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Rashmi Raman - Student, 4th Year, NUJS, Kolkata

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The term used by this paper to encompass all the human forays into the world of biomedical genetic research and engineering is genetic adventurism , a term that the researcher hopes conveys the sum and substance of all that this research symbolizes in terms of its nature and scope; from analyzing from an Indian perspective, the intricate nuances of biomedical engineering in this country and to come to the conclusion that India is ready to approve a leap into genetic adventurism. Chaos is a buzzword of today. It is modern science’s euphemism for its incurable ignorance vis-à-vis any cell, animal, person or event. Science knows that each of the foregoing will be assertively unique, but science can never predict what exactly it would be. Science is wiser about the uniqueness only after the event is a fait accompli. How and why?

At 4:30 p.m. on 19th October, 2005, UNESCO’s General Conference, gathered in Paris for its 33rd session, adopted the Universal Declaration on Bioethics and Human Rights. The text, adopted by acclamation, addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions. The Declaration meets a genuine and growing need for international ethical standards in this area. This need is due to the proliferation of practices that go beyond national borders, often without a regulatory framework.
The text adopted today provides a coherent framework of principles and procedures that can guide Member States in the development of national policies, legislation and codes of ethics . Wherever such an ethical framework is lacking, the Declaration will incite and assist in filling the gap . While it is still up to States to create legal texts and instruments appropriate to their cultures and tradition, the general framework proposed by the Declaration can help globalize ethics in the face of the increasingly globalized sciences.

The first principle established by the Declaration is the respect of human dignity and human rights, with an emphasis on the following two points: The interests and welfare of the individual should have priority over the sole interest of science or society. And If the application of the principles of this Declaration is to be limited, it should be by law, including laws in the interests of public safety, for the investigation, detection and prosecution of criminal offences, for the protection of public health or for the protection of the rights and freedoms of others. Any such law needs to be consistent with international human rights law. Several other principles are set forth. Some are already well-established informed consent, respect for privacy and confidentiality, non-discrimination and non-stigmatization but the notion of social responsibility is new. It stresses that progress in science and technology should promote the well-being of individuals and of humanity, notably by improving access to quality health care and essential medicines as well as to adequate nutrition and water. The principle of sharing benefits is also affirmed (different forms of sharing are proposed), as is the safeguarding of the environment, the biosphere and the various biodiversities.

Science Versus Technology: Einstein Versus Frankenstein
Science is superior to any resultant technology, that is the argument in this section of the paper. There may be misuses and manipulations of all the technologies that are harnessed by science, but the science - the knowledge behind it all is indefatigable, and that is why it is superior to any resultant technology. The ‘sanctity of life’ argument that supremacists in the West have raised to point out the Einstein versus Frankenstein dichotomous possibilities in genetic adventurism is defeated on this account. The argument that ‘naturally’ born children are ‘better’ than ‘artificially’ created ones starts off with a truckload of assumptions. What is ‘natural’, and then again, what is ‘unnatural’. My contention is this is not the ‘sanctity of life’ violated by treating it in certain ways, as history is witness to and the past has shown will there not always be rapists, murderers, despots, wars, and human tragedies that will militate against the so-called ‘sanctity of life’? In response to that, it can only be said that there is no ‘wrong’ in science. The anti-science is always a resultant technology.

What is this thing called science?
The possibility of human cloning, raised when Scottish scientists at Roslin Institute created the much-celebrated sheep ‘Dolly’, aroused worldwide interest and concern because of its scientific and ethical implications. The feat, also generated uncertainty over the meaning of ‘cloning’ - an umbrella term traditionally used by scientists to describe different processes for duplicating biological material.

