Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov
Personal Statements
The preceding ten chapters constitute the official body
of this report; it stands as the work of the entire Council.
In the interest of contributing further to public discussion
of these issues, and of enabling Members of the Council to
speak in their own voice on one or another aspect of this
report, we offer in this Appendix personal statements from
those Members (and groups of Members) who have elected to
submit them:
Statement of Rebecca
S. Dresser, J.D., M.S.; Mary Ann Glendon, J.D., M.Comp.L.;
Charles Krauthammer, M.D.; and James Q. Wilson, Ph.D.
Statement of Rebecca
S. Dresser, J.D., M.S.
Statement of Daniel W.
Foster, M.D.; Michael S. Gazzaniga, Ph.D.; Janet D. Rowley,
M.D.; Michael J. Sandel, D.Phil.; and James Q. Wilson, Ph.D.
Statement of Francis
Fukuyama, Ph.D. and James Q. Wilson, Ph.D.
Statement of Michael
S. Gazzaniga, Ph.D.
Statement of Robert P.
George, J.D., D.Phil; Mary Ann Glendon, J.D., M.Comp.L.; Alfonso
Gómez-Lobo, Dr. phil.; William B. Hurlbut, M.D.; and Gilbert
C. Meilaender, Ph.D.
Statement of Robert P.
George, J.D., D.Phil and Alfonso Gómez-Lobo, Dr. phil.
Statement of Leon R.
Kass, M.D., Ph.D.
Statement of Paul McHugh,
M.D.
Statement of Janet D.
Rowley, M.D.
Personal
Statement of Professor Dresser, Professor Glendon, Dr. Krauthammer,
and Professor Wilson
This document represents a singular achievement. To achieve
unanimity on any issue in bioethics is difficult enough. To
achieve it on an issue as contentious as the treatment of
a human embryo is more difficult still. Yet, this Council
has found unanimous consensus on the recommendations in this
report. Even more remarkable is that this unanimity has been
achieved on a Council of such extraordinary philosophical
and ideological diversity.
Regardless of our different positions on the moral status
of the embryo and on the autonomy that ought to be granted
to science, it turns out that we can agree on certain fundamental
human goods that are at stake and that deserve not just moral
but legal protection. As a result, we are in a position to
recommend to Congress, which represents a similar diversity
of philosophical and ideological inclinations, a concrete
roadmap on how to proceed.
These recommendations establish basic guidelines—"fences"—defining
activities that lie outside the bounds of decency, while at
the same time providing the converse service of defining the
boundaries within which we continue to contend and disagree.
We are proud to associate ourselves with this document.
Rebecca S. Dresser
Mary Ann Glendon
Charles Krauthammer
James Q. Wilson
Personal Statement
of Professor Dresser
Reproduction and Responsibilitymakes several major
contributions. First, it is a detailed and comprehensive account
of existing policy and professional standards relevant to
assisted reproductive technologies (ARTs). Second, it highlights
significant gaps in the current oversight system.
One such gap concerns safety. The federal regulatory system
fails to ensure that newly developed ART interventions receive
the same level of scientific and medical review as do other
novel interventions with potential human applications. As
a result, novel ART interventions may be attempted in human
subjects without sufficient preclinical data showing that
the approach is safe enough to try in humans. Such interventions
may also enter the medical arena without the rigorous evidence
of safety and efficacy normally required before drugs and
other products are approved for clinical use.
Protection of human subjects can also be inadequate. Infertility
specialists developing new approaches are not always affiliated
with an academic or other medical center mandating institutional
review board evaluation prior to human applications. Thus,
there is no assurance that prospective parents will be informed
of a technique’s unproven status, its risks, and the alternative
measures that might be available to them. Another problem
is that federal agencies lack policies explicitly
addressing situations in which investigational modifications
affecting embryos could have health consequences to a later-born
child. The children whose health could be affected by ART
innovations, as well as the parents of such children, should
benefit from the same regulatory protections governing human
research and introduction of new medical interventions as
do other human beings.
More extensive oversight by the Food and Drug Administration
would be one way to address these regulatory gaps. Yet as
Reproduction and Responsibility observes, more assessment
and analysis are needed to determine which specific regulatory
actions would be most effective and least burdensome. At the
same time, this report supplies a solid foundation for moving
forward with oversight to protect people affected by ART in
the research and clinical settings.
Reproduction and Responsibilitymakes a third contribution
in offering additional guidance for federal oversight. One
activity the report discusses is stem cell and other research
that requires the destruction of human embryos. I agree with
my colleagues Daniel Foster, Michael Gazzaniga, Janet Rowley,
Michael Sandel, and James Wilson that certain legislative
recommendations in this report could be helpful in advancing
the current national debates over cloning and human embryonic
stem cell research. The longstanding congressional restrictions
on federal funding for embryo research and similar longstanding
disputes over the ethics of creating embryos for research
suggest that meaningful policy changes will require those
with diverse views to cooperate and to seek common ground.
