Surplus embryos: An unsolvable problem or a false problem?
Gonzalo Herranz.
department of Humanities Biomedical Sciences, University of Navarra.
lecture in International Symposium "Ethical and legal issues of the embryo".
Fundación Ramón Areces and association Española de Bioética.
Madrid, Tuesday, 7 November 2000.
Plan and parts of the intervention.
Human supernumerary embryos (HES) are result of the dynamics of efficiency and competition that dominate the field of in vitro fertilisation. Reproductive medicine practitioners are under pressure to improve the quality of their services: they cannot give up any opportunity to optimise their results, even if this requires them to sacrifice other values.
Right from the start, thanks to ovarian stimulation, the aim was to obtain as many oocytes as possible issue in order to select the best ones. All of them were fertilised in order to obtain as many embryos as possible issue . With the embryos, the process was repeated selection process, in order to transfer the most selected ones to the mother's uterus. Such a selective process usually left a small number of inferior quality embryos as a disposable residue issue . These were the first EHS.
The phenomenon, in the dimensions it has today, appeared linked to embryo freezing techniques: only cryopreservation makes it possible to store an uncountable issue of embryos, with which to overcome the frequent failures of the technique. With the frozen embryos, new attempts at embryo transfer can be made without having to repeat the always tedious process from the beginning.
Gradually, as the performance of the techniques improved and reproduction centres progressed along the learning curve, the issue of frozen embryos grew. An increasingly higher number of embryos per stimulation cycle was obtained average . However many embryos there were, it never seemed like too many, because in the freezing/thawing process quite a few embryos succumbed. Moreover, in many cases the embryo reserves were exhausted without achieving pregnancy.
But, in fact, the issue of embryos that had no way out began to grow: they were the new EHS. Sometimes there were too many of them because the intervention had been successful: the parents were happy with the child or twins they had had, and did not decide to increase their offspring. Other times, the failed experience was too strong for them to try again immediately, and they postponed the next attempt for a future that never came.
After a while, alongside EHS, a new subject appeared, that of abandoned human embryos, those whose parents were not aware of them: sometimes because the mother's health made it inadvisable to attempt pregnancy; sometimes because the marriage had broken up, or one of the spouses had died, or they had moved to a remote location and could no longer be located. The American Society for Reproductive Medicine Ethics committee considers an embryo to be abandoned when more than five years have passed without any sign of life from the parents, while diligent efforts have been made to contact them at the last known address, and there are no written instructions from the couple as to what is to be done with the embryo1.
We do not know for sure how many EHS there are in the world. Figures for frozen embryos are not usually recorded. The detailed annual reports of official monitoring bodies or scientific societies do not include such data.
As a result, the figures given are often mere estimates, sometimes very discordant. It is said that in the United States there may be more than 400,000 EHS. The annual I report of the National Commission of Assisted Human Reproduction estimated that in 1998, in Spain there were about 25,000 frozen embryos2.
Undoubtedly, the number of frozen embryos will continue to grow. Some reasons have been invoked to predict that issue will stabilise or may even decrease. Thus, oocyte freezing has been mentioned, but it does not seem that any substantive change can come from this: the probability of a child being born from the fertilisation of frozen oocytes does not exceed one percent3. It is thought that long embryo culture may operate as a selective mechanism that allows the transfer of blastocysts of good vitality, while making embryos that have not achieved a competitive development redundant.
But it seems that neither oocyte freezing, a promise that, because of its low yield, is still waiting to become a reality, nor long culture can effectively oppose the uncontrolled growth of the issue of EHS. The ethos of efficiency that presides over the internship of assisted reproduction will have to change first. Furthermore, in order to avoid the biological and economic problems caused by multiple pregnancies, it has been established as a professional rule that no more than two embryos should be implanted per cycle, which will contribute to the growth of issue of EHS4.
As the issue of EHS grows, so will the issue of ethical and legal conflicts that cryopreservation provokes5. And the perplexity of lawyers and ethicists who do not strongly oppose the deliberate production of a surplus of embryos will grow.
The capacity of frozen embryos to give rise to unusually complex legal disputes is astonishing6. Compared to the actual disputes that have arisen, the audacious legal programs of study made following the implantation of the technique today seem extremely naïve or ill-adapted7.
From a legal point of view, not many destinations have been foreshadowed for the EHS. They are few and far between. There is no doctrinal consensus or agreed practical solutions on what to do with EHS.
Three main solutions have been proposed: donation, for procreative purposes, to other couples; donation to scientists for experimental purposes programs of study ; or destruction after a period of time determined by law. But the dominant internship is to prolong cryopreservation indefinitely.
