Introduction

As science continues to push the spectrum of biotechnological possibilities ever further, economic profit for participating regions and vast improvements in the quality of life for all certainly await. However, before the benefits of applying such technology can be realized, many scholars insist that the ethical, social and environmental consequences of altering the natural genetic code must be thoroughly understood. Given our current level of technology, two biotechnological disciplines provide the most immediate possibility for a quality of life improvement and therefore necessitate a thorough analysis of consequences. Specifically, because food biotechnology has the potential to save North Carolina's dwindling agriculture industry and gene therapy has been studied throughout the Research Triangle Park, the social, ethical and environmental issues involved have garnered much debate. This section of our website will compare the benefits created by these forms of biotechnology to the actual and hypothesized consequences of their application.

Food Biotechnology: An overview

Food biotechnology, or the genetic modification of the plants we eat, has been practiced ever since humans evolved from hunting and gathering to cultivating crops. In particular, this "old" biotechnology, as described by the FDA, can be as simple as genetically modifying plants through traditional plant breeding techniques--such as cross-fertilization of selected plants--to produce desired traits ¹. This procedure has been practiced for time immemorial and is considered ethically and environmentally sound.

Nonetheless, as technology has unlocked the mystery of DNA, scientists better understand the genes that are associated with certain advantageous traits in plants. As described by the FDA, this "new" biotechnology, known also as gene splicing, recombinant DNA, or genetic engineering, "involves direct modification of DNA, making it possible to direct and predict changes without introducing extraneous, undesirable traits¹". The advances of "new" food biotechnology hold a tremendous possible benefit for farmers, food manufacturers, consumers and even the environment. However, as with any untested biotechnology, certain ethical, social and environmental questions concerning the altering of Mother Nature's genetic code have been proposed. The following two sections will review the positive and negative aspects of applying biotechnology to the foods we eat.

Positive Aspects of Food Biotechnology

In the early 1990's, the first genetically altered food product was available for sale in the United States. This product, a tomato that ripened on the vine and could be transported without bruising, opened the door for biotechnology to enter, and drastically alter, the food industry and dinner tables of the world. Theoretically speaking, the possible, future benefits of food biotechnology are economically, agriculturally, and environmentally astounding. With a genetically improved seed, farmers have the ability to reduce expenses, reap higher crop yields, use less pesticide, and produce a more nutritious, better tasting crop². Although current biotechnology primarily benefits farmers and food processors by giving fruits and vegetables better shelf life and shipping properties, the proposed future of genetically engineered food is fascinating and highly beneficial to all of society. For example, in an era when millions of people starve in third-world countries because they cannot produce enough food to sustain life, biotechnology offers a hope for the future.

It has been hypothesized that in the future, modified seeds will allow third-world farmers to continually grow food in areas with poor soil or irrigation by developing crops that more efficiently absorb nutrients, also reducing the need for costly fertilizers. Biotechnology could also help prevent disease and malnutrition in the third-world by producing more healthful crops. As a specific example, a strain of "golden rice" that contains high levels of iron and beta carotene could be available within a few years, holding uncountable benefit for the more than 100 million children who suffer from Vitamin A deficiency³. Furthermore, research is already in progress on developing fruits and vegetables that could distribute life-saving vaccines simply through easily distributed, locally grown crops.On a more general level, scientists also believe that future technologies will make food safer to eat. For example, scientists will be able to reduce the natural toxins in food. Specifically, they are already looking at ways to identify the allergenic proteins in foods like milk⁴. At the moment, the products of biotechnology consist of plants that are resistant to insects and tolerant to herbicides. Thus far, approximately 40 genetically altered foods have been approved by the US Food and Drug Administration as safe as naturally grown food¹.

Negative Aspects of Food Biotechnology

Regardless of the potential benefits resulting from food biotechnology, the consequences of its application in the real world necessitate discussion. In particular, concerns about human allergic reactions to altered food, the environment and the use of animal genes in plants have all been mentioned. This section will examine each of these issues in order and in the context of the available literature.

Both traditional and genetically altered foods have the possibility of causing an allergic reaction in a low percentage of people. The risk of potential allergens in biotech food is particularly concerning because of the possibility of transferring a gene that causes allergic reactions to a new food source, without the consumer's knowledge of the transfer. As an example, if a gene from a food that commonly causes allergic reactions, like in fish or peanuts, is inserted into a food where people would not expect to find such allergens, then the food could potentially harm the consumer. While this transfer is within the realm of scientific possibility, the FDA provides adequate oversight, as any food on the market with said characteristics will be labeled and fully disclosed to consumers¹.

