On (Being) “Better than Human” — Part 2

Bioethics @ TIU

I ended my last post by identifying what I take to be an important methodological issue with Allen Buchanan’s pro-enhancement argument in his recent (2011) book entitled Better than Human: The Promise and Perils of Enhancing Ourselves. I want pick up on that point in this post, before moving on to other points of analysis in subsequent posts.

To recap briefly: for Buchanan, addressing ethical concerns regarding the “enhancement enterprise” requires, among other things, a consideration of what human nature is like. And the answer to that question, in turn, is to be found in the findings and pronouncements of evolutionary biology, as set forth in the “Darwinian worldview.” More to the point, for Buchanan, the only source of “evidence” relevant to answering the question of human nature is evolutionary biology. In other words, Buchanan’s approach here is significantly epistemically constrained—only certain sources of knowledge are considered legitimate for purposes of examining morally the enhancement enterprise. This methodological move is significant, for it has the effect of ruling out of court, from the outset, other potentially valuable sources of information regarding human nature, including, particularly, theological reflection.

The obvious question to ask here is: why accept this epistemic constraint in the first place? Presumably, a significant part of the reason for Buchanan’s insistence on this epistemic restriction is another major methodological commitment of his, to which I drew attention in my earlier posts—namely, his commitment to framing his argument in strictly secular, non-religious terms. As I have noted, Buchanan indicates (on one occasion) that he is adopting in this book a “non-religious” approach in order to advance arguments that can be “accepted” by non-religious as well as religious people. Given that methodological commitment, Buchanan presumably views the pronouncements of evolutionary biology—products of the “Darwinian worldview” to which contemporary science is (purportedly) committed, and in terms of which Buchanan seeks to couch his overall argument—as being beyond reproach, evidentially (and therefore epistemically) speaking.

What, then, does Buchanan think “modern evolutionary biology” actually tells us about human nature? In the book’s second chapter, entitled “Why Evolution Isn’t Good Enough,” Buchanan goes to great lengths to argue against what he terms a “pre-Darwinian” view of evolution, according to which “evolution is like a master engineer”— the idea that “organisms are like engineering masterpieces: beautifully designed, harmonious, finished products that are stable and durable (if we leave them alone)” (p. 27). If the “master engineer” analogy is correct, of course, it would seem to imply that we ought not to attempt to change what that “master engineer” has produced. As Buchanan acknowledges, “[i]f that’s what we are like, then biomedical enhancement is reckless indeed. Genetic enhancement—seen as an attempt to change the master design itself—seems especially ill-conceived. The master engineer analogy, if it is accurate, provides a strong augment against genetic enhancement and perhaps against biomedical enhancement generally” (pp. 27-28).

But this analogy, Buchanan says, is mistaken. Instead, he argues, “evolution is more like a morally blind, fickle, tightly shackled tinkerer” (p. 29). I will have more to say in a subsequent post regarding exactly what Buchanan means by this proposed alternative metaphor. For now, suffice it to say that the basic idea is that there’s no good reason to think that “natural selection” is currently doing a good job or that the results of evolution are “good”—either in the sense of being “beneficial” to us, or in terms of what we value as human beings—and therefore ought not to be interfered with. Evolution is, instead, more accurately thought of as being “morally blind”; the processes of natural selection are, more often than not, “nasty, brutish, and long”—displaying utter indifference to human suffering and quality of life. Moreover, rather than being a “master engineer,” evolution is more properly thought of as being a “fickle, tightly shackled tinkerer”–it operates inefficiently and frequently fails to achieve “optimal” design changes. Ultimately, Buchanan contends, “we have to steadfastly resist the common tendency to think that the latest product of the evolutionary process is the best, either biologically speaking or in terms of human values. We can’t say we are the best in either sense, and that’s why we should take the possibility of biomedical enhancement seriously” (pp. 47-48).

The bulk of Chapter 2 is devoted to defending and exploring the implications of accepting this metaphor for evolution over against the “master engineer” metaphor. A discussion of the specifics of Buchanan’s argument here will have to await another post. For now, what I want to emphasize is the conclusion Buchanan draws from this exploration—namely, that “[h]ow we think about evolution—or, if you prefer, nature—makes all the difference to how we should think about enhancement. Interfering with the work of a master engineer is one thing; selectively intervening in the work of a morally blind, fickle, tightly shackled tinkerer is quite another” (p. 29).

Or, as he puts it later in this chapter,

[t]he main point is that to come to grips with the challenges of biomedical enhancement, we need to consider it from the standpoint of evolutionary biology. Remaining stuck in the rosy old, pre-Darwinian view of nature stacks the deck against biomedical enhancement. As we’ll see in later chapters, there are a number of reasons to worry about biomedical enhancement, but the risk of damaging the work of the master engineer of evolution isn’t one of them (p. 51).

Now, to be clear: I don’t want to attempt here to litigate the creation-evolution debate—such a task would go well beyond what can be accomplished in a single blog post (or series, for that matter!). In particular, I do not intend in this post to delve into the disputes among adherents of non-theistic evolution, theistic evolution, and creationism (whether of the “old earth” or “young earth” variety). Rather, the key point I want to make here is that Buchanan’s claims about the evidentiary value of looking at (the products of) evolutionary biology actually cuts both ways, undermining his own argument as well as the position against which he argues. Buchanan wants to say that because the results of natural selection are best characterized as being, to borrow Tennyson’s famous phrase, “red in tooth and claw,” therefore we cannot say whether or not evolution is currently “doing a good job,” and therefore we cannot argue against the enhancement enterprise on the basis of an a priori assumption of a “pre-Darwinian,” “teleological” view of nature according to which our current biological condition is good and thus ought not to be (intentionally) altered. Fair enough. The problem for Buchanan now is, if the

results of evolutionary biology are the only source for relevant data concerning “human nature,” this means that we also cannot appeal to evolutionary biology to argue in favor of the enhancement enterprise either. For simply looking at “the way we are” now biologically—whether that is understood as the product of unguided evolutionary processes, or the result of guided (“theistic”) evolutionary processes, or even the result of direct, special creation not involving evolutionary processes—will not be sufficient, by itself, to tell us how we ought to be biologically. After all, if our current biophysiological constitution is the result of “blind” evolutionary processes, then it is nothing more than a contingent historical accident—merely the result of unthinking, unknowing selective pressures, the consequences of which may or may not be “good” for us, and which certainly cannot be said to be the way things are “supposed to be,” in any meaningful sense of that phrase. If, on the other hand, our current biophysiological constitution is the result either of guided (“theistic”) evolutionary processes, or the result of direct, special creation—both of which would imply an intentional “design,” at least at the outset—we have no way of knowing, simply by observing our current state, whether and to what extent that state is in accordance with that original “design.” For all we know, simply through observation alone, our current condition may be very different than what was originally intended.