Legislative norms are typically at odds with each other in this sector. Some prohibit EHS donation, others tolerate it. Some punish the use of embryos in experiments, others authorise it, with more or less strict or lax conditions, up to 14 days. Different laws set the maximum cryopreservation deadline at one, three, five or ten years, or indefinitely8.
These rules are to be applied by doctors, but the destruction of EHS provokes, among doctors, a strong repugnance, compatible with the unenforced harshness of certain legal or professional rules. There are legal regulations authorising doctors to destroy EHS, such as, for example, the Spanish one9 : but no one, as far as we know, has ever made use of this authorisation. The harshness of certain criteria is met with non-application. Thus, for example, the Ethics committee of the American Society for Reproductive Medicine closed the way to donation for procreation or experimental use, by establishing, in 1997, that if a centre reasonably determined that embryos had been abandoned, the centre could dispose of these embryos by thawing them. Under no circumstances, however, could abandoned embryos be donated to other couples or used in research10. But the fear of possible litigation or the residue of respect for life render these rules inoperative.
A very humanitarian rule proposal by the American Society of Lawyers, which was intended to save the fate of certain EHS succumbed to the push of a hardcore individualist Philosophy . This rule intended that, in the event of dissolution of marriage, where the couple had previously cryopreserved embryos with the intention of procreation [...], if one of the parties wished to proceed in good faith and in reasonable deadline to gestate to term [some of those embryos], assuming the rights and obligations of parenthood, he or she should obtain possession and control of the frozen embryos. The proposal had to be withdrawn, as it did not resist the pressure of the autonomist ideology: everyone is the absolute master of his or her reproductive capacities11.
We can see that the EHS are the losers, even if someone takes their side. This status of disengagement has complex roots, some elements of which can be identified.
I believe that the main contribution that modern medical ethics has made to the men and women of today is that it has awakened their ethical responsibility. Not so long ago, under the old regime of medical paternalism, patients played a passive role: they willingly put their health and their fate in the hands of the doctor. Today this is no longer the case: the patient is invited to understand the status in which he or she is involved and to authorise the doctor's interventions with his or her consent. This places the doctor-patient relationship in an intense field of ethical forces.
How does this apply to the problem at hand?
People who use assisted reproduction techniques often find themselves at a special status . They are anxiously looking for a child. But they do so with a heavy emotional burden, because time is against them and overcoming infertility often affects the stability of the marriage.
Does the information to be given to such persons by the physician include information on the issue of embryos to be created, and should the physician provide information on the problems that may arise in connection with EHS? Is the decision on the issue of embryos to be created a strictly technical matter, such as the subject culture medium to be used, or is it a fundamental ethical issue, which no one can take in the place of the parents?
Modern medical ethics oblige physicians to provide their patients with all ethically significant information, including the risks and consequences of the decisions that may be taken. Responsible couples want this information to be objective and complete, for they cannot be absent from the decisions that are theirs to make and which they must make with full lucidity. The doctor must provide this information at purpose in order to make couples aware of their duties. Patients sometimes tend to turn a blind eye to the truth, but doctors must help them to act responsibly, even if this means not going ahead12.
I have tried to search the literature, and a few forms, for informed consent to embryo freezing if informed and consent is sought on the specific point of issue of embryos that parents authorise their gametes to create. The search has been in vain, with the exception of one reference letter to a law in force in the State of Louisiana13. There is no doubt that in the legal rules and regulations and in the day-to-day reality of assisted reproduction centres, full information is provided, authorisation is sought for many aspects of medical interventions, and also rights are granted to parents on many things that have to do with the embryos already created14. It is argued that the right to decide on the fate of embryos belongs to the parents and that this is a fundamental right, based both on the special link between the "genetic material" and the identity of the person, and on the importance and centrality of reproduction in the life plan of individuals or couples and the non-transferable interest of individuals in controlling their own reproductive capacity.
But, curiously, there is no accredited specialization of the right to determine the issue of created embryos15. Typical in this sense is the annual I report of the Spanish National Commission of Assisted Human Reproduction. In its analytical section it contains some general proposals to reduce the issue of cryopreserved embryos16. And, although it states that the main thing is that couples should take joint responsibility for the fate of frozen embryos, it does not make accredited specialization any claim that couples have any say in the issue of embryos that are produced. It advises that Centres should limit the issue number of embryos they freeze to that rationally necessary to achieve procreation for the couple in question. But, in the moment of truth, the report Withdrawal to establish fixed numerical guidelines, as the Commission considered that it was not appropriate to recommend a limit on the issue of oocytes to be retrieved and fertilised. Logically, the model of form of informed consent C by the Commission does not ask for the couple's opinion on this decisive point17.