Another common critique of food biotechnology concerns the environmental risks involved in producing genetically altered foods. It has been theorized that biotechnology can cause a potential transfer of harmful traits to other plants or have a potential adverse effect on other organisms, in particular endangered species. As a specific example, if a plant has many wild relatives, the passing of the altered gene to an offspring of the plant species could result in wild plants that develop into fast-growing weeds. For the majority of food plants, this will not be a problem as they have few wild relatives. However, for certain plants, such as soybeans or squash, gene transfer can pose a problem due to the existence of wild relatives¹. When such a case exists, crops developed using recombinant DNA methods are reviewed by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service and given an environmental assessment. Even more importantly, companies must perform extensive field tests to demonstrate their crops will not harm the surrounding soil, water, animals or plants before they can sell altered seeds to farmers.

Lastly, several experimental plants have been developed that have copies of advantageous genes found in animals. While scientifically astonishing, this radical departure from the established laws of nature has resulted in the discussion of many ethical and religious implications. As a brief example, the "anti-freeze protein" gene found in the Artic flounder has been spliced into a tomato plant to create a tomato paste that freezes and thaws more efficiently. Although scientifically possible, many consumers are concerned about their health when eating new sources of food. As maintained by the FDA, "the safety of the proteins produced by these genes will be evaluated based on their characteristics"¹. To clarify, if a protein comes from a commonly consumed animal, it will likely be safe. If not, the FDA will thoroughly test and examine the protein as if it were a new food additive. In regard to the ethical and religious predicament, when a scientist adds a new gene from an animal, the plant only gains several new proteins; it does not become a mutant plant-animal hybrid. The new gene works just like any other plant gene; we do not actually have pieces of animals in vegetables. In fact, most people do not realize that many of the genes located in humans are located in plants as well. For example, there is a gene in the human brain that is the exact same as in rice¹.

In conclusion, while the benefits of applying biotechnology to the natural world are widespread and awe-inspiring, the resulting consequences must be meticulously tested and understood before implementation. Fortunately, many of these risks, which are more closely regulated in the United States than anywhere else, have proven thus far to be minimal. For food biotechnology to continue to help mankind, future research must be ethical in nature, consequences must be painstakingly analyzed, regulatory institutions must continue to operate, and the public must play an active role in monitoring our scientists and biotech organizations.

Gene Therapy: An Overview

Genes, which are carried by chromosomes, are the building blocks of life. They are specific sequences of DNA that instruct how to make certain proteins essential to human function and development. When genes are altered so that accurate protein creation stops, genetic disorders can result. In reality, every human carries nearly six defective genes. However, most of us do not suffer any harmful effects from our defective genes because we carry two copies of nearly all genes, one given to us by our mother and the other from our father. Fortunately in most cases, one normal gene is sufficient to avoid all the symptoms of disease. Nonetheless, about one in ten people has, or will develop at some later stage, an inherited genetic disorder, and approximately 2,800 specific conditions are known to be caused by defects (mutations) in just one of the patient's genes. Some single gene disorders are quite common. For example, cystic fibrosis is found in one out of every 2,500 babies born in the Western World⁵. In total, diseases that can be traced to single gene defects account for about 5% of all admissions to children's hospitals . In 1990, gene therapy, which is a technique for correcting defective genes responsible for single-gene disease development, was first tested in the United States. Since then, much research has been done in an effort to map the entire human genome. A map of the human genome will allow doctors to understand the genes that control all diseases to which the humans suffer, and theoretically develop new therapies to treat and predict diseases⁶.
 

Similar to the above discussion concerning food biotechnology, the risks associated with gene therapy are widespread and demand complete understanding. The following two sections will examine the benefits offered by gene therapy compared to the projected ethical and social considerations.

Positive Aspects of Gene Therapy

At present, the favored method for delivering genes into cells uses the natural ability of viruses to deliver genetic material to cells. More specifically, viruses have evolved a way of encapsulating and delivering their genes to human cells in a pathogenic manner. Scientists have tried to take advantage of this capability and manipulate the virus genome to remove disease-causing genes and insert therapeutic genes⁶. Currently, gene therapy has only been approved to treat a limited number of diseases, including ADA (adenosine deaminase). Nonetheless, despite the low level of approved treatments available today, a high level of in-progress research predicts a remarkable future for gene therapy. By clicking on each listed disease below, a new window will open giving the most recent report on each disease with respect to gene therapy:

Parkinson’s Disease
Huntington’s Disease
Thalassaemia
Sickle Cell
Leukemia
Autism
Liver Cancer

Of the 200 therapeutic protocols that have been formally reviewed: 23 deal with HIV infection or AIDS; 33 with single-gene diseases, especially cystic fibrosis; 138 with cancer; and 6 with other diseases⁷. As is evident, the future for gene therapy appears bright, as cures for many of the most deleterious human diseases stand ready to be discovered.