What is cloning? Are there different types of cloning?
There are different types of cloning and cloning technologies can be used for other purposes besides producing the genetic twin of another organism. A basic understanding of the different types of cloning is key to taking an informed stance on current public policy issues and making the best possible personal decisions. The following three types of cloning technologies exist: (1) recombinant DNA technology or DNA cloning, (2) reproductive cloning, and (3) therapeutic 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 cell 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. Dolly or any other animal created using nuclear transfer technology is not truly an identical clone of the donor animal. Only the clone’s chromosomal or nuclear DNA is the same as the donor. Some of the clone’s genetic materials come from the mitochondria in the cytoplasm of the enucleated egg. Mitochondria, which are organelles that serve as power sources to the cell, contain their own short segments of DNA. Acquired mutations in mitochondrial DNA are believed to play an important role in the aging process.

Dolly’s success is truly remarkable because it proved that the genetic material from a specialized adult cell, such as an udder cell programmed to express only those genes needed by udder cells, could be reprogrammed to generate an entire new organism. Before this demonstration, scientists believed that once a cell became specialized as a liver, heart, udder, bone, or any other type of cell, the change was permanent and other unneeded genes in the cell would become inactive. Some scientists believe that errors or incompleteness in the reprogramming process cause the high rates of death, deformity, and disability observed among animal clones.

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.

In November 2001, scientists from Advanced Cell Technologies (ACT), a biotechnology company in Massachusetts, announced that they had cloned the first human embryos for the purpose of advancing therapeutic research. To do this, they collected eggs from women’s ovaries and then removed the genetic material from these eggs with a needle less than 2/10,000th of an inch wide. A skin cell was inserted inside the enucleated egg to serve as a new nucleus. The egg began to divide after it was stimulated with a chemical called ionomycin. The results were limited in success. Although this process was carried out with eight eggs, only three began dividing, and only one was able to divide into six cells before stopping.

How can cloning technologies be used?
Recombinant DNA technology is important for learning about other related technologies, such as gene therapy, genetic engineering of organisms, and sequencing genomes. Gene therapy can be used to treat certain genetic conditions by introducing virus vectors that carry corrected copies of faulty genes into the cells of a host organism. Genes from different organisms that improve taste and nutritional value or provide resistance to particular types of disease can be used to genetically engineer food crops. With genome sequencing, fragments of chromosomal DNA must be inserted into different cloning vectors to generate fragments of an appropriate size for sequencing.

Should humans be cloned?
Physicians from the American Medical Association and scientists with the American Association for the Advancement of Science have issued formal public statements advising against human reproductive cloning. Currently, the U.S. Congress is considering the passage of legislation that could ban human cloning - this was passed in early October last year, but has not yet been enforced against labs. In India, the debate about having enforceable legislation against human cloning is still not priority issue.

The same problems would be expected in human cloning. In addition, scientists do not know how cloning could impact mental development. While factors such as intellect and mood may not be as important for a cow or a mouse, they are crucial for the development of healthy humans. With so many unknowns concerning reproductive cloning, the attempt to clone humans at this time is considered potentially dangerous and ethically irresponsible.

Ethics Meets The Anti-Science
Ethical Questions In Human Genetics
Progress in methods of manipulation of cell calls for progress in the development and support of an ethos of manipulation. A general ban on manipulation would be moral and cultural malpractice . In fact regulation carries greater moral risks and hazards than an individual’s options to choose and to follow his or her conscience.

The human genome is the common heritage of humankind and humankind’s link to other forms of life. Traditional moral principles such as autonomy, privacy, justice, equity, literacy, and responsibility have to be redefined in the light of benefits, risks and uncertainty of applying genetic knowledge. Moral and cultural traditions play an important role in shaping individual and society’s competence to deal with new challenges. Traditions may not be used in an individual way, as traditions also contain antiquated customs, which have to be cut off.

The question of India - Promise and the Price
Bioethics in India is almost non-existent . There is lack of knowledge relating to issues of gene therapy accompanied by lack of discussion about these issues at various levels. There is need for a broad public education system in heath literacy and individual health responsibility. Such education programs should be introduced into the curricula at school level and included at the college/universities level also. A center for ethics in sciences in general and genetic and medical ethics in particular needs to be established, because of the pluralistic nature of the Indian society which is multicultural, multi-religious and multi-ethnic.

