Based on some value considerations, the context in the UK at present is one featured through a high risk aversion to novel technologies. Between these is a deep philosophical and theological questioning of what may be considered as ‘unnatural’, that an inappropriate human intervention in nature. During the time at which it is at ease to critique this if it were said to be a complete concept, since embedded perception of a culture it has really big importance, which has to be taken with all seriousness. A recognisable paradigm shift is taking place. No longer is biotechnology able to depend upon a public agreement of the Enlightenment model of development rode by a specific conquering of the nature power. This is replaced highly by the nation of having a part in nature and requiring to work with balance and harmony.
The environmental and safety effects of genetically modified foods now thus are required to be conceived in a more broader frame of reference than the merely scientific assessment of risk.
The public is at present much aware that changing and harnessing fundamental forces of nature as those in the gene or the atom include many important risks and possibly benefits or advantages. Instead of going further fast to stake a claim in a competitive commercial market, a measure of precaution is at present seen as a much sustainable response in biotechnology for a lot of the people in UK.
GM RISK AS A SOCIAL CONTRACT
If they are to achieve public acceptance, in this fresh context new technologies such as GM food must please an invisible social contract. The society is ready to embrace technology like a distributor of specific services it offered, and does not decline a particular degree of adaptation and risk in conclusion, gave specific fundamental factors are not infringed. These factors are able to be established as:
- Its foundation within the structures of the society
- It does not pressurize anything which is cherished deeply
- The sense of regulation over the forces involved
- The realistic provision of tangible advantages to the consumer
- The magnitude of their consequences, and distribution occasionally
- The relative infrequency of the accident
- The awareness with the technology
A social extent of technology increases if many of these factors become very unbalanced or challenged. Many of these conditions are not met by the applications at present straight away in the case of corn foods. The technology is not familiar and possess no social embedding in the method that, for instance, coal has. It has at present not derived any products of tangible advantage to the consumer, pragmatically. However there have been no important incidents. Comparable to that of introducing a non-indigenous species into a vulnerable ecosystem, GM crops are seen to pose a threat to human safety, wild life and biodiversity. From the BSE crisis, the residual fear derived undermines self esteem, which the regulators or scientists could have taken all eventualities into account.
TAKING SOCIETY’S VEIW OF PRECAUTION SERIOUSLY
It is not adequate anymore to examine GM food safety just opposed to the criteria of the scientist, professional risk assessor or Government civil servant. This information is not to be considered again, thanks to the retreat from increasing standards of scientific rationality. It is to some extent of acknowledgement that, instead of predicting that just this form of rationality was legal, other forms of rationality have their position in deciding too. Any society, which wishes to apply genetic engineering to something as fundamental as food, is required equally to take account of what Max Weber noted about a century ago. GM foods just have a future in OECD states if it accords with individual’s fundamental values, although this is not, at present, the case in UK.
In 1997, Bio Tek was produced by the Danish Ministry of Trade and Industry, which brung together a Professional Group of specialists in the natural sciences, social sciences and philosophy, health sciences, and formed a report on ethics and biotechnology in 1999, which produced the fundamental of the Danish governments’ statement on ethics and biotechnology in 2000.
In 1983, the Canadian Government adopted its initial National Biotechnology Strategy, in 1993 refocusing it, and in 1998 again in order to address a wider variety of issues involving the ethical aspects of biotechnology. The main recent scheme promotes the scientifically sound development, export and application of biotechnology with planned investments. In recognized ten main concern regions and a variety of ideas to help the Government to make the circumstances conductive to sustained growth and novelty in addition to addressing key ethical and social challenges. The government wanted suggestion through roundtable discussions with public and expert consultations prior to finalising the scheme.
