Response of LifeCanada and Alliance for Life Ontario to the Discussion Paper published by the Canadian Institutes of Health Research Human Stem Cell Research
Opportunities for Health and Ethical Perspectives

June 22nd 2001

Introduction

LifeCanada was founded in October 2000 and operates a national office in Ottawa Ontario. It represents over 200 educational pro-life groups across the country.

Alliance for Life Ontario was founded October 16th 1989 it operates a provincial office which is situated in Guelph Ontario. Alliance for Life Ontario is comprised of a board of directors, who represent 62 educational pro-life groups currently operational across Ontario, and a volunteer legal counsel. The purpose of our association is to foster, through education, a greater respect for and legal protection of every human being from fertilization/conception or cloning to natural death.

Our scope of concern includes but is not limited to, induced abortion, euthanasia, new reproductive technologies, embryo and fetal tissue research, fetal development, chastity, parental rights and informed consent.

We have included, in this brief our comments on the CIHR Recommendations and the areas where we have grave concerns. Our utmost concern is the possibility that should our Federal Government accept the CIHR guidelines then

• for the first time in our history, federal funding would be used for the deliberate destruction of a human subject for research purposes
• reducing the human from subject to object i.e. commodity - who is owned and can be destroyed by the State.

We Agree: With the CIHR Executive Summary draft Recommendation # 4 which states:

CIHR should place a moratorium on its funding of the following procedures:

i) creation of embryos by somatic cell nuclear transfer into human oocytes for the purpose of deriving stem cell lines.
ii) research in which human pluripotent stem cells are utilized to create or contribute to human embryos.
iii) research in which human pluripotent stem cells are combined with an animal embryo.
iv) research in which animal pluripotent stem cells are combined with a human embryo

Comment: We believe that it would be equally important that the Ad Hoc Working Group on Stem Cells Research recommend to government that a moratorium should also be placed on private funding of these same procedures in Canada.

"Embryo Splitting"

During the research for this brief we have been made aware of the "scientific fact that individual cells and groups of cells from both totipotent and pluripotent "human embryonic stem cells" can "heal" themselves and exist as new human individuals" "Human embryonic stem cell research" is really human EMBRYO research because "stem cells are obtained by killing embryos, but because these "stem cells" themselves, once separated from the embryo, ARE EMBRYOS. [While] it is true that the cells of the early "totipotent" and "pluripotent" human embryo, WHILE THEY ARE STILL INTACT IN THE EMBRYO AND STILL PHYSICALLY PART OF THE EMBRYO, are "stem cells."

However, ONCE THESE CELLS ARE SEPARATED FROM THE EMBRYO THEY "HEAL" THEMSELVES, BECOMING NEW LIVING HUMAN EMBRYOS, 1.E NEW LIVING HUMAN BEINGS. In the human embryology textbooks it is explained as "regulation. That is, each SEPARATED cell or blastomere has the capacity to "heal" itself, e.g. differentiate itself, back to the single cell zygote stage, or to whatever stage or differentiation is needed by that cell in order to survive AS AN EMBRYO."

Comment: Our understanding is that this also constitutes a form of cloning therefore this embryo splitting should be included in the list of procedures upon which CIHR should place a moratorium on its funding.

Recommendations 1,2,3,5 offend the Tri-Council Policy Statement, August 1998
(Quotes from the Tri-Council Policy Statement will be annotated with the following: TCPS)

1) The above recommendations all involve CIHR funding of the destruction of a human subject whose life began at fertilization We would draw the Working group's attention to the Tri- Council Policy Statement in the following areas,

A Moral Imperative: Respect for Human Dignity (TCPS)
"An ethic of research involving human subjects should include two essential elements:

1. the selection and achievement of morally acceptable ends, and
2. the morally acceptable means to those ends....part of our core moral objection would be using another human being solely as a means toward even legitimate ends."

Comment: While we agree with statements made in the Executive Summary that providing, "therapy in a wide variety of diseases and conditions such as Alzheimer's disease, Parkinson's Disease, diabetes, kidney failure, heart disease and spinal cord injury," would certainly fall within the framework of "morally acceptable ends." We would presume to state that the willful destruction of the human subject, in this case, the human embryo, cannot by any stretch of the imagination be considered a morally acceptable means to those ends and would certainly fall into the category of using another human being solely as a means toward even legitimate ends - therefore both funding of such research and conducting of research which willfully destroys the human subject should be banned.

