Jessica is now a lively and
intelligent 22-year old young woman attending a renowned university in Virginia; she has an
excellent chance of being cured. She is
playing tennis again and is generally feeling well. Unfortunately, she most likely will be unable
to have her own biological children due to the effects of chemotherapy and
possibly the radiation. One must wonder
whether there was any way this could have been avoided.
When Ben was 14, he noticed a
painful lump in his right wrist. An
x-ray showed what appeared to be a malignant tumor arising from the
radius. A CT scan
confirmed the existence of a tumor. A
biopsy revealed an osteosarcoma, a type of bone cancer, the same kind Teddy
Kennedy, Jr. had. Luckily, the cancer
had not spread. Ben was treated with
intensive chemotherapy and surgery, and he, like Jessica, has done extremely
well. Ben is now a 16-year old high
school junior. He, too, is probably
cured and will grow up to be a healthy man just like his father. Unlike his dad, however, it is almost certain
he is sterile, a result of the ifosfamide chemotherapy he received to cure his
cancer.
Jessica and Ben are but two of the thousands of patients
who have been helped to live their lives, relatively healthy and free of
cancer, but are unable to have biological children. A significant percentage of long-term
survivors suffer this complication.[2] Like other people with infertility, the
psychological effects can be consuming.[3]
One commentator has explained these effects occur because:
Parenthood is
an integral part of the life most individuals envision for themselves. This vision is deeply rooted in American
culture and is continually reinforced by social norms. The biological link between parents and
children is a fundamental part of this vision - - most people assume that
someday they will have their ‘own’ children.
Women are raised to see themselves as future childbearers; men, to
understand fertility as central to masculinity.
As a result of this socialization, most Americans consider biological
parenthood as an essential component of a fulfilled life.[4]
Consequently,
because “the desire to have children must be among the most basic of human
instincts, and denying it can lead to considerable psychological and social
difficulties,”[5] infertility often creates one of the
most distressing life crises for the individual(s) dealing with it.[6] The long-term inability to conceive a child
can evoke significant feelings of loss and hopelessness.[7] The literature on the psychological
consequences of infertility shows that infertility can be a devastating
experience, especially for women.[8] Studies have revealed that there are
significant differences between fertile and infertile women, with the latter
having generally higher stress-levels and lower self-esteem.[9] Infertile women have similar levels of
anxiety and depression as compared to women with cardiac disease, cancer,
hypertension, and HIV, thus revealing the intense impact that infertility can
have on an individual’s psychological health.[10] In addition, coping with the multitude of
medical decisions and the uncertainties accompanying infertility can create
great emotional upheaval.[11] Thus, the psychological effects of
infertility may be even more overwhelming in the population of childhood cancer
survivors who have already survived life-threatening illness and have dealt
with numerous medical decisions and treatment.
Some might say that young cancer
survivors should be grateful they are alive and shouldn’t worry about this
“minor” problem, for they can always adopt children or take advantage of the
latest assisted fertilization and reproduction techniques using donor eggs and
sperm. Moreover, when one views dispassionately the severity of known late
effects of chemotherapy and radiation, some of which can be life-threatening,
infertility tends to pale by comparison.
But this attitude ignores the fact that most people prefer to have their
own biological children. Indeed, the
experience of one of the authors seeing adults in our Long Term Follow-Up
Clinic has convinced us of the personal tragedy that infertility due to cancer
treatment is for many survivors. This is
especially true for people who were treated as children, but also applies to
young adult women who suffer the same consequences. Even if services to preserve fertility were
available at the time, it is uncommon for patients and families to have been
consulted or informed of this possibility of this side effect. All-too-often we have seen young women and
men devastated by the knowledge that, in addition to the potential for
treatment-related heart disease and second cancers, they will not be able to
bear or father children. Oncologists who
care for children and young adults spend a lot of time thinking of ways to
avoid both the short- and long-term complications of treatment. Can the sterilizing effects of intensive
chemotherapy and radiation be avoided?
To attempt to circumvent the
sterilizing effects of chemotherapy and radiation on children who have cancer,
we have suggested that fertility preservation services should be available and
offered to all patients who are either of childbearing age at the time of their
diagnosis or have the potential to be so in the future. Patients under the age of 18 would be
provided with the option of having their sperm or ova collected and
cryopreserved (frozen) until they are adults, at which time they would have the
option of using their preserved gametes to have their biological children. For boys and men, the collection would be
obtained using standard techniques of masturbation, and at least one specimen
would be obtained for cryopreservation.
