1. Gene therapy is a novel approach to treating cancer currently in clinical tri
ID: 69220 • Letter: 1
Question
1. Gene therapy is a novel approach to treating cancer currently in clinical trials. But, it is not without risk. Why do you think someone would volunteer for this type of a study? (Explain your reasoning)
2. Why would someone opt to not seek treatment? (Explain your reasoning)
3. Do you think that a survival rate of 2 out of 17 patients can be counted as a success? Explain why or why not?
4. What is the mimimum survival rate required to claim that a treatment is efficacious? Explain your opinion.
5. Would you consider this sort of treatment if you were faced with an inoperable cancer that has not responded to other conventional treatments? Explain why or why not.
Explanation / Answer
1.
The National Institutes of Health (NIH) also plays an important role in ensuring the safety of gene therapy research. NIH provides guidelines for investigators and institutions (such as universities and hospitals) to follow when conducting clinical trials with gene therapy. These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities. The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at one of the RAC’s public meetings.
An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution’s potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research.
2. If you are the person with cancer and you are seriously considering a choice to refuse treatment, I would encourage you to speak with the people closest to you about it. It is possible they will feel hurt, believing you are choosing to die rather than to spend time with them. It would likely be very helpful to them if they understood how and why you made your decision, or what it is you are wrestling with. It is even possible such a discussion will give you a new perspective that leads you to change your mind. This is a situation where a mental health professional may be invaluable. Such a person could help facilitate a discussion between you and the people you are concerned about, and help you each to understand what the other is experiencing. Hopefully this will lead to you supporting each other through this very challenging time
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