December 18th 2001

Genetic medicine: the case of embryonic stem cells

 

 

SUMMARY:

Introduction

 

Discussion:

1-The state of the law concerning embryo stem cells

2-The issue of consent and excess embryo donation

3-Embryonic stem cells: the tiniest of human beings or “just human cells”?

4-Analysis of the jurisprudence surrounding excess embryos.

5-Embryo stem cells and organ donation.

6-The spectrum of the past: an obstacle for embryonic stem cell research.

7-The alternative to embryonic stem cells: fetal and adult stem cells.

8-European member states legislations regarding research on embryos.

9-The birth of the Oviedo Convention.

10-Oviedo’s cornerstone principle: human dignity.

11-preservation of human dignity with the Oviedo Convention.

 

Conclusion

                       

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INTRODUCTION:

“When the human body breaks down, it must be repaired.” [1] Every country is now experiencing a constant lack of organs available for transplantation.  Nothing leads to believe that the general population is getting used to the idea of organ donation, in fact it seems like the reverse is happening.  The taking of organs on dead donors has raised legal, ethical and medical issues regarding the moment of death and the consent to retrieve the organs. 

But the situation is far from ideal.  The waiting list for organs is still growing as the technology for transplants do.  The unavailability of organs has led research to find new ways of obtaining organs.  Research is concentrating specially on two areas:  xenotransplantation and stem cells research.

 

            Xenotransplantation from transgenic animal organs

 

Xenotransplantation is the transplantation into a human body of an animal organ.  The length of organ transplantation waiting lists has long invited researchers to find new source of organs besides artificial ones.  Through genetic modification, researchers try to fabric organs from transgenetics pigs and xenotransplant them to humans. 

There are however two main problems with this new technique.  First, there is an immunological incompatibility between pigs and humans, leading to the rejection of the pig’s organs transplanted.  Second, this technique could also bring the risk of introducing into the human body new viruses.  For all those reasons, numerous researchers believe that the solution to the shortage of human organs lies in the creation of new organs through the culture of human cells.

 

 

 

            Use of human stem cells.

 

At the origin of most pathology affecting industrialized populations, is the destruction of the architecture of the organ’s tissue.  One way to solve this problem is to reconstruct the damaged tissue by transplanting new healthy cells.  Those new cells would then either replace the cells destroyed or modified by the illness.  This therapeutic strategy is mostly based on the use organs from a dead donor, or in rare occasions, from a live donor[2]. 

Unfortunately, this technique has two crucial limits: on the one hand, the scarcity of organs available, and on the other hand, the chronic risks of immuno-suppression to avoid the rejection of the new organ.  The therapeutic use of stem cells could very well turn out to be a revolutionary way to treat those illnesses and lesions, at least this is the hope.

The aim of stem cells research is to develop cells and tissues intended to be later transplanted into patients suffering from diabetes, Alzheimer’s disease, Parkinson’s’ disease, heart failure…  All those diseases do not have yet any efficient treatment or way to cure, there lies the great hope of stem cell research. 

Stem cells are present at every stage of human development, from children to adults.  Technology is now available to obtain stem cells from adult tissues, fetal tissues, cells of the internal mass of the blastocyst, from embryo.

“Excess embryos”, that is the embryos that are no longer necessary to a parental project after a fertilization treatment in vitro (FIV), might be used as a source of embryo stem cells.  Stem cells may also be obtained from naturally aborted fetuses and blood contained in the umbilical cord at the time of birth.  Adult stem cells are obtained from tissues like bone marrow, skin, blood, and used for transplantation.  One of the limits to the use of adult stem cells is the difficulty to isolate adult stem cells and their weak predisposition to differentiate themselves into different types of cells (this point is still being debated over, as some studies seem to demonstrate that adult stem cells might have the same differentiation potential as younger stem cells[3].) 

Stem cells research is torn between the amazing potential of those cells and the deep moral and legal concerns about the type of research that they involve.  One of the deepest issues is the use of human embryo stem cells.

 

 

            The ethical concerns about using human embryonic stem cells.

 

One of the most important issues raised by the use of embryo stem cells is their method of removal.  Removal and later use of tissues create a difficult problem: those cells can only be obtained by in vitro culture of embryos. Then, stem cells are removed from the embryo.  This process means the end of the implantation of the embryo for reproductive purposes.  The embryo is “instrumentized” before being disposed of.  This technique is troublesome when one thinks that the embryonic phase is one of the earliest phases of human life.

