Critical Commentary on Summary Article

Here is the link again, for the article listed and summarized below--the pre-publication version of the President's Council on Bioethics report Human Cloning and Human Dignity: An Ethical Inquiry.

(http://www.liebertonline.com/doi/pdf/10.1089/073003102761698007?cookieSet=1)

Now that we've offered a summary of this article--which also serves as a recap for much of this blog--we are interested in engaging with it more fully, and examining it more critically.

This article skillfully outlines nearly all of topics important to the current debates over cloning technologies, and raises the crucial ethical questions that society and science alike must grapple with as cloning technology advances. It recognizes that we cannot separate these ethical questions and debates from cloning, or try to analyze cloning without taking them into consideration. Try as we might, it is nearly impossible to discuss the role and future of cloning in society and science, without thinking about the ethics involved: do we have the right to manufacture life, or "manipulate some human beings for the benefit of others?" Does the potential good that may be derived from therapeutic cloning techniques outweigh moral and ethical qualms? Questions such as these must always remain in the back of our heads as we take on the challenge of exploring the biotechnology of cloning in medicine.

One thing that this article failed to mention, is the notion of cloning genes and genes alone, rather than cloning for reproductive purposes or cloning human embryos for scientific purposes. Although the article distinguishes between "cloning-to-produce-children" and "cloning-for-biomedical-research" it does not make any further differentiations in the types of cloning that may be used "for biomedical research." Yes, of course, one such type of cloning is the cloning of human embryos, so that cloned stem cells may be harvested and manipulated for therapeutic uses in a patient (this is the only type of cloning-for-biomedical-research that the Council considers in this article). But there is another type of cloning, also for research and medical purposes, that is ignored. Scientists are able to clone specific genes, introduce them to a vector of some sort (a plasmid, for instance), and then insert the recombined DNA into an organism; as the inserted cells divide, the target gene will be perpetuated in the organism (see the blog posting on gene-altered goats as an example of this cloning technology). Why does the article neglect this type of cloning? Is it simply that this method is seen as less ethically problematic? Does this method border on gene therapy and DNA recombination, and fall outside the realm of what is considered 'true' cloning?

We find it problematic that the Council does not recognize this type of cloning. Perhaps, even if they did not deem it worthy of greater consideration or evaluation, they might have explained their reason for its exclusion. For instance, they decided not to examine it deeply because they believe it is less of an ethical dilemma, or they think that it is already widely accepted as a safe scientific procedure.

Additionally, in our research we found a number of recent articles on the cloning of other animals. Although the article defines the notion of animal cloning, it is no more than a passing mention of this technology. We wondered why they dismissed this form of technology so easily. True, it is not exceedingly relevant to the issues that the Council focuses on, but we think it is an important omission to acknowledge. As later articles in our blog demonstrate, companies have started saying that they will clone your pets--if this becomes a common practice, our society will slowly become accustomed to the idea of animal cloning (even if the idea is still revolutionary today). What if we become de-sensitized to animal cloning? Then, suddenly, human cloning is not such a big leap to make. We think that the article may have benefitted from delving into the issue of animal cloning a bit more.

The Council does as it promises to do, and provides sound discussions and opinions on the many ethical considerations relevant to cloning technologies. It presents both sides of each debate, even when the Council members were in consensus: for instance, the Council agrees in its position against cloning-to-produce-children, but it still lists the common arguments in favor of this type of cloning. Let us turn to the discussion on the ethics of cloning-for-biomedical-research:

Clearly, both sides of the debate have strong foundational arguments. We think that most people would agree that trying to alleviate human suffering is a noble cause, and one that is generally supported. But we also ideally want to respect all human life, no matter how young. The difference between being for or against biomedical cloning can often come down to a simple time line: at what point in development do we consider an embryo to be morally equivalent to any other human? This is a matter of personal opinion, which is why the cloning debates can be so heated. Some people believe that as soon as an egg is fertilized, it is a potential human, and deserves to be treated as any other human. Others say that an embryo has only "intermediate moral status" until it is a month old... It will always be difficult, perhaps even impossible, to come to any sort of agreement on this. We must consider what this means for cloning--if the people cannot agree, does it fall to the government to decide for us?

The Council, of course, writes this article for the purpose of recommending some course of action for the government to take with regard to public policy. What should we do about cloning? Is regulation necessary? Should cloning be banned altogether? The very fact that this is the purpose of the Council demonstrates how far we are from considering cloning in terms of healthcare. We have not even decided whether cloning should be legal. We recognize that many of the articles considered in this blog do not address cloning's position in the healthcare debates, but this is because cloning is too new of a technology, too underdeveloped and imperfect, to be considered as a viable treatment or therapy just yet. Until we understand cloning, and all its implications more fully, and until we have perfected techniques of cloning and conducted further experimentation and research, we cannot be sure that cloning will actually prove to be as useful as we currently hope.

Many researchers and scientists claim that cloning holds great promise: that some cloning techniques may help to develop treatments for diseases such as Parkinson's, or may lead to a huge leap forward in regenerative medicine. But for now, we do not know. We do not know if we will ever succeed in these ventures, or if we will ever be able to clone safely enough. There are many hurdles to overcome before cloning will be considered in the formal healthcare debates.

For now, we, the people of America, must engage in these debates on cloning technologies. We must decide whether we believe that cloning is ethically wrong, or whether we think potential benefits outweigh known costs. We must show our support of cloning, or we must petition for a ban on this technology. But first, we have to make sure that we have all the facts straight.

Summary Article

http://www.liebertonline.com/doi/pdf/10.1089/073003102761698007?cookieSet=1

In 2002, the President's Council on Bioethics published the results of their discussion on the issue of cloning technologies. This article is the "Pre-Publication Version" or outline of their report, Human Cloning and Human Dignity: An Ethical Inquiry. It summarizes clearly and concisely many of the issues that we have presented in this blog, regarding the technology of cloning, both for reproductive and therapeutic purposes. The Council strives to answer some of the important questions that we also have been exploring: what is cloning, and what does it mean? Where does it now stand in society and in science, and how do we think about it? How should we deal with cloning? Do we accept and embrace it as a potential therapy, or do we reserve such positive judgment because of the many ethical dilemmas it entails?

In this article, the President's Council tackles the problem of cloning, and seeks to offer advice about what the public policy regarding cloning should be. Why? Because, they claim, cloning has broad implications in both science and society, and we have now reached the point where we must address the issues it raises, rather than trying to ignore them. The article starts off by asking, "Human Cloning: What is at Stake?""The notion of cloning raises issues about identity and individuality, the meaning of having children, the difference between procreation and manufacture, and the relationship between generations. It also raises new questions about the manipulation of some human beings for the benefit of others, the freedom and value of biomedical inquiry, our obligation to heal the sick (and its limits), and the respect and protection owed to nascent human life."

These are, in a nutshell, the big ethical questions surrounding both reproductive and therapeutic cloning technologies. They are also the many reasons why such a careful examination of cloning is necessary. The authors recognize that in general, "people do not regard it [cloning] as just another new technology." Along with the fact that cloning as a technology is still underdeveloped and far from the perfection that we require of our medicines and therapies, this is perhaps the biggest reason that cloning has not factored into healthcare debates at all. People are scared of cloning. Cloning cannot be accepted as simply as prosthetics or biopharmaceuticals; it is far too personal, and "touches fundamental aspects of our humanity" in ways that other biotechnologies do not. We are not ready, as a society, to think about cloning in terms of healthcare just yet.

The Council describes the common methods of cloning, including somatic cell nuclear transfer. It also recognizes the proximity of cloning to stem cell research, and differentiates between 'regular' human embryonic stem cells (and the discovery of multipotent cells, which are "currently being studied intensely for their possible uses in regenerative medicine") and stem cells from cloned embryos, which may overcome the problem of transplant rejection (i.e, the implantation of foreign tissue triggering the immune system; note that if cloned cells are used, these cells may not be perceived as "foreign"). The article also distinguishes between what is widely termed reproductive cloning, or "cloning-to-produce-children," and therapeutic cloning, or "cloning-for-biomedical-research." It explores each technology separately, and analyzes each one (in terms of ethical dilemmas) on its own.

