[Carolyns]

Hi Believe51,

Thank you for your warm heartfelt concern. I follow your struggles as well and you and your husband are in my thoughts and prayers.

With regard to other trials, there may be others that I can qualify for when the time comes (could be a week or two). Wednesday I am meeting with a doctor about the Heat Shock Protein trial. Today, I do not qualify for any trials that are recruiting (that I know of) and there may not be trials open in a week or two either. The key words here are "qualify and open". Practically speaking my doctor believes that the TDM1 trial is the next best chance for me. It has shown the greatest results with less side effects even compared with the remaining largely "off label" chemo's that are up next for me. The most recent TDM1 trial opened and closed so fast that more than 100 patients were left standing in line without rain checks. I hope that those folks were able to find something else.

To me the question I will ask was already asked at ASCO and pointed out to me by our dear Lani from an article posted, “Another issue to ponder, Dr. Peppercorn pointed out, is whether there is "a clear rationale for withholding an experimental therapy outside of a trial, when we are prepared to use it to treat a patient within a trial."

My answer is NO. There is no clear rational for withholding or closing incurable cancer patients out of trials. The side effect of this choice for many is death. Some may have drug treatments off label that have even worse known side effects than the trial drugs… side effects like congestive heart failure.

Incurable breast cancer patients are living long with breast cancer and our numbers are growing. There is little to no “evidence” in our treatment. In a sense everything we do is an experiment with risks both known and unknown taken every day by the patients, their medical teams, the drug companies and the government. In my opinion this is just a failed process with false choices. I beleive that it can be updated to be a win, win, win for all with the will to do so. I do not believe that allowing incurable breast cancer patients into these trials would hurt clinical trial participation or that it should hurt the data if the FDA would remove this inclusion requirement. This is a failed process and people are dying because of it. I believe that updating this process will allow many of us to live to see the cure and contribute to finding the cure faster.

Think back to the scene in the movie “Living Proof” where the early participants in the Herceptin trial were not allowed to continue. How did they feel when they were turned away? How did their doctor feel when he had to turn them away? Who benefited? Not the patient. These trials are our life support and we deserve admission in the sunlight.

I have faith in the universe and believe that the right door will open for me. I also have the strength right now to voice my serious concerns around this issue. It doesn’t have to be this way. Thank you for your support and concern and mine for you is coming right back at you.

Love, Hope, Peace,
Carolyn