Even if the use of embryo stem cells could open the door to “science miracles”, curing Alzheimer’s disease, diabetes...we cannot ignore that the benefit of curing some cannot justify everything.  Moreover, the focus on the properties of embryo stem cells should not lead scientists in forgetting research on adult stem cells, which might very well reveal themselves as useful as the embryo ones.

The fear is that research using human embryo tissue could pull medicine down the slippery slope to a world where the unborn human beings are harvested for the cells they could provide to another human being.  On the other hand, the human embryo stem cells that have already been collected may be a sufficient source of cells for future replacement tissue, so that no new embryos are required.

 

 

            Preliminary: what are embryo stem cells?

 

Shirley J. Wright recently[4] answered this question.  Embryo stem cells form a very early stage in human development and remain in an undifferentiated state for only a short period of time.  They are first clearly recognizable about five to seven days after fertilization, when a human embryo forms a structure called a blastocyst.  Consisting of merely 140 cells, this hollow, fluid-filled sphere gives little indication that it could develop into a complete person.  There are two types of cells in the blastocyst at this stage.  Trophoblast cells, which form the “shell” of the sphere, will become the supporting tissues of the fetus such as placenta.  Inner-cell-mass cells, which are located at one end within the blastocyst, are the undifferentiated cells that will divide and develop into the individual.

The inner-cell mass begins to differentiate when it forms the three fundamental germ layers of the embryo, known as the ectoderm, the mesoderm and the endoderm.  Each of theses germ layers has a specific destiny as a particular set of tissues in the mature individual, and all organs are ultimately derived from them.  The ectoderm will form the skin, the eyes and the nervous system.  The mesoderm will form bone, blood and muscle tissue.  And the endoderm will develop into the lungs, liver and lining of the gut.  Because the inner-cell mass gives rise to a complete individual, these cells are considered to be totipotent.  When inner-cell mass cells are cultured in a dish they are called embryo stem cells.

 

 

 

 

 

DISCUSSION:

 

            In our discussion, we will first describe the state of the law concerning human embryo stem cells research and the issue of consent when giving embryos to research.  Next, we will concentrate on trying to define the status given to embryos, thereby rendering research on embryonic stem cells sound or not.  We will do so by looking at the two extreme views concerning the embryo: the tiniest of human beings or “just a cluster of cells”, and the organ donation analysis of the research.  Then, we will look at the main criticisms, the spectrum of past science abuses and the possible alternatives sources of stem cells.  Finally, a short analysis of the European Union’s dealing with the subject will also guide us through our analysis of embryonic stem cells use.

 

 

            1-The state of the law concerning human embryonic stem cells.

 

The National Institutes of Health (NIH) guidelines, announced in August 2000, allow federal funding for research with stem cells that have been removed from human embryos.  The rules forbid research on the embryo itself, which is prohibited by federal law.

In 2001, federal funding of research using embryonic stem cell lines was uphold by the new administration.  In August 9th 2001, President George W. Bush declared: “As a result of private research, more than 60 genetically diverse stem cell lines already exist. […] I have concluded that we should allow federal funds to be used for research on these existing stem cell lines […] where the life and death decision has already been made. […] This allows us to explore the promise and potential of stem cell research […] without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life[5].”

According to President Bush’s statement federal funding of medical research on the existing stem cell lines will promote the sanctity of life “without undermining it[6]” and will allow scientists to explore the potential of stem cells to benefit the lives of millions of people who suffer from diseases so far with no known cure.

Federal funds will only be used for research on existing stem cell lines that were derived:  with the informed consent of the donors; from excess embryos created solely for reproductive purposes; and without any financial inducements to the donors. 

In order to ensure that federal funds are used to support only stem cell research in the determined parameters, the NIH examines the derivation of all existing stem cell lines and created a registry[7] of those lines that satisfy the federal criteria.  No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or the cloning of human embryos for any purpose. 

 

 

            2-The issue of consent and excess embryo donation.

 

NIH draft guidelines so far require the agreement of both gamete donors before the embryos are used in research.  The draft requires that in vitro fertilization clinics not only have special rules for obtaining consent for the use of the excess embryos for research but also that there should be a clear separation between the decision to create embryos for infertility treatment and the decision to donate early human embryos in excess of clinical need for research purposes.  Moreover, only frozen early human embryos should be used, and couples should be approached about donation only at the time of deciding the disposition of excess embryos.