After offering such background information, the Council begins to discuss the ethics of cloning-to-produce-children. It acknowledges that this technology may serve positive purposes, but goes on to say that arguments in favor of reproductive cloning "pay insufficient attention to the well-being of the cloned child-to-be." It also states that the cloning technologies currently available have rates of morbidity and mortality far too high to be considered acceptable--the procedure is unsafe for both parent and child, and there is no plausible way to conduct research in an ethical way in order to determine whether the technology may be improved to make it unquestionably safe. Five main other objections to this type of cloning are presented:

1. Problems of identity and individuality: wouldn't a cloned child be overshadowed throughout his or her life by memories of the original person? How well could he or she develop a sense of identity, knowing that someone identical has already lived a life and established an identity?

2. Concerns regarding manufacture: cloned children would be the first "designer babies" and might "contribute to increased commercialization and industrialization of human procreation."

3. Prospect of a new eugenics: who will be cloned and who will not be? Will parents opt for cloning a child to avoid the possibility of having a baby with some genetic defect? Will parents clone if they believe that they possess some "outstanding genetic traits"?

4. Troubled family relations: what happens when a child is also his mother's brother, or a grandparent is also a parent to their grandchild? How do family systems still function?

5. Effects on society: if people know that there are cloned children out there, how will attitudes towards children as a whole change? Might this type of cloning "set the precedent for future nontherapeutic interventions into the human genetic endowment"?

The Council offers this conclusion.

"For some or all of these reasons, the Council is in full agreement that cloning-to-produce-children" is not only unsafe but also morally unacceptable, and ought not to be attempted."

Although the Council is able to come to this strong conclusion concerning cloning-to-produce-children, they are somewhat more divided on the issue of ethics of cloning-for-biomedical-research. "On the one hand," the authors note, "such research could lead to important knowledge about human embryological development and gene action, both normal and abnormal, ultimately resulting in treatments and cures for many dreaded illnesses and disabilities. On the other hand, the research is controversial because it involved the deliberate production, use, and ultimate destruction of cloned human embryos, and because the cloned embryos produced for research are no different from those that could be used in attempts to produce cloned children." This is the crux of the matter.

Those in favor of cloning-for-biomedical-research believe that the duty of doctors and others in the biomedical profession to relieve human suffering may be greatly advanced by this technology, and that this type of cloning may allow for the treatment of many diseases and disabilities. These Council members write that, "The moral objections to this research are outweighed by the great good that may come from it." Some members do not see an ethical problem in therapeutic cloning, even though scientists will be creating human embryos with the intention of destroying them. Others acknowledge their own qualms about the ethics of this type of cloning, citing three main issues. Firstly, they understand that nascent human life deserves respect, but believe that embryos before a certain stage do not need to be considered "the moral equivalent of a human person." Secondly, they recognize the concerns regarding the creation of embryos for use and destruction, but emphasize that they will not be mindlessly destroyed, but used "in the service of life and medicine." Lastly, they claim that researchers can be prevented from "going too far" and can be deterred from developing cloned embryos beyond the blastocyst stage.

Of course, several Council members also present the moral case against cloning-for-biomedical-research. Their main argument states that:

"It is morally wrong to exploit and destroy developing human life, even for good reasons, and that it is unwise to open the door to the many undesirable consequences that are likely to result from this research. We find it disquieting, even somewhat ignoble, to treat what are in fact seeds of the next generation as mere raw material for satisfying the needs of our own."

This point of view argues that the human embryo, even in its earliest stages, should be considered as deserving of respect and protection as a baby, a toddler, a child, an adult. It also claims that allowing cloning-for-biomedical-research means that our society is sanctioning the creation of human life solely for the purpose of its use in labs, its use in research, and then its destruction, which is a slippery slope that leads...who knows where? The Council members against this type of cloning list three other risks of allowing therapeutic cloning, all of which involve "significant moral harm to our society."

In conclusion, the Council explores possible options for implementing public policy concerning the technology of cloning, ranging from complete prohibition, to a temporary moratorium, to self-regulation by researchers. In the end, though, the Council offers two recommendations.

Majority Recommendation:

"Ten members of the Council recommend a ban on cloning-to-produce-children combined with a four-year moratorium on cloning-for-biomedical-research. We also call for a federal review of current and projected practices of human embryo research, pre-implantation genetic diagnosis, genetic modification of human embryos and gametes, and related matter, with a view to recommending and shaping ethically sound policies for the entire field." The moratorium on therapeutic cloning would allow (or force) both sides, those for and those against, to present their arguments publicly. This would allow the American people to understand the issues more fully and make an informed opinion. It would also give more time for research to be conducted, which would allow scientists a chance to evaluate how promising this biotechnology really is.

Minority Recommendation:

"Seven members of the Council recommend a ban on cloning-to-produce-children, with regulation of the use of cloned embryos for biomedical research....Permitting cloning-for-biomedical-research now, while governing it through a prudent and sensible regulatory regime, is the most appropriate way to allow important research to proceed while insuring that abuses are prevented." Similar to the majority opinion, this opinion holds that cloning-to-produce-children should not be practiced. However, this opinion differs in that it considers further experimentation necessary in order to make advances in this field, which in turn will help determine this technology's true value. This opinion holds that strict regulation would prevent abuse of the technology. 

Look out for further analysis on this article!

Cloning for the Commoner

This entry was originally posted November 15th:

2001 TIMES Article Human Cloning: Baby, It's You! And You, And You... by N. Gibbs et al

I found this article after searching through and reading articles about cloning and society. Published in 2001, this article reviews the hopes, dreams, and fears of the American public around the issue of cloning, particularly as it relates to human genes. Prior to publishing the article, TIME ran a poll that found that 90% of Americans thought cloning humans was a "bad idea." Following the poll, TIME painted cloning in a very optimistic light, focusing on the potential benefits cloning could have for sterile couples (or gay couples), and for organ transplantation. It is a very interesting snapshot of optimism in a time before legislation battles on cloning became serious, and in particular, debates over stem-cell research. The article references the Realien group, which is considered a religious cult whose primary focus is creating human clones. At the time of the article, it was considered quite possible that news of the creation or existence of a human clone would break in a matter of months, maybe even weeks. Considering this, the article is very optimistic about the extent of time and investment it would take to produce a human clone. The article appears very expectant of an underground, outcast group popping up with a clone. As we now know, this has not happened. The cost necessary to do this is just too great, and the depth of the hope gauged by the article was far off the actual level that actually existed. There was not enough hope to fuel private investment to make these technologies a reality. The truth is, these sorts of advances will only come about with federal funds, as we can see with our 20/20 hindsight.

After reading this article, it is striking to note the lack of urgency or hope in treatment through cloning technologies outside of the medical community today. Indeed, cloning seemed to be seen solely through the lens of reproduction. Has fear of extremists, indeed, ruined the enthusiasm for success? The inhibitory legislation that passed as a result of this fear has kept us from potentially saving lives. But, because cloning is such "old news," and nothing has come out of it yet (or at least, nothing has come to fruition), is it now dull in the eyes of the public? What needs to happen for the commoner to get behind the idea of continuing research in cloning?

Clearly, these are important questions to answer, especially if it is our goal to introduce cloning to the healthcare debates. If the public is too scared of cloning technologies, if they are ignorant of the potential benefits it may provide to the diseased and disabled, then we will be hard-pressed as a society to see cloning advance enough, and be supported enough, to make it into healthcare debates.

A. Wilde

Cloning pets: worth it?

http://www.nytimes.com/2009/01/01/garden/01clones.html?_r=1&scp=5&sq=cloning&st=cse

The December 2008 New York Times article by Eric Konigsberg, “Are Cloned Pets the Real Thing?”, is simultaneously a human interest story about Lou Hawthorne, the owner of BioArts, a biotech company out of California, and an account of the state of pet cloning today. Hawthorne had his company create clones from Hawthorne with the three clones of Missy. preserved DNA of his mother’s old dog Missy. He extols the virtues of cloning your pet, claiming that Missy’s clones all have her qualities: “she was an amazing dog: superior intellect, incredibly beautiful, obedient, a phenomenal temperament… all those qualities are represented [in the clones].” However, since he is the owner of one of the only companies which offer dog cloning services, one can see why he may be more inclined to see pet cloning as a way to get your old dog back, personality and all.