The collection for females would be more invasive and would need to be
done through a surgical procedure since the “usual” way of obtaining eggs via
the time-consuming process of hormone stimulation cannot be used (see
below). Oocytes would be gathered as
ovarian cortical slices using laparoscopic techniques.[12]
Thus, the age range for the girls who could use this service would be
based on whether the physician believed he/she could obtain a sufficient tissue
specimen. For girls who would be having
abdominal surgery as part of their cancer treatment or for another reason
(usually diagnosis, or possibly oopexy for pelvic radiation therapy), the
laparoscopy would occur at the same time.
However, the girls who would not need abdominal surgery would need to
undergo a separate laparoscopy to obtain the cortical slice. For both procedures, the girls would have to
be sedated under general anesthesia.
Finally, only one ovary would be biopsied in each female patient due to
both the low, but real, risk of ovarian damage, and the fact that more than
enough eggs can be harvested.
However, as simple as this
proposal might appear on first review, there are many pitfalls and potential
roadblocks that arise when practical implementation looms near. In the remainder of this article, we will
discuss the medical, ethical and legal aspects of fertility preservation in
cancer patients, especially children: all three areas present challenges that
need to be addressed and overcome in order to provide the highest quality of
care to this vulnerable population and thus attempt to not deprive them of one
of life’s greatest fulfillments.
Finally, we will discuss the program we have created at Duke that we
suggest could serve as a model at other institutions.
THE
MEDICAL AND ETHICAL
CHALLENGES
We believe that boys, girls, men,
and women should be offered the opportunity to take advantage of fertility
preservation services, but the implications of participation are different for
the two sexes. Thus, we will discuss the
access to gamete preservation by boys and young men first, since they are
relatively straightforward. Let us first
describe exactly how this is done and some of the obstacles.
The technology to collect semen
by masturbation and then to store it by cryopreservation has existed for some
time and is quite successful. With
advanced assisted reproduction techniques like intracytoplasmic sperm
injection, the number of viable sperm available upon thawing is not as crucial
as it once was when artificial (in vivo)
insemination was the only available method.
Cryopreservation of sperm is fairly simple and straightforward, does not
require enormous amounts of equipment, and is also relatively inexpensive. Semen can be stored in this way almost
indefinitely, or at least for many years without significant loss of viability.
For typical semen collection in
healthy adult males, multiple samples are taken over a two to three week
period.[13] Delays of this length of time before
initiating cancer therapy for children are usually not possible due to the
necessity for starting treatment quickly because most cancers in young people
are very aggressive and rapidly growing.[14]
Consequently, boys may only be able to provide one or two ejaculates at
best. Furthermore, the size or volume,
and thus the number of viable gametes, may be affected by both the age of the
child and the severity of his illness.
Having a small sample, however, does not decrease the potential benefit
of the entire process because “a single ejaculate, even if of poor quality,
will usually contain at least a few million living sperm” that can be
cryopreserved for later use.[15] Some young cancer patients may have a
difficult time ejaculating, which could also be an impediment to successful
collection.[16]
There are biological reasons why
it is difficult to collect viable sperm from pre-pubertal boys, but this has
not stopped some investigators from either doing testicular biopsies[17]
or using the technique of electroejaculation (this approach is most often used
in paraplegic men who wish to father children and are impotent due to their
spinal cord injuries).[18] While the former has not been reported in the
literature to have been tried in the United
States, where the proscriptions against using
unproved and risky technologies on minors are widely observed, perhaps we may
need to reconsider this policy in this special population of boys. However, there is no question that the
chances of success (defined as obtaining viable spermatocytes) using invasive
techniques are very low in pre-pubertal boys due to the lack of spermatogonia
and other cellular machinery necessary for sperm production. It is possible that these approaches should
be reserved for boys who have entered puberty but may not be capable of
producing an ejaculate by masturbation for any number of physical or
psychological reasons. Likewise, these
technologies may circumvent some of the religious or social proscriptions
against masturbation
in which many people believe (see below).
In our Reproductive Endocrinology
Clinic, like many others around the nation, private rooms are equipped with a
television and a videocassette player, along with sexually explicit (some would
call them pornographic or obscene: see below) tapes and magazines. In the United States, few societal taboos
exist about allowing consenting adult men to view sexually explicit materials
(if they wish) to masturbate to produce one or more semen samples, although
many people of faith find this disturbing.
There may be moral, ethical, physical and religious obstacles to
collecting semen samples from male minors by the same methods used for adults,
i.e., using sexually explicit materials as masturbatory aids. Boys would require their parents’ consent to
the procedure and collection (and thus their permission to masturbate), which
could cause them and their parents psychological discomfort, embarrassment, or
possibly humiliation. It is unlikely,
however, that these feelings would be so severe as to cause the collection
procedure to be labeled “risky,” especially because it would seem that
masturbation in this setting would be less “taboo” and more clinical. However,
proper counseling should be available to these boys to lessen the risk of any
possible psychological harm and to increase the potential benefit of the entire
process. What this counseling should
consist of is less clear. In our
experience, consultation with male physicians, adult friends, fathers, and even
members of the clergy has been helpful.