What these considerations highlight is the need for a broader normative framework within which to understand the significance of our current biophysiological condition and the implications, if any, that might flow from that state. We need some way of determining (a) whether or not our current biophysiological state is best understood as being a good, bad, or indifferent state of affairs; (b) whether or not attempting to “enhance” that state would be a good, bad, or indifferent course of action; and, accordingly, (c) how specific means of “enhancement” ought to be evaluated morally, in light of (a) and (b). Significantly, none of these questions can be answered simply by observing our current biophysiological condition.

To that end, theological reflection—and, specifically, Christian theological reflection—would seem to be, at the very least, a legitimate candidate for such a normative framework within which to think about and to evaluate the “enhancement enterprise.” Christian theology, in particular, proposes a coherent set of answers to such questions as who we are, how we got here, and where we are going—placing human beings in subordination to a God who designed, created, and sustains the universe and all that is in it, ordering it to His ends and for His purposes—thereby embedding human beings within the bounds of certain circumscribed limits that, arguably, are not rightly transgressed. Spelling out the details of this framework is beyond the scope of this post. The key point for present purposes is that this is the sort of framework that is needed to answer the relevant questions about the “enhancement enterprise”—crucial questions that a simple appeal to the “Darwinian worldview” cannot answer.

This is not to suggest that the Christian worldview is (necessarily) the only possible framework within which to think about these issues. Indeed, there may be numerous other possible such frameworks. The key point I want to emphasize here is that in limiting the legitimate sources for reflection on the enhancement enterprise to only that which can be said to fall within the purview of the “Darwinian worldview,” Buchanan is needlessly—indeed, one might argue, unfairly—excluding the sorts of resources that might be able to address the kinds of central questions about

the enhancement enterprise that the Darwinian worldview is incapable of addressing in its own terms.

http://www.bioethics.net/2013/04/on-being-better-than-human-part-2/

04/01/2013

Where the World Finds Bioethics Site Updated: Fri Jul 5 | 1:10 PM EDT

Cloning Information : Online Articles

Any discussion about cloning needs to begin with careful definitions.  Cloning can occur at the level of DNA, at the level of the single cell, or at the level of the whole organism.  Typically, ethical attention is focused upon cloning in the context of the genetic copying of a whole organism.  While the cloning of non-mammals has occurred in research contexts for many years, the cloning of the first mammal, Dolly the sheep, surprised many in the scientific community.  What quickly followed was the cloning of other species and intense speculation about the possible cloning of humans.  Cloned human embryos have been produced, but there are no reliable reports that any have been implanted in a woman’s uterus, let alone developed to birth.  Cloning to birth has come to be called ‘reproductive cloning’, whereas cloning embryos so that their stem cells may be extracted for possible research or therapeutic use has come to be called ‘therapeutic cloning’.  The key ethical issue with therapeutic cloning is the moral status of the cloned embryo, which is created solely for destruction.  The ethical issues with reproductive cloning include genetic damage to the clone, health risks to the mother, very low success rate meaning loss of large numbers of embryos and fetuses, psychological harm to the clone, complex altered familial relationships, and commodification of human life. 

http://www.bioethics.org.au/Resources/Online%20Articles/Other%20Articles/Cloning,%20Stem

%20Cells%20and%20Ethics.pdf pdf

http://www.bioethics.org.au/Resources/Online%20Articles/Opinion%20Pieces/1301%20Achieving%20national%20regulation%20of%20human%20cloning.pdf

http://www.bioethics.org.au/Resources/Online%20Articles/Opinion%20Pieces/1102%20Cloning%20sometimes%20nice%20and%20sometimes%20nasty.pdf

http://www.bioethics.org.au/Resources/Online%20Articles/Opinion%20Pieces/1002%20Selling%20Dolly%20an%20ethics%20hoax.pdf

WHAT ARE SOME ISSUES IN CLONING?

We saw in What are the Risks of Cloning? that the success rate in cloning is quite low. Even if we can increase the odds of success, problems can arise during the clone's development, both before and after pregnancy. Despite these risks, supporters of human reproductive cloning see it as a possible solution to infertility problems. Others support therapeutic cloning to create embryonic stem cells for research and medicine.

What are the possible implications of cloning to society? All of us - researchers, policymakers and the public - have a responsibility to explore the potential effects of cloning technologies on our lives so that we can make informed decisions.

For each new application of cloning technologies, we must consider:

What are the benefits? What are the risks? Whom will the technology help? Does it have the potential to hurt anyone? What does this mean for me? For my family? For others around me? Why might others not share my view?

Ethical, legal and social issues.

There are several types of issues to consider as we think about cloning.

Ethical issues are those that ask us to consider the potential moral outcomes of cloning technologies.

Legal issues require researchers and the public to help policymakers decide whether and how cloning technologies should be regulated by the government.

Social issues involve the impact of cloning technologies on society as a whole.

Some questions to ponder.

The questions raised here have no clear right or wrong answer. Instead, your response will depend on your own set of values, as well as the opinions of those around you.

Who has the right to have children, no matter how they are created? Who doesn't? Why? Is human cloning "playing with nature?" If so, how does that compare with other reproductive

technologies such as in vitro fertilization or hormone treatments? Does cloning to create stem cells, also called therapeutic cloning, justify destroying a human

embryo? Why, or why not? If a clone originates from an existing person, who is the parent? What are some of the social challenges a cloned child might face? Do the benefits of human cloning outweigh the costs of human dignity? Should cloning research be regulated? How, and by whom?

WHY CLONE?

Research advances over the past decade have told us that, with a little work, we humans can clone just about anything we want, from frogs to monkeys and probably even ourselves!

So, we can clone things, but why would we want to? Let's look at some of the reasons people give to justify cloning.

1. Cloning for medical purposes

Of all the reasons, cloning for medical purposes has the most potential to benefit large numbers of people. How might cloning be used in medicine?

Cloning animal models of disease

Much of what researchers learn about human disease comes from studying animal models such as mice. Often, animal models are genetically engineered to carry disease-causing mutations in their genes. Creating these transgenic animals is a time-intensive process that requires trial-and-error and several generations of breeding. Cloning technologies might reduce the time needed to make a transgenic animal model, and the result would be a population of genetically identical animals for study.

