[phil]

Schoonder, are you referring to Congress' HELP Committee ? which " oversees " This FDA ? We met w/ them in 2011, Sen. Harkins' aides saw Lorraine, listened , but made only a half -hearted attempt to talk w/ FDA . Each pol. party covers up for their own. But we will be back. They wont be at San Antonio anyway.
This FDA was mad at Big Pharma for not finishing trials they had promised to finish after getting acc. appr in the early 2000's. and felt some drugs ( avstin ) had too much risk . They could have kept avastin appr for metastatic tnbc, but they dont listen to pts in-put , so they revoked it completely. This FDA, w/ a rookie Prez., cracked down , revoking Avastin . Gen, fought back and appealed , along w/ the Avastin super -responders. FDA was pissed, completely affected thier scientific judgement, and they blocked t dm-1. Plus Dr. Pazdur wants longer testing to prove overall survival stats, overriding time to progression, which was gold standard before new FDA commish gave Dr. Pazdur free reign over trial approvals.
Paula , I have some public speaking exp. but always nervous. We think of what we've been thru, all those who never got a chance , and go for it. Politely ask ? at forums , who knows maybe a media person will hear you. Do it for our friends Jay, Jennifer, Tracys mom , who never got the chance to try it. Maybe T DM-1 Miracles will be there as " Living Proof " to add thier input , like Lorraine has . Many T DM-1 ers honestly dont know how lucky they are to have gotten it. and counter This FDAs saying Lorraine is an " outlier ', unusual. Shes unusual only because they rejected appr.
Docs wont say much, but they all thought it should have been appr. in 2010. If they speak against This FDA or Pharma, they get blacklisted from future trials. maybe a famous doc, like Dr. Susan Love, who isnt doing trials ?, might speak. Dont count on it.
We focus on This FDA for reform , others involved later. To Genentech, and Pharma in general, we have already said, " If you think your drug is good enough to be considered for Acc. Approval, its good enough to give out as compassionate use. " Theres not enough comp use , and the mechanism is way too unwieldy.
So go , mingle , tell anyone interested to talk w/ Lorraine. say to anyone, , why wasnt it appr in 2010 ? shouldnt there be an expose' , investigation to prevent such a slowdown from happening again ? get their e-mails and send them to us. We are always ready to talk ! God Bless , have a great time !!