the weeks following Jessie’s death. Many scientists believed that the boy was healthy enough where he should not have needed gene therapy at all. Therefore a “healthy” teenaged boy had just died from an “unnecessary” treatment. The FDA began their investigation immediately. They found many problems associated with the way the University of Pennsylvania conducted the Gelsinger gene therapy trial. Before Gelsinger began the treatments his ammonia levels were too high. The researchers should have waited until they got lower to begin the trial. A second thing that the University did wrong was that they failed to report that two other patients had had serious side effects from the Gelsinger type gene therapy. Lastly, the scientists failed to mention in the consent discussion that they had with the Gelsinger family about the deaths of monkeys given similar treatment.In response to the Gelsinger case there was much talk about whether the safeguards surrounding gene therapy were good enough. The NIH Director, Dr. Harold Varmus, established the Advisory Committee to the Director Working Group on NIH Oversight of Clinical Gene Transfer Research (the Working Group) to review the role of NIH in oversight of clinical gene transfer research. The Working Group includes people from scientists to bioethicists to representatives of the general public. They met in May 2000 to decide if there needed to be any additional NIH measures taken to minimize risk associated with gene therapy. They came to the conclusion that research in the field of human gene transfer should be kept under a close watch and patients should be extremely protected. Hopefully, committees such as the NIH and FDA will continue to regulate and watch over the advancement of gene therapy. This field is advancing quickly and the government regulations need to advance with it.Perhaps the biggest danger of gene therapy may not lie in what is happen...