Cloning stem cells for research

Stem cells are the body's building blocks, responsible for developing, maintaining and repairing the body throughout life. As a result, they might be used to repair damaged or diseased organs and tissues. Researchers are currently looking toward cloning as a way to create genetically defined human stem cells for research and medical purposes. To see how this is done, see Creating Stem Cells for Research, a component of the Stem Cells in the Spotlight module.

"Pharming" for drug production

Farm animals such as cows, sheep and goats are currently being genetically engineered to produce drugs or proteins that are useful in medicine. Just like creating animal models of disease, cloning might be a faster way to produce large herds of genetically engineered animals. Find out more about this research in the feature article Pharming for Farmaceuticals.

2. Reviving Endangered or Extinct Species

Have you seen Jurassic Park? In this feature film, scientists use DNA preserved for tens of millions of years to clone dinosaurs. They find trouble, however, when they realize that the cloned creatures are smarter and fiercer than expected.

Could we really clone dinosaurs?

In theory? Yes. What would you need to do this?

A well-preserved source of DNA from the extinct dinosaur, and A closely related species, currently living, that could serve as a surrogate mother

In reality? Probably not. It's not likely that dinosaur DNA could survive undamaged for such a long time. However, scientists have tried to clone species that became extinct more recently, using DNA from well-preserved tissue samples. For an example, see "Can we really clone endangered or extinct animals?" on the right side of this page.

3. Reproducing a Deceased Pet

No joke! If you really wanted to, and if you had enough money, you could clone your beloved family cat. At least one biotechnology company in the United States offers cat cloning services for the privileged and bereaved, and they are now working to clone dogs. But don't assume that your cloned kitty will be exactly the same as the one you know and love. Why not? See Cloning Myths.

4. Cloning Humans?

To clone or not to clone: that is the question. The prospect of cloning humans is highly controversial and raises a number of ethical, legal and social challenges that need to be considered. To explore some of these, see What are Some Issues in Cloning?

Why would anyone want to clone humans? Some reasons include:

To help infertile couples have children To replace a deceased child

From a technical standpoint, before humans are cloned, we need to have a good idea of the risks involved. How sure can we be that a cloned baby will be healthy? What might go wrong? To evaluate the technical challenges to cloning, see Risks of Cloning.http://learn.genetics.utah.edu/content/tech/cloning/cloningrisks/

WHAT ARE THE RISKS OF CLONING?

When we hear of cloning successes, we learn about only the few attempts that worked. What we don't see are the many, many cloning experiments that failed! And even in the successful clones, problems tend to arise later, during the animal's development to adulthood.

Cloning animals shows us what might happen if we try to clone humans. What have these animals taught us about the risks of cloning?

1. High failure rate

Cloning animals through somatic cell nuclear transfer is simply inefficient. The success rate ranges from 0.1 percent to 3 percent, which means that for every 1000 tries, only one to 30 clones are made. Or you can look at it as 970 to 999 failures in 1000 tries. That's a lot of effort with only a speck of a return!

Why is this? Here are some reasons:

The enucleated egg and the transferred nucleus may not be compatible An egg with a newly transferred nucleus may not begin to divide or develop properly Implantation of the embryo into the surrogate mother might fail The pregnancy itself might fail

2. Problems during later development

Cloned animals that do survive tend to be much bigger at birth than their natural counterparts. Scientists call this "Large Offspring Syndrome" (LOS). Clones with LOS have abnormally large organs. This can lead to breathing, blood flow and other problems.

Because LOS doesn't always occur, scientists cannot reliably predict whether it will happen in any given clone. Also, some clones without LOS have developed kidney or brain malformations

and impaired immune systems, which can cause problems later in life.

3. Abnormal gene expression patterns

Are the surviving clones really clones? The clones look like the originals, and their DNA sequences are identical. But will the clone express the right genes at the right time?

In Click and Clone, we saw that one challenge is to re-program the transferred nucleus to behave as though it belongs in a very early embryonic cell. This mimics natural development, which starts when a sperm fertilizes an egg.

In a naturally-created embryo, the DNA is programmed to express a certain set of genes. Later on, as the embryonic cells begin to differentiate, the program changes. For every type of differentiated cell - skin, blood, bone or nerve, for example - this program is different.

In cloning, the transferred nucleus doesn't have the same program as a natural embryo. It is up to the scientist to reprogram the nucleus, like teaching an old dog new tricks. Complete reprogramming is needed for normal or near-normal development. Incomplete programming will cause the embryo to develop abnormally or fail.

4. Telomeric differences

As cells divide, their chromosomes get shorter. This is because the DNA sequences at both ends of a chromosome, called telomeres, shrink in length every time the DNA is copied. The older the animal is, the shorter its telomeres will be, because the cells have divided many, many times. This is a natural part of aging.

So, what happens to the clone if its transferred nucleus is already pretty old? Will the shortened telomeres affect its development or lifespan?

When scientists looked at the telomere lengths of cloned animals, they found no clear answers. Chromosomes from cloned cattle or mice had longer telomeres than normal. These cells showed other signs of youth and seemed to have an extended lifespan compared with cells from a naturally conceived cow. On the other hand, Dolly the sheep's chromosomes had shorter telomere lengths than normal. This means that Dolly's cells were aging faster than the cells from a normal sheep.

To date, scientists aren't sure why cloned animals show differences in telomere length.

Supported by a Science Education Partnership Award (SEPA) [No. 1 R25 RR16291-01] from the National Center for Research Resources, a component of the National Institutes of Health, Department of Health and Human Services. The contents provided here are solely the

responsibility of the authors and do not necessarily represent the official views of NCRR or NIH.learn.genetics.utah.edu/content/tech/cloning/cloningrisks/

CLONING MYTHS

In What is cloning? we learned what it means to clone an individual organism. Given its high profile in the popular media, the topic of cloning brings up some common, and often confusing, misconceptions.

Misconception #1: Instant Clones!

Let's say you really wanted a clone to do your homework. After reviewing What is Cloning? and Click and Clone, you've figured out, generally, how this would be done. Knowing what you know, do you think this approach would really help you finish your homework...this decade?