The report’s recommendations emerged from this sort of process.
Members of this Council know all too well the impediments
to achieving consensus among individuals with very different
positions on the moral status of early human life. Barriers
to consensus also exist when group members disagree on the
moral and social value of technologies that enable more people
to have biologically related children, expand opportunities
to test embryos and fetuses for genetic traits, and offer
researchers new avenues for studying preimplantation embryos.
Reproduction and Responsibility represents a deliberative
success, for it includes a collection of recommendations endorsed
by people with extremely diverse values and beliefs about
these matters. Thus, its greatest contribution may be to demonstrate
that mutual respect, accommodation, and compromise on embryo
research and acceptable ART practices are possible in this
pluralistic and polarized country of ours.
Rebecca S. Dresser
Personal Statement
of Dr. Foster, Dr. Gazzaniga, Dr. Rowley, Professor Sandel,
and Professor Wilson
We endorse the legislative recommendations contained in
this report, on the following grounds: First, the limitations
these regulations impose on the treatment of embryos in assisted
reproduction and research give proper expression to the moral
significance of human embryos. Although we do not regard embryos
as the moral equivalent of fully developed human beings, we
believe that they are more than mere things, and should not
be used wantonly or treated with moral indifference. The proposed
regulations offer a way to prevent such wanton or casual treatment,
and so accord human embryos the respect they are due.
Our second reason for supporting these regulations is that
they point to a possible solution to the vexed issues of cloning
and stem cell research that could overcome the current impasse
in the U.S. Senate. Despite widespread opposition to reproductive
cloning, the Senate has been unable to ban it because of disagreement
about cloning for biomedical research. The obvious solution
is to detach the two questions, but until now, it has proven
difficult to do so. One way of banning reproductive cloning
alone would be simply to prohibit the transfer of a cloned
embryo into a woman’s uterus, as Britain has done. Some object,
however, that such a law would effectively make it a crime
not to destroy a cloned embryo.
The formulation proposed in this report offers a way of
banning reproductive cloning that avoids that difficulty.
It proposes that Congress “prohibit attempts to conceive a
child by any means other than the union of egg and sperm.”
We believe that this language provides a way for Congress
to ban reproductive cloning while agreeing to disagree on
the question of cloning for biomedical research; such a solution
would prevent attempts to created cloned children while allowing
debate to continue about cloning for stem cell research and
regenerative medicine.
The proposed regulations, taken together, also point toward
a possible compromise on federal funding of stem cell research.
Some object to embryonic stem cell research on the grounds
that embryos are persons and therefore inviolable. But others
object on different grounds. They worry that, in the absence
of clear limits, embryo research could lead down a slippery
slope of exploitation and abuse: if today we derive stem cells
from blastocysts, tomorrow some might seek to transfer embryos
into a women’s uterus, or even a pig’s uterus, to grow organs
for transplant, creating the nightmare prospect of embryo
farms, fetuses exploited for spare parts, and the commercialization
of human life.
One great merit of the regulations contained in this report
is that, if implemented, they would address the slippery slope
argument against embryonic stem cell research by assuring
that such research is done responsibly, within carefully prescribed
limits. No embryos used for research could be used or preserved
beyond a 10-14 day limit, or transferred into a woman’s uterus
or an animal’s body to grow organs for harvest; nor could
embryos be bought and sold. Regulations such as these will
not fully satisfy the objections of those who oppose stem
cell research on the grounds that blastocysts are morally
equivalent to babies. But by assuring that stem cell research
is conducted within carefully prescribed limits, these regulations
effectively address the concern that stem cell research today
will lead us down a path to exploitation and abuse tomorrow.
The proposed regulations could, therefore, point the way toward
a compromise on federal funding along the lines that Senator
Bill Frist proposed in July 2001:
After grappling with the issue scientifically, ethically
and morally, I conclude that both embryonic and adult stem
cell research should be federally funded within a carefully
regulated, fully transparent framework. This framework must
ensure the highest level of respect for the moral significance
of the human embryo. Because of the unique interaction
between this potentially powerful new research and the moral
considerations of life, we must ensure a strong, comprehensive,
publicly accountable oversight structure that is responsible
on an ongoing basis to moral, ethical and scientific considerations.
Senator Frist proposed a number of regulations, similar
in spirit to the ones proposed in this report, that would
permit federal funding of embryonic stem cell research, at
least on cell lines derived from blastocysts from in vitro
fertilization (IVF) clinics that would otherwise be discarded.
Although we would not restrict stem cell research to blastocysts
left over from IVF clinics, we realize that this remains a
controversial question. The compromise toward which the regulations
in this report point might leave aside the question of funding
for stem cell research on cloned embryos, and move forward
on areas of potential agreement.