The issue of consent from the donor, basic issue, is lead by the main concern regarding the donation of excess embryos, that the couple might be vulnerable to pressure from the medical team to donate embryos for research purposes.  Indeed, the in vitro fertilization (IVF) process might represent a couple’s last chance at getting their own child.  Additionally, there are other candidate-couples to fertilization.  This situation might leave a couple inclined to please the medical team, in an effort to achieve their goal.  If asked to donate eggs or embryos at the time of their IVF, the chance of a couple to even be able to really make a free choice in that important decision is slim. 

 

            3-Embryonic stem cells: the tiniest of human beings or “just human cells”?

 

Senator Sam Brownback is quoted as saying that embryonic stem cell research reminds him of Nazi experimentation: “they used the same sort of argument, that they are going to be killed anyways.”

In the same trend of thoughts, one author[8] was observing that it is not because we condemn criminal to be sentenced to death that we collect their organs...

On the moral ethics of embryo stem cells research, Roman Catholic Cardinal Bevilaqua of Philadelphia stated “the use of stem cells is wrong because it inescapably requires the killing of embryonic human beings whose lives are reduced to research material[9].”

All those arguments against the use of embryo stem cells sound very compelling at first glance: the “killing” of human beings, the reminder of the Nazi regime… However, those arguments fail to address the more important question: what are really stem cells?

The arguments we just mentioned view the embryo stem cells as the tiniest human being.  As is, it deserves the protection and respect of all human beings, among its rights would be the right not be killed, and the right to live.

In response to that argument, the co-author of the legislation in favor of federal funding[10] explained that the cells are no longer embryos, but only stem cells extracted from embryos, making experimentation with them not equivalent to experimenting with embryos.  This analysis of the research seems however a little too rhetorical: “we are not experimenting on embryos, just on cells taken from embryos.”  Moreover, the argument fails to address the fact that after the harvest of its stem cells, the human embryo can longer be used for reproductive purposes and therefore will eventually be disposed of.

More compelling in favor of the research is the argument that embryo stem cells, at the research stage, resemble more to a cluster of cells.  Peter Singer[11], in its analysis of the status of the embryo in the laboratory, answers the two claims of opponents to research (1-the embryo is a human being. 2- the embryo is a potential human being.)

First, Singer opposes the qualification of human being for an embryo on scientific grounds.  Singer’s proposition is based on the premise that human beings are individuals.  For the embryo to be a human being, it would have to also be an individual.  But an embryo might not be the precursor of an individual.  Indeed, up to about fourteen days after fertilization, the embryo can still split into 2 genetically identical embryos.  An embryo, up to this point, may be the precursor of one or two individuals. 

According to Singer, this scientific fact poses a problem to the argument who stress the continuity of an existence from conception to adulthood.  The author finally gives away with the “absurdity” stemming from the thought of the embryo as an individual at the time at which it is “only a cluster of cells[12]” by giving us a vivid case scenario.

“Considering the embryo as the first stage of an individual human being, we might call it Mary.  Now, suppose that the embryo divides itself into two identical embryos.  Is one of them still Mary, and the other one Jane?  If so, which one is Mary?  There is nothing to distinguish the two, no way of saying that the one we call Jane split off from the one we call Mary, rather than vice versa.  So should we say that Mary is no longer with us, and instead we have Jane and Helen?  But what happened to Mary?  Did she die?  Should we grieve for her?  There lies the absurdity of maintaining that the embryo is an individual.”

Second, Singer questions the proposition that an embryo is a “potential human being.”  The author then goes on to compare the potential of an embryo in the uterus to the one of an embryo in the laboratory.  An embryo, implanted in the uterus, is most likely to realize its potential, unless we voluntary interfere with its natural process.  The “laboratory embryo”, on the other hand, will only realize its potential to its most (i.e.: fetus and eventually adult human being) provided that a deliberate human act is carried out.  And this need for positive action is not the end of what the “laboratory embryo” needs.  Probabilities are next in the way:  the probability of a given embryo that has been transferred to the uterus actually implanting there, and leading to a continuing pregnancy is less than 20%. 

In Singer’s demonstration, IVF technique has only reduced the difference between the “embryo in a glass dish” and sperm and egg considered together.  Specifically, the probability of a child resulting from a given IVF embryo and the probability of a child resulting from an egg that has been placed in a fluid to which sperm has been added are similar.  So far, eggs and sperm can be disposed of and no one is claiming that they should not be “killed” because of they have the potential to become a human being.

This analysis raises the question of whether it would be a good idea to treat embryo stem cells as we do sperm for example.  In the current state of the law, sperm is treated as a replenishable tissue, just like blood, and both statutes and jurisprudence refuse to recognize property rights in replenishable tissues. 