A common misconception is that a clone, if created, would magically appear at the same age as the original. This simply isn't true. You remember that cloning is an alternative way to create an embryo, not a full-grown individual. Therefore, that embryo, once created, must develop exactly

the same way as would an embryo created by fertilizing an egg cell with a sperm cell. This will require a surrogate mother and ample time for the cloned embryo to grow and fully develop into an individual.

Misconception #2: Carbon Copies!

Your beloved cat Frank has been a loyal companion for years. Recently, though, Frank is showing signs of old age, and you realize that your friend's days are numbered. You can't bear the thought of living without her, so you contact a biotechnology company that advertises pet cloning services. For a fee, this company will clone Frank using DNA from a sample of her somatic cells. You're thrilled: you'll soon have a carbon copy of Frank - we'll call her Frank #2 - and you'll never have to live without your pal! Right?

Not exactly. Are you familiar with the phrase "nature versus nurture?" Basically, this means that while genetics can help determine traits, environmental influences have a considerable impact on shaping an individual's physical appearance and personality. For example, do you know any identical twins? They are genetically the same, but do they really look and act exactly alike?

So, even though Frank #2 is genetically identical to the original Frank, she will grow and develop in a completely different environment than the original Frank or will have a different mother, and she will be exposed to different experiences throughout her development and life. Therefore, there is only a slim chance that Frank #2 will closely resemble the Frank you know and love.

Supported by a Science Education Partnership Award (SEPA) [No. 1 R25 RR16291-01] from the National Center for Research Resources, a component of the National Institutes of Health, Department of Health and Human Services. The contents provided here are solely the responsibility of the authors and do not necessarily represent the official views of NCRR or NIH.http://learn.genetics.utah.edu/content/tech/cloning/cloningmyths/

Cloning describes the processes used to create an exact genetic replica of another cell, tissue or organism. The copied material, which has the same genetic makeup as the original, is referred to as a clone. The most famous clone was a Scottish sheep named Dolly.

There are three different types of cloning:

Gene cloning, which creates copies of genes or segments of DNA Reproductive cloning, which creates copies of whole animals

Therapeutic cloning, which creates embryonic stem cells. Researchers hope to use these cells to grow healthy tissue to replace injured or diseased tissues in the human body.

NIH: National Human Genome Research Institute

http://www.nlm.nih.gov/medlineplus/cloning.html

Cloning/Embryonic Stem Cells

The term cloning is used by scientists to describe many different processes that involve making duplicates of biological material. In most cases, isolated genes or cells are duplicated for scientific study, and no new animal results. The experiment that led to the cloning of Dolly the sheep in 1997 was different: It used a cloning technique called somatic cell nuclear transfer and resulted in an animal that was a genetic twin -- although delayed in time -- of an adult sheep. This technique can also be used to produce an embryo from which cells called embryonic stem (ES) cells could be extracted to use in research into potential therapies for a wide variety of diseases.

Thus, in the past five years, much of the scientific and ethical debate about somatic cell nuclear transfer has focused on its two potential applications: 1) for reproductive purposes, i.e., to produce a child, or 2) for producing a source of ES cells for research.

Cloning for Reproductive Purposes

The technique of transferring a nucleus from a somatic cell into an egg that produced Dolly was an extension of experiments that had been ongoing for over 40 years. In the simplest terms, the technique used to produce Dolly the sheep - somatic cell nuclear transplantation cloning - involves removing the nucleus of an egg and replacing it with the diploid nucleus of a somatic cell. Unlike sexual reproduction, during which a new organism is formed when the genetic material of the egg and sperm fuse, in nuclear transplantation cloning there is a single genetic "parent." This technique also differs from previous cloning techniques because it does not involve an existing embryo. Dolly is different because she is not genetically unique; when born she was genetically identical to an existing six-year-old ewe. Although the birth of Dolly was lauded as a success, in fact, the procedure has not been perfected and it is not yet clear whether Dolly will remain healthy or whether she is already experiencing subtle problems that might lead to serious diseases. Thus, the prospect of applying this technique in humans is troubling for scientific and safety reasons in addition to a variety of ethical reasons related to our ideas about the natural ordering of family and successive generations.

Scientific Uncertainties

Several important concerns remain about the science and safety of nuclear transfer cloning using adult cells as the source of nuclei. To date, five mammalian species -- sheep, cattle, pigs, goats, and mice -- have been used extensively in reproductive cloning studies. Data from these

experiments illustrate the problems involved. Typically, very few cloning attempts are successful. Many cloned animals die in utero, even at late stages or soon after birth, and those that survive frequently exhibit severe birth defects. In addition, female animals carrying cloned fetuses may face serious risks, including death from cloning-related complications.

An additional concern focuses on whether cellular aging will affect the ability of somatic cell nuclei to program normal development. As somatic cells divide they progressively age, and there is normally a defined number of cell divisions that can occur before senescence. Thus, the health effects for the resulting liveborn, having been created with an "aged" nucleus, are unknown. Recently it was reported that Dolly has arthritis, although it is not yet clear whether the five-and-a-half-year-old sheep is suffering from the condition as a result of the cloning process. And, scientists in Tokyo have shown that cloned mice die significantly earlier than those that are naturally conceived, raising an additional concern that the mutations that accumulate in somatic cells might affect nuclear transfer efficiency and lead to cancer and other diseases in offspring. Researchers working with clones of a Holstein cow say genetic programming errors may explain why so many cloned animals die, either as fetuses or newborns.

Ethical Concerns

The announcement of Dolly sparked widespread speculation about a human child being created using somatic cell nuclear transfer. Much of the perceived fear that greeted this announcement centered on the misperception that a child or many children could be produced who would be identical to an already existing person. This fear is based on the idea of "genetic determinism" -- that genes alone determine all aspects of an individual -- and reflects the belief that a person's genes bear a simple relationship to the physical and psychological traits that compose that individual. Although genes play an essential role in the formation of physical and behavioral characteristics, each individual is, in fact, the result of a complex interaction between his or her genes and the environment within which he or she develops. Nonetheless, many of the concerns about cloning have focused on issues related to "playing God," interfering with the natural order of life, and somehow robbing a future individual of the right to a unique identity.

Policy and Regulation

Several groups have concluded that reproductive cloning of human beings creates ethical and scientific risks that society should not tolerate. In 1997, the National Bioethics Advisory Commission recommended that it was morally unacceptable to attempt to create a child using somatic cell nuclear transfer cloning and suggested that a moratorium be imposed until safety of this technique could be assessed. The commission also cautioned against preempting the use of cloning technology for purposes unrelated to producing a liveborn child.

