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CLONING

We now turn to moral problems which recent advances in genetic engineering have thrown into sharp relief. We consider such issues from three domains of advancing technology: cloning, stem cell research and surrogate motherhood. Some moral problems emanating from cloning, stem cell research and abortion overlap. But cloning and stem cell research also give rise to more complex theological and metaphysical questions. A brief biological background on cloning and stem cell research helps in understanding these issues.

Biological Background

A clone is an exact genetic copy of a molecule, cell, plant, or animal. It is no novel phenomenon but common in nature. Whenever single cell organisms like bacteria reproduce by cell division, the resultant cells are clones of the original cells. Similarly, when a worm is divided into two parts, each part will regenerate into a full genetic duplicate of the original worm. Identical twins resulting from separated embryos in uterus are natural clones.

Scientists extract DNA from the cell of an adult mammal and insert it into a hollowed out donor egg. By jump-starting the egg with a jolt of electricity, they can create an embryo that would become, if implanted into a surrogate mother, the cell donor’s patient’s identical twin. Animal cloning has been done successfully in laboratories since 1990s. Dolly, a female domestic sheep is the first mammal cloned from an adult somatic cell. As we discuss later, adult stem cells are far less potent than embryonic stem cells. Ian Wilmut, Keith Campbell and colleagues at the Roslin Institute cloned Dolly. The cell used as the donor for the cloning of Dolly was taken from a mammary gland of another sheep. After cloning was successfully demonstrated through the production of Dolly, many mammals including pigs, deers, horses and bulls were cloned.

As for human beings, no cloning is allowed. Human cloning is as yet only a theoretical possibility. Moral discussions on human cloning are based on futuristic scenarios.

Arguments in favour of cloning

(1) An important unresolved problem in psychology is how human beings acquire their traits of character. Are such traits derived mainly from one’s biological make-up or are the outcomes of the environment in which one is raised or the result of chance factors? This knowledge will help in developing in formulating appropriate approaches to child development. Children will grow into healthy, happy adults and be able to realize their potentials.

(2) Cloning can benefit society by creating clones of great scientists, artists, and sportsmen/women. It is simplistic to assume that great scientists or mathematicians such as Max Planck or Carl Gauss can be reproduced through cloning. Besides native intelligence, other factors like unique early life environment and interest in fruitful research areas explain great scientific achievement. Obviously, these are not replicable. However, factors which contribute to creativity such as tenacity, concentration, determination and self- belief can be created to some extent through a right combination of heredity and environment.

(3) Healthy and happy life of an individual greatly depends on his heredity. It can endow him with a long, disease-free life and cheerful temper; or it can render one’s life short and troublesome physically and psychologically. By cloning an individual who has no major debilitating or psychological problems like depression, healthy and happy individuals can be produced.

(4) Many parents desire that their children should have specific talents or traits. They may want their children to have scientific or artistic talents in some directions. In some measure, cloning can produce such offspring.

(5) In future, cloning can be a solution to infertile couples. But as we noted, at present cloning is prohibited for such reproductive purposes. It raises many intriguing ethical issues. But in principle it is a way for infertile couples to have child biologically related to them.

(6) As we have seen, cloning can help in saving lives. The Ayala parents in California had a child in the hope (which was fortunately realized) that it could provide bone morrow to their other child afflicted with a fatal disease.

(7) Though reproductive cloning is illegal, therapeutic cloning for creating replacement tissues or ‘body spare parts’ holds great promise. An embryo can be created for generating an organ for transplant.

Arguments against cloning

(1) Cloning deprives the clone of the right to be a genetically a unique individual. It impairs the uniqueness of on individual, and is intrinsically immoral. However, philosophers disagree on this point. Mere presence of an identical being---in a distant land or planet---in no way affects an individual. Even if an individual knows about the existence of his double or genetic copy, it makes no difference to him. Further, cloning does not produce another individual biologically indistinguishable from the original. This can be seen from the followingtable.

Relationship

Correlation of traits in %

Identical twins*

50

Fraternal twins*

25

Non-twin siblings

11

Strangers

Close to zero

*Fraternal twins are“dizygotic,” meaning that they developed from two different eggs fertilized by two different sperm cells, while identical twins are “monozygotic” i.e. they developed from a single fertilized egg that split.