We must master the benefits and risks of genetic knowledge as well as the power of manipulation to strengthen the ethos and ethics of responsibility in support of individual self-determination, cultural diversity and political stability. The UNESCO Declaration also covers the application of the principles embodied in the Indian ICMR Guidelines, calling for professionalism, honesty, integrity and transparency in decision-making as well as the creation of independent, multidisciplinary and pluralist ethics committees. Referring to transnational practices, it specifies: When research is undertaken or otherwise pursued in one or more States the host State(s) and funded by a source in another State, such research should be the object of an appropriate level of ethical review in the host State(s) and the State in which the funder of the research is located. This is similar to a lot of the ideals the 2000 Guidelines speak about in the Indian context, but the qualitative difference comes, as usual, in the chasm between policy and implementation.

Reprogenetics And ‘Playing God’
Genetic Privacy And Privacy Laws

The origin of this polemic lies in the fact that various parties have valid claims to the same information family members, research associates and the patients themselves. The UNESCO Universal Declaration on the Human Genome and Human Rights states in Article 5 I that the right of every individual to decide whether or not to be informed of the results of genetic examination and resulting consequences should be respected. The efficacy of grounding such a right solely in terms of choice is doubtful . In the US, the Genetic Privacy Act, 1995 was drafted as part of the ELSI and this legislation protects what it delineates as the ‘genetic rights’ of every person . Especially in case of children, who may be carriers of fatal genes and similar threatening situations , the question before the wisdom of medical jurisprudence is which approach to adopt the parental ‘imagined consent’ approach or the ‘best interest’ approach? It is submitted that the parental discretion approach is the incorrect method to adopt since the child / carrier may be subject to stigmatization on these grounds. Secondly, a child’s genetic status is the child’s private genetic information and should not be determined or disclosed unless there exists compelling reason to do so.

Human Rights And Human Experimentation & Research
The best interests of children, fetuses and embryos are all different issues and raise concerns at different levels. That is the primary argument for rejecting UNESCO’s model of clubbing anyone below the age of 16 in the same bracket they ignore persons who have no age at all the embryos and fetuses.

There needs to be a recognition of the moral status of the unborn human life. Dilemma between the pro-life and pro-choice groups has lead to the debate in which the pro-life groups recognize the fertilized egg to be protected like any other person and will not accept determinative research in the early embryo . They do not accept embryo research but accept benefits from such research. Many bio-ethicists recommend that the benefits should not be used, but they may be used for dying and suffering patients and when one might feel there is no need to care how the remedies are obtained. Once a technology has been developed for a good purpose it can be used for moral as well as immoral purposes. The needs of developing countries are so great that the First World should show greater understanding, brotherhood and concern for the development of the best possible technologies . Human manipulation of nature mirrors human self-understanding, values and morals; the clue to avoid risk in technology is to strengthen individual and cultural competence in moral risk assessment and personal responsibility . New knowledge and new forms of manipulation challenges human race and human culture with wider dimensions of responsibility and risk competence. They require development of an ethos and ethics of responsibility. One cannot agree with those ethicists who ask for a ban or severe control of the development and use of new technology.

The cases of misplaced motherhood, jeopardized family relations and other skewed social equations are linked to the issues thrown up by genetic adventurism . Consider the case of the human doppelganger created by cloning a single, fertile female the child would be similar in all genetic senses to the ‘mother’; who, having brought the child to term, would be the biological parent of the child, but she would not be its genetic mother; the genetic parents would be the single set of grandparents, or the parents of the adult female . So the child and her mother would be twin sisters, and the children of the child would be the children of the mother these are the possibilities thrown open by re-progenetics; defying all socially accepted norms and institutions and fiercely protected mores in social relationships.