The policy statement goes on further in part "It is unacceptable to treat persons solely as a means ( mere objects or things) because doing so fails to respect their intrinsic human dignity and thus impoverishes all of humanity. And ..it translates into the requirement that the welfare and integrity of the individual remain paramount in human research." (TCPS)

Comment: It would be our conclusion therefore that Recommendations 1,2,3,5 offend the Tri- Council Policy Statement on the two essential elements for research involving human beings which respects human dignity. The human embryo is seen as an object/commodity not a subject - and is used solely as a means. We believe that it is a universally held belief that it is never morally nor ethically acceptable in research to destroy an innocent and vulnerable human subject, who has no means of giving free and informed consent - to fulfill "The basic desire for new knowledge and understanding" or to attain morally acceptable ends.

We would agree with the Working Group's statement in Recommendation 3 "Creation of human embryos by in vitro fertilization for the purpose of deriving stem cell lines should not be supported" .However, we are dismayed that in recommendation 3 the Working group would support the destruction of human embryos who "remain after fertility treatments." Reference to these individuals even in the Tri Council Policy Statement is made under "human embryonic material" or "spare" or "left-over"as in the report of the Working Group.

Comment: How does language such as the aforementioned used to describe a totally complete and unique human being satisfy the requirement "It is unacceptable to treat persons solely as means (mere objects or things).."?

Respect for Human Dignity: (TCPS) "The cardinal principle of modern research ethics, as discussed above is respect for human dignity. This principle aspires to protecting the multiple and interdependent interests of the person - from bodily to psychologically to cultural integrity..."

Comment: It is our belief that recommendations 1,2,3,5 offend the above cardinal principle - as every human subject used in this research would be destroyed in order to harvest the required stem cells. We can only ask, "How is this protective of the human subject's bodily integrity?

Respect for Free and Informed Consent: (TCPS)
"....Respect for persons thus means protecting the exercise of individual consent.....the principle of respect for persons translates into a dialogue, process, rights, duties and requirements for free and informed consent by the research subject."

Comment: It is our view that since there is no possible way to access free and informed consent from the human embryo (research subject) the principle of respect for the person is again offended by these recommendations. It might be argued by some, that the parents might give consent on behalf of their child, however we see this as a fallacious argument - when in this instance the parents would be consenting to the child's willful destruction. We refer the Working Group to the following, noted under;

Respect for Vulnerable Persons: (TCPS)
"Respect for human dignity entails high ethical obligations towards vulnerable persons...Children, institutionalized, or others who are vulnerable are entitled, on the grounds of human dignity, caring, solidarity and fairness to special protection against abuse, exploitation or discrimination. Ethical obligations to vulnerable individuals in the research enterprise will often translate into special procedures to protect their interests.."

Comment: We believe that special procedures should include;

1. A total ban on both private and public funding of unethical research which destroys a human subject at any stage of its development after fertilization; and
2. A total ban of unethical research which entails the destruction of the human subject at any stage after fertilization.

Respect for Justice and Inclusiveness:(TCPS)
"Justice connotes fairness and equity...Justice concerns the benefits and burdens of research.... It thus imposes particular obligations towards individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge."

The Working Group states the following, on page 18 under Discussion.

"Research on existing human pluripotent stem cell lines will not be sufficient to fully understand and explore the potential of such lines. It will be important to discover how cell lines vary, how stable the pluripotent phenotype is, and how susceptible cell lines are to differences in derivation and maintenance conditions....."

Comment: It is our estimation the above passage is a prime and glaring example of how human embryos will be exploited for the advancement of knowledge. In order to fulfill the desire for new knowledge and understanding - it is directly and willfully intended that the human subject used for the purposes of this research will be destroyed.

Ethics and Law: (TCPS)
"..Human rights legislation prohibits discrimination on a variety of grounds. In addition, most documents on research ethics prohibit discrimination and recognize equal treatment as fundamental.."

Comment: We would remind the Working Group that in no other situation would the killing - which we consider the ultimate harm, abuse or maleficence - of the human subject used in research - be morally nor ethically acceptable.

Within our Criminal Code the human embryo or foetus is referred to as a "child" whom the Tri- Council Policy Statement recognizes is in need of "special protection from abuse, exploitation or discrimination" - our Canadian Charter of Rights and Freedoms under Legal Rights (7) guarantees that "Everyone has the right to life, liberty and security of the person..."under Equality Rights (15) (1) states "That every individual is equal before and under the law and has the right to legal protection and in particular, without discrimination based on race, national or ethnic origin, colour, religion, sex, age, or mental or physical disability"

We note with concern the reliance of the Working Group on article 9.4 (d) of the Tri-Council Policy Statement which considers ethically acceptable, "Research involving human embryos [which] takes place only during the first 14 days after their formation by combination of gametes."

We find this contradictory to many of the statements on respect for human dignity and the fundamental nature of equal treatment stated in the Tri -Council Policy Statement and would remind the Working Group that discrimination based on age is forbidden by our Charter.