           

            To better our understanding of the issues raised by the use of embryo stem cells, an analysis of the status of the same embryo in a different judicial setting might be most useful.

 

            4-Analysis of the jurisprudence surrounding excess embryos.

 

The jurisprudence concerning excess embryos has so far been limited to the future of embryos after a divorce, a death and generally focusing on the reproductive rights stemming from the existence of the frozen embryos.  The subject might be different from ours; however, it is a great indicator on the court’s opinion of the status of embryos.

            One of the most interesting decisions is Davis v. Davis, a 1992 decision from the Supreme Court of Tennessee[13].  This case is one of the few that address the question of the disposition of cryogenically- preserved product of in vitro fertilization, i.e. of “frozen embryos”, in case of the divorce of its genitors.  The Davises got married in 1979 and thereafter unsuccessfully tried to conceive a child.  First, their attempts at natural conception failed because of Mrs. Davis’ multiple tubular pregnancies.  Next, adoption turned out to be prohibitively expensive for the couple.  Lastly, the Davises turned to IVF as their ultimate option to become parents.  Unfortunately for the couple, no pregnancy resulted from the IVF process and in February 1989 Mr. Davis filed for divorce. 

 

The divorce proceedings were only complicated because of the issue of the disposition of the frozen embryos.  Mrs. Davis then demanded the control over the frozen embryos with the intent to have them transferred to her own uterus, in a post-divorce effort to become pregnant.  Mr. Davis objected, saying that he preferred to leave the embryos in their frozen state until he decided whether or not he wanted to become a parent outside the bounds of marriage.  Later, in the litigation, Mrs. Davis, now remarried, no longer wished to utilize the frozen embryos for herself, but wants authority to donate them to a childless couple.  Mr. Davis is adamantly opposed to the idea of donation and would prefer to see the frozen embryos discarded.

 

The trial court originally decided that the embryos were “human beings” from the moment of fertilization and thereupon awarded custody to Mrs. Davis and directed that she “be permitted the opportunity to bring these children to term through implantation[14].”  The court of appeals reversed, finding that Mr. Davis had a “constitutionally protected right not to beget a child where no pregnancy has taken place[15].”  The court of appeals further held that “the parties share an interest in the seven fertilized ova[16]” and remanded the case to the trial court for entry of an order vesting them with “joint control… and equal voice over their disposition[17].”   The Tennessee Supreme Court granted certiorari. 

           

The scientific testimony section of the court’s decision is enlightening to our present issue of embryo stem cell research as to the status of the frozen embryo.  The Tennessee highest court first emphasized the proper terminology to be used.  As the court reminded us, semantic is crucial in this context, because “language defines legal status and can limit legal rights.  Obviously, an “adult” has a different legal status than does a “child.”  Likewise, “child” means something other than “fetus.”  A “fetus” differs from an “embryo[18].” 

            Next, the court discarded the expert testimony of a French genetist, Dr. Jerome Lejeune, finding that his testimony “ revealed a profound confusion between science and religion[19].  Indeed, Dr. Lejeune testified that he was deeply moved by the mother wanting to rescue her babies from this “concentration can[20]”, and thereafter concluded that Mr. Davis had a moral duty to try to bring these “tiny human beings[21]” to term.  Instead, the highest court of Tennessee rather turned its attention to the testimony of Dr. Irving Ray King, the gynecologist who performed the IVF procedures, so should we.

            Dr. King testified that the currently accepted term for the zygote immediately after division is “preembryos” and that this term applies up until fourteen days after fertilization.  This fourteen-day period defines the accepted period for preembryos research.  At about fourteen days, he testified that the group of cells begins to differentiate in a process that permits the eventual development of the different body parts which will become an individual.  This proposition was supported by the American Fertility Society[22], stating that at the eight-cell stage, the developmental singleness of one person has not been established.  Indeed, each blastomere, if separated from the others, has the potential to develop into a complete adult.  Beyond the eight-cell stage, the production of the IVF procedure looks more like a multicellular entity, rather than a “loose packet of identical cells[23].” 