Recent scientific developments illustrate the need to adjust
federal funding policy along the lines Senator Frist proposed
in 2001. Only 17 cell lines are currently on the NIH Registry
and available for federally funded research, and many of those
are subject to stringent licensing requirements. In March,
Harvard biologist Douglas Melton announced the creation of
17 new embryonic stem cell lines that he is making available
free of charge to scientists for noncommercial research purposes.
The Harvard stem cell lines meet all the criteria proposed
by Senator Frist: They were derived, using private funds,
from blastocysts left over from IVF clinics that would otherwise
be discarded, with the consent of the donors. And yet, under
current federal policy, research on these cell lines is ineligible
for federal funding. The reason: Unlike the 17 stem cell lines
currently available for federal funding, the new Harvard cell
lines were derived after 9:00 P.M. on August 9, 2001, the
deadline announced by President Bush in his address to the
nation on stem cell research.
Whatever one’s view of the moral status of the embryo, it
is difficult to understand the moral distinction between research
on stem cell lines created before 9:00 P.M. on August 9, 2001,
and research on stem cell lines created since. We endorse
the regulations proposed in this report in the hopes that
these regulations can point the way to a national compromise
on cloning and stem cell research that will enable this country
to promote the promise of stem cell research while upholding
the highest ethical standards.
Daniel W. Foster
Michael S. Gazzaniga
Janet D. Rowley
Michael J. Sandel
James Q. Wilson
Personal Statement of Professor
Fukuyama and Professor Wilson
We believe that the Reproduction and Responsibility
report is a very important document that articulates a broad
moral consensus over the limits that our society should place
on new reproductive procedures now made possible by technology.
The proposed legislation, if passed, would ban certain clearly
unacceptable techniques (including reproductive cloning) while
at the same time neither prohibiting nor condoning research
cloning or other forms of embryo research. As such, it shows
a way to get past the current deadlock that leaves the United
States as one of the few developed countries without guidelines
on these issues.
Appropriate as these guidelines are, we believe that they
represent only a first step toward a more complete regulatory
approach needed to deal with new technological possibilities.
Today we can foresee possibilities like reproductive cloning
or human-animal hybrids that should be banned. But technology
will move quickly and in the future pose ethical challenges,
as well as scientific and medical opportunities, that we cannot
today imagine. It will be difficult and inappropriate for
Congress to intervene seriatim as these developments occur.
What is called for instead is a modernization of our existing
regulatory structure to allow it to respond with flexibility
in such cases, taking account not simply of the safety and
efficacy of new procedures but of ethical concerns that would
be widely shared in our society.
Our hope is that the current report will represent not the
final word on the subject of legislative limits but the beginning
of a broader discussion of regulatory oversight of new reproductive
technologies. As a general rule, we do not welcome government
intrusion into scientific inquiry and into the reproductive
choices made by parents. But regulation frequently facilitates
scientific advance and individual choice by reassuring the
public that it is being done responsibly. That is the light
in which the current report should be seen, as well as hoped-for
future efforts to update and modernize our regulatory system.
Francis Fukuyama
James Q. Wilson
Personal Statement of Dr. Gazzaniga
This is a complex report. The explicit objective of this
report is to propose some sort of regulatory mechanism that
monitors the possible uses and misuses of a variety of existing
artificial reproductive techniques. The policy recommendations
made at the end of the report are presented in that context.
At the same time the importance of this report is the implicit
implications of those recommendations. While unstated, the
implication is to ban reproductive cloning, but is silent
on biomedical cloning. It is hoped that this will allow stem
cell research to go forward in some way that is advancing
this biomedical pursuit and public good. I accept the foregoing
rationale for concurring with this report as articulated by
Foster, Rowley, Sandel, Wilson and myself, but I do so reluctantly.
I much prefer a more broad and bold explicit statement.
What overhangs this discussion is the question of the moral
status of the embryo. In what follows, I present my thoughts
on that issues as concurrently published in a letter to Science.
In the meantime I feel obliged to stake out a far more assertive
position. The current compromise does not capture the goods
that can be achieved by allowing biomedical cloning to go
forward with the full support of the federal government for
not only research on spare IVF embryos, but also biomedical
cloning that allows somatic cell nuclear transfer procedures.
The report does not make explicit that federal funding for
research should go on for all of these endeavors.
The reason the explicit aspects of this report are now proposed
is because federal funding has been withheld from embryo research
of any kind in the past. It is now clear proper epidemiological
studies would be good not only for ART but also for a wide
variety of other current medical practices. By not explicitly
allowing federal funding for biomedical cloning as well as
new stem cell lines we are painting ourselves into yet another
corner down the road.
