they may alter more than the cells that the scientists intended to change. Another danger is the possibility that the immune system may have severe allergic reactions to the vector itself. Even if the immune system does accept the virus, there is still a concern that it may be possible for transferred genes to be over expressed. This would produce so much of the missing protein that it would become harmful. Also, an immune system reaction could potentially make the viruses less effective when the patient uses them over time. Since gene therapy is such a new and possibly dangerous field there are many safeguards that the government has tried to set up to regulate it. Before any gene therapy experiment in humans can begin, researchers need to pass many steps of review. They must first demonstrate their ideas in the lab with no live subjects, and then try the treatment on animals. If the animal data looks good then they may consider the therapy for people. The researchers next step is to present their proposal to the review board for their own university or drug company. This board will consider things such as the risks that the patients will be taking while participating in the gene therapy research. Then the experiment may need approval by the National Institutes of Health's Recombinant DNA Advisory Committee (RAC). The NIH, which includes more than 20 institutes and offices, created this committee in 1974 to consider ethical, scientific and safety issues related to recombinant genetic experiments. The researchers final step is to send their proposals to be reviewed by the Food and Drug Administration. This is slightly controversial because, some people argue that the FDA does not know enough about gene therapy to make proper decisions concerning new trials of it. Two times, in the history of gene therapy, researchers have gone behind the backs of the government to do gene therapy research. In 1971, Stanfield Rogers of...
