Good point, Schoonder - I'll bet Ms. Desmond-Hellman would have some interesting perspectives. Someday maybe I'll get the opportunity to talk to her, but it's not at the top of my list as I feel I've gotten a good amount of input already.
Personally, my homework assignment for myself this weekend is this:
1. Haul out the reams of data I've collected (much of which was posted on the other thread).
2. Heed the advice I've received about the best possible way for ME to impact this which is to write, and encourage others to write to the FDA and congresspeople and make my voice heard.
The FDA is first for me; Gene/Roche is in ongoing talks with the FDA to get clear direction on what it will take to get TDM1 approved. So now is a good time for them to hear from ME.
3. MY main points will include my Her2/TDM1 resume, the significance of using Her2 directed therapies vs. "all available options", the need for Her2 target options, urgency of the unmet need as it relates to Stage IV folks, and the need for the regulatory/approval process be in synch with the direction and velocity of the science. The purpose of the FDA is to protect patients from harmful or ineffective treatment. The impact of the current FDA approach is achieving the opposite - preventing access to effective and low toxicity medicine. Somehow all in one letter.
I'm continuing, and will continue to collect data, find alliances and look for ways to help organize and support people. But I do believe I, and we, have a considerable number of cogent arguments and a unique perspective as Her2+ patients.
I know, from participating in the other thread,
http://her2support.org/vbulletin/sho...ay+tdm1&page=2that there are a good number of you who are well armed and articulate enough to do the same. In fact, I'm plagiarizing from some of you!
So my homework is to get off my butt and write the letters. It's a start. I'll show you mine when it's done...and I'd like to see yours too!
FDA Contacts and how to contact congress below:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Commissioner Margaret Hamburg, M.D.
301-847-3531 (fax)
margaret.hamburg@fda.hhs.gov
Deputy Commissioner Joshua Sharfstein
301-796-5040 begin_of_the_skype_highlighting 301-796-5040 end_of_the_skype_highlighting
joshua.sharfstein@fda.hhs.gov
Director Dr. Janet Woodcock
Center for Drug Evaluation and Research
Building WO51
Room 6133
Mail stop HFD-001
301-847-8752 (fax)
janet.woodcock@fda.hhs.gov
Director Richard Pazdur, M.D.
Office of Oncology Drug Products
Building WO22
Room 2212
301-796-9909 (fax)
richard.pazdur@fda.hhs.gov
Contacting congress:
http://www.contactingthecongress.org/