Sindi Daci: Biomedical Cloning—One Step Closer to a Revolution
Consider the following two questions:
How would you like to have another you…a clone with traits superior to your own?
Alternatively, how would you like to have an entire lifesaving organ created from just a single one of your cells?
These two questions fundamentally revolve around the age-old idea of cloning, but they highlight different uses of cloning. Biomedical cloning, also referred to as therapeutic cloning, is the cloning of patient cells that can then be used to create tissues and organs.
It is important to note that while human embryos have been cloned, there has never been a verified case that a viable human has resulted from the procedures. Therefore, given that parts of this area in science are unexplored, this paper will examine the reported potential procedures, risks, and complications associated with cloning. Ideally, human cell cloning would allow a person to use their own genetic material during transplantations. That reduces the risk of rejection which occurs when the recipient's immune system recognizes the transplant as foreign and proceeds to attack the organ or tissue. Cloning cells is a powerful tool in the science community. There is the possibility of using embryonic stem cells from cloned embryos to treat debilitating disorders. However, controversy in the field of cloning is still prevalent. For years there has been disagreement over the entity that should regulate cloning. There are advocates for international standards, federal laws, and state level enforcement of policies. In addition, the implementation of the 14-day rule, the Dickey-Wicker Amendment, and multiple bills have prohibited scientists from extensively exploring biomedical cloning. As a result, finding solutions using biomedical cloning have been put on hold.
Before analyzing ethical and legal issues surrounding cloning, it is crucial to differentiate between biomedical and reproductive cloning. Both forms utilize the process of somatic cell nuclear transfer (SCNT). This process involves removing the nucleus from an egg cell and replacing it with a diploid nucleus from a somatic cell. A somatic cell is a body cell other than an egg or sperm. Once the nucleus of the somatic cell is inserted into the egg cell, scientists reprogram and manipulate the cell to see how it will react and divide under certain procedures. Specifically, scientists are interested in the cell division that leads to the formation of a blastocyst which is the development stage of an embryo. In SCNT, there is a single genetic parent, so the blastocyst has DNA that is very similar, if not identical, to the donor of the somatic cell.
However, the process starts to diverge after the formation of the blastocyst.
In reproductive cloning the blastocyst would be implanted in the uterus of a woman where “the embryo develops into a fetus that is then carried to term” (Rugnetta). The theoretical result would be a child identical to the donor of the somatic cell. It is evident that this form of cloning does not have any relation to embryonic stem cell research or the discovery of treatments to save lives.
On the other hand, in biomedical cloning the blastocyst would never be implanted in the uterus of a woman. Scientists would only study the embryonic stem cells that result from SCNT. They would examine that “These stem cells are genetically matched to the donor organism, holding promise for studying genetic disease” (Eurostemcell). The goal for biomedical cloning is the creation of tissues and organs originating from the cloned cell. A patient would use their own genetic material to combat cell damage that is caused by harmful diseases. This would reduce the risk of rejection associated with new tissues. Furthermore, the study of embryonic stem cells could produce new tools to combat debilitating disorders such as Alzheimer’s and Parkinson’s disease. These neurodegenerative diseases involve the loss of functioning neurons. The “transplantation of stem cells has shown promise for improving functional recovery for Alzheimer's disease” (Choi). Researchers believe these stem cells could potentially provide a way to replace the damaged neurons in the brains of people suffering with these diseases. This is just one-way biomedical cloning helps society. It is also important to note that reproductive cloning does not appear to have any role in this potential treatment method.
Therefore, biomedical cloning must not be accepted as the equivalent to reproductive cloning. If a human clone were to be created, there would be considerable health risks. For example, scientists have observed complications with animals that are cloned, and predicted that similar health issues could arise in human clones. Since human cloning has never occurred, scientists observe that “Data on the reproductive cloning of animals demonstrate that only a small percentage of attempts are successful, many of the clones die during all stages of gestation...” (The National Academies of Sciences, Engineering, and Medicine). These types of outcomes lead to “warnings that any attempt to clone humans might carry considerable health risks''(Jones). The clone would be subject to unpredictable consequences and a shortened life span. Reproductive cloning would be used by “individuals who wish to have a child that is genetically identical with them” or for the collection of “genetically identical tissue from a cloned fetus or newborn” (National Academy of Sciences). As a result, reproductive cloning does not aspire to improve medicine nor save human lives. However, biomedical cloning supports embryonic stem cell research in order to find cures for diseases.
Even though biomedical cloning may sound more advantageous than reproductive cloning, there is still hesitancy in this field. Individuals worry that allowing any type of cell cloning will lead to the inevitable exploitation of cloning research. As a result, the use of embryos raises serious ethical concerns, leading to the development of the 14-day rule, an international ethical standard. Under the 14-day rule, “scientists have agreed never to allow human embryos to develop beyond two weeks in their labs” (Regaldo). Many countries such as the UK and Canada have turned this rule into a law. Other countries, including the US, have merely accepted it as a standard in the science community, but have not passed any formal legislation. The fourteenth day is significant because this is when the first signs of a developing central nervous system start to appear in the embryo.
Scientists and researchers today are challenging the 14-day rule. In countries that implement the rule less strictly, scientists have begun extending the time period that they can grow embryos. Currently, scientists are advocating for the time period to be extended to approximately 28 days in order to conduct further experimentation regarding the development of organoids. The revision of this rule signifies how lenient enforcement of policies can undermine the initial purpose of these rules.