I firmly believe that the problems underlying all of these
social and medical dilemmas derive from a profound misunderstanding
of what an embryo is and is not. If greater understanding
could be brought to that issue, we all could move forward
in a reasoned and rational way. The following forthcoming
letter to Science (“Human Being Redux,” April 16, 2004)
was prompted by the recent advances in biomedical cloning
in Korea and addresses this issue:
Here we go again. It was two years ago that as one of
the member’s of the President’s Council on Bioethics, I
among others outlined a logic for letting biomedical cloning
go forward. No one is for reproductive cloning—or cloning
for baby making as it is sometimes called. But cloning for
biomedical research, a process that only involves cells
in a Petri dish and might well relieve untold human suffering
is another matter.
Now, two years later, the good scientists of South Korea
have made a major advance in biomedical cloning. They have
shown the world that careful and caring biomedical cloning,
cloning that allows for the production of stem cells, which
might lead to breathtaking remedies for horrible diseases,
is possible. Two years ago the reason many people were against
letting the American biomedical community into this intellectual
and scientific hunt was that by allowing biomedical cloning,
the human race would lose its dignity. Tell me, does any
reader feel diminished in the past few days? Do the one
million Americans who suffer from Parkinson’s disease, whose
human dignity has been brutally robbed from them, feel an
even greater affront?
How did we get into this mess, the position that the greatest
biomedical discovery machine in the history of the world,
the American basic science enterprise, is sitting on the
sidelines? It is in part due to religious zealotry and in
part due to superficial reasoning by well meaning people.
At the center of the discussion is the belief on the part
of some that a blastocyst, the entity in the Petri dish,
is morally equivalent to a living post-natal human being.
For those who simply assert that equivalence, no matter
what the scientific data might be, there is nothing more
to be said. But for those who think the equivalence is due
to ‘scientific fact’ there is hope they may come to a deeper
understanding of the nature of the problem.
Many people recognize that the human embryo, the entity
that is created by the union of an egg and sperm, carries
all the genetic information of a member of the human species.
Thus, they call the embryo a human being. Of course, to
develop into a human being, the embryo has to become implanted
into the uterus of a woman and be allowed to develop. This
potential to become a human being is what sticks in the
minds of the supporters of the moral equivalence argument
and this is why manipulations of embryos for anything but
normal reproduction is not acceptable to them.
Looking at a minuscule ball of cells in a Petri dish,
so small that it could rest on the head of a pin finds one
hard pressed to think of it as a human being. After all,
it has no brain or capacity to think and feel. The ball
of cells has the potential if it was to be implanted into
a woman but so do the egg and sperm ‘set’ before they meet.
Why don’t we revere those entities? Well, it is argued,
because they don’t have the full compliment of genetic material
that could make up a human being. Those that see a bright
line here, the line between an entity with the combined
genetic material versus the uncombined entities, are forgetting
the central discoveries of neuroscience and developmental
psychology.
Merely possessing the genetic material for a future human
being does not make a human being. The developing embryo
that becomes a fetus that becomes a baby is the product
of a dynamic interaction with its in vivo environment, its
post-natal experiences, and a host of other factors. A pure
genetic description of the human species does not describe
a human being. A human being represents a whole other level
of organization as distinct from a simple embryo as an embryo
is distinct from an egg and sperm. It is the dynamics between
genes and environment that make a human being. Indeed, most
of us are willing to grant this special status to a developing
entity way before it actually exists, but surely not before
the entity even has a brain.
The South Korean scientists seem to understand these distinctions.
They are not in the baby making business and want no part
of it. They have constructed a great fence around developing
embryos through a cloning process unfolding in a Petri dish.
Their embryos are allowed to develop for only a few days
whereupon the all-important stem cells are harvested for
possible therapeutic use and at the exact same time the
rest of the cell mass dies. There is no slippery slope here,
there is no beginning of the much-feared world of cloned
humans and the like. The Koreans have found a way to let
biomedical cloning go forward with all of its spectacular
promise for restoring human dignity to the seriously diseased
and infirmed patients of the world while at the same time
not in any way creating a social atmosphere to use such
advances for baby making. What could be better?
America can solve its dilemma quickly and easily. Congress
could vote to outlaw reproductive cloning. At the same time,
they could allow biomedical cloning to go forward. The definitional
problem of what it means to be a human being is becoming
clearer and the much feared slippery slope argument has
been put to rest. Biomedical cloning, Si, reproductive
cloning, No!
Michael S. Gazzaniga
Personal Statement of Professor
George, Professor Glendon, Dr. Gómez-Lobo, Dr. Hurlbut, and
Professor Meilaender
With the release of this report, the President’s Council
on Bioethics has continued and advanced the development of
its position on difficult and controverted questions that
arise at the beginning of human life. We append these comments
in order to offer a brief analysis of what the Council has
said and to place what it says here into the context of its
earlier work. In particular, we think it important to highlight
a few recommendations for interim legislation offered by the
Council at the very end of the report. It is essential to
see what the Council has said and equally essential to note
where it has been silent.