 

            The court next used as a reasoning start point the legislation of abortion.  The Davis court first turned to its State legislation and found that Tennessee’s abortion laws explicitly demonstrate that viable fetuses in the womb are not entitled to the same protection as “persons.”  Indeed, Tennessee adopted the trimester approach to abortion outlined by the Unites States Supreme Court in Roe v. Wade[24].  Under the trimester approach, a woman may decide on abortion within the first trimester of pregnancy but after three months, and before viability, abortion may occur at a properly regulated facility.  Even after viability, fetuses are not given legal status equivalent to that of a person already born[25].  From this legislative framework, the Davis court concluded that embryos, as they develop, are accorded more respect than mere human cells because of their burgeoning potential life.  Second, the court turned to Federal law, which explicitly refused to hold that the fetus possesses independent rights under law.  The Supreme Court even concluded in Roe v. Wade, “the unborn have never been recognized in the law as persons in the whole sense[26].”  Moreover, as Justice O’ Connor recognized in a later Supreme Court decision[27], “[v]iability remains the ‘critical’ point.”

 

            The Davis court concluded its analysis by stating that the stage of fetal development is far removed, both “qualitatively and quantitatively, from that of the four-to eight-cell preembryos[28].”  The court even commented that left undisturbed in the mother’s uterus, a viable fetus has an excellent chance of being brought to term and born live.  In contrast, a preembryo in a peri dish, if late transferred, has only a 13-21 percent chance of achieving actual implantation.  Of these pregnancies, between 56 percent and 75 percent result in live births[29].   

           

Finally, the Davis defined the interest of the gamete donors in their frozen embryos.  The court found very helpful the ethical standards set by the American Fertility Society.  Three major ethical positions have been articulated in the debate over preembryos status.  At one extreme is the view of the preembryos as a human being after fertilization, which requires that it be accorded the rights of a person.  This position entails an obligation to provide an opportunity for implantation to occur and tends to ban any action before transfer that might harm the preembryos or that is not immediately therapeutic, such as freezing and some preembryo research.  At the opposite extreme is the view that the preembryo has a status no different from any other human tissue.  With the consent of those who have decision-making authority over the preembryos, no limits should be imposed on actions taken with preembryos.  A third view, the most widely held, takes an intermediate position between the other two.  It holds that the preembryos deserve respect greater than accorded to human tissue but not the respect accorded to actual persons.  The preembryo is due greater respect than other human tissue because of its potential to become a person and because of its symbolic meaning for many people.  Yet, it should not be treated as a person, because it has not yet developed the features of personhood, is not yet established as developmentally individual, and may never realize its biological potential[30].  The court adopted the “third way”, concluding that preembryos are not, strictly speaking either “property” or “persons”, but occupy an interim category that entitles them to special respect because of their potential for human life. 

 

            Besides the jurisprudence, stem cell research may also be problematic, regarding of its line of funding in several States due to their legislation.  So far, nine States statutes may be interpreted as prohibiting embryo stem cell research. 

Louisiana’s law for example recognizes a human embryo outside the womb as a “juridical person”, and prohibits the destruction of a viable fertilized ovum[31].  Louisiana’s statute further states: “The use of a human ovum fertilized in vitro is solely for the support and contribution of the complete development of human in utero implantation.  No in vitro fertilized human ovum will be farmed or cultured solely for research purposes or any other purposes[32].” 

            In Maine, the law prohibits the “use [of]...any live fetus, whether intrauterine or extrauterine...for scientific experimentation or for any form of experimentation[33].”  A legal analysis commissioned by the National Bioethics Advisory Commission concluded that this law bans research on in vitro embryos altogether[34].

            As for Massachusetts, its law prohibits “use [of] any live human fetus whether before or after expulsion from its mother’s womb, for scientific, laboratory, research or other kind of experimentation[35].”  The section goes on to define “fetus” as including an “embryo.”

            In Michigan, the law provides that “[a] person shall not use a live human embryo... for nontherapeutic research if... the research substantially jeopardizes the life or health of the embryo[36]...”  This statute would most likely be found against embryo stem cell research.

            In Minnesota, the law prohibits using or permitting the use of “a living human conceptus for any type of scientific, laboratory research other experimentation except to protect the life or health of the conceptus[37]...” Earlier in the statute, “conceptus” is defined as “any human organism, conceived either in the human body or produced in an artificial environment other than the human body, from fertilization through the first 265 days thereafter[38].”  The Minnesota statute does indeed encompass the embryo at the stage of research where the stem cell would be harvested and therefore can be argued to prohibit the research on embryo stem cells.

            In North Dakota, the law provides: “A person may not use any live human fetus, whether before or after expulsion from its mother’s womb, for scientific, laboratory, research, or other kind of experimentation[39].”  A legal analysis commissioned by the National Bioethics Advisory Commission concluded that this law “would ban embryo stem cell research using either IVF embryos or aborted conceptuses[40].”