The issue is that we don’t know how much of behavior is actually genetically based: even Hawthorne acknowledges that “when it comes to such highly trainable creatures as dogs, it’s pretty difficult to know where nature ends and nurture begins.” For example, Hawthorne’s mother insists that the late Missy and her new clones are “not at all alike.” And many of the Missy clones’ special qualities can be seen as a product of environment, and not genes (obedience and temperament, particularly). Many who wish to clone their pets do not simply want a physically identical copy, but one which has all the personality traits of the original. Because we know that many factors other than genetics go into forming an individual, it is nearly impossible for a pet to be recreated to the owner’s satisfaction. But this is the claim Hawthorne makes and this is how companies such as BioArts are able to make money.

A part of the story which particularly interested me was that Hawthorne held auctions, offering BioArts’ dog cloning services to the four highest bidders (who ended up paying from $130,000 to $170,000 for the clones). To “offset accusations of elitism,” Hawthorne ended up also offering the services pro bono to a fifth client out of the search. Like any new technology, as of now, pet cloning is extremely expensive and therefore limited to the wealthy. Though Hawthorne’s move was largely symbolic, it’ll be interesting to see in the future how pet cloning companies deal with claims of elitism. Since the companies and the technologies are still very new (and flawed) it’s not surprising a single clone can take $100,000 or more to produce. As time goes on and the price of clones gets lower and lower, less wealthy families may gain access to pet cloning services. But whether they will be satisfied with their clones? According to Hawthorne, yes. According to his mother, not necessarily.

EDIT: http://www.bioarts.com/press_release/ba09_09_09.htm
September of this year, BioArts announced that it would no longer offer dog cloning services. The reasons cited in the press release by Lou Hawthorne include a "tiny market," "unethical, black market competition," weak intellectual property protection laws, and the unpredictable nature of cloning. Perhaps we are not yet ready to face the ethical and public policy issues of cloning?

A. Suchecka

The potential effects of human cloning on society

http://www.sciencemag.org/cgi/content/full/sci;296/5566/314?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cloning&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

"Human Cloning and Our Sense of Self," written by Dan W. Brock, a professor in the Department of Philosophy at Brown, and published in April of 2002, offers a philosophical perspective on some of the moral implications of human cloning. He addresses three main concerns people have when it comes to cloning: that cloning would injure their sense of individuality, that it would affect their value as a person, and that it would affect their sense of freedom in their life decisions. Though the author admits that it’s possible that cloning would bring about these three effects, he largely aims to diffuse the public’s fears about human cloning.

Amidst all the news about the biology and politics of human cloning, I found it refreshing to get a glimpse of how a philosopher sees cloning. I think the author’s main point was that if there are any negative effects on a person’s self-worth due to cloning, it is because of false notions and personal beliefs about cloning. The author argues cloning would not actually result in a loss of individuality and uniqueness, unless it is defined as strictly genetic uniqueness (e.g. although identical twins are in fact genetically similar, we can see that they are distinct and unique individuals). Widespread human cloning could result only in a psychological, perceived loss of individuality. It’s a fine line: one could argue that the perceived loss of individuality is as bad as an actual loss.

The article also deals with the potential effects of human cloning on the perceived value of life. “It is the nature of a being,” the author writes, “not how it is created, that is the source of its value and makes it worthy of respect.” He cites the example of children who are created using technologies such as in vitro fertilization, but who are obviously treated as equal to children created using the ‘natural’ way. The article also addresses the concept of genetic determinism: the idea that a person’s genome completely determines their traits, their character, and essentially, their life. The author seems skeptical that if human cloning became widely used, genetic determinism would be the rule, since it is clear that genes are only a part of what makes us who we are.

I think this would be a good article for everyone to read, but especially those who are highly critical of cloning or who fear the moral implications of human cloning. The article is simply written and easy to follow and addresses the moral issues of human cloning in a fairly unbiased way. The only issue may be that the article was published in Science Magazine, which is hardly a layperson’s choice for science news. I really appreciated that the author laid out his argument in a very logical way and every step of the argument was based on rationality and not feelings. Too often, when it comes to controversial issues like stem cells, genetic engineering, and cloning, the public is swayed by arguments that appeal to their feelings rather than their logic. Articles such as this one can help to educate the public about what human cloning could possibly mean for individuality, human value, and freedom. As cloning becomes more and more feasible, these moral issues could potentially impact health care debates. Though we do not have the capability to clone a human being just yet, we are getting closer and closer. Someday, not as distant as one might think, we may have the capacity to clone a human and when that day comes, we’ll have to address these philosophical questions of the morality of cloning.

A. Suchecka

Are you For or Against Cloning?

http://library.thinkquest.org/24355/data/reactions/proconmain.html
Check out the three links on this website: arguments for and against cloning, as well as some really interesting and provoking statements about the ethics of cloning, opinions about banning cloning, etc.
This website offers links to three pages: one that outlines some of the common arguments in favor of cloning, one that lists some arguments against cloning, and one that shares the statements/opinions of people and organizations in regard to their stances on cloning.
Clearly, cloning is an extremely controversial technology. Fear plays a large role in this controversy, but sound scientific arguments are present on both sides of the debate. This website may help the average person come to an informed personal opinion on the topic of cloning.

What I found to be the most interesting part of this website is the page with several quotations about cloning:
1. Libertarian Party: Steve Dasch, chairman- "Politicians should not have veto power over the creation of new life - especially human life...That’s why the Libertarian Party supports reproductive freedom of choice for Americans-whether they choose to reproduce using the traditional method, or artificial insemination, or in-vitro fertilization, or cloning... if cloning research is banned, millions of people could suffer." Can cloning really be compared to artificial insemination of in-vitro fertilization? Is it just as legitimate a form of reproduction as any other? Or do we have to take into consideration the fact that these other methods have been rather perfected (or at least significantly more developed) and have fairly high success rates, and an acceptable cost/benefit ration, while cloning is still hugely inefficient? When we look at Dolly, 277 reconstructed embryos resulted in 1 birth; is that even close to an acceptable numbers game to subject a human to? Yes, maybe we want people to have reproductive rights. But who are the millions of people who will "suffer" if cloning is banned, and what will this "suffering" entail?

2. Foundation of Economic Trends: Jeremy Rifkin, president- Proposing a world-wide ban on cloning, he says it should carry a penalty "on par with rape, child abuse, and murder."
Why is cloning anything like rape or child abuse or murder? What do these things have in common? Do you agree that these are the appropriate punishments?

3. Church of England Board of Social Responsibility: Mary Seller- "The antics of a few cranks and Hitler types" should not impede cloning research. "Cloning. like all science, must be used responsibly. Cloning humans is not desirable. But cloning sheep has its uses."
How do we stop people from abusing the technology of cloning? Where do we draw the line between someone conducting useful research, and someone who is a "Hitler type"? I

agree that cloning needs to be used responsibly. It could potentially be very dangerous. So how do we keep knowledge out of the wrong people's hands? Is cloning technology going to have to be guarded like the knowledge needed to make an atomic bomb? Can we even make that comparison? Also, we have to consider what differences there actually are between cloning humans and cloning animals. Do we as humans have different rights to protect than animals such as sheep do? Why is it okay for us to manipulate sheep in this way? And why can we alter the genes of sheep, but we cannot use pigs to produce transplantable organs? Even if we draw the line between humans and animals, where is that seemingly arbitrary line drawn within cloning in animals?

4. Clones Rights United Front: Randolfe Wicker, founder- "We’re fighting for research, and we’re defending people’s reproductive rights... I realize my clone would be my identical twin, and my identical twin has a right to be born." This seems to be a matter of controversy over definitions. Is a clone really the same thing as an identical twin? Do we not have to take into consideration the matter of shortened telomeres, and the fact that clones are generally created from much older cells? We still do not fully understand how adult cells are reprogrammed to become stem cells again, and as long as we don't have this knowledge can we really equate a clone with a twin?