We would challenge the Working Group to explain why it has taken a graduated approach to the human embryo. If it is unethical to research on human subjects older than 14 days what landmark occurs at 14 days that makes this so? Science informs us that the human being created at fertilization is always a new, genetically distinct human being, alive and developing - in which case this new life should be accorded respect for its human dignity from fertilization onward. It is implied in the Working Paper that Canada wishes to be a leader in this field world- wide.

Comment: It would be our suggestion then, that this Working Group encourage our Federal Government to take that leadership and ban all research which involves the destruction of a human subject at any age from fertilization to natural death.

Recommendation: To end this part of our discourse we would suggest that any further policy discussions or clarifications of existing regulations should reflect the reality that to fund or indeed conduct human embryonic stem cells research which would inherently include the willful destruction of the human subject - in order

1) to conduct the research or

2) at the end of the research (14 days) - is a landmark turning point in human research which has - for the first time treated the human subject as object or commodity which in the words of the Tri-Council Policy statement, "..thus impoverishes all of humanity."

Shifting Public Opinion

Several times the Working Group makes note of shifting public opinion as one of several reasons why clear guidelines must be drafted.. In a recent newsletter entitled "Stemming the News Flow", May 2001, the Statistical Assessment Service noted the media's,

"Eagerness to publicize embryo-related breakthroughs is understandable, but as political stakes were elevated, the subsequent silence on non-embryo developments was striking. Medical advances will continue whether the media attend to them or not. But policy decisions (and public comprehension) are not served by selective attention ( whether by the political right or left) to research on grounds other than strictly scientific merit."

Comment: We believe that the public has not been given impartial information concerning both embryonic stem cell research and adult stem cell research through the media to date. Until that situation is altered, public opinion will continue to be based on "feelings" and "emotional response" to Hollywood idols such as Mary Tyler Moore who has diabetes, Christopher Reeve with his spinal injury and Michael J. Fox with Parkinson's disease - all using their tremendous influence to convince the public that embryonic stem cell research is the only chance they and others like them have of any cure.. We would also state that this Ad Hoc Working group appears also not to have been totally impartial or has not fully served informed public opinion with the limited information it quotes concerning adult stem cell research in the executive summary;

"Stem cells with more a limited range of differentiation and growth potential have also been derived from a number of adult tissues. These may also be useful therapeutically and, although they are currently less versatile than ES and Eg calls, they would have the advantage of minimizing immune rejection problems if derived from the patient..."

ADULT STEM CELL RESEARCH

"In our judgement, 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...The claim that there are alternatives to using stem cells derived from embryos is not, at the present time[9/99], supported scientifically. We recognize however, that it is a matter that must be revisited continually as the demonstration of science advances."

"Ethical issues in Human Stem cell research, " National Bioethics Advisory Commission, September 1999 (emphasis added)

The use of adult stem cells is a viable, ethical and "less morally problematic alternative" to the use of embryonic stem cells research.

Comment: Scientists have only recently come to understand that adult stem cells hold more promises for the future than had been previously thought. We note that the following research findings were available prior to the Ad Hoc Working Group's paper and we are curious that none of this research appears to have been taken into consideration when the group made its recommendations. Following are but a few statements made concerning the burgeoning studies on adult stem cell research which are exploding all over the world and provide a legitimate alternative area of research on stem cells.

* "This [isolating stem cells from fat] could take the air right out of the debate about embryonic stem cells..it makes it hard to argue that we should use embryonic cells."

* "With the newest evidence that even cells in fat are capable of being transformed into tissue through the alchemy of biotechnology, some scientists said they are beginning to conclude they'll be able to grow with relative ease all sorts of replacement tissues without resorting to embryo or fetal cells....every other week there's another interesting finding of adult stem cells turning into neurons or blood cells or heart muscles."

* "In a finding that could offer an entirely new way to treat heart disease within the next few years, scientists working with mice and rats have found that key cells from adult bone marrow can rebuild a damaged heart - actually creating a new heart muscle and blood vessels.." "We are currently finding that these adult stem cells function as well, perhaps even better than, embryonic stem cells."

* "Umbilical cords discarded after birth may offer a vast new source of repair material for fixing brains damaged by strokes and other ills, free of the ethical concerns surrounding the use of fetal tissue, researchers said Sunday."

* "PPL Therapeutics, the company that cloned Dolly the sheep, has succeeded in "reprogramming" a cell -- a move that could lead to the development of treatments for diseases such as diabetes, Alzheimer's and Parkinson's The Scotland based group will today announce that it has turned a cow's skin cell into a beating heart cell and is close to starting research on humans...The PPL announcement..will be seen as an important step towards producing stem cells without using human embryos.."