Among the Council’s recommendations is the following: Congress
should “prohibit attempts to conceive a child by any means
other than the union of egg and sperm.” Were such legislation
enacted, it would be unlawful to attempt to produce a child
through cloning. Readers should note with care the definition
given in a footnote of the act prohibited here. It is “the
creation ex vivo of any such human embryo with the intent
to transfer it to a woman's body to initiate a pregnancy.”
Two important implications follow:
(a) One might, of course, produce a human embryo by somatic
cell nuclear transplantation or some other cloning technique
with no intent whatsoever to transfer it to a uterus (no
doubt in order to conduct research on such an embryo, what
the Council has elsewhere called “cloning-for-biomedical-research”
and for which some use the incorrect language of “therapeutic
cloning”). About this possibility the Council is entirely
silent. It does not recommend or endorse such action. Nor
does it take a position about whether it should be legally
permitted or forbidden. In the absence of any new recommendation,
readers may therefore rightly conclude that the Council’s
earlier majority recommendation (in its report, Human
Cloning and Human Dignity) that a four-year moratorium
on all cloning-for-biomedical-research should be instituted
continues to be the Council’s position.
(b) Because the prohibited act would be the “creation
ex vivo” of a human embryo by any means other than the union
of egg and sperm “with the intent to transfer it
to a woman’s body to initiate a pregnancy,” the Council's
recommended legislation would never require the destruction
of any embryo. The prohibited act is not—it is crucial to
note—implantation in a woman’s uterus of embryos, but, rather,
creation of such embryos with the intent to implant.
Implantation, apart from creation with the intent to transfer,
is not in any way prohibited. Hence, this actually provides
additional clarity to the Council's recommendations
in Human Cloning and Human Dignity.
There is one important issue on which the Council has not
yet achieved sufficient agreement to offer a recommendation—and
on which it, therefore, is entirely silent in the recommendations
of this report. That is the issue of the use in research of
human embryos at an early stage of development that have been
conceived ex vivo by union of egg and sperm (i.e., embryos
that are not created by SCNT or other asexual process of reproduction).
The Council has been able to agree that research on human
embryos should be prohibited beyond a designated stage of
their development. (Some members of the Council would extend
the period up to fourteen days after fertilization, but none
favors permitting research on embryos that have developed
beyond that point. Others would draw the line at ten days
or earlier. We, and perhaps other members of the Council,
have grave concerns about research that destroys human embryos
at any stage of their development.) But the Council says no
more than that. In particular, we should note two significant
silences:
(a) The Council is entirely silent about whether research
on human embryos before the 10/14 day limit should be conducted
or legally permitted, and, hence, the Council has in no
way endorsed such research.
(b) Because of its silence on this matter, the Council
does not endorse the destruction of human embryos at any
stage of their development.
Although the Council’s earlier report, Human Cloning
and Human Dignity, dealt only with embryos produced by
cloning, these silences cohere well with the position endorsed
by the Council majority in that report and with current policy
of the federal government to prohibit federal financing of
any research using stem cells derived from human embryos produced
after August 9, 2001 (the date of the institution of that
policy). Chapter 2 of the Council's earlier report, Monitoring
Stem Cell Research, has explored the moral underpinnings
and legal significance of that policy, and the recommendations
the Council now makes in this new report represent a further
advance in drawing out some of the implications of that moral
commitment.
We are, therefore, happy to join all our colleagues on the
Council in endorsing the recommendations in Reproduction
and Responsibility, and we are pleased that we have been
able, especially in areas of great controversy, to agree on
the matters we have briefly outlined above.
Robert P. George
Mary Ann Glendon
Alfonso Gómez-Lobo
William B. Hurlbut
Gilbert C. Meilaender
Personal
Statement of Professor George and Dr. Gómez-Lobo
In our statement attached to the Council’s report Human
Cloning and Human Dignity and in other writings, we have
set forth our reasons for holding that human beings are entitled
to full respect and legal protection, irrespective of age,
size, location, stage of development, or condition of dependency.
We reject the proposition that human beings may at certain
stages of development, for example, the embryonic, fetal,
and infant stages, legitimately be treated as disposable research
material. So we support the ban on federal funding of experimentation
and research involving the deliberate destruction of human
beings in the embryonic stage, or any other, and we hope that
the day will come when such experimentation and research is
effectively prohibited. At the same time, we understand and
fervently share the desire of those who favor embryo-destructive
experimentation and research to develop cures for dreaded
diseases and add to the sum of human knowledge. We believe
that biomedical science should move forward aggressively by
every ethically legitimate means. We do not, however, believe
that deliberate embryo killing is morally defensible.