There are no easy answers to any of these questions. Perhaps this is one of the big reasons that the debate over cloning remains so heated. There is no clear black or white--everything seems to be a shade of gray, and individuals are left to ponder the questions and come up with their own opinions. This may be one of the biggest obstacles to the advancement of using cloning technologies in medicine. And it may also mean that the government (or federal agencies) will need to step in, in order to make one decision.

C. Heard

Cloned Cells Bring Hope of Therapy for Parkinson's Disease

http://www.timesonline.co.uk/tol/news/science/article3607659.ece

This article, published in March 2008, reports on "the first time that cloned stem cells have been used to reverse disease in the same animals from which they were derived." In an experiment lead by Lorenz Studer, somatic nuclear transfer was used to create nearly 200 lines of cloned embryonic stem cells. Because Parkinson's disease is associated with a deterioration of dopamine-producing neurons, these stem cells were manipulated in vitro to form dopamine neurons, which were injected back into the mice (from which the embryonic stem cells were cloned). According to this article, "when mice received neurons grown from their own cloned stem cells, their neurological symptoms improved and they showed no signs of rejecting the transplanted tissue."

This experiment, as the article states, could have far-reaching implications. If the same process could be mimicked with human cells, we may be well on our way to a potential therapy for Parkinson's. But we still have a long way to go. As with many articles we have read, the tone of this report is guardedly optimistic. Yes, this experiment is an amazing breakthrough using the biotechnology of cloning. But mice and humans are a very different matter. The article cautions its readers not to get their hopes up quite yet. Although the experimental procedure shows promise, the article warns that "only two groups, one in Britain and one in the US, have succeeded in cloning human embryos, and none has yet produced stem cells from a cloned embryo." So how, realistic, really, is it to believe that this therapy will soon be used in humans? The article also notes that cloning is hugely inefficient; scientists are still not able to consistently produce a viable line of cloned embryonic stem cells. On the contrary, "cloning... [usually] requires hundreds of eggs to produce a single viable clone, [which] is also expected to limit therapeutic applications."

Despite the fact that these statements may seem negative in tone, the article overall is being more realistic than pessimistic. It notes that there are many intermediary steps that need to be taken before this kind of therapy can be applied to human patients. But it quotes experts who claim that the results are exciting and will eventually be useful in treating humans. One scientist is quoted as saying, “This is a very well conducted study that provides further proof-of-principle of the idea of ‘therapeutic cloning’ using a mouse model. Ideally one of the next steps will be to repeat the whole procedure with a monkey model, in which all the individual steps have now been established. This will allow much better tests of functional recovery and safety.”

Overall, the article presents a very fair few on the developing technology of therapeutic cloning. Progress is being made, but we should be careful not to count our chickens before they hatch. Scientists have still not mastered cloning completely; it is a fickle science that we still need to improve our understanding of, in order to utilize it most effectively. Although a decade has gone by since Dolly was cloned, and many people assumed that cloning would soon become common practice, we are still only making slow advances. But they are advances nonetheless, and should not be under-credited.

Readers should also notice the several controversies that are subtly raised in this article. First, is the "inefficiency of cloning." When hundreds of eggs are still required to produce a viable clone, how ethical is it to even consider using this technology in humans? Can we even imagine asking a woman to hyper-ovulate to this extent, in order to harvest her eggs in what still may be a failed attempt to produce an embryonic clone? I think we as a society will only consider these procedures acceptable in humans when the technology of cloning has been fine-tuned, and is much more efficient and consistent.
The article seems to agree. It states that "many scientists think that the main use of cloning will be to make laboratory models of disease for medical research, rather than treatments to be given to patients. This can be done by inserting human DNA into animal eggs, which will be allowed under the Human Fertilisation and Embryology Bill." Here, then, we will not be asking a woman to use her own eggs. Instead, animals will be made to bear that burden. But how ethical is this? How would animal rights activists respond to this? And how do we feel about the government stepping in to decide this issue with a federal bill?

Clearly, in trying to solve one controversy, scientists may run into another. Because cloning is still not fully understood or developed, many thorny issues abound. Hopefully, as scientists learn more about how to improve these technologies, some of these issues will no longer be a problem.
But for now, we must accept each small step forward that is made, and look to how we can improve and refine cloning technology to apply it safely and ethically to human patients.

C. Heard

Were You Aware That You Could Have Consumed Cloned Animal Meat?

One sometimes forgets how much of an effect science has on our daily lives. In the world of cloning, it is sometimes difficult to comprehend the magnitude of new discoveries and the changes that our lives undergo as a result. For example, did you know that it is possible that you have eaten meat from a cloned cow? On January 8th, 2007, Nature Biotechnology, an online scientific journal, published a study, conducted by Xiangzhong Yang and associates, about the use and production of cloned cattle, and other mammals. Research on the cloning of animals has been taking place for years, specifically with research on cloning cattle having been conducted for over twenty years. These cattle are being cloned in one of two ways, either by embryonic cell nuclear transfer (ECNT), or by somatic cell nuclear transfer (SCNT). The only difference between the two is that SCNT uses adult somatic cells and ECNT uses embryonic cells- but the technology used in both procedures is identical.
In effect, embryo cloning by embryonic cell separation is simply a higher tech version of selective breeding. Selective breeding in animal agriculture has been used for years to increase the reproduction of high-grade specimen. The only difference is that instead of mating a steer and a female cow together that are likely to breed daughters that produces lots of milk, the embryo from a female cow that produces a lot of milk would be split into two, three, or four separate embryos that all produce high milk producing cows.
This article is important because it addresses a couple key issues relating to animal cloning and the resulting products. Number one, it addresses the fact that in general, the majority of the public is unaware that they could have consumed cloned meat. The article states that, “Most of these ECNT cloned cattle were valuable breeding animals that almost certainly produced thousands of progeny.” To those who greatly oppose embryonic research, and who also buy meat at the average supermarket, this could prove a major ethical problem. Any of us who eat meat could have eaten meat from a cloned animal, or one of their offspring. There is currently no differentiation in identification for meat that is from a cloned or non-cloned animal. As a result of this, although studies show that, “there are no reports on health-good or bad-of humans who have consumed meat or milk from these cloned animals,” there is not a reliable system in place to track the real reactions humans have to cloned animal meat and milk.

However, the second important part of this article is that it reaffirms what was held to be the standard when it comes to the products of cloned animals- “”More than 1000 commonly used parameters, including amino acid composition, fatty acid composition, proportion of meat and fat, organ weight and organ histopathology…fit the food industry normal ranges and did not differ significantly from meat and milk from naturally reproduced cattle.” That is, although the meat hasn’t been tracked, there is a great amount of evidence to support the idea that meat from cloned animals is not harmful to humans.
This article also briefly addresses some of the worries that both animal rights advocates and human safety advocates are concerned with. For one, sometimes with SCNT and ECNT calves and lambs suffer from “large offspring syndrome,” which is when animals are too large at birth. In addition, “other symptoms, such as placental abnormalities, edema, large umbilicus or perinatal deaths” can occur. Breeding animals that are more likely to suffer from these conditions can be viewed as inhumane. Is it ethically and morally sound to continue this research when it increases the likelihood that more animals will suffer from various abnormalities and pain? Do the ends justify the means?

full article link: http://www.nature.com/nbt/journal/v25/n1/full/nbt1276.html

S. Sneed

The Pet Clone Wars

http://www.time.com/time/world/article/0,8599,1878398,00.html

This is a very recent article (Feb. 10. 2009) from Times about fierce competition among Korean biotechnology labs for commercial use of pet cloning. Times editor Jennifer Veale writes about the most recent commercial use of biotechnology.

To summarize, there are two major players in South Korea- RNL BIO, sponsored by Seoul Univeristy and Sooam Biotech Research Foundation, associated with BioArts International in the States.

