BIO's Commitment to the Socially Responsible Use of Biotechnology
MEDICAL PRIVACY AND GENETIC DISCRIMINATION
BIO recognizes the need for confidentiality of all individually identifiable medical information. We support national policy-legislation or regulations-to protect the confidentiality of all personal medical information, including data derived from genetic tests. The industry believes that an individual's medical information must be respected, treated confidentially and safeguarded from discriminatory misuse. This protection must be balanced, however, with the need to continue valuable medical research into new diagnostic tests, therapies and cures. BIO believes that protecting patient privacy and promoting medical research are mutually attainable goals.
In September 1996, BIO's board of directors called for strong controls on the use of all confidential medical information, including genetic information. At BIO's urging, 11 national biotechnology industry groups from around the world have also endorsed the call for strong protections against the misuse of personal medical information.
BIO supports legislation that prohibits insurers from denying individuals insurance based on their genetic information. People should have the option of using diagnostic or predictive tests that can help them recognize early warning signs of disease and seek proper treatment. This option could be jeopardized if genetic information were used to discriminate.
STEM CELLS
Researchers can now separate early, undifferentiated stem cells from blastocysts-the 5-day-old ball of cells that eventually develops into an embryo. Such embryonic stem cells can differentiate into any cell type found in the human body, and they also have the capacity to reproduce themselves. The ability to maintain stem cell lines in culture and direct their development into specific cell types holds the potential to save many lives by controlling cancer, re-establishing function in stroke victims, curing diabetes, regenerating damaged spinal cord or brain tissue and successfully treating many diseases associated with aging.
These undifferentiated cells lines are also powerful research tools. By studying these cells, we will begin to understand the mechanisms that guide cell differentiation and de-differentiation.
Scientists have also learned that undifferentiated cells from other tissue (for example, "adult" stem cells) have value. BIO supports research on these cells. However, according to the NIH and the NAS, only the embryonic stem cell can be turned into any cell type.
On August 9, 2001, President Bush announced federal funding would be allowed for research on embryonic stem cell lines that were derived from blastocysts prior to 9:00 p.m. that day. Fewer cell lines than anticipated are available for federal funding. A stem-cell bill calling for the relaxation of the restrictions passed the House in 2005 and the Senate in 2006. President Bush vetoed the legislation, however, and the House failed to override the veto, leaving the 2001 restrictions in place. In the meantime, privately funded research has advanced and use of stem cells in human clinical trials may start soon.
CLONING
Cloning is a generic term for the replication in a laboratory of genes, cells or organisms from a single original entity. As a result of this process, exact genetic copies of the original gene, cell or organism can be produced.
BIO is opposed to human reproductive cloning-using cloning technology to create a human being. BIO was one of the first national organizations to offer public support for voluntary moratorium on research into cloning a whole human being. Human reproductive cloning would involve taking the nucleus of a somatic cell (a body cell that is neither an egg nor a sperm) of a person and inserting it into an unfertilized egg from which the nucleus has been removed. The egg containing the somatic cell nucleus is then implanted into a woman's uterus. In theory, this would lead to the development of a human being after a gestation period. Reproductive cloning is too dangerous and raises far too many ethical and social questions to be undertaken. There are grave moral, ethical and safety concerns surrounding this issue.
Another type of cloning involves somatic cell nuclear transfer to an egg, as described above. However, as the egg divides, the undifferentiated cells are kept in culture and never implanted. A few days after cell division begins, stem cells are separated from the rest of the cells. The stem cells continue to divide, creating a cell line that is genetically identical to the somatic cell from which the nucleus was removed.
Undifferentiated cells that are genetically identical to the patient have remarkable therapeutic potential. Given the proper environments, these cells could develop into new tissues that could replace diseased tissues and cure diseases such as diabetes, Parkinson's, Alzheimer's and various types of cancer and heart disease. This avenue of study could produce replacement skin, cartilage and bone tissue for burn victims and nerve tissue for those with spinal cord or brain injuries. Research is also going on regarding the environmental cues, genes and structures that direct cell differentiation into whole organs composed of different tissue types. This application of cloning technology is often referred to as therapeutic cloning, or somatic cell nuclear transfer (SCNT).
One reason for doing SCNT is to understand the process of reprogramming-how the egg cell takes genetic material from a fully differentiated cell and turns it back into an undifferentiated cell. Once that process is understood, egg cells would not be needed and this process could be replicated in a lab.