However, religious beliefs
against masturbation may create major obstacles for boys and men, as some
religions teach that masturbation is a sinful activity. For instance, Orthodox Jews believe it is
sinful and immoral to masturbate because it “waste[s] the seed.”[19]
The Church of Jesus Christ of Latter-day Saints, which believes that
propagating children is an obligation of their faith, is adamantly opposed to
masturbation.[20] The Church declares that “[m]asturbation is a
sinful habit that robs one of the Spirit and creates guilt and emotional stress.”[21] Roman Catholicism teaches that procreation
should occur only in the sanctity of a marriage between a man and a woman.[22] So, traditionally in Catholicism, “any form
of reproductive manipulation is considered morally wrong.”[23] In fact, in 1987, the Vatican issued an
encyclical entitled Donum Vitae (“Instruction on Respect for Human Life in Its
Origin and on the Dignity of Procreation”), expressing the Church’s moral
opposition to techniques of procreation that deliberately severed the
procreative and unitive ends of sexuality, including donor insemination and in
vitro fertilization.[24] In addition, all Catholic sexual acts rest on
the principle that procreation in an essential aspect of human sexuality, so
the church believes every genital act must be open to the possibility of
conception, which is why masturbation has been forbidden.[25] However, with the new Catechism issued in
1999, the Catholic Church declared that masturbation is not necessarily sinful.[26] Many, if not all, evangelical Protestant
faiths in the United States and
elsewhere, proscribe masturbation as sinful.
Thus, different religions espouse different views on masturbation that
could be an impediment to the boys and young men taking advantage of this
technology. Indeed, we believe that the
thoughtful input of clergy and theologians should be an integral component of
any comprehensive fertility preservation program.
We next discuss female patients,
whose situation is much more complicated and involved. Treatment damage to ovarian function can take
many forms, and it can be difficult to accurately predict, except in certain
circumstances, whether a woman would maintain fertility years after therapy has
ended. The baseline infertility rate for
couples in the United States is about
10-15%, so one would have to assess increased risk above this rate for young
women due to cancer treatment. Indeed,
an accurate assessment of the risk of infertility in girls and young women as a
consequence of cancer treatment is exceedingly difficult to construct because
of the paucity of well-designed studies to address this question. Whereas the data for the dose-response
toxicity relationship for alkylating agent chemotherapy for males is reasonably
well established, the same cannot be said for females, leaving both clinicians
and researchers to estimate (or simply guess) the risk. Thus, much more research will be required to
obtain this information before it can be applied in a clinical setting. Nonetheless, female cancer patients, even
those who may not be at high risk for infertility, are increasingly demanding
fertility preservation. This topic is of
great relevance and urgency due to the proliferation of commercial infertility
clinics offering to preserve fertility by cryopreservation of ovaries and oocytes
(see below). Even though these
techniques are unproven that has not prevented many of these companies and
clinics from selling these services to this extremely vulnerable population of
young women (see, e.g., http://www.givf.com/ovary.cfm).
From a technical perspective,
gamete preservation for girls is, for a variety of reasons, more challenging
than for boys. Unlike sperm
preservation, where collection and freezing techniques have been used in
healthy males for years, and the use of frozen sperm to later produce healthy
babies is well-documented, the collection, freezing, and use of ovarian tissue
for purposes of reproduction, is still highly experimental. In addition, the collection of ovarian tissue
is much more physically intrusive, and requires surgery. These two factors – a greater level of
medical intrusiveness and risk, and less likelihood of a successful outcome –
mean that designing a program for girls and young women requires heightened
sensitivity to the ethical concerns. The
principles of beneficence and nonmalificence are paramount in our treatment of
minors, especially when they (and their parents) are as psychologically
vulnerable as those who have just been told they have cancer, the treatment for
which could cause infertility. Special
care must be taken to not take advantage of these patients and families, even
for such a noble cause.
For
instance, while it highly likely that Jessica is infertile, it is by no means
definite. The accepted definition of infertility is “one year of frequent and
unprotected coitus without conception, suggesting a diminished capacity to
conceive and reproduce.”[27] This definition is most applicable to females
since the ability to get pregnant is dependent upon a number of mutually
dependent and independent factors, including successful ovarian follicle
formation and ovulation, transit of the mature egg down the fallopian tube and
fertilization in the uterus followed by implantation. Meanwhile, all men have to do is produce
sufficient functional sperm that can fertilize an egg. However, in a significant percentage of
infertile couples the problem does not lie with the female partner, as the male
could have a low sperm count, for example.