Our nation is divided on the question whether human beings
in the embryonic stage deserve full respect and legal protection,
and that division is reflected on our Council as it is in
the Congress. However, the nation is not divided, nor is the
Council or the Congress, on the question whether some
limit must be placed on the destruction of nascent human life
for purposes of experimentation and biomedical research. There
is near unanimity in rejecting the idea of generating human
embryos and gestating them for the purpose of harvesting their
tissues and organs. Even those of our colleagues and fellow
citizens who are prepared to countenance the destruction of
human embryos in the blastocyst stage for what they regard
as a greater good agree that the law should forbid damaging
or deadly experimentation on embryos at later stages of development.
Yet federal law currently establishes no limit. In the present
report, we join in unanimously recommending that Congress
establish a certain number of days beyond the first cleavage
after which embryo-destructive experimentation is legally
prohibited.
Our report does not designate a particular number of days,
though no member of the Council has suggested that embryo-destructive
research should be permitted beyond fourteen days after the
first cleavage. Some would set the limit at ten days, others
perhaps earlier. As noted, we ourselves are among the members
of the Council who favor protecting human life from the very
beginning by banning the use of living human embryos at any
stage of development as disposable research material. Until
this becomes politically feasible, we support efforts to accord
as much protection as possible by limiting the number of days
beyond which the law tolerates deliberate embryo killing.
It is important to understand that the Council’s recommendation
here is not to authorize embryo-destructive research
up to a certain limit. It is only to prohibit such research
beyond a certain limit. Because in the absence of legislation
this research remains unrestricted, a prohibition of embryo-destructive
research beyond a certain limit does not amount to authorizing
research up to that limit.
It is our hope that citizens who share our fundamental commitment
to the principle of the full and equal dignity of every member
of the human family will join us in endorsing the Council’s
unanimous recommendation to Congress to establish a limit
on embryo-destructive research. We pledge to join with them
in working to establish yet more complete protection for human
life in all stages and conditions.
Robert P. George
Alfonso Gómez-Lobo
Personal
Statement of Dr. Kass
The intersection of assisted reproduction and genomic knowledge
confronts us with a daunting array of new opportunities and
new questions. But the question of questions in this field
is this: Can human beings find a way to govern the uses of
biotechnology, so as to have it serve worthy human ends without
eroding human freedom and dignity? And if we can, how
shall we do it? This report on the regulation of biotechnology
is offered as the first step in what I hope will be a serious
and vigorous national attempt to answer these questions.
The report begins that attempt by properly defining the
field, and asking questions not just about one or another
technique, but about the ways in which biotechnologies of
reproduction touch the lives of children, women, and men.
This report is not about cloning, stem cell research, or the
moral status of human embryos, though it certainly bears on
them. Those topics the Council addressed in previous reports.
This report is about the larger whole of which those controversies
are parts, and by looking at the whole the Council has managed
to find common ground in particular areas where before none
seemed to exist.
Although its recommendations may be helpful in making progress
on some familiar and contested policy questions, the report’s
major contribution is to show how a heterogeneous group of
individuals, whose opinions range almost as widely as those
of the American people, has agreed on the need to set limits
on some uses of some biotechnologies, in order to protect
common values.
Such agreement has been lacking in the past because people
on very different sides of the issues have feared or opposed
formal governmental oversight and regulation in this area.
Some scientists and biotechnologists want no interference
with scientific research and medical progress, and oppose
especially those restraints that rest on moral grounds. On
the other hand, some people with profound moral objections
to certain types of research do not want to see governmental
regulation of this field, fearing it would implicitly sanction
the activity being regulated. I appreciate the reasons and
principles behind these two stances. But I respectfully submit
that both groups have principled reasons to seek and support
public policies that defend shared values. Prudent scientists,
technologists, and entrepreneurs should realize that it is
in the interest of responsible science for them to join the
regulatory discussion and propose some principles and boundaries
that they themselves could welcome and would like to see upheld.
And prudent defenders of the sanctity of human life should
realize that it is a Pyrrhic victory to keep the federal government
out of certain activities, if the price of such a stance means
that worse practices are allowed to proceed without oversight
or regulation in the private sector.
This report demonstrates that when people of such different
views do pursue some common ground, practical ways forward
can be found, even while serious disagreements remain. I hope
that people on all sides of these issues, in the Congress
and the public, will take up the challenge posed by this report,
will take the first steps recommended in this report, and
will take further steps along these lines as well.
Those further steps should try to expand the scope of common
agreement, and also to seek more lasting ways to turn agreement
into concrete policy. After all, bioethics commissions come
and go. They take up important issues. They write reports.
Sometimes, as in this case, the reports contain recommendations
that may find a willing audience. But they have no oversight
or regulatory authority. Their power consists only in their
ability to persuade, and that is as it should be.
But in this rapidly developing world of biotechnology, where
the human import of the changes we are undergoing is hard
to discover and where social institutions lag far behind in
their ability to cope with the new challenges that innovations
may bring, a case can be made for the importance of trying
to devise suitable regulatory institutions and activities
that could help protect society’s basic values, even as we
continue to treasure the benefits that biotechnology will
continue to bring us. Legislation and prohibitions are suitable
only for a few rare violations (such as human cloning, or
euthanasia, or some of the prospects taken up in this document).