In my view, the serious question of what to do with supernumerary human embryos does not have answers that are both ethical and practicable. The proposed alternatives, indefinite cryopreservation, donation to other couples, donation for destructive research , or outright destruction, are not, separately or together.
The weak and questionable alternatives of prolonged in vitro culture or pre-implantation diagnosis do not seem to be a solution to such a huge problem. These techniques would serve to select and discard embryos considered to be of poor vital quality or Genetics. But it must not be forgotten that the dynamics of selection is insatiable: it is necessary to have a lot of "material" to choose the optimum.
Not so with indefinite cryopreservation: it would be absurd to expand year after year the issue of liquid nitrogen tanks to store tens of thousands, hundreds of thousands of frozen embryos, petrified in time, "in limbo, like unclaimed umbrellas in the lost property office of a railway station "18.
Donation to other couples is not: as a recent work points out, embryo donation is much talked about, but little practised. As if the legal problems were not small enough19 , the complexity of its psychosocial and ethical implications create confusion and uncertainty for potential donors and recipients. Recipients want to know a lot about the psychological and genetic background of donors. Donors have to overcome their emotional attachment to the embryos, and place these creatures of theirs in the hands of people whose traits and lifestyles they do not know20.
Destruction is not. No words (letting die, not allowing growth, destroying) can disguise the hard fact that a human creature was created to live and is left to perish. This is yet another case of moral repugnance that reached massive proportions in 1996 in the UK, when public outcry led to the extension of the deadline conservation legislation21.
Nor, finally, is the destructive research , which reduces human embryos to the status of consumables, incompatible with the minimum respect required for the human subject in biomedical experimentation. No goals of research are so valuable that they can legitimately be achieved at the cost of human life. This is what the Nuremberg Code said, what the Helsinki declaration affirms and what the agreement on Human Rights and Biomedicine of the committee of Europe, ratified by Spain, imposes on us, which, in its article 2, proclaims the primacy of the human being when it tells us that "the interest and welfare of the human being must prevail over the exclusive interest of society and science".
Faced with a problem of this size and complexity, the wise thing to do is to avoid it, the prudent thing to do is to minimise it as far as possible.
Deliberately not producing human supernumerary embryos is a morally and scientifically sustainable decision. It is a solution that clashes, on the one hand, with the interests of in vitro fertilisation teams, highly motivated to reach the maximum level of efficiency, prestige and competitiveness; and, on the other, with the preferences of the users of the techniques, who are often interested in saving themselves the inconvenience, risks and costs of restarting the clinical process. But seen from a perspective of justice, which gives the human embryo its due, it follows that for these preferences and marginal achievements, we are paying a prohibitive price: the precarious existence of thousands of surplus embryos.
Annex: Is it acceptable that people who undergo in vitro fertilisation are so indifferent to the fate of the EHS?
If the process of obtaining informed consent for in vitro embryo production is taken seriously, to produce supernumerary embryos is to bring to life, as the fruit of a calculated decision and with the help of technology, human beings in order to place them in a state of maximum defencelessness. Instead of fathering them as children, treating them with profound respect, caring for their individual destiny with the utmost diligence, they are reduced to the status of disposable things.
This is a matter of extreme moral intensity. In principle, the parents go for in vitro fertilisation in search of a longed-for child. They say to the doctor: We want to have a child, our child. The embryos that are created on laboratory are created to live. They are not creatures begotten casually, inadvertently, irresponsibly, in a fit of eroticism and passion. They are brought into existence intentionally, in order to be children, with full deliberation, with the help of the technical artifice of laboratory.
And yet, to all appearances, doctors and parents agree to produce embryos without much realisation of what they are doing, unwilling to realise that these are real children for whom they must feel responsible. Many parents," says a British clinical embryologist, "ask for their embryos to be frozen without thinking through all the implications. And then they abandon them mentally and physically. 22 They create them simply for the dubious benefit of efficiency and convenience.
In fact, half-willingly, but willingly, certain embryos are brought into the world as spare parts never used, poor human beings with a short and instrumental life expectancy, with no chance to develop and flourish. Their more fortunate siblings are given the chance to live. They are abandoned. And this by virtue of mere chance or the application of morphological criteria of dubious validity.
The widespread indifference on the part of parents is alarming. Someone has dared to say that fatal decisions are, after all, a defining feature of the moral profile of reproductive medicine23.
We must be open to hope. In today's pragmatic and secularist society, the idea that the unborn child is important, that the interests of embryos are to be taken seriously, is slowly gaining a social basis and argumentative force. As Annas argues, the assisted reproduction industry caters to the desires of adults, and those desires constantly override the interests of children24.
