Read this article to learn about the benefits, positive and negative effects, ethics, legal and social implications of biotechnology.
Advances in biotechnology, and their applications are most frequently associated with controversies.
on their perception to biotechnology, the people may be grouped into three broad categories:
1. Strong opponents who oppose the new technology, as it will give rise to problems, issues and concerns humans have never faced before. They consider biotechnology as an unnatural manipulative technology.
2. Strong proponents who consider that the biotechnology will provide untold benefits to society. They argue that for centuries the society has safely used the products and processes of biotechnology.
3. A neutral group of people who have a balanced approach to biotechnology. This group believes that research on biotechnology (with regulatory systems), and extending its fruits to the society should be pursued with a cautious approach. The risks and benefits of the developments of biotechnology may not be much different from that of any other branch of science.
Benefits of Biotechnology:
The fruits of biotechnology are beneficial to the fields of healthcare, agriculture, food production, manufacture of industrial enzymes and appropriate environmental management. It is a fact that modern technology in various forms is woven tightly into the fabric of our lives. Our day-to-day life is inseparable from technology.
Imagine life about 1-2 centuries ago where there was no electricity, no running water, and sewage in the streets, unpredictable food supply and an expected life span of less than 40 years. Undoubtedly, technology has largely contributed to the present day world we live in.
Many people consider biotechnology as a technology that will improve the quality of life in every country, besides maintaining living standards at a reasonably higher level. The probable positive and negative effects of biotechnology, with special reference to developing countries are given in Table 61.2.
ELSI of Biotechnology:
Why so much uproar and negativity to biotechnology? This is mainly because the major part of the modern biotechnology deals with genetic manipulations. These unnatural genetic manipulations, as many people fear, may lead to unknown consequences. ELSI is the short form to represent the ethical, legal and social implications of biotechnology. ELSI broadly covers the relationship between biotechnology and society with particular reference to ethical and legal aspects.
Risks and ethics of biotechnology:
The modern biotechnology deals with genetic manipulations of viruses, bacteria, plants, animals, fish and birds. Introduction of foreign genes into various organisms raises concerns about the safety, ethics and unforeseen consequences.
Some of the popular phrases used in the media while referring to experiments on recombinant DNA technology are listed:
i. Manipulation of life
ii. Playing with God
iii. Man-made evolution
The major apprehension of genetic engineering is that through recombinant DNA experiments unique microorganisms or viruses (either inadvertently or sometimes deliberately for the purpose of war) may be developed that would cause epidemics and environmental catastrophes. Due to these fears, the regulatory guidelines for research dealing with DNA manipulation were very stringent in the earlier years.
So far, risk assessment studies have failed to demonstrate any hazardous properties acquired by host cells/organisms due to transfer of DNA. Thus, the fears of genetic manipulations may be unfounded to a large extent. Consequently, there has been some relaxation in the regulatory guidelines for recombinant DNA research. It is now widely accepted that biotechnology is certainly beneficial to humans. But it should not cause problems of safety to people and environment, and create unacceptable social, moral and ethical issues.
The public fears of biotechnology, besides some of the risks, social and ethical issues can be better understood with special reference to the following:
1. Therapeutic products for use in healthcare.
2. Genetic modifications of foods and food ingredients and their consumption.
3. Release of genetically engineered organisms into the environment.
4. Applications of human genetic research.
Recombinant Therapeutic Products for Human Healthcare:
It is fortunate that there is no serious criticism about the use recombinant products for medical applications. This is mostly because the therapeutic products and strategies are designed to cure diseases, alleviate sufferings and improve the quality of life. Further, the products are used under the medical supervision. In general, the recombinant products designed for human healthcare are more readily acceptable by the public. Good examples are the use of insulin, interferon’s, tissue plasminogen activator and various vaccines
Genetic Modifications and Food Consumption:
The overall objectives of genetic modifications with reference to foods are listed:
i. To increase the quality and quantity of existing foods.
ii. To produce new products.
iii. To improve the financial returns.