RNL was the first company to successfully clone dogs after Dolly was cloned in 1996 by Ian Wilmut. Since 2005, RNL has cloned 35 dogs and five wolves while Sooam has cloned 75 dogs.

(image on the right- actual ads on RNL's web site rnl.co.kr)

Although the article gives credit for what Lee, the leader of RNL, has achieved, it is skeptical about its success in the future. It is not only too expansive-$150,000 per dog- but also concerns many ethical issues to become popular among the general public.

It is predicted that the service charge will be much lower in few years, but I'm not sure if many would support the technology which so many oppose.

In fact, people have been exposed to so many negative images of 'cloning'. The recent series of Starwars and the movie The Island only emphasized how dangerous and threatening cloning can be.
Those images are so clear in my mind that I'm not sure if many would love to have anything 'cloned' in their houses. Especially 'pets' which people seek love and comfort from. Pet and clones just don't match.

Cloned pets were interesting subjects, but the most interesting part (for me) of this article is this: other interesting potential uses of cloned pets. Where do we go from here?

Other than cloning the deceased pets of the clients, there are "service dogs" that can be used to "detect cancer and narcotics". For example, there is a top drug-sniffing dog that is actually used in Incheon Airport of South Korea. Or this pet cloning technique can also protect the endangered dog breeds.

However, the future Lee sees from this technique is different. Pointing out the fact that canines share similar diseases patterns with humans, he sees it as the potential medical resource. Lee plans on producing a "transgenic" dog whose DNA would be manipulated by the animal reproduction experts. This dog would give much clearer picture of the role of genes and treatments for the diseases such as diabetes or Alzheimer's disease that are uncurable today.

This is an alternative to human cloning which is under a fierce debate among political, ethical, religious and medical groups. Because human cloning is so controversial and may be banned permantently, this could be a promising field for better understandings of genetics. Of course, this will upset many experts that fight for animal rights, however considering its vast potential uses, it is likely to be supported by majority of the people.
Well, one thing for sure is that it's going to be easier than reaching an agreement over human cloning.

Although this is such a small commercial field, this is business, therfore there still exists a conflict over patents. Sooam and BioArts are accusing RNL BIO of violating licensing agreements. BioArts claim that its Dolly patent covers the dog cloning as well while RNL claims that they are operating under the dog-specific patent, the Snuppy patent.
It's ironic how we see cloning as the technique that is yet to come while two companies are arguing over a patent just like they would do over a normal product on the market.

This provided another perspective on cloning. It provided the most recent products of cloning on the market and the competition among the scientists who reproduce them.

The products discussed in this article were not GM food products but pet dogs- human's best friend. It made me wonder how close we are to clone anything we can imagine.


M. Han

Vatican Takes an Action Against the Human Cloning

http://edition.cnn.com/2004/WORLD/europe/02/13/vatican.clones.reut

http://vatican.va/roman_curia/secretariat_state/2004/documents/rc_seg-st_20040927_cloning_en.htmlst_20040927_cloning_en.html

Vatican released the "Document of the Holy See on Human Cloning” in reaction to the stem cell research in 2004- the year when South Korean scientists successfully extracted the stem cells. The CNN news reports (Feb. 10. 2004) that Vatican officials openly condemned human cloning in the same year.

The Church’s bioethics advisor criticized the cloning of human embryos stating that cloning is similar to what “Nazis tried to do in WWII concentration camps.” This did have a strong influence; it was the pope who drove former President George W. Bush, a Catholic, to attempt to ban all forms of cloning in Congress and in the United Nations.

The document on Vatican's web site shows the Church’s official stand on this issue. To summarize, Vatican is against the research using the embryonic cell, however, is passively supportive of the use of adult cell. Feeling the pressure of society’s expectation and the enormous potential of biotechnology, Vatican states that “the Holy See is convinced of the need to support and promote scientific research for the benefit of humanity.” This is quite a deviation from the conservative character of Catholics on scientific controversies.

Contrary to what one would expect from a document issued by a religious group, this document does not make any direct reference to the Bible or God. It is a rather scientific document written by a person with a solid understanding in stem cell research. Vatican specifically bans the use of embryonic cells not only by addressing the moral issues, but also by specifically addressing the technical challenges and difficulties. The risks this document addresses include possibility of seeding cancer, causing tumor formation and transferring genetic disorders.

This article grasped my attention among the flood of scientific documents written by biotechnology specialists. The Catholic Church’s interference with this issue reminded me of the European history course I took during high school; the glorious days of the Church and its officials. Although we live in a secular society now, it is apparent that religion, especially the Catholic Church still is one of the strongest voices on many social issues. Religion cannot be neglected for it shapes the moral values and worldly view of its followers. As shown in President Bush’s case, Church is still the standard of worldly ethics and has a strong influence on policies. The Vatican officials reach out to its believers by clearly stating its opinion and expectations. They go beyond the old Bible-which may seem irrelevant to our world- by applying their own set of beliefs on a recent social issue. The Catholic Church, however, did not simply state its opinion but supported its position with thorough arguments. It employed specialists who proved that the Church was not just being archaic and stubborn but rather reasonable and flexible.

This article highlighted the fact that cloning is a multi-faceted issue. It concerns fields beyond biotechnology. Policy makers should expand their horizon to consider not only the techonological challenges but also religious or ethical controversies.

M. Han

Therapeutic cloning: technological and public policy limitations

http://www.nytimes.com/2008/01/18/us/18embryos.html

“Cloning Said to Yield Human Embryos”

This New York Times article by Andrew Pollack from January 18th, 2008 reports on a small, San Diego-based biotech company called Stemagen which was the first to create human embryos from the skin cells of two adult males. Some experts quoted in the article were skeptical about the significance of the findings since the embryos only grew to the blastocyst stage and it’s unclear whether (a) they were sufficiently healthy to survive had they been implanted in a womb and (b) embryonic stem cells could actually be derived from the clones. Nonetheless, the chief executive of Stemagen says that the company has “at least shown the opening to the cave that has the holy grail” (the ‘holy grail’ being the ability to create, via cloning, patient-specific embryonic stem cells in order to treat diseases such as Parkinson’s and diabetes).

As previously discussed (see post: “Some Facts About Cloning”), the goal of this kind of cloning, referred to as therapeutic cloning, is not to clone human beings, but to create embryos in order to harvest stem cells that can be used to treat diseases. Stem cells have the potential to differentiate into any type of cell in the body, which is why they have great promise in treating diseases such as Alzheimer’s. The NYT article does say that the official statement from Stemagen is that the company is “not interested in creating cloned babies, something that is illegal in places and morally repugnant to many people.” However, in my opinion, the article does not draw a clear enough line between therapeutic and reproductive cloning. Or rather, for the average reader with no knowledge of different kinds of cloning, it muddies the line with sentences like “Although the embryos grew only to a very early stage, the work could also theoretically be seen as a step toward creating babies that are genetic copies of other people.” This ambiguous kind of wording could influence public perception of therapeutic cloning and link it, to its detriment, with reproductive cloning. Since the majority (90% as reported in the TIME poll cited in post: “Cloning for the Commoner”) of Americans think that cloning humans is a bad idea, tying therapeutic cloning with the cloning of people can only do harm to public perception of therapeutic cloning technologies.

One aspect of this article I particularly liked was that it not only presented Stemagen’s claims, but also presented the limitations of the study. So the overall message isn’t that science has made a huge leap in cloning technology, but rather, a small step has been made in the right direction (or as Stemagen puts it, we’ve been “shown the opening to the cave”). Maybe not as concrete of an advance as one would like, but I think in the end, more representative of how science really works. The article offers feedback on the researchers’ claims from different experts, some who are extremely optimistic about the results, and some decidedly less so. This process of peer review is essential to science in general, but particularly in the realm of public health debates. When policymakers need to decide whether a particular technology is worth investing money in, or indeed, as is the case with cloning, whether the technology is morally right, they should be informed of the context of each finding. In order for the public and the policymakers to make good decisions about the development and use of cloning technology, such as in the case of the new "Human Cloning Prohibition Act of 2009" (see below), they need to be informed by experts of what each new finding really means: good and bad.