DOES BBSRC SUPPORT THE DEVELOPMENT OF COMMERCIAL GM CROPS IN THE UK
If the BBSRC support the development of commercial GM crops in the UK cannot be a answered with a straightforward ‘yes’ or ‘no’. The de-merits and merits of individual applications of GM in various crop species and surroundings must be examined on a case by case foundation by the suitable regulatory bodies. Specific decisions cannot be made by BBSRC’ because it’s role does not allow it. Some GM plants could strongly look like plants bred by conventional events, i.e. the inserted genes may perhaps have been induced (but much gradually) by conventional plant breeding. Other GM plants may perhaps have genes (e.g. those from bacteria, which defend against pests) that might not be induced by conventional breeding. This variation might be essential in evaluating GM plants for commercialisation. Other large factors are:
- The species of the crop plant (and consequently if it is able to cross among with wild relatives, organically grown crops etc)
- Its planned use (food use/not) and site
- The nature of the inserted genes (e.g. gives traits, which would selective benefit to other plants/not).
ISN’T BBSRC DUCKING ITS RESPONSIBILITIES BY FAILING TO EITHER ACTIVELY ENDORSE COMMERCIAL GM CROPS OR REJECT THEM
It is not. Statements prepared concerning the behaviour of GM foods and GM crops have to be based on sound science. Nevertheless, scientific proof is not just the factor, which has to be taken into account. BBSRC understands that there are ethical, political and social issues that also require being well thought-out.
WHAT CONSIDERATION IS GIVEN TO WIDER ETHICAL AND SOCIAL DIMENSIONS WHEN BBSRC DECIDES TO FUND GM RESEARCH
BBSRC Strategy Board reconsiders BBSRC’s research portfolio yearly, to make sure that it is both emerging and capturing scientific chances, which can offer a foundation for responding to wider social concerns, and technological innovation. An example of the latter is the £4.5M Gene Flow in Plants and Micro-organisms idea (2000) funded jointly with the Natural Environment Research Council, which investigates issues of gene flow from non-GM and GM crops. Every BBSRC-funded researcher has to abide by the suitable legislation on released and contained GM plants. BBSRC’s grant awarding Research Committees believe if proposed investigation raises any social or other ethical issues, and if they believe that it does, they request opinion form an Advisory Group, which includes bioethicists. The set could then apply for extra information from the researcher(s) before reporting to BBSRC. latest grantholders are necessary to think social implications of their work and to remark upon them, plus to offer BBSRC with a non-technical summary, which may be used in answering queries.
GENE THERAPY
Gene therapy is the allegation of genes into an individual’s tissues and cells to take care of a disease, and hereditary diseases wherein a imperfect mutant allele is exchanged with a useful one. Even though the technology is yet in its infancy, it has been used with a little achievement. Antisense therapy is not severely a type of gene therapy, although is a genetically-mediated therapy and is usually well thought-out together with other techniques. Gene therapy using an Adenovirus vector.
A new gene is put into an adenovirus vector, which is used to launch the customized DNA into a human cell. If the handling is triumphant, the latest gene will create a useful protein.
The biology of human gene therapy is extremely complicated, and there are a lot of methods that yet require to be developed and infections that require to be known much fully before gene therapy can be used roughly. The public policy discussion surrounding the probable use of genetically engineered material in human subjects has been evenly difficult. Main members in the dispute have come from the fields of government, region, biology, philosophy, politics, medicine, and law all carrying various views to the debate.
BASIC PROCESS
In the majority of gene therapy studies, a ‘corrected’ gene is put into the genome to swap an ‘abnormal,’ disease-causing gene. A carrier known as a vector has to be used to transport the therapeutic gene to the patient’s target cells. At present, the most frequent sort of vectors is viruses, which have been genetically altered to carry normal human DNA. Viruses have progressed a means of summing up and transporting their genes to human cells in a pathogenic manner. Scientists have attempted to attach this capability by manipulating the viral genome to get rid of disease-causing genes and put in therapeutic ones. Target cells like the patient’s lung or liver cells are diseased with the vector. The vector next unloads its genetic material including the therapeutic human gene in the target cell. The generation of a functional protein product as of the therapeutic gene brings back the target cell to a standard condition.