            In Pennsylvania, the law prohibits “knowingly perform[ing] any type of nontherapeutic experimentation or nontherapeutic medical procedure... upon any unborn child[41]...” Earlier in the statute, “unborn child” is defined as ‘an individual organism of the species homo sapiens from fertilization until live birth[42].”

            In Rhode Island State, the law prohibits the use of “any live human fetus, whether before or after expulsion from its mother’s womb, for scientific, laboratory research, or other kind of experimentation[43].”  A legal analysis commissioned by the National Bioethics Advisory Commission concluded that this law “ban[s] research on vitro embryos altogether[44].”

            In South Dakota, a law enacted in 2000 proscribes that it is a crime to “conduct nontherapeutic research that destroys a human embryo”, or “to conduct nontherapeutic research that subjects a human embryo to substantial risk of injury or death[45].”  Under South Dakota law, it is also unlawful to ‘use for research purposes cells or tissues that [a] person knows were obtained” by doing such harm to embryos[46].”  “Human embryo” is defined under the statute as “a living organism of the species Homo Sapiens at the earliest stages of development (including the single-celled stage) that is not located in a woman’s body[47].”  Thus, this law seems to ban not only the destruction of the embryo to obtain stem cells (regardless of the source of funding), but also research using the resulting cells (regardless of whether the cells were harvested in that State or elsewhere.)

 

            At least in those nine States, we can observe a deep concern for the rights and protection of the embryo.  However, the vast majority of States follows the Federal compromise and does not oppose the research on embryo stem cells.  Another way to view the use of “excess embryos” is the organ donation approach.  Under this later approach the use of those embryos and their cells might take an entire new meaning.

 

            5-Embryo stem cells and organ donation.

 

            If we take the position that the cells no longer have the potential for developing into an independent human life, then statutes concerning organs donation may be applicable to the embryo stem cells.  Indeed, organ donation statutes address the question of who controls the disposition of human organs and tissue with no further potential for autonomous human life.  The area is governed by the Uniform Anatomical Gift Act

Moreover, as some have noted, one could be attached to the principle of dignity that should protect to some degree the embryo and still favor embryo stem cell research.  Indeed, it is difficult to be convinced that defrosting an embryo and throwing it down the drain is respecting its dignity.  Instead, integrating the embryo to a research protocol seems to be a more acceptable proposition.  This would indeed translate in a actual form of solidarity, that one could compare to the gift of organ from a dead man to a live one, thereby manifesting solidarity beyond death, in the case of the embryo beyond development.

 

            If considering the use of embryo stem cells as a new way of organ donation would help strike the ethical balance in favor of the research, some, on the other hand, bring the spectrum of past abuses of science to argue in favor of its prohibition.

 

 

 

            6-The spectrum of the past: an obstacle for embryonic stem cell research.

 

            One argument in favor of embryonic stem cells states that the potential of this research is so great that we cannot not pursue it, the greater good of the needy patients is at stake and the promises of stem cells way to great to slow down.  But the greater good cannot justify any means to reach that good.  International instruments have recognized that very dilemma and stated that the means to those laudatory ends may not include the harm or death of human subjects.  The Nuremberg code states that regardless of goods yielded to society, research using human subjects must conform to certain ethical and legal concepts, primary among which are the use of qualified scientists and correct scientific information, the human subject’s informed consent, and a minimal level of personal risk to the subject.  The Declaration of Helsinski states: “In research on man, the interests of science and society should never take precedence over considerations related to the well-being of the subject.” 

 

 

            Another powerful argument against embryonic stem cell

research is the historical abuse that society has already committed on weaker individuals, thereby sacrificing those individuals for the “greater good of society or of science.”  The atrocities of the Nazi experiments with captive Jews in concentration camps are often compared to embryo stem cell research.  In Nazi Germany, Jews were considered “sub-humans” and experiments on them, even leading to death, were performed under the idea that they were going to die anyway and so they might as well be of some use.  Shadows of that idea are emerging from time to time.  In the Willowbrook experiments, mentally retarded children were purposefully infected with infectious diseases in order to study the diseases to later prevent later populations from infections.  In the Tuskeegee experiments, black males suffering from syphilis were not administered penicillin, in order to observe the progression of the diseases.  Elderly male nursing home patients were injected with cancer viruses to see if the would form antibodies.  Mentally retarded children in state institutions were fed feces to study hepatitis.  Most recently, the United States government[48] performed radiation experiments on thousands of unsuspecting patients, service personnel and urban populations.  All these experiments were performed without the informed consent of the human subjects experimented on. 

