Monday, March 30, 2009

Weekend of questions

Good morning! Well, I am happy to report that the Dungans are all doing well. This weekend was fundamentally no different for us. There were lots of chores around the house and a fair amount of to keep me busy. Believe it or not I am working on two research grant proposals. What can I say, it is the research nerd side of me. The other surprise of the weekend was a high volume of calls regarding the ch14.18 antibody. Thankfully, I was able to get much of this done without giving up too much time with the kiddos. We had fun despite the seemingly hectic schedule and questionable weather.

The ch14.18 antibody is a truly difficult issue for many families right now. There are so many kiddos that are in that window where they need the antibody right now but can't get it because it is still under FDA hold. Families not quite at that point are concerned too. They are wondering whether they will be eligible for the antibody when it becomes available again. The most common questions I hear are (a) when will the antibody be available and (b) will I be eligible. I wish I could tell anybody that I had the answers. There just aren't any as of this moment. Unfortunately, I also don't know when there will be.

It is a very complicated topic. I have heard many raise their voice in protest that this must be an issue with the COG. That is a wrong assumption. There are issues involved that we as families have not even begun to consider. Believe it or not, reopening the trial and getting the drug into kids is not really under the control of the COG. While the COG is integrally involved in the decisions, it is ultimately up to the FDA, CTEP and the NCI to give them the go ahead to move forward. The COG will not be able to move until these other groups agree on the proper course of action given several different issues. Bottom line, the COG is as anxious to get this trial back open and this drug flowing back into high risk kids as we are. To a certain extent, their hands are tied.

So, what does all of this mean. Well, it means we don't know when the trial will be available or for whom. I am quite sure that the eligibility criteria will be even more strict than they were before the FDA closed the trial. The FDA will certainly require certain restrictions to protect our kids and to try and prevent further restrictions. While this is great for the safety of the kids that are eligible to receive the therapy, this will be a problem for those that find themselves ineligible. My suggestion is to position yourself. Find out if your child is likely to be eligible - ask your oncologist. Keep an ear out for news on when the trial will open and check to see if you will fit within that window of opportunity. If you don't see your child fitting into either one of these criteria then I would start investigating other alternatives. It is as simple as that. I wish it weren't but, if I was in that position, that is exactly what I would be doing.

It will take purpose.

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