TYPES OF GENE THERAPY
Gene therapy could be classified into these types:
- Broad methods
- Germ line therapy
- Somatic cell gene therapy
Many gene therapy approaches are being assessed, including:
- Launching a new gene into the body to assist battle an infection
- Swapping a mutated gene, which causes infection with a healthy copy of the gene
- Inactivating, or ‘knocking out,’ a mutated gene, which is not functioning properly
Generally, a gene cannot be put straight into an individual’s cell. It has to be transported to the cell using a vector, or carrier. Vector systems are able to be separated into;
- Non-viral vectors
- Viral vectors
Genetic research has advanced in a dramatic fashion in the previous decade or so, to the point where it has at the present become probable to try therapeutic genetic modification, in a few cases of human genes, where a defects exists which manifests itself in specific serious infections. This likelihood, called the gene therapy, is just in its infancy. Currently, no one recognizes how efficient it will show to be, even in the little conditions which is being tried – if it will just be of relatively limited application, or if it will open much broader potential. It puts up with both over-optimistic claims from some quarters and overstated hazard from others, over which the church requires to be discerning. It is not probable to state precisely where the potential opened up by today’s technology will guide in terms of future developments have been occurring at a bewildering speed. Our knowledge of human nature not just identifies our God-given potential and capabilities, but also our failings and limits. Scientific query at its finest should bring an appropriate humility, which identifies both the wonder and also the contigence and smallness of the human condition in the created order. It distinguishes the restrictions to human understanding and knowledge. We are restrictions, and our understanding of the universe is partial, not perfect and conditioned by the social and cognitive structures we have used in making our scientific knowledge.
The more controlling and difficult the technology, such as genetics engineering, the more essential this is. Genetics is yet a fairly young science, and its applications in gene therapy are at extra rudimentary step. This calls for prudence and the process of the ‘precautionary principle’, till we have sensible proof concerning probable side effects on the body overall. For instance, gene therapy looks to improve the major role of a defective gene, like stimulating a vital protein, by replacing or manipulating it. But either the mechanism, or the gene used to induce it in the body, could possess secondary effects which require be monitoring and assessing over a due period of time.
In the late 1960’s leading geneticists proved an amazing sense of humility and responsibility in organising a temporary, voluntary moratorium on specific aspects their investigation, as the specific problems and risks were examined. As investigation has developed subsequently, and a number of of the early fears did not appear to be realised, this restraint did not carry on, but there stays between many genetics a sense of caution, and concern for the broader implications of their work. There is an imperative need to progress this sense inside the research community – where ethical acuteness does not usually match the technical skills, and where constant pressures for promotion or recognition, the need to preserve funding, and just becoming immersed in research for its own sake, can leas to unthinking science.
Nevertheless, of more concern, is the influence of commercial pressures from the biotechnology industry and from time to time from national governments, where the economic potential from genetics is able to be viewed with inadequate regard for other thoughts. The desire of some, initially in the USA, and next in the UK and somewhere else, to patent the mapped parts of the human genome is a revealing example of the interruption which can result.
In medical terms, it can be argued that to mend defective DNA so that the right implementation of a gene is restored is an additional extension of medicine, that has in the previous 50 years taken us into hitherto unidentified areas like organ radiation therapy, transplants and in vitro fertilization. Since our understanding of the human body and its implementation has improved, we can at present envisage treating patients at a genetic level. In this logic, it would appear to lift no ethical trouble if, instead of injecting a very important protein that is deficient in a patient, the gene which should be stimulating the body to make that protein may have its normal role restored. Somatic gene therapy can be noticed as a special case of medical treatment, in the logic of focussing well-known questions by the dangers of a fairly unidentified region of science, and the novel power and specificity of the level of intervention in the body.
Of more concern is the generation of fake optimism on the part of anybody concerned – health authorities, scientists, Government, medical staff, and particularly any commercial biotechnology firms which market the diagnostics kits, drugs or other supplies. It is essential to resist the enticement to oversell one’s scientific therapy or product or discovery, to prevent from making impractical expectations by the public generally, and particularly vulnerable groups who may be anxious for any kind of remedy. It appears probable that it will be many years before over especially modest claims could be complete of gene therapy, but naturally, we pray and hope that its guarantee may possibly will be accomplished in important developments for sufferers from many diseases including cystic fibrosis.
