Consent Review

The first step to become part of the clinical trials is to review and sign the consent form. Thursday Jan. 15 was when we had scheduled to review the consent form. I flew in Wed. late night getting to my hotel room about 1am. We started the review of the consent form at 8:30am. There were several Dr’s and staff in the room for the review. It probably looked bad that I was yawning during the review, because I had only slept about 5 hours the night before. I made it through the 16 page in depth review.

There is one potential side effects that states: “It is possible that if the treatment does work, you may be disturbed and uncomfortable having more vision”. My face was probably quite funny when we reviewed that and I asked “Isn’t that what we are shooting for here?” I think we all got a good laugh at that. A Dr. said that they have to cover all the potential outcomes as possible side effects. There is another part that is funny about “you should not father a baby for a minimum of 4 months after gene therapy.” I laughed at this and said I already have my 2 children and no plans for more. Dr. Bennett said that in the LCA trial they had the same note in the consent form which was really funny seeing that there were some boys who were 8 years old in that study. Can you imagine having to tell an 8 year old boy that that they can’t father a child for 4 months?  A friend asked me later why that comment would be in the consent form. My response was so I don’t create my own genetically modified superhero X-men team and take over the world (during the day of course, as none of us can see at night).

Risk analysis is a major function of what I do. I analyze potential outcomes vs possible benefit. For me, this clinical trial makes sense when I look at the outcomes in 10 years. To simplify the analysis, I am considering my current vision as OK and ten years from now my vision will be poor without participating in the trial. I chose 10 years, because I feel this is a realistic potential for this to be a viable approved procedure if all goes well (this could be slow or fast depending on the time for each phase of the study and approval time is unknown). I have two options(participate in trial or not) and there are two possible outcomes(success or not). Below are the 4 possible outcomes for my eyes in 10 years:

Participate in Trial
Yes No
Trial Successful Yes 1 eye OK from trail, 1 eye Poor, but can get surgery to not get worse Both eyes poor, but can get surgery to not get worse
No Both eyes poor, small chance of trial eye poor sooner Both eyes poor

The other reason I signed the consent form is for my daughter, as she is now a carrier. For many years, I considered not having any children because I did not want to pass on CHM. I have come to realize that children having joy and happiness in life have nothing to do with any obstacles that are in their lives. There will always be obstacles in your life to overcome whether it’s genetic, random chance or self induced. Being there for your children when they need you and being the best parent you can be creates a lifestyle for your children to have the ability to overcome any obstacle. To quote Albert Einstein “We cannot solve our problems with the same level of thinking we were at when we created them.”

A cane is now with me when I travel in airports, as people tend to seem lost and not paying attention to where they are walking. This is quite comical, as everyone is at an airport for a purpose to go somewhere and there are enough signs to be able to figure out where you need to go. With a cane people apologize to running into me. Without a cane people get mad at me for hitting them. People also attempt to contain small children when I am walking near by, which I truly appreciate since they move fast and are below my field of view.

My flight home was uneventful, but it reminded me of the last time I flew. I had just scanned my ticket to board when the gate agent asked me if I needed any assistance. No I did not need any help, I told her. She was extremely polite and asked again “Sir, are you sure you don’t need any help?” I told her I have tunnel vision, so I am good in a tunnel. At this point the woman behind me had been listening and started laughing extremely hard. She quickly contained herself and profusely apologized for laughing at my comment. I told the lady behind me that it is no problem and was meant to be a joke. I was glad someone laughed at it, because at this point everyone was looking at me at the gate area. The gate agent with a straight face told me that was not funny and I shouldn’t be making jokes about a serious situation. Not sure what everyone else thinks, but if you can’t have fun and make jokes about yourself then you are living life too seriously.


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