Fbae Logo
Home | | Support Us | Contact Us
Goals & Objectives Our Position False Propaganda Important Publications Important Links Events News Biosafety
Fbae Header Home




Biotechnology and Bioethics

S. B. Sullia
Emeritus Professor & Formerly Head of  the Department
Department of Microbiology & Biotechnology
Bangalore University, Bangalore-560056

The recent advances in the field of biotechnology have brought into focus several ethical issues. While anti-biotechnology activists are over rating the risks of biotechnology, it is time for the scientists to make a scientific and objective analysis of the social issues involved, and make it known to the public who will, otherwise, be carried away by the emotional rhetoric by the less informed but highly vocal section of the society.

Ethics is the science of morals and rules of conducts recognized in human society and apply to individuals living together in a society. The inventions in the field of genetic engineering and related fields of molecular biology will affect  not only ourselves but the plants , microorganisms, animals and the entire environment and the way we practise agriculture, medicine and food processing. An increase in our ability to change life forms in recent years has given rise to the new science of 'bioethics'.  Bioethics can be defined as the systematic study of human conduct in the area of life sciences and health sciences, keeping in view the moral values and principles existing during the particular period.

During the last few decades there has been a growing feeling that technology has led to many problems along with benefits leading to a strong anti-technology  trend. Adverse opinion regarding science, even if it is in a small minority of people, can lead to protest actions  as seen in recent examples of protests over the release of 'Genetically Modified Organisms' (GMOs), animal rights movement,  sex determination of foetuses and abortion etc. There have been terror campaigns conducted against scientists, and destruction of laboratories and test farms concerned with genetically modified crops. This is true of several countries and the anti-biotechnology movement is gathering wind. There has been a feeling that the scientists are  not  transparent and on the contrary are arrogant about their research capabilities. The term 'genetic engineering' evokes the most emotional response as the people has not understood the term in its simplicity but have equated it  with nuclear science which has given man the most destructive of powers. Genetic engineering should simply mean the technology to introduce, delete or enhance a particular trait in an organism by introducing foreign genes or altering the existing ones. Genetic engineering is only a part of  biotechnology  which involves the application of technology  for using living organisms to provide  better services for mankind.

The concerns regarding the introduction of GMOs is that the new genes may enter other organisms or that the new organisms themselves may replace existing organisms in the ecosystem. The ecological system is very complex and we cannot yet predict these results, but we must walk carefully as the environment is already in bad shape because of overexploitation. There is concern about protecting species diversity. There is also concern regarding the powers to control nature being vested in private companies where commercial concerns dominate.

Animal rights
Animal rights activists claim that using animals for experimental purposes is not ethical. In most experiments animals are made as models for human  systems for experimentation as humans cannot be used for this purpose. Drugs for use against AIDS are being tested on mice. The other alternative to mice is the chimpanzee and the mice look the better option. This means that the animal right concept is highly subjective. For example, our emotional response to rats and puppies is different. Historically, there was never any evidence of humans treating animals on par with their own species. Animals were thought to be less sensitive to pain and  experiences. Animal rights protectionists are unable to explain how do they know about the feelings of animals so as to plead for them. One could argue that pigs may prefer to be slaughtered, how do we know? As there is no communication, one never knows but there are indirect moral obligation theories.  For instance, it is wrong to torture animals as it desensitizes us to human suffering and makes us more prone to violence. There are many sects in India who would not torture animals or kill animals for food. They are vegetarians by choice, not by poverty. Killing animals for experiments can be considered as 'sacrifice' where inevitable but it may be better to use cell culture experiments where live animals can be spared.
Genetically engineered  animals are becoming the  preferred source of animal experiments as they could be of uniform quality for reproducible results.  Genetic modification of animals is criticised  in the same way as the creation of  other GMOs. So far as the rights of animals is concerned, they have no intelligence or rationale to claim any rights even though the intelligence levels of some animals such as dolphins is very high. As rights are always associated with duties, when we cannot think of any duties assigned to them how can we think of rights?  It is, however, reasonable that we treat them with more respect and compassion , not just with pity. There are already several painless experiments performed on animals and anaesthetics are used often. More possible suffering  may be heaped  on animals than experimental infliction of pain by confining them to small cages. It is argued that using animals to prepare vaccines may benefit the animals themselves as they and their kins may be protected against diseases.