Current technology has allowed
physicians who specialize in infertility to overcome many potential obstacles
associated with conception. For
instance, women who are capable of ovulating but who have blocked fallopian
tubes (from prior infection, for example) can have mature oocytes harvested by
laparoscopy, fertilized in vitro, and
embryos inserted into the uterus for implantation. However, in Jessica’s case, if she were
infertile, it would be impossible to say whether it was due to some
pre-existing condition, her treatment, or some combination of the two.
Chemotherapeutic agents or
radiation can cause ovarian damage; because of this it would be preferable to
obtain oocytes before starting therapy. If one could wait for several weeks to
start anti-cancer therapy, and if the primary disease would not contraindicate
giving hormones to induce super-ovulation, then one could potentially harvest
hormonally mature eggs, fertilize them in
vitro, and freeze the embryos for later use. This is possible because the
technology for cryopreservation of embryos is well established, although
cryopreservation of immature oocytes from ovarian tissue is still
experimental. Presumably, this approach
could be used for a woman who knew she wanted to have children (or more
children) and had a male partner (or not) available. However, having the time to undergo these
procedures and having a male partner to fertilize their eggs is a rare
situation for these young women. For
minors and women without partners, this is impossible. Furthermore, for some patients, the use of
high doses of hormones that stimulate hyper-ovulation might be contraindicated
due to the potential for increasing the rate of cancer cell growth, clearly
something that we would not want to do.
Young women with estrogen receptor-positive breast cancer would fall
into this group.
More commonly, treatment must be
started right away, and there is little time available to obtain hormonally
mature eggs. Many reproductive
endocrinologists have begun to offer to take ovarian cortical slices (biopsies)
by laparoscopy to cryopreserve for later use.
Unlike hormonally mature oocytes, which cannot withstand the rigors of
freezing and thawing very well, immature eggs are more resistant to thermal
stress. The frozen ovarian tissue would
then be thawed at a later date and implanted into the same patient (autologous)
with the hope that it could function normally.
The challenge is that a successful human pregnancy has yet to result
from this approach. While this technique
has worked to produce offspring in a number of species, such as rodents and
ungulates, the same cannot yet be said for humans. It is encouraging, however, to note that
ovarian slices have been successfully “auto-transplanted” into several women to
restore hormonal function, including ovulation, although not pregnancy. Although we suspect it is only a matter of
time before this technique is perfected for women, it has not stopped
commercial (and a few academic) centers from offering this “service” (ovarian
cortical slice harvesting and freezing) to women and, in at least one report
from England and Israel, to girls under the age of 18 years.[28]
What about providing the service
to girls under the age of 18 in the United
States?
From the medical standpoint, it would be theoretically possible to
obtain ovarian tissue from even very young children (< 8 years of age), and
maybe even babies. However, the ability
to even find the ovaries in small girls would be a challenge. If one could find
them, their size most likely would preclude taking only part of the gland,
meaning a unilateral oophorectomy (total removal of the ovary) would be
necessary. Furthermore, the ability to
do this procedure with a laparoscopic approach diminishes with decreasing
age. Thus, young girls may have to
undergo open pelvic surgery to obtain oocytes to cryopreserve for later
use. If the child needed abdominal
surgery anyway (say to biopsy or resect an abdominal tumor), one could make the
argument there is minimal-to-no added risk in removing part or all of an ovary
at that time. It may, nonetheless, be
less controversial to offer ovarian cryopreservation to pubertal girls. While the laparoscopic surgery they would
undergo is low-risk as far as surgery goes, it still involves some risk of
bleeding and infection, which might not be a risk the girls (or their parents)
are willing to take.
This is especially true when we
are unable to predict the true risk of ovarian damage from various cancer
therapies (see above). We are thus faced
with a situation in which we have a combination of unproven, yet potentially
useful and proven in the future, technologies, a surgical intervention of known
risks (laparoscopy), and only a very loose estimate of the risk of infertility
due to a particular cancer treatment as the data set upon which we rely for
both policy formation and individual patient recommendations. This is true for both girls and women, but
especially so in minors. Offering
medical interventions to patients for which there is current proven benefit
outside of an approved research program is ethically questionable for adults
and undoable in children for whom the principle of beneficence outweighs all
other considerations. There are
exceptions to this rule in which the potential for societal or “class” benefit
may apply (Phase I clinical trials of new anti-cancer drugs in children is one
such example), but these are uncommon.
The financial impact of fertility
preservation is another major consideration.