A. Suchecka

The Human Cloning Prohibition Act of 2009

Ever since its emergence into the public conscious, politicians have been wrangling with the concepts and ideology of human cloning. Currently, there are no federal laws in the United States that ban cloning completely. However, there are regulations that forbid federal funding for research into human cloning. In addition, there are some states that restrict both therapeutic and reproductive cloning, as well as some states that just ban reproductive cloning.
Thus far, gridlock between members of the Senate has impeded any direct law vindicating or outlawing human cloning. However, this all might change very soon. Letters inundate Congress in support of and against human cloning. Lobbyists are knocking at the doors of Congressmen trying to make their points and show their data. With the new Obama administration and new changes in the medical industry on the horizon, it is likely that the issue of cloning will be fought over by both parties harder than ever.
One of the newest bills in the House of Representatives is the “Human Cloning Prohibition Act of 2009” which was introduced by republican representative Jeffrey Fortenberry on January 6th 2009. On February 9th, 2009, this bill passed into the second step in the many faceted process of passing an act, it was referred to Committee. Specifically, it was referred the Subcommittee on Crime, Terrorism, and Homeland Security.
The summary of this bill [written by the Congressional Research Service, a well-respected nonpartisan arm of the Library of Congress] is as follows:

“1/6/2009--Introduced.

Human Cloning Prohibition Act of 2009 - Amends the federal criminal code to prohibit any public or private person or entity, in or affecting interstate commerce, from: (1) performing or attempting to perform human cloning; (2) participating in an attempt to perform human cloning; or (3) shipping, receiving, or importing the product of human cloning for any purpose. Sets forth criminal and civil penalties for violations.
Provides that nothing in this Act shall restrict areas of scientific research not specifically prohibited by this Act, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.”

The reasons stated for the necessity of this bill include: scientific support of the idea that cloning humans poses a “risk of producing children who are stillborn, unhealthy, or severely disabled,” the idea that human cloning could lead to manufacturing of children, the idea that clones if they survived, would not have mothers or fathers, and that with the development of cloning persons could be cloned without their knowledge. While some of the reasons outlined in this bill are viable- such as the likelihood of unhealthy clones, some of the reasons, such as child manufacturing is highly unlikely. In effect, this bill is based primarily on moral principles, as well as hypothetical various potential outcomes of the future, and has a very limited amount of scientific fact as its base. However, it does provide a few interesting moral positions, and ideas that are presented in a straightforward manner.

To see the full text of the H.R. 110: Human Cloning Prohibition Act of 2009 please go to this link:
http://www.govtrack.us/congress/billtext.xpd?bill=h111-110

S. Sneed

The Ethics Of Cloning

http://content.nejm.org/cgi/content/full/351/3/207

What makes a person? At what point do we become sentient beings?
On July 15th, 2004, an article was published in the prestigious New England Journal of Medicine about the ethics of embryonic cloning. Much of the center of debate on cloning lies in the morality behind the act of therapeutic cloning, or the formulation of human embryos for research purposes. The author of this article, Michael Sandel, discusses and compares both the argument supporting the idea that embryos are classifiable as persons, and the argument that embryos are not sentient creatures and thus should not be classified as persons.

The article opens making the point that it would be rare to find a doctor, or any person who, “would dispute the idea that respect for human dignity imposes certain moral restraints on medical research.” The ultimate question is does the “destruction of human embryos in stem-cell research amount to the killing of human beings?” This question is immeasurably complex and underlies the foundation of one of the most prominent ethical debates of this time.
The movement against stem-cell research is often referred to as “embryo objection,” and the supporters of this movement believe that “extracting stem cells from a blastocyst is morally equivalent to yanking organs from a baby to save other people’s lives.” In essence, they believe that a cell in the embryonic stage is due the equivalent rights and treatment as a fully developed baby. Those who hold this belief may do so simply because of their personal moral belief, or it could be the result of one of many possible religious beliefs, an example being that “ensoulment occurs at conception.” The author notes that there are those who do not try to defend their beliefs on a religious base, but simply state that all of us begin life as an embryo and therefore, if our lives are worthy of respect, so are those of the embryos. These persons argue that the value of our lives does not increase with age. I agree with the author in that while these can be strong moral arguments, they are theoretically and scientifically unfounded.
The author gives an extremely suitable analogy comparing embryos and humans to acorns and oak trees. He states that, “Although every oak tree was once an acorn, it does not follow that acorns are oak trees, or that I should treat the loss of an acorn eaten by a squirrel in my front yard as the same kind of loss as the death of an oak tree felled by a storm. Despite their developmental continuity, acorns and oak trees are different kinds of things. So are human embryos and human beings.” The importance of being sentient, or being aware of being alive, is the major difference between human beings and embryos. The point in development at which a human being becomes sentient is undefined, but it is highly unlikely that it occurs during the portion of time that these embryos are being used.
In addition, the author states that there seems to be a mentality among those opposing embryonic research that those of us who do support embryonic research would treat embryos without care, and view them with indifference. The author points out that this is not true, and that “one need not regard the embryo as a full human being in order to accord it a certain respect. To regard an embryo as a mere thing, open to any use we desire or devise, does, it seems to me, miss its significance as potential human life.” I completely agree in that it is important to recognize the potential of embryos, and to recognize that yes, we did all originate from the same form that we are trying to manipulate and that it is due a certain degree of respect. However, it is important to remember that while embryos are potential humans, they are not humans. They are “potential.” They are not yet self-aware and sentient. We are not using them to make cosmetics, or create a new unnecessary product- we are using them to help try to find a way to save the lives of living, sentient people.
I encourage anyone interested in the morals of therapeutic cloning to read this article. The author, Michael Sandel, has a doctorate degree in philosophy and provides lots of other interesting arguments that challenge the conventions of the stem-cell research debate.

S. Sneed

FDA Approves Drug from Gene-Altered Goats

http://www.nytimes.com/2009/02/07/business/07goatdrug.html

I found this article while browsing the NY Times online for relatively recent stories about cloning and cloning technologies. Just earlier this year, the FDA approved "the first drug produced by livestock that have been given a human gene." A herd of 200 bioengineered/transgenic/"pharm" animals--in this case goats--all have a human gene that codes for the production of a certain human protein that can help prevent the formation of some fatal blood clots. Whenever the goats lactate, the gene is turned on, and the protein is produced. It may then be harvested in large quantities, purified, and given as drug therapy to patients with a rare disorder.

This article reports on a huge turning point in the technology of cloning. The US government stated in 2008 that meat, milk, and other food products from cloned animals were safe. But for the first time, the FDA is now supporting a therapy that is a direct product of cloning technologies. Cloning has been accepted as a valid form of producing medical treatments. The article recognizes that drugs have been derived from animals before (as we know, bovine insulin used to be used widely for diabetics). But "this is the first drug from a herd of genetically engineered animals created specifically to serve as living pharmaceutical factories."

Of course, the cloning of goats and their use as "factories" has brought on great controversy. Animal rights activists, as one could predict, are not too pleased with the prospect of animals being treated as "tools." But there are other issues with this technology as well. As the NY Times mentions, we have no idea what might happen if a goat ran away, or got loose somehow, and came into contact with other goats. What if one bioengineered goat somehow bred with a normal goat--what would happen to the human gene?

What kind of consequences might there be if this human gene started spreading throughout a wider and wider goat population? Yes, this is a legitimate fear, but the article does not dwell on it, or try to instill fear in its readers. It goes on to acknowledge other, similar drugs that show great promise, such as one new "drug, produced in the milk of transgenic rabbits, to treat hereditary angioedema, a protein deficiency that can lead to dangerous swelling of tissues." The article treats cloning not as a threat or danger, but as a valid and scientifically sound technology that deserves respect. And in doing so, it encourages its readers to do the same.