Regulations have been made to prevent animal abuse taking all the above ethical considerations and the need for the science to develop. It is now necessary to use alternatives whenever available. The alternatives include using of  in vitro experiments using cell lines, embryos or larvae, or isolated organs , and computer simulation. Where unavoidable animals such as rats and mice can be used for toxicity testing because here we place higher value to human life than animal life.

Gene Food
Several genetically modified foods have entered the market in the last three decades. These include new protein sources from bacteria, filamentous  fungi and yeasts, and genetically manipulated plants and animals. Plants may be genetically manipulated for better yield, disease resistance or better nutritional quality of  the product. In any case all these foods have evoked antagonistic responses from environmentalists. The fears about gene food are that they may transfer some genes to the consumers and more important that they may be toxic or carcinogenic. The first apprehension is the result of ignorance. Almost all the raw vegetables and fruits we eat have their genes intact and we have been literally taking genes into our gut all along. The genes are not transferred from the gut to human cells and if this were to occur we could have developed millions of new traits through the ages. Gene food is no different from other food in this respect. Our body is exposed to genes from bacteria , fungi and viruses which live in our body as harmless residents and their genes have not been adopted by our cells. The other concern regarding toxicity, allergy and carcinogenesis  is genuine and any genetically modified plant product needs to be tested for toxicity before release as there may be some secondary metabolic effects from the inserted genes. The most controversial gene manipulation has been the insertion of the Bacillus thuringiensis gene  (Bt gene)  which has now entered more than 400 foodstuffs, mainly soybean and corn.  The Bt toxin, the product of this gene is, however, known to be active only in the gut of the insect larva where alkaline conditions exist and not in the human gut. In many European countries, it has been made mandatory to label genetically modified food so that the buyers could make their choice.

There have been more profound concerns regarding the safety of meat produced from genetically altered animals. Treating animals with recombinant bovine somatotropin(BST) for increased milk yield  and feed-conversion efficiency has been approved in USA but not in Europe. There have been reports that partially digested BST is biologically active in humans, inducing nitrogen retention.  The lowest levels of concern is with regard to medicines derived from recombinant DNA technology. The insulin produced from  E. coli   that is genetically manipulated is  widely accepted.  The tissue plasminogen activator(TPA) and streptokinase derived through gene manipulation for use  as a blood clot dissolving agents are very well accepted.

Applied genetic engineering
There is no major ethical debate about the use of microorganisms to produce products from industrial chemicals to alcohol. Microbes have been used for production of drugs such as antibiotics, blood clotting factors, interferons, interleukins, growth hormone and many other human proteins. Recombinant DNA techniques are used to produce new vaccines, e.g., the vaccine against hepatitis-B. Veterinary drugs and vaccines are also being produced using microbes with new technology. Bacteria can be used for production of biopolymers that can be processed into polypropylene-like plastic using food waste for growing the bacteria.
Environmental applications of microorganisms include their use as biopesticides, biofertilizers and as agents to mitigate environmental pollution. Bioremediation and phytoremediation  are two processes where microbes and plants are used respectively for pollution alleviation.

Regulations for GMOs
It is mandatory in most countries that all proposals for the release of  new organisms to the environment should be reviewed by some regulatory authority. There have been various definitions of GMOs but in most cases organisms made by the use of recombinant DNA technology only are included and those made by the conventional breeding techniques are excluded. Some scientists feel that all forms of new organisms should be included because it is the product that is important than the technique. The attributes of the product can be considered for risk assessment. There are methods developed to model the potential risks. The five main criteria for evaluating environmental impact are, a) the potential for negative results, b)the survival of the organism, c)the reproductive mechanism, d) the transfer of genetic information, and c)the transport or dissemination of the organism.