Each country has its own regulations for introducing foods into the market. For instance, in USA, the Food and Drug Administration (FDA) regulates the introduction of foods, drugs, pharmaceuticals, and medical devices into the marketplace.
As regards the foods and food ingredients developed by genetic engineering, the FDA believes that no new regulations are needed. The existing regulations for the assessment foods for safety by toxicity, allergen city and impurity testing are adequate.
If the chemical composition of the existing food is altered by genetic modification, it should be specified, and the new product should be accordingly labeled. To highlight the public perception of genetically modified foods, some selected examples of food ingredients and their acceptance, or certain controversies related to their use, are briefly described.
Chymosin is milk clotting proteolytic enzyme that hydrolyses the milk protein casein to produce curd, which in turn is processed into cheese. Traditionally, chymosin is derived from the stomach of calves in the form of rennet.
By genetic engineering techniques, the chymosin gene was cloned and expressed in E. coli. This resulted in a large scale and cost- effective production of chymosin. The chemical composition, structure and biological activity of recombinant chymosin were identical to the chymosin of rennet. FDA gave license to chymosin for its commercial use, and it is now widely used in cheese making.
In 1989-90, an unusually high incidence of the disease eosinophilia-myalgia syndrome (EMS) was reported in USA. EMS is a rare disease with muscular pain and respiratory complications, and may be fatal. Investigations revealed that the victims of EMS were consuming large quantities of food supplement tryptophan (obtained from one company).
This tryptophan was produced by genetically engineered microorganisms. Chemical analysis of the commercial preparations revealed the presence of certain metabolic derivative of tryptophan. The most important among them was 1 -1′ ethylene — bis (tryptophan) which was responsible for EMS (based on the results of animal experiments).
It was concluded that the pharmaceutical company did not take adequate care for purification of tryptophan. Consequently, recombinant tryptophan (even without the impurities!) was banned for human consumption in USA.
Bovine somatotropin story:
Bovine somatotropin (BST, also known as bovine growth hormone), when injected to dairy cattle, increases the milk production significantly. By recombinant DNA technology, the gene for BST was cloned and expressed in E. coli. The recombinant BST (rBST) so produced, when injected to cows was found to increase milk production by 20-25%.
The effect of rBST was considered from two aspects — on the animals and consumers:
1. Effect of rBST on animals:
Administration of rBST can produce localized swelling at the site of injection. There may be some other adverse effects like increased susceptibility to infection, decreased reproductive capability. The proponents of rBST argue that these problem could occur even in normal animals.
2. Effect on human health:
The natural BST or even rBST increases the body levels of insulin-like growth factor-l (IGF-I) which in turn enhances milk production. There is evidence that IGF-I stimulate growth of cancer cells. This causes concern among the consumers of milk produced by using rBST.
The counter argument is that rBST injection, after about 100 days of lactation begins, is not associated with increased levels of IGF-I. The opponents of rBST strongly feel that since milk is consumed by most people, any inherent risk, however small is unacceptable.
Recombinant BST was licensed in USA, for use in dairly cattle in 1994. Some countries in fact have banned the use of rBST. There are some people (particularly among the scientists) who believe that the hue and cry raised against rBST is more due to economic and political reasons. It is feared that by rBST use, the dairy industry may be controlled by large industrial groups and the small dairy farms may become unprofitable. The rBST story is an interesting illustration of the problems surrounding the use of genetic engineering.
Recombinant Foods and Religious Beliefs:
Some of the ethical concerns of the use of recombinant foods are related to religious beliefs, besides food habits. For instance:
i. Transfer of pig genes into sheep may offend the sentiments of Jews and Muslims.
ii. Introduction of animal genes into food plants may invite opposition by strict vegetarians.
iii. Transfer of human genes to food animals may be unacceptable to some people.
iv. Feeding of human gene — containing organisms to animals sounds in bad taste (at present, the genetically modified yeast that produce recombinant proteins after their use, are fed to animals).