Re-progeneticists have come up with even more fascinating possibilities for the future of the ‘Brave New World’ . A pregnant woman carrying a female fetus within her body is carrying not only her daughter, but also the egg that will give rise to her grand daughter and part of the genetic combination for her great grand daughter so, the egg that gave rise to her, was produced by her mother’s body when she was still a fetus !

Supposing a female fetus is aborted, but the newly formed ovaries are salvaged from its body; the eggs in those can be made to mature under suitable conditions and generate an embryo; the child born from this will be the child of a mother who was never born . The protocol antithesis of the debate centering on these issues in re-progenetics is based on the wholly misconstrued ideas of genetic adventurism that have been popularized over the years.

Conclusion: From Here...To Where?
The overwhelming scientific consensus is that genetic determinism is false. In coming to understand the ways in which genes operate, biologists have also become aware of the myriad ways in which the environment affects their expression. The genetic contribution to the simplest physical traits, such as height and hair color, is significantly mediated by environmental factors (and possibly by stochastic events as well). And the genetic contribution to the traits we value most deeply, from intelligence to compassion, is conceded by even the most enthusiastic genetic researchers to be limited and indirect.
It is difficult to gauge the extent to which ‘repugnance’ toward cloning generally rests on a belief in genetic determinism. Hoping to account for the fact that people ‘instinctively recoil’ from the prospect of cloning, James Q. Wilson wrote, ‘There is a natural sentiment that is offended by the mental picture of identical babies being produced in some biological factory. ’ Which raises the question: once people learn that this picture is mere science fiction, does the offense that cloning presents to ‘natural sentiment’ attenuate, or even disappear - Jean Bethke Elshtain cited the nightmare scenarios of ‘the man and woman on the street,’ who imagine a future populated by ‘a veritable army of Hitler's, ruthless and remorseless bigots who kept reproducing themselves until they had finished what the historic Hitler failed to do: annihilate us.’ What happens, though, to the ‘pity and terror’ evoked by the topic of cloning when such scenarios are deprived (as they deserve to be) of all credibility
Until recently, there were few ethical, social, or legal discussions about human cloning via nuclear transplantation, since the scientific consensus was that such a procedure was not biologically possible. With the appearance of Dolly, the situation has changed. But although it now seems more likely that human cloning will become feasible, we may doubt that the practice will come into widespread use.

I suspect it will not, but my reasons will not offer much comfort to the critics of cloning. While the technology for nuclear transplantation advances, other technologies notably the technology of genetic engineering  will be progressing as well. Human genetic engineering will be applicable to a wide variety of traits; it will be more powerful than cloning, and hence more attractive to more people. It will also, as I have suggested, raise more troubling questions than the prospect of cloning has thus far. - Robert Wachbroit

Essentially, through this paper, the hope is being expressed that, by a systematic breakdown of arguments against genetic adventurism, largely a First World imposition on the Third World, it can be shown that there is nothing inherently evil, wrong or unnatural about genetic adventurism; in this slippery slope of human existence that we are teetering on today, it is the thinking community of the world alone that makes any judgments, decisions or steps and it is time India took that step ahead.

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Select Bibliography Of Sources
Primary Sources
1. ICMR Ethical Guidelines For Biomedical Research On Human Subjects, 2000
2. UNESCO Universal Declaration On Bioethics And Human Rights, 2005

