Ethical Issues in Biotech

Because it is grounded in the use of living organisms to produce drugs and food, the biotech industry has been grappling with several ethical issues, as more and more products become available. Remarkably, the nascent industry proactively moved to regulate itself as early as the 1973, shortly after Drs. Herbert Boyer and Stanley Cohen successfully recombined DNA by forming the Recombinant DNA Advisory Committee (RAC) to explore the consequences of this achievement and to investigate the risks involved in conducting research in this area. During the next decade, as basic research moved toward product development, the industry again acted proactively by formulating and adopting safety standards for industrial manufacturing using organisms derived using recombinant DNA technology. Today, work on stem cells, cloning, and the development of genetically modified crops are the main sources of controversy.

Stem cell research
The stem cell controversy derives from the potential power of these undifferentiated embryonic cells to become differentiated into virtually any type of cell found in the human body. Scientists have the ability to maintain and focus the development of such cells to replace existing cells that are either cancerous or which have lost their capacity to function normally due to accidents and/or disease. Thus, in addition to cancer, patients suffering from diabetes, stroke, brain and spinal cord injuries, and diseases associated with aging can potentially have a new source of healthy cells. The consequences of successfully implementing this vision have raised enough questions that the NIH issued a policy in 2000 that would allow some research under strict federal oversight. In August 2001, the Bush administration restricted the policy somewhat but permitted continued federal funding. Subsequently, the NIH has issued update guidelines to the industry to implement the new policy.

Cloning
Cloning refers to the laboratory replication of genes, cells, or organisms from a single entity, meaning that exact copies of genes can be made. Although the National Bioethics Advisory Commission (NBAC), with industry agreement, has acknowledged the moral, ethical, and safety consequences of this activity, there is, nevertheless, one strand of cloning research that is supported by the industry.

Therapeutic cloning or somatic cell nuclear transfer (SCNT) refers to the use of undifferentiated cells that are genetically identical to those of a patient, and hence have no potential of incurring rejection. Such cells can develop into new tissues targeted to replace diseased tissues and offer promising new treatments for Alzheimer's, Parkinson's, heart disease, and many cancers.

Food and agriculture controversy with the European Union
Perhaps the most heated debate, however, surrounds the development and marketing of genetically altered crops. Agricultural scientists have long experimented to develop varieties of crops - among them soy, corn, cotton, etc. - that are hardier, more disease and pest resistant, and more nutritious. Success in this area has been remarkable: by 2002, a full 74 percent of the total US soybean crop acreage, 71 percent of cotton, and 32 percent of corn used biotech breeding methods. Biotech has also produced fruits and vegetables (e.g., tomatoes and raspberries) that are longer lasting, less prone to disease, and have delayed ripening. Aquaculture has produced salmon and other fish that breed faster, cost less, and is more sustainable than fishing in the wild. Overall, the biotech food market is estimated to expand 18 percent to $5 billion by 2005.

Yet despite these advantages, concerns remain both at home and abroad. In July 2003, critics took to the streets in Sacramento, CA, decrying the use of "terminator" genes and raising the possibility that cross-pollination of genetically altered foods with those grown in the wild will harm plant diversity and pose unknown health dangers to humans who consume them. Also in July 2003, the European Union (E.U.) recently ended the 5-year moratorium on genetically altered crops it imposed in 1998 to have time to study health and safety concerns and to develop a system of tracing and labeling biotech foodstuffs. The E.U. requires such crops have clear labels. The US, along with Argentina and Canada, formally requested a panel of experts from the World Trade Organization (WTO) to rule the E.U. guidelines illegal. The U.S. and its allies claim that the guidelines are cumbersome, difficult to implement, and constitute a trade barrier. American farmers claim they lost some $300 million per year in lost corn exports. Furthermore, the U.S. wants full and unconditional acceptance of biotech-based foodstuffs.