Laissez-faire, while reflecting the honored American principles
of freedom and choice, offers no guidance other than the market.
Regulation would seem to offer a superior alternative, even
if it is far from clear what form it should take or how it
might be effected.
Concrete steps like those proposed in this report might
begin to pave the way toward greater clarity on such questions,
and they may help us to see whether or not further regulation
is called for, what forms it might take, and what common goods
it should seek to uphold.
The path forward is difficult, but people on all sides have
something vital to defend, not only for themselves but for
all of us. I would hope that people might join together, as
we have tried to do here, to seek out the common ground and
to try to gain greater understanding of and control over where
biotechnology is taking us.
Leon R. Kass
Personal Statement
of Dr. McHugh
I am pleased to endorse the legislative recommendations
that have emerged from our Council’s discussions and are contained
in this report. I believe the report will help move our governmental
representatives toward important solutions in a most problematic
arena. I also think this publication will encourage the American
public to believe that thoughtful and coherent policies can
and will emerge from these disputed matters, in part because
of the enterprises of this Council.
I do, though, want to take this opportunity to repeat a
point I made during our meetings about the President’s regulatory
decision on August 9, 2001, when he permitted some stem cells
derived from embryos produced by in vitro fertilization to
be used in federally funded research. In essence I see that
effort as a prototypic example of an attempt to balance out
“conflicts of goods” that can arise with biotechnology regulation.
I hold that President Bush (in trying to respond to concerns
that the previous administration’s and Congress’s decisions
banning destructive human embryonic research were holding
back crucial work) presented American scientists not just
with some identified stem cell lines but also with the opportunity
to prove their points. Since many Americans (including me)
along with governments of other Western nations believe that
the use of in vitro fertilization as a source of experimental
tissues is seriously problematic, our best scientists could
treat the approach offered by President Bush as they might
any priority decisions over federal support and funding. They
could take the partial support offered at the moment and return
to the source after employing that support to develop more
compelling data demonstrating what has been accomplished and
what is now more clearly in prospect and not to be denied.
Anyone who has worked on an NIH grant review board knows and
expects just such behavior from scientists who receive less
financial support than they requested and a priority score
that they find perverse.
I sense from our conversations that scientists resent the
idea that in this arena “non-peers”—i.e., people lacking their
scientific credentials—are voting on the “priority score”
and so may influence the outcome. But not only are other matters
in question here than the quality of the science, we are now
accustomed to representatives from the public on Institutional
Review Boards (IRBs) and hospital Ethics Committees dealing
with biotechnology, and we have occasionally celebrated the
wisdom these people bring to the enterprises. I think the
most helpful and productive stance is to presume that the
President’s regulatory proposal is a good-faith effort to
define the problems and priorities on the basis of contemporary
knowledge as he sees it. Disagreements with him should be
supported with new results from the research his proposal
permits.
In essence I support the regulations as proposed here and
am honored to have had the opportunity with my colleagues
on the Council to play a small role in their development.
Paul McHugh
Personal
Statement of Dr. Rowley
The latest report of the Council on Bioethics focuses on
the ethical issues surrounding aspects of assisted reproductive
technology (ART) and the potential misuses of the technology.
The report is a review and restatement of previous reports
with a relatively complete review of the agencies, government
and others, who have an interest in and potential jurisdiction
over various aspects of ART. In my view, the report should
have done much more to applaud the medical advances that have
occurred leading to the effective treatment of an important
medical problem, namely infertility, rather than focus primarily
on the potential hazards and misuses of the new technologies.
In addition, I think it is important to note plainly that
some of the major concerns highlighted in the report could
be resolved relatively painlessly by changes in current governmental
regulation, at the state and at the federal level. I am also
disappointed that the report does not call for federal funding
of basic and clinical research seeking improved methods of
assisted reproduction or for mandated health insurance for
ART services. Both of these measures would help to reduce
the risks of ART to women and children.
One area of concern includes the lack of comparative data
on the outcome of in vitro fertilization (IVF) both with regard
to long-term health effects on the women involved and on the
children born using the various techniques. Because this is
a rapidly moving area of medical practice, meaningful comparisons
between older techniques and current practices and the impact
of the changes on the success rate (full-term pregnancies)
and health of the child are not as complete as one would like.
However we are not as ignorant as indicated in the report.
There are solid data from other countries with more integrated
health care systems that the risk of ovarian cancer is not
increased in women using IVF; hyperovulation syndrome is rare
(as this report notes, it may be as low as 0.5 percent), relatively
easily treated, and mostly occurs if the woman becomes pregnant.