           

As the American Bioethics Advisory Commission[49] noted: “It is interesting that many of such breeches of research ethics took place in experiment involving vulnerable populations of human beings, whose “personhood”, perhaps, was considered to be less than adequate.  It is also interesting that much of it was federally funded, and justified for “the greater good of society”, for the advancement of scientific knowledge or for national security reasons.”

            The threat of those abuses seems a very compelling argument at first but this argument fails to realize that embryo stem cells are not the “tiniest of human being” and have no “personhood”, whether or not we consider it adequate.  At the stage of research, the embryo has no longer the capacity to become an embryo and therefore will never attain the state of personhood.  The justified fear of research sacrificing human life for a greater good might be addressed in the case of embryo stem cells research by a better definition of what are those stem cells are and how they are harvested.  As we earlier mentioned, embryo stem cells do originate from excess embryo donations for which the gametes donor no longer have a parenting project.  Unlike later fetuses however, those embryo are taken at a very early stage where they are more a cluster of human cells than a fetus.  Some have rightfully found the embryo, even at this early stage, deserves some respect because of its potential and symbolical value.  Expression of that respect may be found by ensuring that the research is done by competent researchers and under strict research protocols.

 

            If the spectrum of past abuses can be overcome, the scientific questioning of the use of embryonic stem cells might however be more difficult.  Indeed, alternatives to the use of embryo stem cells might very well be possible and may even be more useful in curing awaiting patients.

 

 

            7-The alternative to embryonic stem cells: fetal and adult stem cells.

 

            A number of advocates against the use of embryonic stem cells in research argue that such are unnecessary due to the numerous studies tending to show that stem cells derived from adults are equally or more promising for medical research than those derived from embryos.  Already, adult stem cells have been used successfully in clinical trials to treat cartilage defect in children, restore vision to patients who were legally blind...

            More precisely, researchers already reported, that stem cells taken from adult tissues retain the ability to become several different types of tissues: brain cells can become blood cells and cells from bone marrow can become liver.  The overwhelming evidence from the scientific community is that the new discoveries in adult stem cell research rival the development previously found only in embryo stem cells. 

One of the most exiting aspects to adult stem cell research is the advantage it may have over embryo cells, adult stem cells may be harvested directly from the patient.  Because those cells are retrieved from the patient, any development of cells or tissue that may occur outside the body would not be rejected if implanted back into the body.  This technology would indeed be the “perfect” answer in circumventing the risk of rejection that embryonic stem cells may still pose.  On the other hand, embryo stem cells raise the amazing possibility of made-to-order, person-specific cells or organs to transplant into a needy patient.  With the technology used to produce the cloned sheep Dolly, any human somatic cell could be fused with an enucleated donor human egg cell that is then stimulated to develop into a blastocyst embryo.  The inner-cell mass could then be harvested from the blastocyst.  A specific tissue could then be grown from the embryonic stem cells, which could be implanted into the original donor.  The advantage of this cloning method is that the embryonic stem cells would be compatible with the donor of the somatic cell.  This would prevent any graft rejections due to immune-system incompatibility.  To date, however, no one has derived embryonic stem cells using this technique, but the feasibility of this technique has been demonstrated.  Moreover, the technique used in cloning embryo stem cells is unacceptable under the federal funding guidelines.

 

            Another important advantage of adult stem cells is the presence of “precursor” cells, cells that have already been committed to becoming one type of cell.  While precursor cell’s morphing potential is narrower, many scientist believe that turning them into medical treatments will be much easier, because they are further along in their development[50].

 

In favor of embryonic stem cells research, in July of 2001, the National Institutes of Health released an internal report touting several advantages of using stem cells formed in embryos within days of fertilization, that is coming from excess embryos, over stem cells harbored in the bodies of children and adults.   The report focused more on the scientific aspect of embryo stem cell research rather than on its purely ethical aspects.  However, as we have already mentioned, our legal system does need definitions before it can apply a legal status.  Adult, fetus, embryo and gamete have different characteristic and that is the way the law will distinguish among them and each will be awarded a legal status of its own.

            The report cites several advantages of using embryonic stem cells, specifically their ability to transform themselves into virtually every type of cell in the body.  The report concluded that: “[c]urrent evidence indicates that the capability of adult stem cells to give rise to many different specialized cell types is more limited than that of embryonic stem cells.”  The report also questioned whether sufficient supplies of adult stem cells could be created to allow for therapeutic applications, such as using stem cells in transplants to regenerate organs or tissue damaged by disease.  NIH scientists noted, “adult stem cells are rare” and “often are difficult to identify, isolate and purify.”  Embryonic stem cells, on the other hand, “can be generated in abundant quantities in the laboratory.”  From a practical perspective in basic research or eventual clinical application, it is significant that millions of cells can be generated from one embryonic stem cell.