Like most medical services involved with fertility, insurance companies,
and government health care payers rarely, if ever, cover the costs of the
procedures. While the freezing and
storage of ovarian tissue is probably not that much more expensive than the
analogous service for sperm, the costs associated with surgery, anaesthesia,
and hospitalization are considerable and must be totally borne by the patient
and/or her family. At many institutions,
this cost can approach $5000 or more.[29] Does this mean that we can only offer the
(potential) preservation of fertility to people who can afford to pay for
it? Such a prospect undoubtedly raises
issues already at the forefront of discussions about disparities in access to
medical care based upon socioeconomic, racial, and ethnic factors. Unfortunately, this point is almost
completely academic, as there are few medical centers that take care of adults
(and even fewer pediatric centers) that have programs in place to offer gamete
cryopreservation to all their patients who may be at risk.[30]
However, we have had to confront this challenge at our own institution
and develop a unique solution (see below).
THE
LEGAL CHALLENGES
In order for any individual to
take advantage of the service of collecting and cryopreserving his or her
gametes, the law requires that the patient provide informed consent to undergo
the procedures. The purpose of informed
consent, which requires a physician to disclose to the patient “all the facts
which mutually affect the rights and interests of [the patient] and the
surgical risks, hazards, and dangers, if any . . . ,”[31]
is to protect the rights of the patient, while promoting bodily integrity and
self-determination among patients.[32] Thus, “[u]nder the informed consent doctrine,
physicians are obligated to provide each patient with information necessary to
enable the patient to make an intelligent decision about whether to undergo a
recommended procedure, consent to an alternative treatment option, or refuse
treatment altogether.”[33] The following represent the six types of
information typically required for consent to be considered informed: (1) the
diagnosis; (2) the nature and purpose of the treatment or procedure; (3) the
expected outcome and probability of success; (4) the material risks, benefits,
and consequences of the proposed treatment or procedure; (5) the alternatives
to the proposed treatment and supporting information regarding the
alternatives; and (6) the effect of no treatment or procedure, including the
effect on the prognosis and material risks associated with no treatment.[34]
For children to use a fertility
preservation service, their parents must provide consent. The parents must consent because children are
considered to be immature; consequently, the law assumes they are unable to
make important decisions affecting their lives.[35] The law, therefore, provides adults with the
authority to make decisions for children that adults are free to make for
themselves. The premise of this law is
that the parents are the first best caretakers of the child and that they have
an interest in this role that warrants legal protection.[36] Thus, the requirements of informed consent
that would apply to competent adults, such as explaining the nature of
potential benefits, would simply apply to informing the parents about their
decision to permit their children to use the service.
Although it is not legally
required, children should be given the chance to voluntarily agree to use the
service, by giving their “assent.”
However, if this is done as part of a research program, Institutional
Review Boards are required to demand minor assent as part of informed
consent. “The assent process should be
tailored to the age, maturity and psychological state of the children involved
and should be easy for the children to understand.”[37] It should also include a discussion of any
discomforts and inconveniences the child may experience if he/she uses the
service.[38] Such assent allows the child to feel
empowered and to feel as if he is taking part in making decisions about his
treatment. It may, therefore, make him
feel more at ease about what he will endure.[39] The process is not just about getting the
child to agree to use the service, but rather it is about making sure the child
understands the procedures and what it means to preserve his gametic material.[40] These details may differ in other countries.
Three consent situations could
arise with respect to offering this service to children: (1) the child assents
and the parents consent to use the service; (2) the parents consent to the
child’s use of the service, but the child does not assent; and (3) the child
assents and wants to use the service, but the parents will not consent. In the context of informed consent, with
respect to the first scenario, there should be no problem with the child using
the service, so long as there really is informed consent. Under the law, if the second scenario were to
happen, the parents would have the right to force the child to use the
service. However, we do not believe that
this situation would happen very often, and it would be highly unusual for a
physician to force a child to undergo these procedures. Finally, the third scenario presents the most
problems, not only legally, but also ethically.
Due to a child’s unique status in the law, doctors should not treat the
children against their parents’ wishes, although they may desperately want to.
In addition to the principle of
informed consent, legal issues exist surrounding disposition and ownership of
specimens. Are the frozen gametes
property, and if so, who owns them and what can they do with them? These issues take on even more complications
and have more ramifications when analyzing collecting and freezing gametes from
minors. One of the major issues is whether the gametic material should be
classified as “property.”
The law provides people with the
right to control their property.
