Last year, a woman died in a phase I gene therapy trial. Her death, unlike that of Jesse Gelsinger, may not be related to the clinical trial she was participating in. The direct cause of her death was fungal infection, which can be caused by an arthritis medication she was also taking. Of course, the study was immediately halted when the woman died, but late in November, the FDA gave their go-ahead to resume the trial. The researchers, as well as others not directly involved with the case, all agree that it is appropriate to recommence the work. However, the victim’s husband disagrees. He insists that it is still not sure whether the trial had no part in her death.

To me, it is clear that a majority of the evidence supports the continuation of the trial. However, we must ask ourselves whether a majority is sufficient. I am not sure as to the details of the investigation, but I do know that the death and the FDA’s decision were separated by only four months. If, as the researchers claim, there has been a full investigation, it is certainly acceptable to continue the study. However, if the husband is correct, and the investigation was incomplete, the researchers have an ethical duty to fully understand the death. As the Belmont report states, they are obliged to minimize the risks of the study, and an unexplained death certainly presents huge potential risk.

I am inclined to believe the researchers in this case, particularly because they are backed by the FDA and independent scientists. However, there are indications of negligence. Despite the apparent responsibility shown in this study, I wonder how a fungal infection killed someone if there was proper care provided to the patients. In particular, this woman should have been carefully watched for such infections, because of her other medications. It is the responsibility of the researchers to go beyond regular care when performing clinical trials. Not only is it important for the research, but it may also save lives.

Sources: http://query.nytimes.com/gst/fullpage.html?res=9C0CE6D81E39F935A15752C1A9619C8B63&scp=1&sq=gene+therapy&st=nyt
and http://www.iht.com/articles/ap/2007/09/16/america/NA-FEA-MED-US-Gene-Therapy-Timeline.php