            One question remains however unclear: how about using embryo germ cells derived from fetal tissue instead of embryo stem cells derived from excess embryos?  Dr John Gearhart, from Johns Hopkins University in Baltimore, Maryland, derived its germ cell line from aborted fetal tissue.  Such a change in research orientation would indeed end the controversy surrounding the disposal of the frozen embryos.  However, as the most recent NIH report indicated: “Human embryonic stem cells and embryonic germ cells[51] differ in some characteristics, however, and do not appear to be equivalent[52].  Embryo stem cells and fetal stem cells differ not only in their origins, but also with respect to their behavior in vivo.  In addition, embryo stem cells have been propagated for approximately two years in vitro, for several hundred population doublings.  Also, embryo stem cells will generate differentiated cell types, if injected into immunocompromised mice colonies, while fetal stem cells will not[53].

 

            In an effort to define the limits of embryonic stem cells research, historical, ethical, medical and legal arguments have thus far been our focus.  Now, we will turn to our neighbors and see if they have resolved the conflict we are facing or at least how they address it.

 

8-European member states legislation regarding research on embryos.[54]

 

Embryo stem cells research not only is a controversial subject with the United States but in many countries, including the European Union’s.  Very recently, an American private research company proudly announced its success in cloning the first human being.  Inevitably, this new discovery raised bioethics concerns, most of which are raised by embryo stem cells research.  Other countries were also questioning this new step. 

While everyone seems concerned about the research, it also seems that one of the argument for allowing it is that, “if we do not pursue the research on embryo stem cells, some other country will and we will be held back[55].”   That same argument has been used in many countries.  This argument is less than persuasive and can be refuted simply by remembering the common sense principle that it is not because “everyone is doing it, that it is appropriate if I do it.”  Pursuing embryo stem cells cannot be declared ethically and legally sound just because it is done.  Moreover, “two wrongs do not make a right” tell us the saying: embryo stem cells research must be analyzed on its principles and not as a common practice.

 

When analyzing the issues raised, a quick look at other countries’ legislation will help us.

 

Country

Legislation

Research

limited length

cryoconservation

conditions and objectives of the research

other restrictions

ethics committee

Austria

On reproductive medecine (1992).

not allowed.

 

one year.

embryo donation is not allowed.

Conditions of access to reproductive medecine: stable heterosexual relationship. Aim: procreation. Works only if an ovocyt is implanted.

 

Belgium

There is no specific legislation but a Royal decision that regulates IVF clinics. (1999) A governmental proposition on embryo research is currently discussed.

allowed under certain conditions.

 

 

In authorized IVF clinic, need to obtain the approval of a Bioethics commission

 

There is a ethics commission at every institution capable of doing research (ie: universities…). Those commissions approved the protocols of research.

Denmark

On reproductive medecine (1997)

allowed under certain circumstances

14 days from conception (excluding the cryoconservation time)   

one year with the authorization of the couple

Conditions: authorization of a regional ethics commission.  Aim: improving IVF techniques, preemplantation diagnostic of the embryo.

fusion of genetically differents embryos or parts of embryos is forbidden.  Ova used for research may not be transferred in utero

national Commission on Ethics for the health and Research ( consultation role)

Finland

on medical research (1999)

allowed under certain conditions.

14 days from conception.    

15 years (then it must be destroyed).

Conditions:research is only done by authorized agencies and with the parents' consent.

It is forbidden to create embryos for the purpose of research.  Research on fetus can only take place after written consent from the pregnant women.  Research that modifies the genetic line is not allowed (unless it is for the limited purpose of prevention a fatal disease.)

The National Authority of Medical and Legal matters give authorization to research to the agencies.

France

on bioethics (1994). A modification of that law is currently debated on whether to authorize research on embryos

allowed under certain conditions.

7 days.

5 years.  During this time the couple may donate the embryo to another sterile couple.

Conditions: must be useful directly to the embryo or to reproductive medecine; authorization of both parents is needed; authorization of an independent commission is also necessary.

cloning, creation of chimera and embryo for research purposes are not allowed. Modification of a germinal line is also forbidden.

National Consultative Committee on science and biology ethics (1983).  The Committee is opposed to the incorporation of the European Directive 98/44/CE on patentability into national law.

Germany

on protection of embryos (1992).