Nowhere in the report is it indicated that the risks to women
of a natural pregnancy are far greater than the procedures
associated with IVF. Adequate federal funding (as recommended)
would allow accurate data collection on the effect of ART
on the women who have participated and the health and performance
status of children born using ART, correlated with the various
techniques used in the early stages before implantation. Such
data are important, and, as the Council insists in this report,
participation in such a longitudinal study should be voluntary,
rather than required by law.
In addition, these medical practices are generally not covered
by insurance so the costs are born by couples desperate for
a biologically related child of their own. This restricts
ART to only those families that can afford it. The report
criticizes professional societies for inadequate and conflicting
guidelines in Chapter 2. In contrast, in Chapter 10, the report
says that there are a host of reasonable guidelines in place.
Many ART clinics follow the guidelines established by the
societies but some (the number is uncertain) flaunt them,
apparently with impunity. I believe that having ART covered
by insurance would be the most effective means of oversight
because if clinics did not conform to agreed upon guidelines,
they would not get paid. As shown by a recent study in the
New England Journal of Medicine (347: 661, 2002), fewer
embryos are implanted in states with insurance coverage for
ART and multiple births are one of the major causes of maternal
and infant morbidity and mortality. Informed discussions to
create guidelines with effective means of enforcement, as
well as federal funding in certain areas, are a far more rational
route than Congressional legislation.
The report also sounds alarms about privately funded research,
raising the fear that because there are no federal laws regulating
research, individuals are free to pursue avenues of research
of their own choosing using human embryos. In fact, some of
these privately funded researchers have already developed
new embryonic stem cell lines that are likely to help advance
our understanding of the potential of human embryonic stem
cells for better treatment. Allowing these cell lines to be
used for federally funded research is required if we are to
make meaningful progress.
The report identifies other areas of research that appear
to be irresponsible, namely attempts to fuse two species to
try to form a human/animal chimera. Such experiments are rare
and are unlikely to succeed beyond a preliminary mixing of
cells because of the genetic incompatibility of the two species.
Other bioethical issues relate to the possible use of preimplantation
genetic diagnosis for non-medical indications, especially
for sex selection. This is not done by reputable clinics and
could be abolished by vigorous oversight. I believe that promoting
data collection and availability of insurance coverage would
be far more effective than opposing these highly uncommon
practices. Some futuristic scenarios discussed in Chapter
3 that consider the prospect of increasing control over the
genetic characteristics of children seem to me very far-fetched,
and the ethical issues raised are, therefore, not in my view
anything to be concerned about.
Providing data on the costs and results of individual clinics
is, at first glance, a worthy proposal. Data gathering in
this field involves complicated issues of privacy, as well
as a need for strict controls in data analysis. For instance,
data should be obtained and presented in a manner that reflects
the patient population and should include most especially
maternal age. Are some clinics willing to accept couples that
have failed at other clinics and may be likely to fail again?
In other words, are the populations seen at different clinics
comparable?
Much of the final part of the report’s description of the
options and recommendation is related to concerns for human
dignity and what is seen by some as the trumping of this concept
by technology. At present there is unanimous agreement that
(1) human embryos should never be transferred to the body
of nonhuman species or to a human womb except to produce a
live-born child and that (2) a child should only be the result
of the union of egg and sperm. There is less agreement on
how long human embryos should be cultured ex vivo, although
current practice is no longer than 14 days.
Yet legislating in this area, even when well meaning, is
a tricky and risky business, and there is a danger of overreaching
and excessive zeal that could, if unchecked, interfere with
sound research and beneficial treatment. There are many other
areas of concern that are probably not suitable for being
considered as an option for legislation; and although the
Council’s final recommendations avoid them, the presentation
(in Chapter 9) of possible substantive policy options
puts forth dubious suggestions that might seduce the careless
or the zealous legislator. For example, the question of ooplasm
transfer is not as clear-cut as it might seem. If infertility
is due to defects in maternal mitochondrial DNA, the fusion
of the nucleus from her oocyte with ooplasm from a normal
donor cell might be a rational treatment. So why ban it? Should
there be legislation related to non-disease-related genetic
screening? How serious a problem is it in the US? Should we
restrict gene therapy in embryos with single gene disorders
if it becomes safe? These are all questions that need thoughtful
discussion before moving headlong into a legislative ban,
and although this report does not call for such bans, some
observers and commentators would surely like to enact them.
Thus, I am concerned that, despite the limited character of
the final recommendations in Chapter 10, Congress might make
use of the report’s outline of some possible substantive
legislative options in Chapter 9 to do real damage to beneficial
research and medical treatment.
In my personal view, what should the Council recommend?
In addition to the two items listed above, the top priority
is for increased federal funding for basic research to develop
the best conditions that will result in healthy babies as
well as collecting data on the health of mothers and children
involved in IVF. Responsible professional societies and patient
advocates should be more forceful in developing comprehensive
practice guidelines and then enforcing them. As indicated,
universal insurance coverage for infertility would provide
a strong lever for such enforcement.
Janet D. Rowley
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