There are different components of the risks. The probability of each component occurring must be multiplied to count the likelihood of harm. If the likelihood of the occurrence of  any component is zero, then the final outcome will be zero.

These components include:
I) incorporation of gene for hazardous trait into an organism
ii) chance of release into natural environment
iii)survival of the organism there
iv)multiplication of the organism in the environment
v) chance that this will be harmful.

The methods of evaluating GMOs vary between countries. Usually there will be several agencies involved depending on the nature of the proposal. The harsh rules in Europe may lead biotechnology companies to conduct trials in other countries with liberal laws. Many scientists feel that the regulations are too stringent because the potential hazards of biotechnology are over rated.

Human Genome Project

The human genome project is a major scientific effort to unravel the mysteries of human DNA. It began in 1990 as a 15 year project, with a budget of 3 billion US dollars, funded by the US Department of Energy and the National Institutes of Health, USA. Later the effort became global with several academic institutions from different countries, funded by US joining the pursuit forming the 'International Human Genome Sequencing Consortium', with also the collaboration from the Wellcome Trust of  London, UK.  There was a parallel effort by private companies, the leader being  Celera Genomics, Rockville, Maryland, USA. The project was completed ahead of time, in May 2003 due to rapid technological advances. The results of human genome sequencing were published simultaneously by the two rival groups.  Dr. J. Craig Venter, President, Celera Genomics, published it in Science, and Dr. Eric Lander, representing the International Consortium and the Wellcome Trust, published it in Nature.

Understanding the sequence of the human genome raises certain ethical dilemmas.
Physicians will be able to detect critical flaws in DNA long before, the person has actually got the genetic disease. In some cases this will be useful, for immediate treatment can be given.  But often nothing can be done about the damage and this leads to several complications. Does anyone wish to know about the defects that cannot be corrected?  What happens when the employers and insurance companies want to know the genome sequences of  those whom they wish to employ or insure? There may be pressure on parents to abort foetuses that are genetically defective. However, the future biomedical technology should be able to solve many of these problems.

Now that the human genome project is completed,  the knowledge gained should be considered the common property of all the humanity. There is also the fear that the information may fall mostly in the hands of multinational drug companies. There is public concern about patenting of such genetic material which is common to all.  It is considered immoral by some people to patent certain cell lines of tribals and other communities.

Bioprospecting is the process of exploration of  biodiversity of this planet, but in effect it has become a search for microorganisms or plants with potential to yield new industrial or pharmaceutical products and commercialize them. There was a strong tendency towards patenting useful microbes and medicinal plants but most countries have now banned the patenting of any kind of life form, be it genus, species, variety or strain. Any new process can, however, be patented.

Fears of genetic determinism
The idea that the answer to all our problems lies in the genes may lead to several ethical problems as we have now the blueprint of the human genome.  People may attribute certain kinds of behaviour, e.g., gambling, drinking, violence, homosexual tendency etc. with genes without understanding the complex interaction between genetics and environment. The idea that we can change ourselves may give a moral choice which is highly subjective. It is doubtful whether the society will allow the free individual choice for genetic manipulation unless there is a medical reason.

The word Eugene means 'well born' or 'hereditarily endowed with noble qualities. Eugenics is the age old science of selective breeding to increase the population of people with 'good genes'. The idea could be used in the modern context for reducing the number of individuals with genetic defects. The former concept can be misused to eliminate certain races  but the latter concept  is much more useful. At present it is difficult to link traits connected to mental ability, talents etc. with specific genes and it will take time before we are able to harvest the benefits of human genome project.

