views expressed in Jane Maienschein's book, Whose View of Life?, are clarified:

[...] As always, the hype surrounding embryonic stem-cell research is being played out in newspaper headlines touting miracle cures and ethical crises. Religious and right-to-life groups are seemingly lined up against scientists, although the research community itself is not in universal agreement.  Amid this cacophony, reading Jane Maienschein's thoughtful book, Whose View of Life?, is a quiet pleasure.

[...] Her fundamental argument is that society should engage in a better-informed and wider-ranging debate about cloning, stem cells, and other bioscience issues, so that different points of view can be drawn together in light of historical developments. We're not on the brink of some bioethical catastrophe, she says, and what's more, society's view of when an embryo becomes "human" has shifted significantly over time.

[...]  Maienschein is careful throughout to keep her argument balanced and conciliatory. Her personal view on what sort of research ought to be allowed is pretty clear, especially in the concluding chapter, but never dominates. That isn't to say she shies away from pointing out her personal bad guys. For example, when she writes about Bush's decision to limit federal funding for embryonic stem-cell research she quotes him as saying, "I have made this decision with great care, and I pray it is the right one". Later, she ponders: "In a country founded on separation of church and state, it is not clear why it is prayer that should guide an American president to policy decisions about bioscience."

And when it comes to Leon Kass, the Bush-appointed chairman of the bioethics council, she pulls no punches. "These self-proclaimed ethicists insist that they know what is true and right and good, and they will dedicate themselves to its advocacy no matter what", she writes. "This is disturbing. This is, however, where . . . Leon Kass's 'wisdom of repugnance' may lead us, for he relies heavily on his own intuitions, on his assumptions that our intuitions will match his and that if they do not match there is something wrong with us."

Instead of prayer and intuition, Maienschein recommends tolerance, humility, and the avoidance of "false dichotomies" that pit science against religion, or saving the life of a sick person against taking the life of an embryo. Neither science nor religious morality alone have the answers, she argues.

So the answer is: Yes, rational, informed debate is possible, albeit uncommon.  I am glad to see articles such as McChonchie's showing up in a newspaper, I agree with The Lancet's  editorial that encourages scientists to join the public debate, and I concur with them that the Internet can and does play a role in educating the public. 

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