The Clothier committee stated ‘we share the view of others that there is at present insufficient knowledge to evaluate risks to future generations’. They suggested that germline therapy ‘should not yet be attempted’ and this now has turned out to be law Britain. This is a harmless, pragmatic response, however it drops short of an appropriate ethical assessment of the issue, because it concentrates on our presently inadequate means to assess risk to future generations, and does not address the underlying issue of whether or not we possess any right to settle on for them. In practice, it might not matter, as it is difficult to observe on what foundation it could ever be decided that a scientific assessment of the risk was now probable. Every application would most probably need a programme of full-blown human trails, of necessity extending over many generations, deciding for and maybe putting at danger those very generations. Furthermore, by meaning, it would be hard to recognize which were generational effects that had resulted from the therapy.
In just mechanistic terms, the logic has some force, but what is of some concern that all of these arguments automatically suppose that either discarding of unused embryos or termination of pregnancy beneath these conditions is a medically and ethically satisfactory and routine response. This is an unsound method to obtain, since it ignores and omits any necessity to assess the ethical and moral problems involved in either of these alterations techniques, whatever one’s view of them. It also appears to mean that to have ethical reservations at this stage is being observed by the medical profession as heterodox. It is not the aim to search the issue of abortion at this stage, but to emphasize what would be a disturbing trend in how these issues are assessed and presented. It is of crucial significance that the moral reservations of several individuals are taken seriously.
Connected to this is the question of whether embryo or germline gene therapy could steadily be used to get rid of a specific genetic defect like Huntington’s chorea from the population, i.e. negative eugenics. Even if human germline therapy ever turned out to be technically practicable, it is difficult to picture that it would be likely for over some rare cases, fairly apart from the ethical considerations. The technical risks, cost and problems concerned in applying it on the scale, which would be required to get rid of a given gene from a population, would just be prohibitive.
REGULATION AND COMMERCIAL PRESSURE
At present, the potential opened up by genetics are extremely regulated in the majority of western states. In the UK, genetic investigation and its applications in gene therapy are severely controlled by certain bodies like the national Gene Therapy Advisory Committee and local and regional ethical committees for universities, hospitals and research institutes. These take a heavy dependability in a region where latest developments are taking place all the time. This is an appropriate response to the matters expressed earlier. It is essential that, whilst not exaggerating the authoritarian hurdles that require to be cleared by applicants, these committees do not lose their ethical cutting edge among the many pressures positioned on them, both out with and within. There could be a job for stimulating public understanding of their activities, and therefore rising their accountability to society.
There is possibly to be rising pressure from commercial interests to decrease regulation to develop the economic prospects to their investments. There is both an improper and proper feature of this. A great deal of the investigation into human genetics, and particularly its transfer into effective therapy, depends there being a commercial advantage from marketing and developing a medical product. In the USA, blooming assumptions for recent biotechnology companies have rapidly foundered in many liquidations, and it is assumed that the market will be support relatively a small number of, larger companies. Clinical and testing traits can be very much pricey, so there has to be a stage of net investment return to create new genetic developments economically worthwhile. Set alongside this are market pressures just to make the most of profitability, particularly in the short term, with no proper regard for the several other features of a company’s responsibility in society. In the field of human genetics, it is of the greatest significance that our society needs that private organisations bear these broader public responsibilities to the full.
It is also important to recognise that there are limits to society’s ability to control a technology. Regardless of how well rules are drafted, and ethical committees vet and examine investigations and healthcare organizations, human goodwill is yet a requirement for ethical behaviour in every field of technology. Biotechnology normally works on a little scale, which makes it simpler to conceal improper, illegal or inhuman practices, whether private clinics and institutes, inside large corporations, or just by individual unethical scientists working in secret. Nevertheless, the scale of clandestine applications can just be restricted, with no public disclosure and resulting outcry. Of more concern would be where specific practices were authorized by a national Government with looser malicious intent or ethical standards, and were next traded internationally. It would be naïve to assume that genetic abuse would not happen again.