The religious groups, in general, are selective about the foods to be eaten. However, they are not so rigid when it comes to the use of medically- derived products. For instance — Jews and Muslims may accept pig-derived insulin for use in diabetic patients. This is due to the fact that all religious faiths consider human life is the most valuable, and its preservation the first priority. Further, the general belief is that the human body is violated only by oral consumption and not by injection or surgical interventions.
Eating genes every day!
Every day, we eat plants and animals and various products derived from them, besides a large number of bacteria. In other words, we regularly consume genetic material, the DNA, organized into genes in various organisms! So far no one has attempted to categorize genes as vegetarian and non-vegetarian, as we do for foods!!
Are GM Foods Safe?
The production of transgenic plants and animals by genetic engineering techniques has now become routine. These organisms will enter the food chain in the form of genetically modified foods (GM foods). Some social and environmental groups are against the consumption of GM foods. These people insist that the GM foods should be specifically labeled.
As regards the safety of GM foods, opinions range from one extreme that they are absolutely safe, and improve human nutrition to the other that they should not be consumed at all. Most of the people have opinions somewhere between these two extremes.
Release of Genetically Engineered Organisms:
The release of genetically engineered organisms (GEOs), also called as genetically manipulated organisms (GMOs) into the environment has been a controversial issue; and continues to be so. It is feared that the release of GEOs into the environment could have far-reaching consequences.
This is due to the fact that the living GEOs proliferate, persist, disperse, and sometimes may transfer their DNA into other organisms. It is further feared that there exists a possibility of GEOs displacing the existing organisms, besides creating new species. This may lead to severe environmental damage. For the reasons stated above, the regulatory authorizes are very careful in permitting the field trails of GEOs. Further, the release of GEOs into the environment has to be carefully monitored and recorded.
Ice-minus Pseudomonas syringae:
A genetically modified strain of Pseudomonas syringae was the first GEO that was given permission for field trails (in 1987). This organism is a genetically engineered ice-minus strain, when sprayed onto the leaves could prevent frost damage to the plants.
Field trails with other GEOs:
A number of open-field trails have been conducted with several GEOs during the past two decades or so. The studies concluded that the genetically modified microorganisms do not persist in environment for long, do not transfer the genes into other organism and do not exhibit any abnormal biological functions. Thus, the initial apprehensions on the use of GEOs appear to be unfounded.
Release of transgenic plants and animals:
The transgenic plants developed for higher quality and quantity of foods, in general, are more liberally permitted to go to fields. It is generally believed that the transgenic plants do not significantly differ from the natural cultivars (traditional plants) obtained by plant breeding experiments.
The transgenic Bt-plants such as cotton, corn, soybean and potato were approved for cultivation in USA. However, some countries did not allow Bt- plants in their fields e.g. Bt-rice was not allowed in Philippines, Bt-cotton in France.
The transgenic animals have not posed as big a problem as the transgenic plants. This is due to the fact that animals can be much easily identified and contained (since copulation is animals can be done as desired, unlike in plants where pollination is difficult to control).
A majority of transgenic animals are used for medical purposes, hence they are generally appreciated. But the major problem for transgenic animals comes from animal activists. Many people, and also some Governments, are suspicious of the use of GEOs due to various reasons-risks, societal beliefs and economic concerns.
The most serious hazard associated with genetic engineering is the construction of harmful biological agents (viruses, microorganisms) either deliberately or otherwise. However, so far there have been no records of any new infectious agents created by recombinant DNA technology.
Most of the countries of the world are signatories to the Biological Weapons Conventions of 1972. As a signatory, a nation pledges ‘never to produce microbial or other biological agents, or toxins, whatever may be their method of production, for use in wars’. Many people are, however concerned about the possible use of gene manipulations for military purposes.
Applications of Human Genetic rDNA Research:
The ultimate goal of advances in biotechnology is for the benefit of mankind (either direct or indirect).