In counter, it is argued that no important rationally justifiable interests or rights of an individual will be affected by the existence of a clone.

(2) Another objection to cloning relies on what may be called ‘an open future argument’ or ‘right to ignorance of a certain sort’. According to this argument, the future of a clone appears to him or her like a rerun of an earlier life. It resembles a refurbished model. The clone may lose feelings of novelty or miss elements of surprise which are part of normal life. He may have a sense of following a well- worn path in life. Knowledge of the life experience of the original person, his successes and failures in life, will constrain the clone’s future; it will shut out many experimental life moves he could have made. In reply, it is argued that such fears are exaggerated. Besides one’s genetic make-up, external circumstances will affect his/her course of life. The life histories of identical twins---natural clones---are often very different.

(3) It is further claimed that even if we discount the arguments based on need for individual identity or for open future, the clone nevertheless experiences psychological distress. He may regard himself as no more than a duplicate or a photocopy without individuality and deprived of prospects of open life horizons. This point has been answered earlier. We may note further that since these feelings are irrational and incorrect, they merit no consideration.

(4) Although reproductive cloning is prohibited, many writers point to alarmist future possibilities. They can be termed as ‘brave new world’ anxieties. Aldous Huxley, in his novel Brave New World, envisaged a future society in which different social categories such as proletarians, clerks, intellectual workers and political leaders are genetically created as test-tube babies. They are pre-programmed, and each fits snugly into his social station, experiencing no discontents or grievances. Cloning can theoretically be used to similar sinister purposes. One may Xerox many Hitlers or murderous soldiers for savage regimes. These fears belong more to science fiction than to any possiblereality.

(5) Human beings have to be considered as ends in themselves and not as instruments for achieving some other goals which transcend intrinsic human worth. This view is widely accepted among philosophers. While it may apply to reproductive cloning, its force is greatly reduced in settings of gene therapy.

(6) Cloning may appear to violate the principle of individual personal autonomy. Once a clone is created with various predispositions, he will no longerdevelop intoa free, spontaneousbeing. This point is partly valid. But all said and done, cloning only creates certain attributes and dispositions in individuals. These are potentialities and can be used in diverse ways by an individual.

(7) Writers also point to some other risks of cloning. It can reduce diversity among human beings which nature has created, and lead to some form of human monocultures. Cloning is tantamount not to exercising procreation rights but to manufacturing human beings which can never be justified. Cloning is open to danger that people may be cloned without their knowledge or consent. Cloning messes up family relationships. If a woman bears her husband’s clone, is he the father to the son she bears or its twin brother?

(8) According to Micahel J. Sandel, cloning alters our perspective on nature and undermines important human values. Human beings are children of nature and have no role in creating their biological make-up. Whatever natural talents or traits or abilities they have are gifts of nature. We attribute these aspects of being to God, nature or chance. This creates in us a sense of humility and reverence towards nature. If we control this function of nature, we take our biological destiny into our hands.

This may not be an unmixed blessing. At present, we accept our biological endowments in a spirit of resignation. New technologies can make parents responsible at least partly for the traits of their offspring, and thus create moral dilemmas for them. They may be blamed for their choices or inaction. Cloning may reduce our sense of solidarity with our less fortunate fellow human beings. Often we attribute their misfortunes or failures to luck and chance. Once character and success become matters within our volition, we may blame the failures of others on their own incapacity. In this way, we lose empathy for them. In short, there may be grave dangers in tinkering with the tried and tested ways of wise nature.

In conclusion, we may note that cloning is in experimental stage yet. The first law regulating cloning is UK’s Human Fertilisation Embryology Act (1990). It permits licensed research using human embryos only for very limited purposes involving studies into infertility treatment, congenital diseases, and causes of miscarriages, contraception techniques and the detection of genetic abnormalities.