Similarly, in 2001 the National Academy of Sciences issued a report stating that the United States should ban human reproductive cloning aimed at creating a child because experience with reproductive cloning in animals suggests that the process would be dangerous for the woman, the fetus, and the newborn, and would likely fail. The report recommended that the proposed ban on human cloning should be reviewed within five years, but that it should be reconsidered "only if a new scientific review indicates that the procedures are likely to be safe and effective, and if a

broad national dialogue on societal, religious and ethical issues suggests that reconsideration is warranted." The panel concluded that the scientific and medical considerations that justify a ban on human reproductive cloning at this time do not apply to nuclear transplantation to produce stem cells. Several other scientific and medical groups also have stated their opposition to the use of cloning for the purpose of producing a child.

Cloning for the Isolation of Human ES Cells

The cloning debate was reopened with a new twist late in 1998, when two scientific reports were published regarding the successful isolation of human stem cells. Stem cells are unique and essential cells found in animals that are capable of continually reproducing themselves and renewing tissue throughout an individual organism's life. ES cells are the most versatile of all stem cells because they are less differentiated, or committed, to a particular function than adult stem cells. These cells have offered hope of new cures to debilitating and even fatal illness. Recent studies in mice and other animals have shown that ES cells can reduce symptoms of Parkinson's disease in mouse models, and work in other animal models and disease areas seems promising.

In the 1998 reports, ES cells were derived from in vitro embryos six to seven days old destined to be discarded by couples undergoing infertility treatments, and embryonic germ (EG) cells were obtained from cadaveric fetal tissue following elective abortion. A third report, appearing in the New York Times, claimed that a Massachusetts biotechnology company had fused a human cell with an enucleated cow egg, creating a hybrid clone that failed to progress beyond an early stage of development. This announcement served as a reminder that ES cells also could be derived from embryos created through somatic cell nuclear transfer, or cloning. In fact, several scientists believed that deriving ES cells in this manner is the most promising approach to developing treatments because the condition of in vitro fertilization (IVF) embryos stored over time is questionable and this type of cloning could overcome graft-host responses if resulting therapies were developed from the recipient's own DNA.

Ethical Concerns

For those who believe that the embryo has the moral status of a person from the moment of conception, research or any other activity that would destroy it is wrong. For those who believe the human embryo deserves some measure of respect, but disagree that the respect due should equal that given to a fully formed human, it could be considered immoral not to use embryos that would otherwise be destroyed to develop potential cures for disease affecting millions of people. An additional concern related to public policy is whether federal funds should be used for research that some Americans find unethical.

Policy and Regulation

Since 1996, Congress has prohibited researchers from using federal funds for human embryo research. In 1999, DHHS announced that it intended to fund research on human ES cells derived from embryos remaining after infertility treatments. This decision was based on an interpretation "that human embryonic stem cells are not a human embryo within the statutory definition"

because "the cells do not have the capacity to develop into a human being even if transferred to the uterus, thus their destruction in the course of research would not constitute the destruction of an embryo." DHHS did not intend to fund research using stem cells derived from embryos created through cloning, although such efforts would be legal in the private sector.

In July 2001, the House of Representatives voted 265 to 162 to make any human cloning a criminal offense, including cloning to create an embryo for derivation of stem cells rather than to produce a child. In August 2002, President Bush, contending with a DHHS decision made during the Clinton administration, stated in a prime-time television address that federal support would be provided for research using a limited number of stem cell colonies already in existence (derived from leftover IVF embryos). Current bills before Congress would ban all forms of cloning outright, prohibit cloning for reproductive purposes, and impose a moratorium on cloning to derive stem cells for research, or prohibit cloning for reproductive purposes while allowing cloning for therapeutic purposes to go forward. As of late June, the Senate has taken no action. President Bush's Bioethics Council is expected to recommend the prohibition of reproductive cloning and a moratorium on therapeutic cloning later this summer.

Prepared by Kathi E. Hanna, M.S., Ph.D., Science and Health Policy Consultant

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What is cloning? Do clones ever occur naturally? What are the types of artificial cloning? What sort of cloning research is going on at NHGRI? How are genes cloned? How are animals cloned? What animals have been cloned? Have humans been cloned? Do cloned animals always look identical? What are the potential applications of cloning animals? What are the potential drawbacks of cloning animals? What is therapeutic cloning? What are the potential applications of therapeutic cloning? What are the potential drawbacks of therapeutic cloning? What are some of the ethical issues related to cloning?

What is cloning?

The term cloning describes a number of different processes that can be used to produce genetically identical copies of a biological entity. The copied material, which has the same genetic makeup as the original, is referred to as a clone.

Researchers have cloned a wide range of biological materials, including genes, cells, tissues and even entire organisms, such as a sheep.

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Do clones ever occur naturally?

Yes. In nature, some plants and single-celled organisms, such as bacteria, produce genetically identical offspring through a process called asexual reproduction. In asexual reproduction, a new individual is generated from a copy of a single cell from the parent organism.

Natural clones, also known as identical twins, occur in humans and other mammals. These twins are produced when a fertilized egg splits, creating two or more embryos that carry almost identical DNA. Identical twins have nearly the same genetic makeup as each other, but they are genetically different from either parent.

What are the types of artificial cloning?

There are three different types of artificial cloning: gene cloning, reproductive cloning and therapeutic cloning.

Gene cloning produces copies of genes or segments of DNA. Reproductive cloning produces copies of whole animals. Therapeutic cloning produces embryonic stem cells for experiments aimed at creating tissues to replace injured or diseased tissues.

Gene cloning, also known as DNA cloning, is a very different process from reproductive and therapeutic cloning. Reproductive and therapeutic cloning share many of the same techniques, but are done for different purposes.

What sort of cloning research is going on at NHGRI?

Gene cloning is the most common type of cloning done by researchers at the National Human Genome Research Institute (NHGRI). NHGRI researchers have not cloned any mammals and NHGRI does not clone humans.

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How are genes cloned?

Researchers routinely use cloning techniques to make copies of genes that they wish to study. The procedure consists of inserting a gene from one organism, often referred to as "foreign DNA," into the genetic material of a carrier called a vector. Examples of vectors include bacteria, yeast cells, viruses or plasmids, which are small DNA circles carried by bacteria. After the gene is inserted, the vector is placed in laboratory conditions that prompt it to multiply, resulting in the gene being copied many times over.

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How are animals cloned?

The technique used to clone whole animals, such as sheep, is referred to as reproductive cloning.