Secondary Sources
Articles & Expositions

1. Alok Bhattacharya, Strings Attached, The Statesman, Nov. 3, 2003
2. Anjana Ahuja, Not Life As We Know It, The Statesman, Nov. 24, 2003.
3. Anjana Ahuja, Our Fateful Genes, The Statesman, Dec. 8, 2003
4. B. S. Wilfond Et Al, Cancer Genetic Susceptibility Testing: Ethical And Policy Implementations For Future Research And Clinical Practice, (1997) 25 J Law Med & Ethics 243.
5. C. Ngwena & R. Chadwick, Genetic Diagnostic Information And The Duty Of Confidentiality: Ethics And Law, (1993) 1 Med Law Intl 73.
6. Cf. J. Husted, Autonomy And A Right Not To Know, In R. Chadwick, M. Levitt & D. Shickle, The Right To Know And The Right Not To Know, Cavendish, London (1997).
7. D.C. Wertz & J.C. Fletcher, Privacy And Disclosure In Medical Genetics Examined In An Ethics Of Care, 5 Bioethics 212 (1991), At 221,
8. Guidelines Needed For Stem Cell Research, The Hindu Businessline, Dec. 29, 2005.
9. James Q. Wilson, The Paradox Of Cloning, Weekly Standard, May 26, 1997
10. Jean Bethke Elshtain, Ewegenics, New Republic, March 31, 1997
11. Kalpana Sharma, Can Clinical Trials Ever Be Truly Ethical? The Hindu, Dec. 6, 2005
12. Leon Kass, The Wisdom Of Repugnance, New Republic, June 2, 1997
13. Loane Skene, Genetic Secrets And The Family: A Response To Bell And Bennett, (2001) 9 Med L Rev 162.
14. R. C. Lewontin, The Confusion Over Cloning, New York Review Of Books, October 23, 1997
15. Revised Outline Of A (Unesco) Declaration On The Protection Of The Human Genome, Eubios Journal Of Asian And International Bioethics 5 (1995), 97-99.
16. Science Meets With The Law, Ian Wilmut, Roslin Research Publication, News, Current Science, Vol. 85, No. 11, 10 December 2003 (1517- Meeting Report).
17. Suhita Chopra Chatterjee, Hopes On Healthcare, The Statesman, Nov. 9, 2003

Books & Treatises
1. A.F. Chalmers, What Is This Thing Called Science? Open University Press, London (1976).
2. Derek Morgan, Issues In Medical Law And Ethics, Cavendish, London (2001).
3. E. O. Wilson, Sociobiology: The New Synthesis, Harvard University Press (1975).
4. Gordon Graham, Genes - A Philosophical Enquiry, Routledge, New York (2002).
5. Human Experimentation & Research, George F. Tomossy & David N. Weisstub, The International Library Of Medicine, Ethics & Law, Dartmouth (2003).
6. J.K. Mason, R.A. Mccall Smith Et Al, Law And Medical Ethics, Butterworths Lexis Nexis, 6th Edn., London (2002).
7. James D. Watson, A Passion For Dna: Genes, Genomes, And Society, Oxford University Press, London (2003).
8. John Harris, Clones, Genes, And Immortality: Ethics And The Genetic Revolution, Oxford University Press, London (1998).
9. June Goodfield, Playing God: Genetic Engineering And The Manipulation Of Life, Harper Colophon Books, N Y (1977).
10. Lars Noah & Barabara A. Noah, Law, Medicine And Medical Technology, Cases And Materials, University Casebook Series, Foundation Press, New York (2002).
11. Lee M. Silver, Remaking Eden:Cloning, Genetic Engineering &The Future Of Humankind, Phoenix Publishers, N Y (1999).
12. Lisa Yount, Genetics And Genetic Engineering, University Press, New York (1997).
13. Mae Wan-Ho, Genetic Engineering: Dream Or Nightmare? Revised Edn., Gill & Macmillan (1999).
14. Marc Stauch & Kay Wheat Et Al, Text, Cases & Materials On Medical Law, 3rd Edn., Routledge Cavendish, London (2006).
15. P.D.G. Skegg, Law, Ethics & Medicine, Studies In Medical Law, Clarendon Paperbacks, London (1990).
16. Richard Dawkins, The Blind Watchmaker, Penguin Books, London (1990).
17. Ted Peters, Playing God? Genetic Determinism And Human Freedom, Routledge, New York (1997).

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