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Bush OKs some embryo stem cell funding 9 August 2001 Excite News

In a long-awaited decision, President Bush announced tonight that he would allow US government funding for embryonic stem cell research, but only on the 60 cell lines already established. He is also establishing a stem cell advisory council to be headed by conservative-leaning University of Chicago bioethicist Leon Kass, which will be comprised of physicians, lawyers, ethicists, theologians and patient representatives.

"Because embryonic stem cell research holds great promise but also the potential of great evil I have decided to proceed with great care," said Bush in his address. The president noted that "because the life and death decision" has already been made concerning the 60 extant cell lines, he decided to allow taxpayers' money to be used for research using those lines, but that no new lines could be created using government monies.

The President's decision represents a compromise between the most conservative, right-to-life position forbidding federal funding of all research with embryonic stem cells, and that favored by many scientists and ethicists, which would allow research to be carried out on "excess" embryos that have been created using in vitro fertilization (IVF) for fertility treatment, but which have not been and never will be implanted in a womb. Bush also said he will back a strong program of federal funding for research on stem cells derived from adult tissue.

Embryonic stem cells are those formed in the first weeks of life, which are capable of forming any of the body's 220 cell types. Based on research to date, most scientists in the field believe them to be more plastic than adult stem cells and thus more useful in developing therapies for neurodegenerative diseases, diabetes, cancer, and many other conditions.

President Bush did not address explicitly the issue of the estimated 100,000 frozen excess embryos which have already been created and will be destroyed rather than used for implantation. Nor did he discuss the murky provenance of some of the extant cell lines - some of which were not created under NIH guidelines, and not created with IRB oversight (including informed consent from the embryo donors).

A nagging question remains as to what oversight - if any - will be extended to privately funded embryonic stem cell research. This week's hearing on a separate issue, human cloning, held at the National Academy of Sciences, cast a worldwide spotlight on the fact that privately funded research - in that case, of human cloning - is moving at its own breakneck speed and without the watchful eyes of government regulation. At the cloning meeting, three researchers declared that they are working to clone a human being. Federal funding of human cloning is prohibited.

Following the presidential broadcast, bioethicist Arthur Caplan noted on network television that the small number of cells lines are not likely to be sufficient to support all publicly funded research. In addition, issues of who has rights to the cell lines, and which patents protect and make exclusive certain cell lines, will have direct impact on the utility of these cell lines.

Princeton molecular biologist Lee Silver added that it is less than clear whether the cell lines are immortalized, and indeed whether some of them might in fact not be true embryonic cells.

Bioethics committee member calls its embryo research policies into question 13 March 2001

by Rabiya S. Tuma, BioMedNet News

As the March 15 deadline looms for applications to perform research on human embryonic stem (ES) cells, a member of the National Bioethics Advisory Committee has taken that committee and the National Institutes of Health (NIH) to task, saying their policies in this area are creating an intractable situation for science.

By defining embryos either as research entities or as future human beings, and by supporting that with a firewall of policies, "we've created a situation in which there never can be research-purpose embryos," said Steven Holtzman, who is chief business officer of Millennium Pharmaceuticals of Cambridge, Massachusetts. "It is a logical feature of that [firewall]. I have a problem with that. And I have a problem with the way we are thinking about this as a society."

Holtzman's remarks are especially timely as researchers await the results of a review of current policy in ES cell research. President Bush has requested this review, even as NIH continues to accept applications for such studies.

According to current US guidelines, researchers can use federal funds for ES cell studies if, and only if, the cells are derived from "spare embryos," already on the shelf in IVF clinic freezers and awaiting disposal. No one may use federal money to study cells derived from embryos created expressly for research, which are called "research-purpose embryos."

Speaking March 12 at Rockefeller University in New York, Holtzman said the distinction between spare embryos and research-purpose embryos emanates from older guidelines on use of fetal tissue, which put protections into place to prevent someone from creating a fetus for purposes other than reproduction. For example, a woman cannot receive money in return for fetal tissue, it cannot be donated with a directed purpose in mind (such as to help cure a disease in a specific person), and finally the decision to donate the tissue must be separate from the decision to terminate the pregnancy.

