What can we do about the delay of TDM-1

[Barbara H.]

Hi Everyone,
I spoke to my oncologist and obviously he is not in a position to get this decision reversed. He is quite upset with the decision because metastatic HER2 patients who have been waiting for the drug are going to die. In fact, there were a number of patients who were scheduled to receive it next week through the expanded access program that will be denied that opportunity.

The reason for the denial is ludicrous. Why would a HER2 cancer patient choose to take awful chemo treatments when more effective target therapies are available? Although the members of the FDA have medical backgrounds, they are not necessarily oncologists, and presumably do not understand the ramifications of the decision they made considering the track record of TDM-1. Obviously, they do not realize the number of patients who will die as a result of their decision.

As many of you know, I was on a phase 1 trial of TDM-1 for two years and it was a miracle drug for me. This drug did not stop working, but I developed lung inflammation. That does still not mean I couldn't try it again in the future.

I am not writing on behalf of myself. It pains me to know that many of you are being denied access to this treatment.

Apparently this decision can be reversed if many of us write and voice our opinions and experiences. The FDA needs to understand why this drug needs to be approved ASAP. They need to know about the number of patients who will lose their lives if they do not reverse this decision. They need to understand their responsibility for these patients.

Unfortunately, I do not have experience being an advocate and do not even know how to get this message out so that the essential people read it. For example, President Obama's 60, 000 letters he receives each day are screened by readers that decide which ten letters he will read on that day. I am also not sure to whom we should send our letters. My oncologist will hopefully let me know if the advocates at the Dana Farber have any ideas.

Please post any suggestions or ideas you may have about this critical situation. Remember, we may be able to make an impact if many of us write.

Thanks for reading and thinking about this issue.

Kind regards,
Barbara Holz