A Sample Ethical Problem
Genetic Innovations for Tomorrow Corporation, or Gift Corp, is announcing approval by the Food and Drug Administration (FDA) of Phase III clinical trials (human studies) to test a service to produce tissue and organ replacements, customized to provide an identical genetic match for its clients. Gift is also planning trials of gene therapy via engineered viruses designed to insert genes into cells to restore normal function. Gift Corp. is a private company with connections to UC Sacramento Medical School.To produce the tissue, Gift Corp. produces clones of the target tissue by purchasing eggs from female students at the university and replacing their nuclei with the nuclei of cells taken from its clients. The technique used for separating the various possible tissues from the growing embryo was patented by Egyptian scientists; however, neither their patent nor the reference to their authorship appears in publications or American patent records.During Phase II clinical trials (animal experimentation), Gift Corp reports success of transplanted tissues, but neglects to mention an observation of allergic reactions in 12.1% of clinical trials of test subjects, including dogs and rhesus monkeys. Private acknowledgements point to an incompatibility between tissue derived from human eggs and tissue found in the test subjects as the reason for the allergic reactions.Initial trials in human subjects, conducted by UC Sacramento Medical School professor Franklin Rosalind, involve muscle replacement. Rosalind proceeded with the trials without having the trial reviewed by his institution due to the fact that he was working at a Gift Corp laboratory. He did, however, previously receive a federal grant from the National Institutes of Health to experiment with tissue cloning using federally approved stem cell lines.
The resulting papers were authored by a number of individuals including some who did not conduct experiments but helped fund the research (the Chairman of the Board and several major investors). Gift Corp also files for and receives a patent on the specific technique used in this tissue service.
While this is obviously a frabricated case, it involves several bioethical issues, including several that we will be tackling with our two topics. Don’t worry about the nuances of these issues yet though. Just give us your thoughts, supported by some of the concepts expounded upon in the “Morality, Ethics, and Culture” post.
- Bryan