Currently, UK law on genetic engineering is largely knowledgeable by predominantly ethical stances which the church would praise. A risk is that pressure is brought to bear to force this or any other biotechnological issue, in advance of correct and thorough understanding, from vested interests – whether political, commercial or even scientific.
There has to be a public accountability of ethical committees, and open discussion of these issues before variations are prepared to legislation or to the decided standards against which committees vet applications. The church is required to carry on making its voice heard in relation to these issues, and we should pray frequently for those on ethical committees who make choices on hard issues beneath substantial pressures.
BOARD OF SOCIAL RESPONSIBILITY STUDY ON HUMAN GENETIC
In 1995, the Church of Scotland’s Board of Social Responsibility, finished an official study on Human Genetics and published a book on its findings, involving some features of gene therapy, but concentrating mainly on queries of genetic screening and testing, and their suggestion for us as society and individuals.
WHAT ARE SOME OF THE SOCIAL AND ETHICAL ISSUES SURROUNDING HUMAN GENE THERAPY
In big measure, the issues are the equivalent to those faced at whatever time a powerful latest technology is made. Specific technologies can achieve great excellence, however they can cause great damage if applied unwisely too.
At present, gene therapy is focused on accuracy of genetic flaws and healing life-threatening disease, and rules are in position for conducting these sorts of studies. Nevertheless, in the future, once the methods of gene therapy have turned out to be easier and much accessible, society will be required to deal with questions that are much complex.
A specific question is connected to the likelihood of genetically altering human sperm or eggs, the reproductive cells, which pass genes onto future generations. (Since reproductive cells are known as germ cells too, this kind of gene therapy is referred to as germ-line therapy.) One more question is connected to the probable for improving human abilities – for instance, enhancing intelligence and memory – through genetic intervention. Even though both genetic enhancement and germ-line gene therapy possess the likelihood to create advantages, probable problems with these events concern several scientists.
Germ-line gene therapy would eternally modify the genetic form of a person’s descendants. Therefore, the human gene pool could enduringly be influenced. Even though these variations would most probably be for the enhanced, a mistake in judgement or technology could possess extensive consequences. In humans, the NIH does not endorse germ-line gene therapy.
In the case of genetic improvement, there is fear that specific manoeuvring could turn out to be a luxury accessible just to the powerful and rich. Several also are concerned that extensive use of this technology could guide to new meanings of ‘normal’ that would reject persons who are, for instance, of just standard intelligence. Furthermore, fairly or not, a number of individuals connect all genetic manoeuvring with history abuses of the idea of ‘eugenics,’ or the understanding of techniques of enhancing genetic qualities through selective breeding.
WHAT IS BEING DONE TO ADDRESS THESE SOCIAL AND ETHICAL ISSUES
Scientists operating on the Human Genome Project (HGP), which has finished sequencing and mapping every one of the genes in humans, have known that the information got from this work, will have profound suggestions for families, society, and individuals. In 1990, the Ethical, Legal, and Social Implications (ELSI) Program was launched to address these issues. The ELSI Program is considered to examine, recognize and address the ethical, legal and social implications of human genetics research all together that the fundamental scientific issues are being studied. Thus, problem areas can be established and resolutions developed before the scientific information turns out to be part of standard health care practice. Additional information concerning the ELSI Program and the HGP can be established on the National Human Genome Research Institute (NHGRI).
SOCIAL ISSUES RAISED BY GENE THERAPY – SOMATIC ENHANCEMENT
Conservatively, the applications of gene therapy are separated into 4 groups: somatic treatments for medical, conditions, somatic enhancements, germ line treatments for medical conditions and germ line enhancements. The main point is that, in the present social climate, it would be extremely difficult to resist somatic enhancements.
Initially, it is particularly difficult to describe, in principle, what is an enhancement, and to distinguish that from medical circumstances. There is a powerful propensity that when something turns out to be technologically manipulable it becomes observed as a problem.