GENE THERAPY

Gene therapy is based on genetics which studies transmission of hereditary traits from one generation to later generations. Life starts in a cell, the basic building block of all multicellular organisms. Human beings have trillions of cells, and each performs a specific function. The cell’s nucleus---its central part that regulates its chemical functions---contains pairs of chromosomes. It is made up of a single molecule of DNA (deoxyribonucleic acid), which carries the blueprint of life in the form of codes or genes that determine inherited characteristics. DNA’s structure contains base pairs formed by nitrogen molecules and arranged in specific sequences. Millions of these base pairs, or sequences, can make up a single gene, specifically defined as a segment of the chromosome and DNA, which contains certain hereditary information. The gene or combination of genes formed by these base pairs ultimately direct an organism’s growth and characteristics by producing certain chemicals, primarily proteins, which carry out most of body’s chemical functions and biological reactions.

Genes and diseases

Defects in genes present within cells can cause inherited diseases like cystic fibrosis, sickle-cell anaemia, and haemophilia. If some chromosomes are missing in a cell, diseases like Down syndrome are caused. A change in proper genetic sequence can cause diseases like atherosclerosis and cancer. Gene therapy replaces missing genes or provides copies of functioning genes to replace defective ones. The inserted genes can be naturally-occurring genes that produce the desired effect or may be genetically engineered (or altered) genes.

Scientists have been manipulating a gene’s structure since early 1970s through a process called gene splicing. The process involves removing a fragment of DNA which holds the needed specific genetic sequence, and inserting it into the DNA of another gene. The resultant product is called recombinant DNA, and the process genetic engineering.

Gene therapy introduces genes into the body to treat diseases. It corrects or replaces the genes which are defective and unable to perform the disease-controlling functions of cells. Somatic gene therapy introduces therapeutic genes at the tissue or cellular level to treat individual patients. Germ-line gene therapy inserts genes into reproductive cells or possibly into embryos so as to prevent children from inheriting the genetic defects of parents. Gene therapy was used first to treat inherited diseases like cystic fibrosis and Huntington’s disease, and later to treat cancers, arthritis, and infectious diseases.

Viral vectors

Most gene therapy at present is somatic gene therapy in which therapeutic genes are inserted into tissue or cells to produce a naturally occurring protein or substance that is lacking or malfunctioning in a patient. Such insertion needs a means of transporting either the entire gene or a recombinant DNA to the cell’s nucleus, where the chromosomes and DNA reside. Scientists use vectors or viruses as molecular delivery vans. The earliest common transport vectors were viruses. They were chosen because they invade cells as part of the natural infection process. They have a specific relationship with the host, which consists in their colonization of certain cell types and tissues in specific organs. As a result, vectors are chosen according to their attraction to certain cells and areas of the body.

First, the cells are removed from the patient’s body, and the virus, or vector, carrying the correct gene is inserted into them. Next, the cells are placed into a nutrient culture where they grow and replicate. Once enough cells are gathered, they are returned to the body, usually by injection into the blood stream. Theoretically, as long as these cells survive, they will provide the desired therapy. Retroviruses and adenoviruses are among the viruses used for transporting genes. More recently, non-viral vectors have been introduced. These vectors rely on the natural biological process in which cells gather macromolecules. Scientists also introduce raw recombinant DNA by injecting it into the bloodstream or placing it on microscopic beads of gold shot into the skin with a ‘gene-gun.’ Scientists arestudyingboth nucleic acid based (in vivo) treatments andcell-based (ex vivo) treatments. Nucleic acid based gene therapy uses vectors (like viruses) to deliver modified genes to target cells. Cell-based gene therapy techniques remove cells from the patient in order to genetically alter them, and then reintroduce them into the patient’s body.

Problems in Gene Therapy

The potential scope of gene therapy is enormous. More than 4,200 diseases result directly from abnormal genes, and many others are partially influenced by a person’s genetic makeup. But many problems outlined below confront gene therapy.

(i) Viral vectors must be carefully controlled; otherwise, they infect the patient with a viral disease.

(ii) Some vectors, like retroviruses can enter normal cells, interfere with natural biological processes, and possibly cause other diseases.

(iii) The immune system recognises and destroys other viral vectors, such as adenoviruses, reducing their therapeutic life.

(iv) It is difficult to maintain gene expression so that it performs its role properly after vector delivery. As a result, some therapies need to be repeated often to provide long-lasting benefits.