“Property rights are viewed as a ‘bundle of rights,’ including ‘the
right to possess, the right to exclude, the right to use, the right to dispose,
the right to enjoy the fruits or profits, and the right to destroy’ the property
in question.”[41]
Because the law in the United
States has been slow in recognizing these
property rights in human biological materials, such as sperm, ova, embryos, and
other cells, it is unclear how the gametic material of the children who use the
proposed service would be treated.[42] Some courts, however, have recognized at
least quasi-property rights in human biological material.
At least one court has considered
the issue of whether sperm is property and determined there is a limited
property interest in human sperm. In Hecht v. Superior Court, 20 Cal. Rptr.
2d 275 (Ct. App. 1993), a man who had been storing his semen in a sperm bank
gifted fifteen vials of his sperm to his girlfriend in his will and then
committed suicide. His adult children
challenged the gift, arguing the sperm should be destroyed because there were
no property rights attached to sperm.
The court did not accept his children’s argument, holding the sperm was
property for the purposes of devise and for the probate court to have jurisdiction
over. The court, however, refused to
apply more general property principles, such as the law of gifts of personal
property, to the gift the man bequeathed to his girlfriend. In making its decision, the court noted sperm
banks generally treat sperm as property, and it acknowledged the American
Fertility Society’s position that “gametes and conceptuses are the property of
the donors.”[43]
In addition, it relied upon the American Fertility Society’s declaration
that donors “have the right to decide at their sole discretion the disposition
of these items, provided such disposition is within medical and ethical
guidelines . . . .”[44] The court then analogized sperm to embryos
and concluded that sperm stored solely for the purpose of artificial insemination
is “unlike other human tissue because it is gametic material that can be used
for reproduction.”[45] The court reasoned further that the value of
sperm lies in its potential to create a child after fertilization, growth, and
birth.[46] Ultimately, the court did not award the sperm
to the girlfriend, because the issue before the court was simply whether a
lower court properly ordered the sperm to be destroyed. Instead, the court reversed that order,
holding the sperm was entitled to be distributed in probate. Thereafter, the probate court ruled that the
girlfriend, based on a distribution formula in a settlement agreement, was
entitled to 20% of the frozen semen.[47]
Although the issue of sperm as
property is unsettled and complicated, the issue is even more problematic with
respect to eggs, primarily because it is rare for unfertilized eggs to be
cryopreserved. Nonetheless, the analysis
of the Hecht court in finding a
limited property right in sperm and finding the value of sperm to be in its
potential to create a child could be similarly applied to the eggs harvested
through the service that will be used later for reproduction. Moreover, given the American Fertility
Society’s position on gametes as donor property, it would be inconsistent for
them to view eggs as anything other than property.
The Hecht court was very concerned that gametic material should be used
as the donor intended. One way to enable
individuals to have their materials used as intended is by recognizing human
biological materials as property, thereby giving the owner an enforceable stake
in them.[48]
Yet, many people are opposed to recognizing property rights in the human
body, arguing that it commodifies the body and demeans human dignity.[49] One can argue, however, that property rights
in human biological materials should be recognized because of the protective
value of the rights, and because it will provide a relatively unified approach
to settling the complicated issues that arise when the status and disposition
of human biological materials are concerned.[50]
Furthermore, it has been argued
that with respect to the question of whether sperm and eggs are property, the
answer should be a resounding yes. If
both are property, the children should have rights to control the materials,
even if only through their parents. But,
to use the services we propose, we believe that children and their parents
should sign a consent form declaring that they will destroy the materials if
the child dies before reaching his or her majority. Similarly, adults will be asked to consent to
this stricture, although the ability to enforce this mandate in adults may be
questionable. We suggest such a
provision because it directly raises the issue of what to do with the frozen
sperm (ovarian tissue) in the event of the child’s death, and requires the
parents (or adult donor) to think about the issue before entering the program,
rather than having it possibly come up for the first time in the
emotionally-charged period following a death.
The parents and the child might feel uncomfortable with being forced to
make this decision because, as the American Fertility Society recognizes,
donors should be able to control the disposition of their gametes, and they
might, at some future point, argue that as a result of the consent form, they
no longer have such control. Thus,
parents and children should be able to determine legally that if the children
die, the gametes will be destroyed, or to determine that they will be stored
until age 18, at which time the children should have control over their
disposition.[51] If both sperm and eggs are property, then it
seems that the donors should be able to contract, through their parents, for
the disposition of the materials, although this is unclear.