In reproductive cloning, researchers remove a mature somatic cell, such as a skin cell or an udder cell, from an animal that they wish to copy. They then transfer the DNA of the donor animal's somatic cell into an egg cell, or oocyte, that has had its own DNA-containing nucleus removed.

Researchers can add the DNA from the somatic cell to the empty egg in two different ways. In the first method, they remove the DNA-containing nucleus of the somatic cell and inject it into the empty egg. In the second approach, they use an electrical current to fuse the entire somatic cell with the empty egg.

In both processes, the egg is allowed to develop into an early-stage embryo in the test-tube and then is implanted into the womb of an adult female animal. Ultimately, the adult female gives birth to an animal that has the same genetic make up as the animal that donated the somatic cell. This young animal is referred to as a clone. Reproductive cloning may require the use of a surrogate mother to allow development of the cloned embryo, as was the case for the most famous cloned organism, Dolly the sheep.

Reproductive cloning may require the use of a surrogate mother to allow development of the cloned embryo, as was the case for the most famous cloned organism, Dolly the sheep.

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What animals have been cloned?

Over the last 50 years, scientists have conducted cloning experiments in a wide range of animals using a variety of techniques. In 1979, researchers produced the first genetically identical mice by splitting mouse embryos in the test tube and then implanting the resulting embryos into the wombs of adult female mice. Shortly after that, researchers produced the first genetically identical cows, sheep and chickens by transferring the nucleus of a cell taken from an early embryo into an egg that had been emptied of its nucleus.

It was not until 1996, however, that researchers succeeded in cloning the first mammal from a mature (somatic) cell taken from an adult animal. After 276 attempts, Scottish researchers finally produced Dolly, the lamb from the udder cell of a 6-year-old sheep. Two years later, researchers in Japan cloned eight calves from a single cow, but only four survived.

Besides cattle and sheep, other mammals that have been cloned from somatic cells include: cat, deer, dog, horse, mule, ox, rabbit and rat. In addition, a rhesus monkey has been cloned by embryo splitting.

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Have humans been cloned?

Despite several highly publicized claims, human cloning still appears to be fiction. There currently is no solid scientific evidence that anyone has cloned human embryos.

In 1998, scientists in South Korea claimed to have successfully cloned a human embryo, but said the experiment was interrupted very early when the clone was just a group of four cells. In 2002, Clonaid, part of a religious group that believes humans were created by extraterrestrials, held a news conference to announce the birth of what it claimed to be the first cloned human, a girl named Eve. However, despite repeated requests by the research community and the news media, Clonaid never provided any evidence to confirm the existence of this clone or the other 12 human clones it purportedly created.

In 2004, a group led by Woo-Suk Hwang of Seoul National University in South Korea published a paper in the journal Science in which it claimed to have created a cloned human embryo in a test tube. However, an independent scientific committee later found no proof to support the claim and, in January 2006, Science announced that Hwang's paper had been retracted.

From a technical perspective, cloning humans and other primates is more difficult than in other mammals. One reason is that two proteins essential to cell division, known as spindle proteins, are located very close to the chromosomes in primate eggs. Consequently, removal of the egg's

nucleus to make room for the donor nucleus also removes the spindle proteins, interfering with cell division. In other mammals, such as cats, rabbits and mice, the two spindle proteins are spread throughout the egg. So, removal of the egg's nucleus does not result in loss of spindle proteins. In addition, some dyes and the ultraviolet light used to remove the egg's nucleus can damage the primate cell and prevent it from growing.

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Do cloned animals always look identical?

No. Clones do not always look identical. Although clones share the same genetic material, the environment also plays a big role in how an organism turns out.

For example, the first cat to be cloned, named Cc, is a female calico cat that looks very different from her mother. The explanation for the difference is that the color and pattern of the coats of cats cannot be attributed exclusively to genes. A biological phenomenon involving inactivation of the X chromosome (See sex chromosome) in every cell of the female cat (which has two X chromosomes) determines which coat color genes are switched off and which are switched on. The distribution of X inactivation, which seems to occur randomly, determines the appearance of the cat's coat.

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What are the potential applications of cloned animals?

Reproductive cloning may enable researchers to make copies of animals with the potential benefits for the fields of medicine and agriculture.

For instance, the same Scottish researchers who cloned Dolly have cloned other sheep that have been genetically modified to produce milk that contains a human protein essential for blood clotting. The hope is that someday this protein can be purified from the milk and given to humans whose blood does not clot properly. Another possible use of cloned animals is for testing new drugs and treatment strategies. The great advantage of using cloned animals for drug testing is that they are all genetically identical, which means their responses to the drugs should be uniform rather than variable as seen in animals with different genetic make-ups.

After consulting with many independent scientists and experts in cloning, the U.S. Food and Drug Administration (FDA) decided in January 2008 that meat and milk from cloned animals, such as cattle, pigs and goats, are as safe as those from non-cloned animals. The FDA action means that researchers are now free to using cloning methods to make copies of animals with desirable agricultural traits, such as high milk production or lean meat. However, because cloning is still very expensive, it will likely take many years until food products from cloned animals actually appear in supermarkets.

Another application is to create clones to build populations of endangered, or possibly even extinct, species of animals. In 2001, researchers produced the first clone of an endangered

species: a type of Asian ox known as a guar. Sadly, the baby guar, which had developed inside a surrogate cow mother, died just a few days after its birth. In 2003, another endangered type of ox, called the Banteg, was successfully cloned. Soon after, three African wildcats were cloned using frozen embryos as a source of DNA. Although some experts think cloning can save many species that would otherwise disappear, others argue that cloning produces a population of genetically identical individuals that lack the genetic variability necessary for species survival.

Some people also have expressed interest in having their deceased pets cloned in the hope of getting a similar animal to replace the dead one. But as shown by Cc the cloned cat, a clone may not turn out exactly like the original pet whose DNA was used to make the clone.

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What are the potential drawbacks of cloning animals?

Reproductive cloning is a very inefficient technique and most cloned animal embryos cannot develop into healthy individuals. For instance, Dolly was the only clone to be born live out of a total of 277 cloned embryos. This very low efficiency, combined with safety concerns, presents a serious obstacle to the application of reproductive cloning.