Negative Aspects of Gene Therapy

Despite promising evidence about the benefits of gene therapy, many critics cite a lack of proven success and ethical and social apprehension as a major hindrance to the advancement of gene therapy.

To start, the lack of success thus far shown by gene therapy is a direct result of many procedural shortcomings. To clarify, the following four factors have kept gene therapy from becoming an effective treatment of disease:

• Short-lived nature of gene therapy - Before gene therapy can become a permanent cure for any condition, the therapeutic DNA introduced into target cells must remain functional and the cells containing the therapeutic DNA must be long-lived and stable. Problems with integrating therapeutic DNA into the genome and the rapidly dividing nature of many cells prevent gene therapy from achieving any long-term benefits. Patients will have to undergo multiple rounds of gene therapy.
• Immune response - Anytime a foreign object is introduced into human tissues, the immune system is designed to attack the invader. The risk of stimulating the immune system in a way that reduces gene therapy effectiveness is always a potential risk. Furthermore, the immune system's enhanced response to invaders it has seen before makes it difficult for gene therapy to be repeated in patients.
• Problems with viral vectors - Viruses, while the carrier of choice in most gene therapy studies, present a variety of potential problems to the patient --toxicity, immune and inflammatory responses, and gene control and targeting issues. In addition, there is always the fear that the viral vector, once inside the patient, may recover its ability to cause disease.
• Multigene disorders - Conditions or disorders that arise from mutations in a single gene are the best candidates for gene therapy. Unfortunately, some the most commonly occurring disorders, such as heart disease, high blood pressure, Alzheimer's disease, arthritis, and diabetes, are caused by the combined effects of variations in many genes. Multigene or multifactorial disorders such as these would be especially difficult to treat effectively using gene therapy⁸.

To overcome these problems, scientists need to create more successful ways to insert genes into the body. To single-gene diseases effectively with gene therapy, researchers must develop vectors that can be injected into the patient and specifically focus on the target cells located throughout the body. More work is also needed to ensure that the vectors will successfully insert the desired genes into each of these target cells .

While the previous apprehension over gene therapy is mainly technical in nature, perhaps the most important obstacle for gene therapy to overcome concerns its social and ethical implications. The following bullets represent many of the questions relating to gene therapy, and each requires personal thought and reflection to determine one’s opinion. Additionally, links to many related ethical and social pages can be found on the resources section of the site.

• What is normal and what is a disability or disorder, and who decides?
• Are disabilities diseases? Do they need to be cured or prevented?
• Does searching for a cure demean the lives of individuals presently affected by disabilities?
• Is somatic gene therapy (which is done in the adult cells of persons known to have the disease) more or less ethical than germline gene therapy (which is done in egg and sperm cells and prevents the trait from being passed on to further generations)? In cases of somatic gene therapy, the procedure may have to be repeated in future generations. In cases of germline therapy, another question relates to the potential for enhancing human capabilities.
• Preliminary attempts at gene therapy are exorbitantly expensive. Who will have access to these therapies? Who will pay for their use?⁸

In response to the profound impact gene therapy has the ability to let loose, The Ethical, Legal, and Social Implications (ELSI) Program was established in 1990 to address these issues. The ELSI Program is designed to identify, analyze, and address the ethical, legal, and social implications of human genetics research at the same time that the basic scientific issues are being studied. In this way, problem areas can be identified and solutions developed before the scientific information becomes part of standard health care practice⁸.

In conclusion, due to a lack of conclusive evidence proving that genetic treatment has produced therapeutic benefits, the future of gene therapy is highly skeptical. Recently, the world’s biggest funder of gene therapy, The National Institute of Health (NIH), endorsed the "extraordinary" potential of gene therapy, while urging that federally funded research shift its emphasis away from human subjects and back to the laboratory . The NIH further suggested that scientists had moved prematurely into human testing and concluded that more benefit would result from investing more time and money in the laboratory, specifically to improve the viral delivery system that carries foreign genes into cells⁶. Similar to the industry of food biotechnology, for gene therapy to positively alter the future of mankind, future research must be ethical in nature, consequences must be painstakingly analyzed, regulatory institutions must continue to operate, and the public must play an active role in monitoring our scientists and biotech organizations.