Much of the rest of the article, which enumerates the benefits of using animals to produce proteins, fits in with what we already know. Many biopharmaceutical companies tried to produce vast quantities of human proteins in big tanks. But they faced problems of building the facilities, and keeping everything entirely sterile. The use of transgenic animals eliminates these practical issues, but of course raises other ethical ones. There is also the risk of a disease killing all the goats.
One question to consider: Where do we go from here? The FDA has given a nod of approval to cloning technologies. If we accept the idea of using goats to produce proteins, how much of a leap is it to accepting the notion of using pigs to produce transplantable organs? Where do we draw the line, and why? What is the line? Does it depend on our view of animal rights, or on what we are willing to place in our own bodies? With this recent approval come a number of questions that we will soon have to answer for ourselves.

C. Heard

FDA Regulation of Cloning

This is a fabulously detailed and interesting article, which accomplishes much of what we are interested in doing with this very blog!
If you are interested in a much more in depth look at the history of FDA involvement in the technology of cloning (and especially human cloning), take a look at this article, published in the Harvard Journal of Law and Technology. The article is too long to go into detail about it here, but it is worth perusing if you are interested in that aspect of the development of cloning technologies.
The article first looks at the definitions and history of cloning, the development of increasingly sophisticated technologies and techniques, and then the FDA's claim to regulation over cloning, which was very much de facto. It goes on the examine the legitimacy of the FDA's claim and the issues surrounding its asserted jurisdiction.
I highly recommend it.

http://jolt.law.harvard.edu/articles/pdf/v15/15HarvJLTech085.pdf

DeMystifying Cloning

http://www.mirm.pitt.edu/news/article.asp?qEmpID=12

It is important to de-mystify new scientific technologies as they are discovered and developed. Otherwise, the public hears vague whispers but never really understands; then one morning, they wake up and a bold headline on the front page of the newspaper declares some new discovery, the media sensationalizes the whole thing, and awe and fear of the unknown settle in. This is what happened, in large part, with cloning. Most people hear the word "cloning" and think of reproductive cloning, creating a mini-me, the imminent danger of human cloning. But what about the other, less threatening types of cloning? What about gene cloning, therapeutic cloning, cloning not a whole animal, but a single cell? For the most part, the public hasn't heard and doesn't know about these technologies.
This article tries to open the blinds and speak in plain language--not scientific, Latin nonsense--so that a regular lay person can actually understand the process of therapeutic cloning, the pros and cons, what is understood and what is still being developed, and perhaps come to an informed opinion about the matter.

This article was published in the Pittsburgh Post Gazette in December 2001. The author lays out the accusations that have been leveled at researchers of cloning, before offering an understandable explanation of therapeutic cloning. The reader is allowed to form his own opinions, without being bombarded by biases.
Russel, a researcher who wrote the article, states that "we have been informed by many that 'human therapeutic cloning' is an evil form of research, equivalent to cloning babies to harvest their body parts. If true, this would be a truly scary prospect. However, it is a gross misinterpretation. Human therapeutic cloning may be a very effective way of curing diseases without some of the ethical dilemmas faced by isolating cells from embryos."
The process of nuclear transfer would allow the patient to re-nucleate an enucleated oocyte with a somatic (or body cell). This is the same process that was used to create Dolly. As Russel puts it, "In a dish, technology will exist to take that cell and simply convince it to multiply -- to clone itself. The resulting cells will not grow into a baby from whom a liver is taken. Instead, they will be convinced to become liver cells and injected into the [patient] to save her life."
Seemingly simple and elegant. Seemingly free from the debate over embryo cloning that we saw mentioned in the previous article. But the article remains vague. "Technology will exist" to manipulate the cell, we are told. But what technology? How will it work? This article leaves us with many questions remaining.
But it serves a purpose, and a very important one. It informs readers so that they may thoughtfully engage in debate, rather than protesting against cloning out of ignorance and fear. It reminds the public that science is not infallible, and that "science does not move forward by a continual advancing of knowledge. We take two steps forward, then discover we were wrong and start all over again." It reminds us that this is a technology still in the process of being fully developed and understood. We cannot demand perfection yet.

Of course, because the technology of cloning was still being developed in 2001, the issue of fitting cloning into health care had not even come up yet. We were still a long way away. But as cloning technologies become more plausible and less hypothetical, the government, Congress, and the FDA have become increasingly interested in regulating or restricting the products of these cloning technologies, as we will see in the following articles.

C. Heard

Predictions from 2000

http://news.bbc.co.uk/2/hi/health/753838.stm

Check out this BBC News article from May, 2000.

As early as 2000, Ian Willmut, a leading member of the Roslin Institute team responsible for the creation of Dilly, was predicting a variety of potential medical treatments that could arise from cloning technologies. Although he opposes the cloning of a human being, he admits to being hopeful about the possibilities that cloned stem cells could provide. If cells from a patient were used to clone an embryo, stem cells could be harvested, manipulated, and injected back into the patient at the appropriate sight (ie, wherever cells or tissue were degenerating).
Wilmut's predictions were scientifically sound. As we learned in class, many researchers and scientists are in fact trying to bring his thoughts to life: working on ways to treat Parkinson's, diabetes, liver damage, arthritis, etc. (the same conditions that Wilmut mentioned years ago!). But nearly a decade has passed, and very little has come to fruition. Recently, there has been moderate success in treating Parkinson's in mice. But for the most part, we are still trying to reach the potential that we recognized so many years ago.

This article is guardedly optimistic. While it notes the huge benefits that cloning technologies could provide, it also acknowledges "the huge hurdles experts must cross to reap them." And yet it remains hopeful, if cautiously so. Wilmut is reported as saying, "It [cloning] could be helpful to treat conditions associated with damage to cells which don't repair themselves - there isn't currently an effective treatment for any of them." And readers are not discouraged from believing this.
Because cloning is such a heated topic, many articles fall into the trap of editorializing, expressing personal opinions and influencing the public's perception. This article succeeds in avoiding such biased reporting. It expresses both sides, and does not clearly favor one argument. Potential is noted, but present failures are as well (in 2000, sheep and cattle had been cloned, but primates had not; gene cloning, however, had been successful in the creation of goats producing human blood clotting protein); the ethical dilemmas surrounding cloning embryos for medical use, and harvesting stem cells from aborted fetuses are both presented.
These are two very thorny debates surrounding cloning technology. While many people agree that the cloning of a human being is taboo, there is nothing even remotely close to a consensus regarding the cloning of embryos. This was true in 2000, and remains true today in 2009. And unlike many ethical dilemmas, which can be considered on a personal level, some broader judgment will eventually have to made regarding such a public medical technology. So although I may be all for the cloning of embryos, if the US government forbids it, my personal ethical decision is over-ruled. But consider, where would you stand on this issue? If the embryo is used solely for medical purposes, is it still dangerous to be producing such a clone? What happens if such technology goes wrong, or gets out of hand?
The article also raises another concern, one that we will return to later. At the very end, the article mentions that "Professor Wilmut also mentioned the genetic modification of pig organs so they can be used in human transplantation - another ethical minefield." If we already slaughter pigs by the millions for pork and bacon, what is the argument against a few more dying to save human lives? Are we valuing a human life over a pig life? Will the pig's quality of life deteriorate because it has been genetically modified? What do we owe pigs (or any animals, for that matter)? These are the questions that we must grapple with in the face of new medical technologies such as that of cloning.

C. Heard

Enough Background Info...

Let's get on with the important part of this blog!
Now that we have some idea of how cloning (both reproductive and gene cloning) first came into being, and we know a little bit about the initial reactions to these new technologies, let's look at the current debate over cloning.

The FDA Steps In

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm150508.htm

In October, 1998 the US Food and Drug Administration sent out a letter regarding human cloning (link above). Because of the successful creation of Dolly, a cloned mammal, and the seemingly rapid developments in cloning technology that followed, people were becoming increasingly worried about the possibility of someone creating a human clone. Many scientists and lay-people alike had realized, in the wake of Dolly's creation, that the world was not ready for this influx of new technologies. Perhaps scientific communities had accepted cloning as a possibility, but they expected advances to take at least 5-10 more years. Now, Roslin Institute was making leaps and bounds, and others were sure to follow. So several urgent questions arose: Would a scientist create a human clone? Should there be any regulations imposed on cloning technologies? Who should be allowed or not allowed to try and create a human clone? Was cloning even ethical to begin with? Should we allow cloning of animals, even?