Researchers have observed some adverse health effects in sheep and other mammals that have been cloned. These include an increase in birth size and a variety of defects in vital organs, such as the liver, brain and heart. Other consequences include premature aging and problems with the immune system. Another potential problem centers on the relative age of the cloned cell?s chromosomes. As cells go through their normal rounds of division, the tips of the chromosomes, called telomeres, shrink. Over time, the telomeres become so short that the cell can no longer divide and, consequently, the cell dies. This is part of the natural aging process that seems to happen in all cell types. As a consequence, clones created from a cell taken from an adult might have chromosomes that are already shorter than normal, which may condemn the clones' cells to a shorter life span. Indeed, Dolly, who was cloned from the cell of a 6-year-old sheep, had chromosomes that were shorter than those of other sheep her age. Dolly died when she was six years old, about half the average sheep's 12-year lifespan.

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What is therapeutic cloning?

Therapeutic cloning involves creating a cloned embryo for the sole purpose of producing embryonic stem cells with the same DNA as the donor cell. These stem cells can be used in experiments aimed at understanding disease and developing new treatments for disease. To date, there is no evidence that human embryos have been produced for therapeutic cloning.

The richest source of embryonic stem cells is tissue formed during the first five days after the egg has started to divide. At this stage of development, called the blastocyst, the embryo consists of a cluster of about 100 cells that can become any cell type. Stem cells are harvested from

cloned embryos at this stage of development, resulting in destruction of the embryo while it is still in the test tube.

In November 2007, using a new cloning method that removes the egg's nucleus without dyes or ultraviolet light, researchers produced the first primate embryonic stem cells. The work involved transferring the nucleus of a skin cell from a male rhesus monkey into the nucleus-free egg of a female rhesus monkey. These embryonic stem cells did not develop into a whole monkey, and researchers said their work was aimed at therapeutic applications. However, the research shows that, with some adjustments, the techniques used to make whole copies of other animals may also work in primates.

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What are the potential applications of therapeutic cloning?

Researchers hope to use embryonic stem cells, which have the unique ability to generate virtually all types of cells in an organism, to grow tissues in the laboratory that can be used to grow healthy tissue to replace injured or diseased tissues. In addition, it may be possible to learn more about the molecular causes of disease by studying embryonic stem cell lines from cloned embryos derived from the cells of animals or humans with different diseases.

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What are the potential drawbacks of therapeutic cloning?

Many researchers think it is worthwhile to explore the use of embryonic stem cells as a path for treating human diseases. However, some experts are concerned about the striking similarities between stem cells and cancer cells. Both cell types have the ability to proliferate indefinitely and some studies show that after 60 cycles of cell division, stem cells can accumulate mutations that could lead to cancer. Therefore, the relationship between stem cells and cancer cells needs to be more clearly understood if stem cells are to be used to treat human disease.

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What are some of the ethical issues related to cloning?

Gene cloning is a carefully regulated technique that is largely accepted today and used routinely in many labs worldwide. However, both reproductive and therapeutic cloning raise important ethical issues, especially as related to the potential use of these techniques in humans.

Reproductive cloning would present the potential of creating a human that is genetically identical to another person who has previously existed or who still exists. This may conflict with long-standing religious and societal values about human dignity, possibly infringing upon principles of individual freedom, identity and autonomy. However, some argue that reproductive cloning could help sterile couples fulfill their dream of parenthood. Others see human cloning as a way

to avoid passing on a deleterious gene that runs in the family without having to undergo embryo screening or embryo selection.

Therapeutic cloning, while offering the potential for treating humans suffering from disease or injury, would require the destruction of human embryos in the test tube. Consequently, opponents argue that using this technique to collect embryonic stem cells is wrong, regardless of whether such cells are used to benefit sick or injured people.

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Last Reviewed: June 12, 2012

http://www.genome.gov/Issues/

AAAS Policy Brief: Human Cloning

Issue Summary | AAAS Resources | Links

 

The issue of human cloning has been the subject of much public debate since the birth of the cloned sheep Dolly was announced in 1997. The profound ethical questions surrounding the prospect of the birth of a human clone have received much scrutiny. In recent months, the debate has included the topic of human embryonic stem cell research, which scientists believe could benefit from experimentation using the procedure pioneered by the scientists who produced Dolly.

Nuclear TransplantationThe Link to Stem Cell ResearchLegislative DebateArguments Against Nuclear Transplantation ResearchArguments For Nuclear Transplantation ResearchThe States' Perspective The International Perspective

Nuclear Transplantation

This procedure is known as nuclear transplantation, or somatic cell nuclear transfer (SCNT). It involves removing the nucleus, which contains a cell's DNA, from an egg cell and transplanting the DNA from an adult cell into the enucleated egg. Under certain conditions, the egg then begins to replicate as though it were a fertilized embryo.

After the egg divides for several days, it produces embryonic stem cells, which are primitive cells that can theoretically develop into virtually any type of cells in the organism, from blood cells to skin cells. Scientists believe that research on human stem cells could lead to new cures for many diseases. The use of nuclear transplantation to produce human stem cells is often referred to as "research cloning" or "therapeutic cloning."

If this entity is implanted into a uterus, it has the potential to develop into a full organism which would have the same DNA as the donor of the adult cell. In other words, the organism would be a "clone." This procedure is known as "reproductive cloning."

The Link to Stem Cell Research

Stem cell research and research cloning are closely linked. Scientists in the private sector have conducted experiments on human embryonic stem cells after extracting them from excess embryos left over from fertility treatments. They hope one day to use these cells for treating diseases, and one of the potential obstacles for such a procedure is rejection of the implanted cells by the patient's immune system. Through nuclear transplantation, stem cells could be created with the same genetic makeup as the patient, which some scientists believe would reduce or eliminate the risk of immune rejection.

Recently, various alternatives to nuclear transplantation have been proposed, including:

deriving stem cells from embryos that are already dead - some consider this procedure to be ethically analogous to removal of organs from a person who has recently died

deriving stem cells by extracting blastomeres (cells formed in the first stages of embryonic development, when the fertilized ovum is split) from living embryos - this procedure is currently used to test IVF embryos for genetic and chromosomal abnormalities, but long-term effects of this extraction on a person's health are unknown

altered nuclear transfer - this procedure alters the somatic cell nucleus before transfer such that it would not have the developmental potential of a human embryo

Click here for more information on these alternatives.

It is important to keep in mind that nuclear transplantation and its alternatives are very recent developments - the science is still in its early stages and there remains much to be learned. While nuclear transplantation has been tested in animals with some success, such tests have not been conducted for many of the alternatives to nuclear transplantation. Similarly, ethical implications have been more thoroughly discussed in regards to nuclear transplantation than its alternatives. Each method poses its own set of ethical concerns.