Out of a balanced sense of responsibility, out of civil awareness of the dignity of every human being, out of medical respect for nascent life, the production of supernumerary embryos must be abandoned.
(1) American Society for Reproductive Medicine, Ethics Committee: Ethical Considerations of Assisted Reproductive Technologies. Disposition of abandoned embryos. Fertil Steril 1997;67. Suppl. 1:1S.
(2) National Commission on Assisted Human Reproduction. I report annual, December 1998. Madrid: Ministerio de Sanidad y Consumo, 1999:34.
(3) Trounson A, Bongso A. Fertilisation and development in humans. Curr Top Dev Biol 1996;32:59-101.
(4) Kmietowicz Z. College urges maximum of two embryos for in vitro fertilisation. BMJ 2000;320:271.
(5) Trounson A, Dawson K. Storage and disposal of embryos and gametes. BMJ 1996;313:1-2.
(6) Robertson JA. Disposition of frozen embryos by divorcing couple without prior agreement. Fertil Steril 1999;71:996-997. Annas GJ. The Shadowlands. Secrets, lies, and assisted reproduction. N Engl J Med 1998;339:935-939.
(7) Robertson JA. Ethical and legal issues in cryopreservation of human embryos. Fertil Steril 1987;47:371-381.
(8) MacKellar C, ed. Reproductive medicine and embryological research. A European handbook of bioethical legislation. 1997-1998. Edinburgh; European Bioethical Research, 1997.
(9) "After two years of cryopreservation of gametes or pre-embryos that do not come from donors, they will remain at the disposal of the corresponding banks" (Art. 11.4 of Law 35/1988 on Human Assisted Reproduction). Incidentally, this clause of the Spanish law creates a well-defined social ethos of irresponsible insensitivity. It tells the parents of the embryos not to worry about their frozen children, because their anxiety will soon be over: after two years, they will be at the disposal of the Bank. The words could not have been better chosen to provoke a strange association of ideas: the parents of the embryo are the insolvent debtor whose assets are seized.
(10) American Society for Reproductive Medicine, Ethics Committee: Ethical considerations of assisted reproductive technologies. Disposition of abandoned embryos. Fertil Steril 1997;67. Suppl. 1:1S.
(11) Forster H, Donley C, Slomka J. Comment on ABA'a proposed frozen embryo disposition policy. Fertil Steril 1999;71:994-995.
(12) Dulioust E, Busnel M-C, Carlier M, Roubertoux P, Auroux M. Safety of embryo cryopreservation: facts and artefacts. Human Repr 1999;14:1141-1145.
(13) Dickey RP, Krentel JB. Couples having IVF should be asked their wishes about spare embryos before egg retrieval. BMJ 1996;313.1078-1079. In this letter to publisher, the authors point out that, since 1986, the State of Louisiana has a law (Civil Code Article La RS 9:121-133) stating that all couples seeking in vitro fertilisation are offered, among other alternatives, the option to decide to inseminate only the issue oocytes of their choice.
(14) Ethics Committee of the American Society for Reproductive Medicine. Informed consent and the use of gametes and embryos for research. Fertil Steril 1997;68:780-781.
(15) Pennings G. What are the ownership rights for gametes and embryos? Advance directives and the disposition of cryopreserved gametes and embryos. Human Reprod 2000;15:976-986.
(16) National Commission on Assisted Human Reproduction. I report annual, December 1998. Madrid: Ministerio de Sanidad y Consumo, 1999:54.
(17) Ibid.: 107-112.
(18) publishing house. What to do with spare embryos. Lancet 1996;347:983.
(19) For example, in France, where the legal rule requires an endless succession of formalities: Ministère de l'emploi et de la solidarité. Nouvelles techniques de reproduction. Décret no. 99-925 du 2 novembre 1999, relatif à l'acueil de l'embryon et modifiant le code de la santé publique. J.O. no. 258, 6 November 1999: 16598.
(20) Kingsberg SA, Applegarth LD, Janata JW. Embryo donation programs and policies in North America: survey results and implications for health and mental health professionals. Fertil Steril 2000;73:215-220.
(21) Boulton A. Britain poised to extend storage of frozen embryos. BMJ 1996;312:10.
(22) Dawson KJ. The storage of human embryos. discussion Destruction of cryopreserved embryos. Hum Repr 1997;12:6.
(23) Schäfer D, Kettner M. Moral concern over cryopreserved human embryos: too much or too little. discussion Destruction of cryopreserved embryos. Hum Repr 1997;12:10-11.
(24) Annas GJ. The Shadowlands. Secrets, lies, and assisted reproduction. N Engl J Med 1998;339:935-939.