On the other hand, many modern
American courts have applied contract law, instead of applying laws concerning
property rights, to help resolve disputes concerning human biological
materials.[52] One case that considered how to treat gametic
materials is the case of Davis v. Davis,
842 S.W.2d 588 (Tenn. 1992). In that case, a husband and wife created
embryos that were cryopreserved without specifying for the disposition of the
embryos if one of them died or if they got divorced. The couple then got divorced, and both
parties wanted control of the disposition of the embryos. T husband wanted to
destroy the embryos because he vehemently did not want to become a father, and
the wife wanted control of them to give them to another couple for
implantation. The Supreme Court of
Tennessee held that the embryos were neither property nor persons under the
law; instead, they held an intermediate status and were entitled to special
respect because of their potential for human life. The court also held that the husband’s right
not to procreate and his right to avoid parenthood outweighed the wife’s right
to see the labors of the in vitro fertilization procedures she endured create a
child. Finally, the court expounded that
disputes in Tennessee involving the
disposition of embryos should be resolved by examining the dispute in the
following manner. The court should first
look to the preferences of the progenitors.
If their wishes cannot be ascertained, or if there is dispute between
their wishes, then any prior agreement regarding their disposition should be
followed. If no prior agreement or contract exists, however, the relative
interests of the parties in using or not using the embryos must be weighed to
divine a result, while giving more weight to the party who wishes not to use
the embryo to procreate.
Although Davis concerned the
legal status of and disposition of embryos, an extension of that court’s legal
reasoning could be applied to the gametes that would be preserved through the
service we propose. As a result, if a
conflict were to arise concerning the disposition of the gametic material of a
child who used the proposed service, and if a court considered the case, it
might follow Davis and permit whatever party did not want to use the material
to create a child to destroy the material.
Applying Davis to the wishes
of a party involved in this service is complicated by the fact that there are
potentially three parties: the child, the child’s parents (assuming they both
want the same result), and the service providers. Perhaps, then, a court would rely on the
second step set forth by the court in Davis and look at
any prior agreements concerning the disposition of the gametic materials. Because this might be the manner in which a
court would determine the appropriate disposition, we will require both the
children and the parents to sign a contract dictating how the gametes will be
disposed of in different situations.
Even different results could
occur than in Davis because it seems that court’s primary reason for finding the
materials were not property was that the eggs had already been fertilized and,
therefore, had the potential to become persons. The materials we would preserve
would not yet be fertilized, so while they would still have the potential for
human life, that potential would be less than for embryos because gametes
differ from embryos in that they do not have the potential for life without
fertilization. As a result, if a dispute
were to arise concerning the disposition of a child’s materials, a court might
determine that gametes are property instead of quasi-property. If this were the case, the child (or, if he
is still a minor, his parents) would have the right to possess, use, dispose
of, and/or destroy his own property. One
also could argue, however, that because the gametes are the materials from
which life is created, they do have the potential for life even if only through
fertilization, such that a court would hold they have intermediate,
quasi-property status.
The Davis court also
noted that agreements regarding disposition of embryos should be presumed valid
and should be enforced in the event of contingencies, such as the death of one
of the parties. However, in a Massachusetts case, a
couple divorced after harvesting frozen embryos.[53] The wife wanted to use some of the leftover
embryos, but the husband did not.
Although consent forms and forms providing for the disposition of the
embryos were signed at the beginning of the process, declaring that the wife
could use the eggs in the event of a separation, the husband then changed his
mind. The court found in favor of the
husband, indicating the signed forms were unenforceable contracts.[54] These contrasting conclusions by courts in
different states highlight the legal uncertainties facing all parties involved
in all aspects of the proposed service.
The foregoing legal analysis
would be applicable primarily in situations where there is a dispute over
disposition and ownership of specimens between the service providers and the
child whose materials were preserved. A
potential dispute could also arise regarding the disposition of the gametes if
the donor child dies but the child’s parents’ desire to have possession of the
materials to be used to create their grandchild. Although we would require the signing of a
consent form, which would indicate that upon the death of the gamete provider,
the sperm or eggs will be destroyed, it is unclear whether a court would
enforce the contract over objections by other parties, such as the service
providers[55]
or the parents, or how a court would determine how to enforce a contract when
the gamete provider is still alive.