Biotechnology largely contributes to human genetic research involving the following areas:
i. Genetic testing and screening for diseases
ii. Genetic portfolios
iii. Human gene therapy.
Genetic testing and screening:
Techniques are now available for prenatal testing to specifically detect whether a fetus carries genetic defects. This will help the parents to be better prepared for the future baby. The negative aspect of prenatal testing is that the couple may opt for abortion even for a minor genetic defect or sometimes for gender bias.
The elucidation of the entire human genome sequence and identification of genes has now become a reality. It may soon be possible to have individual genetic portfolios that will diagnose future health complications e.g. risk for cancer, heart disease. The genetic portfolios (based on the genes) will foretell the individuals’ future which is now being predicted through stars (astrology).
Genetic portfolios of individual may pose certain problems with regard to marriages, insurances. Who would like to be a spouse of someone who will soon be a victim of cancer or heart attack? Which insurance company would insure a person with a very high risk of diseases? Many ethical committees are of the opinion that insurance companies should not require, or should not be allowed to have access to individuals’ genetic portfolios.
Human gene therapy:
Theoretically, correction of genetic defects is possible by gene therapy. The present status of human gene therapy has been described. From the ethical perspective, gene therapy involving introduction of genes into a patient is comparable to the practice of transplantation of organs (e.g., heart, liver, lungs).
Therefore, there is not much controversy over gene therapy, as long as it is intended to be used to alleviate serious medical disorders. However, the gene therapy must be under a close supervision to satisfy medical, legal, ethical and safety implications, besides addressing the public concerns.
Germ line gene therapy:
This is not being carried out at present due to technical, ethical and social reasons. Manipulation of germ cells will lead to serious problems and complications. At one international meeting on biotechnology the following was the final message given to biotechnology companies on the applications of genetic engineering to humans. ‘Provide the information and listen to the public’.
Human Embryonic Stem Cell Research:
The human embryonic stem cell (ESC) lines were established in November 1998. These cells are capable of giving rise to any human cell type. ESC lines open the possibilities of treating diseases with cell therapy. Disorders that involve the loss of normal cells such as diabetes mellitus, Parkinson’s disease, Alzheimer’s disease could perhaps be corrected with cell therapy. This may however, take more time.
There are many ethical and legal issues involved in ESC research, besides several objections raised by the public. In fact, the U.S. Federal Government has banned the use of federal funds for human embryo research for over 20 years. At present, most of research on ESC is being supported by private companies.
After the cloning of the sheep Dolly (in February, 1997), some groups of researchers naturally became interested to explore the possibilities of cloning humans. The very thought of human cloning has become a highly charged and controversial issue. A such, considering the biomedical ethics, most of the countries have banned research related to human cloning. It cannot be predicted at present whether someday human cloning may become inevitable.
Scientists who were awarded Britain’s first licence for human cloning have recently (2005) created an early stage of human cloned embryo by using nuclear transfer. The researchers, as such, are not interested to make babies by cloning. Instead, they wish to create test-tube embryos to supply stem cells that can give rise to every tissue in the body. By this approach, it might be one day possible to repair tissue damages and cure many diseases e.g. Parkinson’s disease, diabetes mellitus.
Biotechnology and the Developing Countries:
A major proportion of research related to biotechnology is carried out by the developed countries.
The fruits of biotechnology are probably, more useful and relevant to developing countries, as illustrated with the following applications:
i. Increased levels of nutrition with improved nutrient composition in the foods (through transgenic plants).
ii. Prevention of child deaths by appropriate immunization (using recombinant vaccines).
iii. Supply of clean drinking water, and improved sewage disposal (by appropriate biotechnological treatments).
Despite the known benefits, some of the developing countries are reluctant to open doors for the advances made in biotechnology. This may be more due to political considerations rather the economic reasons. The applications of biotechnology, particularly to human healthcare, may someday be regarded as a barometer to evaluate the progress of a nation.