The present application of eugenics is to  improve the physical and mental attributes of future generations. One way is to control reproduction by genetic screening. Genes that would certainly lead to defects may be identified and in such cases abortion may be recommended. The other way is to control gene dominance a design by which the genes for certain 'good' attributes in parents may be stimulated to dominate. Sterilization of the mentally retarded has been tried in some countries but this may go against bioethics and human rights, when performed against the wishes of the individual.

Genetic testing: Genetic tests can be conducted on people, foetuses, or embryos to detect defects  on genes associated with Huntington's disease,  cystic fibrosis, Down's syndrome and about 100 other diseases that are genetically controlled. Genetic testing cannot yet reveal whether a person will be beautiful or musically gifted, neither can it create such combinations. The idea of what genes should be passed on to the next generation is called parental eugenics.

DNA fingerprinting  Genetic information through DNA fingerprinting is being increasingly used in legal cases. Forensic science has begun to use small samples of blood or semen from criminal cases to match up with suspects  Parents' and child's DNA fingerprints can reveal real genetic relationships and these are accepted in courts.  There are no ethical issues involved in these applications of  the technology.

Prenatal Genetic Screening
Prenatal screening for the termination of  female embryos is in practice in several Asian countries and this is a development which goes contrary to bioethics.  However, when this technology is applied to screen and terminate foetuses with sex-linked genetic defects, it is a most positive development.

Genetic counselling has developed as a highly sophisticated science. Because of the explosion of information and possibilities that will be available to us in future ethics of medical genetics will also become highly complicated. Stress has to be given to personal choice and confidentiality of information. The geneticists will also be more publicly accountable.

Human gene therapy
Gene therapy involves the process of replacing the defective genes responsible for certain genetic diseases with the correct genes. The genes can be inserted into specific cells of the body where the defect is causing the disease. This is called somatic cell gene therapy.  For enzymes that are diffusible in the body, not all cells need to be treated. A few tissues in the body are enough to produce the enzyme, e.g., adenosine deaminase (ADA) gene used for adenosine deaminase deficiency, the first case of gene therapy actually successfully practised by W. French.  The other class of gene therapy is called germline gene therapy where the gene is inserted to the germline (sperm or eggs) so that during reproduction this gene gets inserted into all the cells of the offspring. Any gene inserted to the embryo is heritable through future generations.

The people who support gene therapy stress the theological principles that  it prevents disease and thus suffering; gene therapy is only a new form of medicine and any medicine is right.  The opponents argue that gene therapy is unusual and it may lead to the abuse of genetic control and to decreasing human value. There is not much opposition to somatic cell gene therapy but germline gene therapy  is not accepted by ethologists.

Human cloning
Experiments with Dolly, the sheep, elicited tremendous reaction from the scientists, lawmakers and laymen, primarily because of the unprecedented media coverage. A large majority of people felt that it is unethical to clone human beings the way the animal was cloned. Some object to human cloning because it is against natural law and the objection is valid to some degree. There is the objection that it would reduce genetic diversity of the species. However, the objection can be overcome if  one could limit the cloning programme to a small portion of the population, maintaining the large reservoir of diversity intact. The more important question being asked is whether the technology is going to benefit the individuals to be born. In any environment, individuals of  similar genetic make up will be more susceptible to epidemics and hostile conditions than diverse populations.

Ethics of  patenting
While protecting one's intellectual property rights is quite essential and is also legitimate, there are several ethical issues involved in patenting life forms.  Even though no species or strain that occurs in nature can be patented according to the current laws,  methods of producing cloned animals, and animal as well as human cell lines and embryos as the product of cloning have been patented. There are several countries that have allowed animal patenting. Patenting would prevent the widespread use of new strains of experimental animals and the cultivation of agricultural varieties. Many companies are involved in making  fortunes from their patented  crop varieties  while  what they have done is merely shifting of the genes which are a natural resource.

The technology is still in its infancy, and it requires at least another decade or two before we can decide what regulatory mechanisms could be evolved. It may be wise to let the science to evolve without undue fears and moratoriums.