Although it might seem unusual
that a parent of a deceased child would want to create a grandchild from the
deceased child’s biological materials, it would not be the first time that such
a request has been made. For example,
Pamela Reno of Reno, Nevada was
devastated when her 19-year-old son killed himself playing Russian Roulette.[56] Although her son had wanted to donate his
organs in the event of his death, she refused to permit doctors to take them
unless they harvested her son’s sperm. The doctors collected and cryopreserved
his sperm, which she plans to use to impregnate her son’s childhood friend and
then raise the children – her grandchildren – herself. Reno explained she
desperately wanted grandchildren and that her son always wanted to have
children, so she was merely fulfilling his wish by creating his son. While this situation is slightly different
from one that could arise with respect to the materials of deceased
child-participants, in that the materials have already been collected and
preserved, it underscores the fact that even previously unimaginable issues can
arise in the context of assisted reproductive technologies. Thus, although this scenario is quite
bizarre, we must realize issues such as this could arise if a child who used
the service we propose dies, because, as the doctor who harvested Pam Reno’s
son’s sperm stated, this is “a request that is becoming more frequent.”[57]
According to a survey of
fertility clinics by researchers at the University of Pennsylvania Center for
Bioethics, 82 requests have been made by wives, girlfriends, or parents for
post-mortem procurement of sperm from deceased individuals who ranged in age
from the early 20s to late 30s, with two of minor age and one 60-year-old man.[58] Like the situation with Ms. Reno, in these
scenarios, the men from whom sperm was requested to be retrieved were dead;
however, with respect to individuals who use the proposed services, their gametes
will have already been preserved. Having
the gametes cryopreserved prior to the donor’s death eliminates one of the
problems with posthumous reproduction, specifically obtaining and using an
individual’s reproductive material without his advance consent.[59]
There have been situations where
individuals with serious or terminal illnesses preserved their gametic
materials, and the materials were used to create a child after their
deaths. In one case, a man preserved his
sperm in advance of chemotherapy so that he and his wife could have children if
the treatment made him sterile.[60] He died three months later, and although
there were no signed documents concerning the disposition of the materials, his
wife claimed that he told her before his death that “there could always be a
child for you.”[61] His wife then was inseminated with the sperm
and gave birth to a daughter a year after her husband’s death.
Similar situations regarding
posthumous reproduction could arise once the children who used this service reach
the age of majority, as they would likely be able to determine what they want
to have done with their gametes. For
example, if a child gets married after he/she turns 18, then he/she might
desire to stipulate that his/her spouse should obtain possession of the
materials in the case of his/her death. Thus, although this scenario would not
be as unusual as individuals creating a grandchild from their deceased child’s
gametic materials, it still raises issues of whether posthumous reproduction is
appropriate and whether we should be facilitating such activity.
The potential for
cryopreservation of ova may extend the options for posthumous reproduction to
the use of cryopreserved oocytes, similar to using sperm for posthumous
conception.[62] Posthumous reproduction by men is technically
simpler and more common than posthumous reproduction with women. With advances in cryopreservation technology,
however, more women could consider the possibility of producing a child with
her genetic material after death.[63] This process could be carried out, because
there are currently no statutes prohibiting posthumous reproduction by women.[64] Thus, as one can ascertain from this
discussion, providing this service could cause legal and ethical dilemmas with
respect to the disposition and ownership of gametes.
As already stated, the issues
concerning the control and disposition of gametic material are complex and
legal doctrines and rules in the area are unsettled. Consequently, if conflicts
were to arise, perhaps courts would resolve the problems by applying property
theories, maybe they would strictly adhere to the contract (e.g., the consent
form), or maybe they would make a determination based on the concern that
gametic material be disposed of as the donor intended, as the court wanted to
do in Hecht. Regardless of how a court would decide a
dispute over ownership of the gametes, one should be aware that not all courts
have enforced contracts providing for the disposition of human biological
materials. It is not clear, therefore,
whether ownership disputes could be prospectively handled through a consent
form.
Aside from the control and
disposition issues, another legal and ethical concern arises from collecting
the children’s gametic material. Taking
organ tissue from girls and young women with cancer, which is very often a
systemic disease, could be highly problematic in that there could be tumor
present in the ovarian slices removed.
Upon auto-implantation at a later date, one could be giving cancer back
to the patient who was otherwise thought to be cured. At least one study has attempted to evaluate
this in experimental animals and has found the risk to be non-existent, at
least for Hodgkin’s Disease, a disorder with a high cure rate and where therapy
is a not-infrequent cause of infertility.[65] However, one will not be able to conclusively
prove that the cryopreserved tissue is tumor-free; thus, patients will have to
assume that risk, small as it may be.
In addition, an objection could
arise to using sperm from a boy or young man who has cancer or using an egg
from a girl or young woman who has cancer to create a child, in that there
could be a heightened chance the child created from that preserved material
will be predisposed to having cancer.
Should we be concerned about the potential preservation of “flawed”
genetic material? By this we mean
genomic DNA (contained in oocytes and sperm) that may predispose future
off-spring to an increased risk for disease (cancer)? While the former practice of eugenics and its
associated forced sterilization of the “unfit” is a thing of the past, the
withholding of gamete preservation from children and adults for whatever reason
is akin to prohibiting them from having biological children (“forced”
sterilization). Furthermore, there
appears not to be an increased cancer risk in the children of long-term cancer
survivors.[66]