(v) Gene regulation is very difficult since they work together for turning other genes on and off. For example, certain genes work together to stimulate cell division and growth, but if these are not regulated, the inserted genes could cause tumour formation and cancer. Scientists yet have no idea on how to make the gene go into action only when needed. For safe and effective treatment, a specific gene should turn on, for example, when certain levels of a protein or enzyme are low and must be replaced. But the gene also should remain dormant when not needed to ensure it doesn’t oversupply a substance and disturb the body’s delicate chemical makeup.

Stem cells

Before considering the ethical issues involved in gene therapy, we need to consider the working of stem cells. A stem cell is a unique type of cell with remarkable qualities. It can differentiate into other types of functional cells like nerve cells or skin cells. It can renew itself, and also form, as mentioned, other cells. However, most stem cells reside in particular organs and tissues, and produce a limited range of cells. Thus, bone marrow cells only produce blood cells. These are known as adult stem cells.

Embryonic Stem (ES) cells are vastly more potent. They can produce any other type of cell--

-blood, brain, intestine, muscles, bone and skin. Hence, they are known as pluripotent. They can be isolated from embryo, and grown in Petri dishes in laboratory. They can grow continuously in culture. ES cells are taken from the pith of inner cell mass of embryo after six days of its growth. The genetic modification of cell in the dish becomes the genetic modification of organism in the uterus.

Human ES cells are obtained from in vitro fertilization clinics. By 1990s, in vitro fertilization has become a way of treating various forms of human fertility. IVF is performed by taking eggs from a woman after ovulation. Typically around 10-12 are obtained and fertilized with male sperm in Petri dishes. The embryos are briefly grown in incubators and implanted in uterus. Not all embryos are implanted. It is unsafe to implant more than three embryos. The other embryos are discarded. It is these embryos which are the source of ES cells.

Moral issues in Stem Cell Research

Some moral issues involved in stem cell research and abortion are similar. Essentially these revolve on when an embryo acquires life and about the sanctity of human life. We have discussed these earlier. Further, use of ES cells, if ever permitted in future in cloning, raises moral questions similar to cloning we discussed earlier. But human cloning is strictly prohibited. No genetically modified embryo is allowed in uterus. Gene therapy is also strictly regulated by governments.

(i) Although gene therapy is a very promising approach to treatment of disease, ethical concerns over its use and ramifications are often voiced. As much needs to be learned about how genes actually work and about their long-term effect, testing these therapies on humans could have disastrous unknownresults.

(ii) As with most clinical trials involving new therapies, including many drugs, the patients participating in these studies are those who have not responded to more established therapies and often are so ill that the novel therapy is their only hope for long-term survival. Their choices are born of desperation and wild hope.

(iii) Another questionable outgrowth of gene therapy is that scientists could possibly manipulate genes to genetically control traits in human offspring that are not health related. For example, if a gene is found that can enhance intelligence of children who are not yet born, will everyone in society, the rich and the poor, have access to the technology or will it be so expensive that only the elite can afford it?

(iv) The Human Genome Project, which is integral for future of gene therapy also has social repercussions. If individual genetic codes can be determined, such information might be used against people. Insurance companies will demand higher premium from disease-prone people. Employers could discriminate between two potential employees, one with a “healthy” genome and the other with genetic abnormalities.

Genetics embodies both the immense promise and the worst fears associated with modern biomedicine. The prospect of altering what many viewed as the blueprint of human life raised questions about ‘playing God.’ While some had hopes of eliminating virtually all disease, others saw the spectre of designer babies and catastrophic unintended consequences.

Stem Cell Guidelines in the Indian Context

ICMR and Department of Biotechnology issued National Guidelines (Guidelines) for Stem Cell Research. According to the guidelines, “There is no conclusive proof of safety or therapeutic efficacy of stem cells in any condition yet. Unfortunately, some clinicians have started exploiting hapless patients by offering unproven stem cell treatments prematurely. Such fraudulent practices need to be stopped urgently, while ensuring that scientifically designed and responsible research on stem cells is not hindered.”