The other reason why it will turn out to be difficult to resist the use of gene therapy for cosmetic/enhancement reasons is the present fashionableness and acceptance of their forms of improvement, like cosmetic surgery. There are at the present several doctors who grew up and went through medical school wanting to heal the alleviate and sick human pain, who are now doing liposuction and facelifts. Enhancement is not limited to the surgeon’s knife: in the US, thousands of small children who do not have growth hormone deficiency are being treated with human growth hormone, however there is not any proof that the treatment even works, in long term. This is an example of the use of biotechnology to change individual’s bodies so as to be conventional to tyranny. One more example is the use, by millions of black women of extremely poisonous chemicals to bleach their skin.
A conservative dispute for the medical uses of gene therapy is that it is, in essence not changed from other kinds of medical technology. If society endorses or as a minimum stands all these other enhancements, we can create a dispute that we should not do the identical type of thing using gene therapy.
I think one of the social reasons for the boom in improvement is post-mortem disillusionment, cynicism, and boredom concerning human condition. The merely area where there is expectation for a better future, is in technologies fulfilling hope to vary the human condition through better bodies, getting rid of diseases, living forever, etc.
The outcome is that with the commercial pressures and the social pressures, doctors’ hopes to limit gene therapy to medical uses are just a dream. There is a business developing gene therapy for baldheads already. The bioethicists have given up the struggle already, since there are not any ethical arguments alongside somatic enhancement that other bioethicists cannot destroy easy enough.
GERM LINE ENGENEERING
The reason why it is astonishing that there is a lot of debates on germ line engineering is that there is no serious dispute for its medical use. In all except rare cases, there are the options of p
In all except rare cases, there are the options of prenatal diagnosis or pre-implantation diagnosis to prevent transmission of disease-causing alleles. (I want to emphasise that I view pre-implantation diagnosis, were it to become widespread, as every bit as dangerous as germ line engineering). In the rare situations where pre-natal or pre-implantation diagnosis would not solve the problem, there is always the option of sperm or egg donation. Finally, not having children, and adoption are traditional possibilities. I would argue that for those couples who are sufficiently concerned about passing on disease-causing genes, these latter possibilities are most appropriate. We should re-examine the current fetish with biological inheritance.
An argument for germ line engineering which is sometimes advanced is that it would be possible to ensure that children are not carriers of recessive genes. People say that they wouldn't want their children to have to worry and to deal with the difficult reproductive dilemmas that they themselves are having to deal with. I have every sympathy for the difficult position such people are in, but worry and difficult dilemmas are part of life. They are best dealt with by counselling or psychotherapy. This certainly does not seem to be an adequate reason for developing germ line engineering technology.
In think, germ line engineering would be a failure much greater than cloning. There should be an unconditional international restriction on germ line engineering, and funding agencies should not fund schemes, which aspire to increase such technology. Many reasons for this are broadly argued on. One which is clear is that, when it has been done to get rid of harmful genes, there will be no way to withstand pressures for use for improvement. A couple of years ago the UNESCO international Bioethics Committee addressed gene therapy, on a bioethical stage. They could not find any adequately convincing ethical arguments against somatic enhancement or ‘medical’ use of germ line engineering; yet the committee was unsuccessful to observe that when these two premises are accepted there can be no logical argument made in opposition to germ line enhancement engineering. A straightforward piece of information is that the major potential or germ line engineering to do things, which cannot be done better by other means, lies in enhancement.
The actually fascinating thing is why many individuals keep quarrelling against ban. I think part of it is just dull old scientific careerism; a fraction of it is philosophical careerism and the wish to be courageously saying something varied to everyone else.
However, there are three fundamental things that guide individuals to entertain the thought of germ line engineering, which are very satisfactorily spelled out in Professor Wivel’s article, which he wrote with LeRoy Walters in Science a couples of years ago. I consider that we’re heading for having a reassessment of a number of things we take for granted, if we wish to end full scale eugenics and germ line enhancement.
The first is the medical imperative, second is the argument that Wival and Walters deployed which was to do with parental reproductive freedom and third underlying force driving development of germ line engineering is what Wival and Walters name the basic ethical of science.
BIBLIOGRAPHY
- Class notes
- Class handouts