More than a year after the birth of Dolly, the FDA stepped in. The FDA sent letters out, stating their claim to regulate human cloning.
I quote: "The purpose of this letter is to confirm to institutional review boards (IRBs) that the Food and Drug Administration (FDA) has jurisdiction over clinical research using cloning technology to create a human being.... This letter is being sent to IRBs at this time because of reports in the media that scientists are contemplating the use of cloning technology to create human beings...

"Clinical research using cloning technology to create a human being is subject to FDA regulation under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Under these statutes and FDA's implementing regulations, before such research may begin, the sponsor of the research is required to submit to FDA an IND describing the proposed research plan; to obtain authorization from a properly constituted and functioning IRB; and to obtain a commitment from the investigators to obtain informed consent from all human subjects of the research.... Since FDA believes that there are major unresolved safety questions pertaining to the use of cloning technology to create a human being, until those questions are appropriately addressed in the IND, FDA would not permit any such investigation to proceed."

The public, and here, the US government, were slightly scared of this new technology, with unknown and maybe limitless potential. Cloning was viewed as somewhat of a threat, and the FDA essentially forbade scientists from pursuing human reproductive cloning without explicit governmental permission.

We will explore whether anything has changed in the past 10-12 years. Is cloning still seen as dangerous by the public? Does the FDA still enforce such strict regulations? How has the FDA gone about regulating other types of cloning, such as gene cloning?

C. Heard

Developing Gene Cloning

Not long after the team of scientists at Roslin Institute created Dolly through the process of nuclear transfer, they took one step further in the technology of cloning, and created a lamb with a human gene in every cell in its body.

The New York Times reported in July, 1997: http://www.nytimes.com/books/97/12/28/home/0808970725sci-clone.html?scp=24&sq=dolly%20sheep%20cloned&st=cse

This was more than 10 yrs ago, and now, the practice of inserting human genes into animals is much more commonplace. For instance, we learned that several GTC Biotherapeutic Products are produced through the implementation of this practice. A cloned gene for a therapeutic protein is inserted (via a vector) into goat body cells. One of these cells is then transferred to an enucleated ooctye, which ideally can be implanted into a surrogate mother--when the baby goat is born, each of its cells still has a copy of the cloned gene. Using selective breeding allows for the creation of many goats, each of which still has the human gene in its cells. Then the gene codes for a human protein that is produced by the goat and can later be isolated to be used in human therapies. The goats become living bio-reactors for mass production of the desired protein. But the first step in the process involves gene cloning!

But how was this advance viewed back in 1997? Did it stir up excitement or fear?

C. Heard

SCIENTIST REPORTS FIRST CLONING EVER OF ADULT MAMMAL

On February 23, 1997 the front page of the New York Times screamed "SCIENTIST REPORTS FIRST CLONING EVER OF ADULT MAMMAL."

(link: http://www.nytimes.com/1997/02/23/us/scientist-reports-first-cloning-ever-of-adult-mammal.html?scp=8&sq=sheep+cloned&st=nyt )

News reached the public for the first time that such a feat was possible... and immediately, debates over the ethics of cloning and the potential for human cloning arose. But even then, Ian Wilmut, one of the leading scientists in the team from Roslin Institute in Edinburgh that succeeded in creating the cloned sheep Dolly, told the press that: ''What this will mostly be used for is to produce more health care products.... It will enable us to study genetic diseases for which there is presently no cure and track down the mechanisms that are involved. The next step is to use the cells in culture in the lab and target genetic changes into that culture.''

Wilmut, as it turns out, was spot on. Today, researchers and scientists are generally much more interested in DNA and gene cloning than in reproductive cloning. DNA and gene cloning hold much more potential for being therapeutically useful, as Wilmut foresaw. However, the public tends to be more excited by and worked up about reproductive cloning, partially because the media often sensationalizes this type of cloning.

As I just mentioned, DNA and gene cloning can be particularly useful in medicine. Specific genes or portions of DNA that code for a desired protein (or that are closely correlated to desired phenotypes) may be isolated and cloned. When the population of cloned DNA is then inserted into a vector or host cell, it will be replicated along with the host DNA, and the coded for protein or trait will, ideally be expressed. As we will see as this blog progresses, this very basic idea of gene cloning and DNA recombination could have wide-ranging therapeutic benefits. But the process is not without critics, and we will explore the opinions of those opposed to cloning as well.

C. Heard

Some Facts about Cloning

Here is a great website that can answer some basic questions about cloning. Check it out! I've copied some of the most interesting/important information below to be used as reference for the rest of this blog.
full article link: http://www.ornl.gov/sci/techresources/Human_Genome/elsi/cloning.shtml

In 1997, the first mammal was successfully cloned. (Previously, in the early 1960s, an South African frog and an Asian carp had both been cloned.) Scottish scientists at Roslin Institute succeeded in creating a sheep named Dolly through the process of nuclear transfer--Dolly was genetically identical to her mother. The creation of Dolly raised the possibility of human cloning, and "aroused worldwide interest and concern because of its scientific and ethical implications."There are many different kinds of cloning. Three types are especially important to know about.

1. Recombinant DNA Technology or DNA Cloning:
"The terms 'recombinant DNA technology,' 'DNA cloning,' 'molecular cloning,' and 'gene cloning' all refer to the same process: the transfer of a DNA fragment of interest from one organism to a self-replicating genetic element such as a bacterial plasmid. The DNA of interest can then be propagated in a foreign host cell. This technology has been around since the 1970s, and it has become common practice in molecular biology labs today."

Essentially, DNA cloning involves isolating the gene of interest (such as a gene coding for the production of GFP, green florescent protein). This gene is cut out of the DNA,

using specific enzymes, and inserted into a vector of some sort, often a plasmid. This plasmid can then be inserted into a host of some sort, perhaps a mouse. Then, as the host cells replicate, the hope is that the plasmid DNA--along with the gene of interest--will replicated as well, and many exact copies of the gene will be made. If the gene can also be turned on, GFP will be produced in the mouse and the mouse may begin to glow green. The specific gene, then, is what is being cloned.

2. Reproductive Cloning:"Reproductive cloning is a technology used to generate an animal that has the same nuclear DNA as another currently or previously existing animal. Dolly was created by reproductive cloning technology. In a process called 'somatic c

ell nuclear transfer' (SCNT), scientists transfer genetic material from the nucleus of a donor adult cell to an egg whose nucleus, and thus its genetic material, has been removed. The reconstructed egg containing the DNA from a donor cell must be treated with chemicals or electric current in order to stimulate cell division. Once the cloned embryo reaches a suitable stage, it is transferred to the uterus of a female host where it continues to develop until birth."

This type of cloning is most controversial, and what most people think of when they think of cloning--making an exact copy of an entire animal, or potentially a human. In many ways, this type of cloning is not very practical. But some companies do exist that offer cloning services to pet-owners, who want to clone their pets for whatever reasons. As reproductive cloning technology improves, many new questions will have to be answered. Should the government regulate human cloning? Is human cloning ethical? Would you want to be cloned, or for someone you know to be cloned? In the future, these questions may become real concerns that future generations will grapple with.

3. Therapeutic Cloning:
"Therapeutic cloning, also called 'embryo cloning,' is the production of human embryos for use in research. The goal of this process is not to create cloned human beings, but rather to

harvest stem cells that can be used to study human development

and to treat disease. Stem cells are important to biomedical researchers because they can be used

to generate virtually any type of specialized cell in the human body. Stem cells are extracted from the egg after it has divided for 5 days. The egg at this stage of development is called a blastocyst. The extraction process destroys

the embryo, which raises a variety of ethical concerns. Many researchers hope that one day stem cells can be used to serve as replacement cells to treat heart disease, Alzheimer's, cancer, and other diseases."

Look on the website (link above) for more information about the uses

of cloning technologies, the risks of cloning, and more!

C. Heard