The guidelines cover individual researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives. The guidelines classify stem cell research into three categories, namely Permitted, Restricted and Prohibited categories. All institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC-SCRT through IC-SCR. All institutes engaged in stem cell research must establish an Institutional Committee for Stem Cell Research. A National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) will monitor and oversee activities at national level and Institutional Committee for Stem Cell Research (IC-SCR) at institutional level. These oversight committees shall ensure that review, approval and monitoring of all research projects in the field of stem cell research are done rigorously and effectively as per the national guidelines. Research using human stem cells shall have prior approval of IC-SCR for permitted research and of the NAC-SCRT for restricted research.

Research on human subjects involving cells and tissues derived from human embryos and foetuses must safeguard human rights, dignity, and fundamental freedom. This includes processes related to obtaining human tissues and cells for research, diagnosis and therapy. The fundamental tenets of beneficence, non-malfeasance, justice and autonomy should be adhered to in all research involving human subjects.

The guidelines make the following observation on status of gene therapy: “Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered as malpractice.”


SURROGACY

Surrogacy means a practice whereby one woman bears and gives birth to a child for an intending (mainly infertile) couple with the intention of handing over such child to the intending couple after the birth. The Surrogacy (Regulation) Bill makes a distinction between altruistic and commercial surrogacy. In altruistic surrogacy, no monetary incentives of any kind are given to the surrogate mother or her dependents or her representative. However, she can be paid for medical expenses incurred on surrogacy and insurance coverage. Commercial surrogacy refers to commercialisation either in whole or part of surrogacy services or procedures. Commercialisation may cover selling or

buying of human embryo or trading in the sale or purchase of human embryo or gametes or selling or buying or trading the services of surrogate motherhood by giving incentives in cash or kind, to the surrogate mother or her dependents or her representative. Medical expenses incurred on the surrogate mother and on her insurance are excluded from incentives.

The Union Cabinet recently approved the “Surrogacy (Regulation) Bill, 2016. India has emerged as a surrogacy hub for couples from different countries for the past few years. There have been reported incidents of unethical practices, exploitation of surrogate mothers, abandonment of children born out of surrogacy and import of human embryos and gametes. Widespread condemnation of commercial surrogacy in India has been regularly reflected in different print and electronic media for last few years. The Law Commission of India has, in its 228th Report, also recommended that commercial surrogacy should be prohibited by enacting a law. Due to lack of legislation to regulate surrogacy, the practice of surrogacy has been misused by the surrogacy clinics leading to rampant commercial surrogacy and unethical practices.

The Bill contains the following main provisions.

(a) The Bill will regulate surrogacy in India by establishing National Surrogacy Board at the Central level and State Surrogacy Boards and Appropriate Authorities in States and Union Territories. The legislation will ensure effective regulation of surrogacy, prohibit commercial surrogacy and allow ethical surrogacy to the needy infertilecouples.

(b) It will allow ethical altruistic surrogacy to the intending infertile Indian married couple between the age of 23-50 years (wife) and 26-55 years (husband).

(c) The intending couples should be legally married for at least five years and should be Indian citizens to undertake surrogacy or surrogacy procedures.

(d) There is a danger that the intending couples could abandon the child, born out of a surrogacy procedure. To avoid this risk the child born out of surrogacy procedure is given the same rights and privileges as are available to the biological child.

(e) The surrogate mother should be a close relative of the intending couple and should be an ever married woman having a child of her own. Her age should be between 25-35 years.

(f) Any woman will be allowed to be a surrogate mother.

(g) The surrogacy clinics shall be registered only after the appropriate authority is satisfied that such clinics are in a position to provide facilities and can maintain equipments and standards including specialised manpower, physical infrastructure and diagnostic facilities as may be provided in the rules and regulations.

(h) No person, organisation, surrogacy clinic, laboratory or clinical establishment of any kind shall-

(i) undertake commercial surrogacy

(ii) issue advertisements regarding commercial surrogacy

(iii) abandon the child born through surrogacy

(iv) exploit the surrogate mother

(v) Or sell human embryo or import human embryo for the purpose of surrogacy.

Contravention of the above provisions shall be an offence punishable with imprisonment for a term which shall not be less than ten years and with fine which may extend to ten lakh rupees.