The 14-day rule may be a national standard, but the US has additional restrictions that are implemented at the state level. For example, New York, Connecticut, and Massachusetts permit the use of embryonic stem cells, while states such as South Dakota entirely prohibit research using embryos.
Consequently, there is indecisiveness regarding the entities that can regulate cloning. In addition to the states implementing their own laws, the FDA strongly argues that regulation of embryonic stem cell research is their responsibility. The FDA claims, “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” (FDA). Some researchers concur with the idea that the FDA’s judgement about cloning is reasonable and objective. Their reasoning includes that the FDA is more qualified than lawmakers to make decisions on issues involving science. However, that is also their weakness. The FDA’s objectivity only addresses efficacy concerns regarding cloning, but they do not consider the ethical issues. For instance, the FDA protects consumers, in this case those inheriting the cloned embryos, but it does not protect the embryos. Therefore, the FDA’s position in the cloning debate is not enough to convince skeptics that they will provide a well-rounded analysis of human cloning.
The other key player in the cloning debate is Congress. Ever since the first cloning, Dolly the sheep in 1997, committees have attempted to pass legislation to regulate cloning. Most of the bills drafted in an effort to prohibit human cloning specified that human cloning would be illegal, but ambiguity surrounded cloning for biomedical purposes. For example, the 108th Congress passed the Human Cloning Prohibition Act of 2003. They implemented a “comprehensive ban on human cloning and prohibiting the importation of a cloned embryo, or any product derived from such embryo”. The bill also addressed critics' concerns by stating “Some opponents of the bill would rather see a ban that would only prohibit cloning when there was an intent to initiate a pregnancy and would still allow scientists to clone human embryos for experimental purposes. This approach to prohibiting cloning would be much less effective and would inevitably be unenforceable” (108th Congress). As a result, common ground was difficult to find, causing the continuous creation of unsuccessful and unstable bills. This is problematic because it does not encourage the idea that a solution will be found. Future members of society are tasked with addressing the issue. This paves a dangerous path of delegating the problem to future generations. Therefore, certain groups arrive one step closer to a solution, but leave details out in hopes that the next group will complete the answer.
Nonetheless, the efforts to create a stable bill have not come to a screeching halt. On September 11, 2015 the Human Cloning Prohibition Act of 2105, H. R. 3498, was introduced. This bill aims to criminalize human cloning for both reproductive and research purposes. However, “This bill does not restrict scientific research using nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans” (114th Congress). This appears to provide a more decisive stance and approach to regulating cloning. It also addresses ethical concerns such as the exploitation of women for eggs in order to create cloned cells. This bill can be seen as countering the utilitarian argument. Utilitarianism is an ethical theory that defends actions as right as long as the action is beneficial to most of society. In this case, using cloned embryos for biomedical research can potentially find cures for a variety of diseases, saving many lives in the process. However, it requires sacrificing eggs and embryos. As a result, utilitarianism would support the destruction of these eggs in order to bring happiness and beneficial results to the rest of society. The bill does not allow eggs, that can potentially turn into a human life, to be sacrificed because many people might benefit from this action. The bill's position is firm in addressing the utilitarian approach in addition to the inevitability of science advancing and leading to cloning.
Even though the US government has not established any laws against cloning, the Dickey-Wicker Amendment was established in 1996. The amendment “prohibited federal funding for ‘the creation of a human embryo or embryos for research purposes’ or for research ‘in which embryos are created or destroyed.’ The original text of the Dickey-Wicker Amendment included embryos produced through ‘cloning’ in its funding prohibition…” (The New Atlantis). This amendment was introduced as a rider bill, additional provision, to the National Institutes of Health’s budget. This law placed another hurdle between scientists studying biomedical cloning and the creation of tissues from embryonic stem cells. However, the Clinton administration found a loophole. They declared that research on stem cells, even if embryos were destroyed by private researchers, was allowed federal funding. They were strategic by highlighting that “embryos destroyed by private researchers, wasn't the same as funding work on embryos” (James). Other administrations followed this interpretation, but in 2010, from the US District Court for the District of Columbia, Chief Judge Royce C. Lamberth placed an injunction on federal funds that were dedicated to stem cell research. He cited the Dickey-Wicker Amendment and how the loophole was a violation of the law. Even though Judge Lamberth was attempting to uphold the law, he also did not take into consideration the consequences associated with preventing research. In 2011, the Obama administration requested that the injunction be removed while the appeal of Judge Lamberth’s ruling was underway. The final result of this legal case was Judge Lamberth reversing his original ruling and the court declaring that the amendment was vague. As a result, the amendment would be open to interpretation and did not limit research on stem cells. It is evident that the federal government places importance on biomedical research since they have found legal ways around the law and have ensured scientists have the resources they need to make scientific discoveries. Therefore, there is an increase in investments for biomedical cloning and the discovery of innovative cures.
Biomedical cloning provides hope for curing many incurable diseases. It can save lives through tissue-transplant operations. Critics of this method strongly oppose this utilitarian approach to determining the morality behind biomedical cloning. Furthermore, the responsibility to regulate cloning has been a constant battle throughout the years. The government, FDA, and society all strongly argue that they deserve a voice in this matter. Each party has their own interests and goals. The cloning debate is far from over and with the improvement of technology, the future of cloning is unpredictable. As science advances, more concrete regulations will need to be implemented in order to ensure fair and legal conduct. That is the only way to safeguard our future as society gets closer to a new medical revolution.
Sindi Daci is a Sophomore at Yale University in Davenport College
Citations
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