Legislative Debate

There is widespread opposition in the U.S. to the birth of a human clone (reproductive cloning). While a few groups argue that cloning is a legitimate form of reproduction, opposition to these arguments is nearly unanimous among scientists and policy-makers, due to both ethical and

safety concerns. To quote the National Academies 2002 report on cloning, "Human reproductive cloning should not now be practiced. It is dangerous and likely to fail."

However, both the U.S. as a whole and the U.S. Congress in particular are heavily divided on the issue of research cloning. Some in Congress support legislation criminalizing nuclear transplantation in humans, whether for reproductive or research purposes, which is a position supported by President Bush. Others in Congress have proposed legislation that would criminalize only reproductive cloning while allowing research cloning. Although various legislation on this issue has been introduced in Congress from 2001 through the present, no agreement has been reached.

Click here to view AAAS's position on human cloning.

Arguments Against Nuclear Transplantation Research

Proponents of a comprehensive ban on nuclear transplantation for research and reproductive purposes raise two main arguments. Religious conservatives argue that human embryos should be afforded a moral status similar to human beings and should not be destroyed, even in the course of conducting research. They also argue that permitting nuclear transplantation would open the door to reproductive cloning, because a ban only on implantation would be difficult to enforce. In this second argument, conservatives are joined by a coalition of environmental, women's health, and bioethics groups who are not unalterably opposed to nuclear transplantation, but believe that it should not be permitted until strict regulations are in place.

Arguments For Nuclear Transplantation Research

Proponents of a ban solely on reproductive cloning that would permit nuclear transplantation research, include a coalition of science organizations, patient groups, and the biotechnology industry. These groups argue that the moral status of a human embryo is less than that of a full human being, and must be weighed against the potential cures that could be produced by research using nuclear transplantation. They contend that a ban on implantation on the product of nuclear transplantation would be no more difficult to enforce than a ban on nuclear transplantation itself. They argue further that criminalizing scientific research, which has been done only very rarely in the past, would set a bad precedent.

The States' Perspective

In the United States, the absence of a national policy in regards to cloning has resulted in states leading the way, pursuing policies either for or against cloning. Opinions vary among the states. As of 2006, fifteen states had laws dealing with human cloning. All either prohibit reproductive cloning entirely or prohibit the use of government funding for reproductive cloning. There is less agreement when it comes to research cloning. Some ban it entirely and some prohibit the use of government funding for it, but others allow it.

While the federal government has not addressed the overall issue of whether cloning is allowed, it has addressed the funding of research via the Dickey Amendment (H.R. 3010, Sec. 509) which

prohibits the NIH from funding research utilizing human embryos derived by cloning.

Please click here for details.

The International Perspective

There is as little consensus among nations as there is among Congress members when it comes to the issue of cloning. In fact, nations are so divided that the United Nations abandoned efforts to create a worldwide treaty on human cloning. Instead, in 2005 the U.N. adopted a resolution aiming to provide guidance to countries attempting to arrive at a position on cloning and stem cell research. Many nations, including the UK, China, and South Africa, have explicitly prohibited reproductive cloning while allowing research cloning. Fewer nations have explicitly prohibited research cloning, which (as of 2006) is allowed in 10 countries.

Please click here for details.

Updated June 6, 2007

http://www.aaas.org/spp/cstc/briefs/cloning/

Cloning

As a consequence of scientific and biotechnological progress during the past decades, new biological therapies involving somatic cells and genetic material are being investigated. The Food and Drug Administration (FDA) described existing legal authorities governing a new class of human somatic cell therapy products and gene therapy products in an October 14, 1993 Federal Register Notice.

On February 23, 1997, the public learned that Ian Wilmut, a Scottish scientist, and his colleagues at the Roslin Institute successfully used a technique called somatic cell nuclear transfer (SCNT) to create a clone of a sheep; the cloned sheep was named Dolly. SCNT involves transferring the nucleus of an adult sheep somatic cell, into a sheep egg from which the nucleus had been removed. After nearly 300 attempts, the cloned sheep known as Dolly was born to a surrogate sheep mother.

SCNT is not reproduction since a sperm cannot be used with the technique, but rather it is an extension of technology used not only in research but also used to produce medically relevant cellular products such as cartilage cells for knees, as well as gene therapy products. On February 28, 1997, FDA announced a comprehensive plan for the regulation of cell and tissue based therapies that incorporated the legal authorities described in FDA's 1993 guidance "Proposed Approach to Regulation of Cellular and Tissue-Based Products

On March 7, 1997 then President Clinton issued a memorandum that stated: "Recent accounts of advances in cloning technology, including the first successful cloning of an adult sheep, raise important questions. They potentially represent enormous scientific breakthroughs that could

offer benefits in such areas as medicine and agriculture. But the new technology also raises profound ethical issues, particularly with respect to its possible use to clone humans." (Prohibitions on Federal Funding for Cloning of Human Beings)

The memorandum explicitly prohibited Federal Funding for cloning of a human being, and also directed the National Bioethics Advisory Commission (NBAC) to thoroughly review the legal and ethical issues associated with the use of cloning technology to create a human being.

"NBAC found that concerns relating to the potential psychological harms to children and effects on the moral, religious, and cultural values of society merited further reflection and deliberation." The report, Ethical Issues in Human Stem Cell Research, September 1999, describes 5 recommendations.

Somatic cell nuclear transfer holds great potential to someday create medically useful therapeutic products. FDA believes, however, that there are major unresolved questions pertaining to the use of cloning technology to clone a human being which must be seriously considered and resolved before the Agency would permit such investigation to proceed. The Agency sent a "Dear Colleague" letter which stated that creating a human being using cloning technology is subject to FDA regulation under the Public Health Service Act and the Food Drug and Cosmetic Act. This letter notified researchers that clinical research using SCNT to create a human being could precede only when an investigational new drug application (IND) is in effect. Sponsors are required to submit to FDA

Recently, FDA sent letters to remind the research community that FDA jurisdiction over clinical research using cloning technology to create a human being, and to advise that FDA regulatory process is required in order to initial these investigations. (March 2001 letter)

On March 28, 2001, Dr. Kathryn C. Zoon, Director, Center for Biologics Evaluation and Research gave testimony before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, United States House of Representatives. Her statement described FDA's role in regulating the use of cloning technology to clone a human being and further described current significant scientific concerns in this area.

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