Embryos are different from fetal tissue, Holtzman says, because we currently have technology to develop important therapeutics and scientific advances using them, but are limited by a distinction about their disposition. Most importantly, US researchers cannot now use public funds to produce ES cells that contain a defined genetic complement. For example, a researcher cannot replace the nucleus of an embryo with a nucleus from a patient, in order to generate pluripotent ES cells.

This sort of work, in Holtzman's view, could lead to new transplant therapies, where host rejection would no longer be an issue. Similarly genetically-defined ES cells would be invaluable to basic researchers trying to understand how early development is controlled and what goes wrong in syndromes such as Down's.

Addressing the philosophical complexity, Holtzman asked the audience to participate in some thought experiments about the social value of embryos. For example, compare how you feel when you think of a woman being paid to become pregnant just to produce an embryo for research. Now think how you would feel if a woman had an ovary removed for medical reasons, and then maintained alive and productive in a tissue culture dish where it could be stimulated to produce viable eggs, which could be fertilized. Do you feel the same about the two situations?

According to Holtzman, most of us do not. Even most people who are opposed to abortion, he says, make exceptions in the case of incest and rape. Looking at these two examples and the abortion debate exceptions, he concludes that the value of an embryo comes not so much from the cells themselves, but rather from the social context of marriage and reproduction. When an embryo is created outside that context, he says, we don't consider it to have the same value, and our reactions correspond.

Another member of the National Bioethics Advisory Committee, ethicist Patricia Backlar of Oregon Health Sciences University, takes issue with Holtzman's view. The decision to distinguish between the two embryo sources is important, she says. It allows important research to go forward while still respecting the very strong concerns of a large part of the population.

"I don't think there is ever a point that you can't change a policy," she told BioMedNet News, "but there are already a lot of people who have trouble with using spare embryos."

One of the newest voices in the debate on stem cells is the Nightlight Christian Adoptions agency in California, which announced on March 8 that it is suing the US government over NIH's plan to fund ES cell research. The agency claims that such research will limit the number of embryos available for infertile couples to adopt.

"Somewhere along the line, here in our society, as new technology comes to bear, we will have to confront the question of whether we, as a society, believe that embryos have the moral status of persons," concludes Holtzman.

Extending the ethical boundaries of stem cell research

Trends in Molecular medicine Research update

Kathryn Senior
Available online 5 March 2001.

Author Keywords: Stem cells; Ethics; UNESCO; IVF

Following the publication of new National Institutes of Health (NIH) guidelines on stem cell research in the US (,cell/stemfactsheet.htm), and the Donaldson report in the UK (, the ethics of stem cell research has become an international focus. On November 6th, in Quito, Ecuador, Michel Revel (Chairman of the Bioethic Committee of the Israel Academy of Science) and Alexander McCall-Smith (Vice Chairman of the UK Bioethics Committee [UNESCO IBC]) presented a report to the Bioethics Committee of UNESCO. `After intense discussion, our report was modified significantly; the conclusions have not yet been approved by UNESCO IBC, but we hope that that will happen at the next meeting in Paris, in February 2001,' reports Revel. The provisional report urges more debate `at appropriate national regulatory levels' to enable a consensus to be reached on what is permissible and what is not, and emphasises that:

particular attention should be given to the rights of embryo donors when spare embryos from IVF treatments are donated for research;
research should come under the auspices of a state-sponsored regulatory system;
alternative technologies for obtaining cell lines from genetically compatible sources should be considered.

Revel hopes that UNESCO IBC's eventual approval of the provisional recommendations will enable an ethical framework for stem cell research in Israel to be made official. Noelle Lenoir, President of the European Group of Ethics (EGE) who made their official response to the Donaldson report on 14 November (see Box 1), agrees that the UK legal system of control of embryo research is exemplary from the point of view of its procedures and scope. `The centralized Human Fertilisation and Embryology Authority has created a framework that allows public debate and a full transparency of new research developments,' she says.