* "Because they have traveled further on a pathway of differentiation than an embryo's cells have, such specific [adult] stem cells are believed by many to have more limited potential than E[mbryonic] S[tem] cells or those that PPL hopes to create. Some researchers however, are beginning to argue that these limitations would actually make tissue-specific stem cells safer than their pluripotent counterparts. University of Pennsylvania bioethicist Glenn McGee is one of the most vocal critics on this point: "The emerging truth in the lab is that pluripotent stem cells are hard to reign in. The potential that they would explode into a cancerous mass after a stem cell transplant might turn out to be the Pandora's box of stem cell research.""

* "Reversal of insulin dependent diabetes using islets generated in vitro from pancreatic stem cells"

* "Thus, duct tissue from human pancreas can be expanded in culture and then directed to differentiate into glucose responsive islet tissue in vitro. This approach may provide a potential new source of pancreatic islet cells fro transplantation."

* "Adult human cytokeratin 19-positive cells reexpress insulin promoter factor 1 in vitro: Further evidence for pluripotent pancreatic stem cell research in humans."

* "Human pancreatic duct cells have also been grown successfully in vitro and induced to differentiate," and " Not only does the use of adult donor ductal cells avoid the controversy of using fetal cells but there are fewer biological problems associated with making beta cells from duct cells than from, for example, embryonic stem cells... Of the techniques described above, the most promising is generation of beta cells from pancreatic duct cells. It is inherently a shorter biological step to make from a duct cell than it is from other possible cells, such as embryonic stem cells and haemopoietic stem cells."

* "Bone marrow cells regenerate infarcted myocardium," "Marrow stromal cells for cellular cardiomyoplast: Feasability and potential clinical advantages."

* "Multilineage potential of adult human, mesenchymal stem cells."

* "Liver from Bone marrow in Humans"

* "Adult stem cells have shown that they can form functional tissues when injected into the body. Bone marrow stem cells have been shown to transform into functional liver and muscle, as well as functional heart tissue, repairing cardiac damage. Bone marrow and umbilical cord stem cells have also been shown to migrate to the brain and provide therapeutic benefit after stroke in animal models. Adult pancreatic stem cells have reversed diabetes in mice and regenerated muscle in an animal model of muscular dystrophy.

Adult stem cells are already being used successfully for the therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, and immunodeficiency diseases, and restoration of sight through regeneration of corneas. And initial clinical trials have begun to repair heart damage using the patient's own adult stem cells. An acceptable, ethical alternative to embryonic stem cells does exist. Adult stem cells are making good on what are only promises of embryonic stem cells.

Therapeutic cloning is therefor unnecessary and unjustifiable. It takes a utilitarian view of human embryos, viewing them not as people, but as property, a commodity that is: this is a "kind of capitalist cannibalism." It will be virtually impossible to provide oversight of the intent of cloning a human embryo, or distinguishing stored IVF embryos from cloned embryos. A complete ban......is the only sufficient answer."

Conclusion:

a) Human embryonic stem cells research is unethical and scientifically and morally unsupportable and should not be funded by public of private finances.

b) Adult stem cells research is making good on promises that are only "potential" with human embryonic stem cells research.

c) The human subject used in any research must never be reduced to a commodity. By inferring that embryos can be "left over" or "spare" after in vitro has already commodified a distinct and genetically unique human being.

d) If Canada wishes to take the lead in this research then it should show leadership by banning human embryonic stem cells research completely.

Alliance for Life Ontario is greatly dismayed that the Ad Hoc Working Group on Human Stem Cells Research appears to have made no effort to inform the government of the tremendous amount of good news which has been provided during the last two years by research study after research study on adult stem cells research. This is a situation of immense magnitude - since the public funding of human embryonic stem cells research is such a landmark decision - which for the first time would allow the deliberate destruction of the human subject in order to conduct the research. We have attached several appendices - on the advancement of adult stem cells research - to this brief for the Working Group's information.

Respectfully submitted,

Mrs Jakki Jeffs
Executive Director
Alliance for Life Ontario

University Faculty For Life, Submission to Working Group on Stem Cells research, Dr Dianne Irving,M.A., Ph.D., May 31st 2001, Part 1: Summary of the Scientific and Ethical Concerns of the University Faculty For Life
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Tri-Council Policy Statement, Ethical Conduct for Research Involving Human Beings - August 1998, Context of an Ethics Framework, C. Guiding Principles 1.4

ibid: The Need for Research: A
ibid:1.5
ibid:1.5
ibid:1.5
ibid:1.6
9.ibid:1.8 F: Ethics and Law

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Dr Mark Hedrick of UCLA, lead author, Los Angeles Times 4/10/01
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4/1001

Dr Donald Orlic, national Human Genome Research Institute - Robert Bazell "Approach may
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