Help me! Compassionate use exceptions needed for trial drugs NOW
Hi All –
I need some advise and words of encouragement as to next steps. I am a heavily pretreated stage IV breast cancer patient. I have dealt with this disease for 20 years now 3 separate times and became Stage IV in 2006. I am a 53 year old single Mom of a 10 year old and I work full time and lead a full and productive life. So far I have responded to all of the approved and clinical trial treatments that have been offered to me for 3 to 6 months each. Eventually the disease forms resistance and I must move to the next most logical treatment. At this point there is an amazing new drug in trials T-DM1. Unfortunately, due to the fact that I am so heavily pretreated I am not eligible for this most promising trial. In my doctor’s opinion and with all of the research I have done this is the best treatment option for my situation.
Compassionate use of trial drugs for heavily pretreated late stage cancer patients is needed now! In my case T-DM 1 is the most promising drug combination on the horizon. This trial is closed to me and is not an option unless something changes fast. I am very angry about this as I feel this is a clear case of the tail wagging the dog. The primary reason I (and thousands of others like me with cancer and other diseases) are not eligible for this treatment is that there is no compassionate care usage approved for trials / trial drugs. As it stands presently, the drug companies must include outcomes of heavily pretreated patient populations like me in the trial results. The feeling is that this heavily treated population might not respond as well as people with less treatments. If this happened it could hurt the chances of these trial drugs getting beyond the trial phase. I would never want this to happen, but…
This drug combination has shown amazing promise and all of the experts in the breast cancer community agree. Do you have any ideas of ways to get the spotlight shown on this issue?
All we need is for the FDA to allow for Compassionate use of trial drugs to heavily pretreated patient populations without inclusion in trial results. We do not wish to slow down or negatively impact trial results. What we would need and deserve is a chance to benefit from these drugs rather than die while waiting for approval. There is no logical reason that we should not have access to this drug combo. Compassionate use of trial drugs for late stage patients needs to be pushed so that people like me can get the best treatment while there is still time.
Thoughts?
Carolyn
Last edited by Carolyns; 06-18-2009 at 11:14 AM..
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