Box 1. European response to the Donaldson report

The European Group on Ethics in Science and New Technologies (EGE), a multidisciplinary group answering directly to the President of the European Commission, accepts the major research interest of human stem cells and their promising therapeutic prospects but nonetheless calls for prudence. `At present, the creation of embryos by somatic cell nuclear transfer would be premature,' the Group concludes. It also recommends that results be disseminated widely and not hidden for reasons of commercial interest, that research should be assessed ethically during the planning stage and that countries should ensure that the demand for spare embryos and oocyte donation does not increase the burden on women undergoing fertility treatment.


`In contrast, the NIH guidelines on stem cell research are purely about what type of stem cell research can attract government funding,' explains Francoise Baylis (Associate Professor of Medicine and Philosophy, Dalhousie University, Halifax, NS, Canada). Although some regulations are in place to cover embryo research in both the public and private sectors, these are less stringent than in the UK. Lenoir points out that `the NIH guidelines are something of a compromise in that they do not really address the ethics of the research itself in sufficient detail.' Revel sees the new guidelines as `a step forward that will allow public research to be funded and published in this area,' but stresses that privately funded research should not dominate this field.

Neil Theise (New York University Medical School, New York, NY, USA), who identified a putative adult liver stem cell last year, notes that there is strong objection to embryonic stem cell research amongst some sectors of the general public in the USA. `Some use recent studies, including my own, as a reason to close down embryonic stem cell research; they argue that adult stem cells may have the full developmental range of embryonic cells.' However, Theise feels that it would be very premature to use this argument to close down embryonic stem cell research, because mechanisms of differentiation of stem cells and ways to manipulate them are years of careful study away. `Losing the opportunity to study embryonic stem cells could mean that we could lose out on some of the enormous therapeutic potential offered by these cells,' he concludes.

Greater transparency and accountability seem to be necessary if stem cell research is to achieve its considerable therapeutic promise. `The first rule for research involving stem cells derived from human embryos should be scrutiny by a public authority, then an open consideration of the details of the research, with adequate follow up. Public debate is important and a case-by-case approach is necessary,' recommends Lenoir. She would like to see a UK-style system implemented in other countries in Europe, and says that `any ethical framework also needs to consider the possibilities for exploitation.' The NIH guidelines and most individual country guidelines state that women or couples who donate embryos for research cannot receive financial incentives. `This is considered necessary to avoid coercion, but as many women have noted, an issue remains in that everyone but those who provide the source material may make large amounts of money out of the products of research. Is it fair that the donors do not get a share?' asks Baylis.

On an international level, there are also worries that stringent regulations governing how stem cells can be obtained could lead to the importation of tissue or cells from countries where the rules are less strict. This was discussed at the 5th World Congress of the International Association of Bioethics (IAB) in London (21 24 September 2000) ( `At the moment it seems clear that most scientists would not want to be involved in the exploitation of women in developing countries, but might this change if there was a serious problem with the supply of embryos for stem cell research? Perhaps, but it is more likely that there would be pressure to change local restrictions. For example, in the US there might be pressure for NIH to fund research involving stem cells derived from research embryos,' reports Baylis. Another issue, says Lenoir, is that the whole expansion of stem cell research is leading to greater commercialisation of human tissue. `This could lead on to human tissue, embryos and even the women who donate them being seen as a `commodity'', she warns.

The future control of stem cell research and embryo research generally is likely to be fraught with problems and will require much more international debate. But will this be possible? `This is a very sensitive issue on a global level; different countries and cultures hold very different views', says Baylis. She points out that lawyers and ethicists are writing about the possibility of international harmonization of regulations, but are unclear about how this will be achieved. `There are two arguments; one that says harmonize now and agree on future research developments; the other that says let individual countries set their own rules based on national norms and mores and then all come together at a later stage to harmonize', she explains. However, as Lenoir concludes, international control may be wishful thinking; `If it happens in the future, that will be wonderful, but in the meantime, the most important thing is to ensure that individual countries develop strong regulations that will ensure a responsible approach to all research involving embryonic tissue.'