HER2 Support Group Forums - View Single Post - TDM1 EAP -Good news for those in TDM1 EAP who need to travel

phil · 08-06-2011, 05:51 PM

Went to DC last wk. Got dose # 9. Latest Ct, counts look great. Still hearing that we will be able to transfer tx. to Boston in about a month. Access will close Sept. 6th. Have heard of at least more women from NYC who have enrolled out of state, Va. Mich. Because the access is closing.
After Sept. 6th, there will only be trials, w/ extra requirements, 30 day wash-out vs. only 2 weeks for access. Closing of access is due to this FDA 's obstinate refusal to see whats right in front of their eyes. No respect for Stage IV Survivors, no compassion. They have decided to make you guinea pigs for thier new , more rigid regs. " Overall Survival " stas. harder to prove, and definitely morally wrong w/ this drug. Until this FDA's ruling on T DM-1 is investigated, overturned. Only way is to bring it to the Publics attention, again, and again. All of you on taxanes, tyk/xel., this FDA is extending your suffering . Denying you a low s/e , even better drug. Call your Congr. Reps. have they called the FDa ? Their own HELP Committee ? Asked Dr. Sebelius in HHS to investigate ?
If you are metastatic Her2 , this drug has to be checked out. If you are suffering w/ s/e of tyk./xel. , and have already progressed on taxanes. You may qualify based on intolerance of tyk./xel. You need an assertive doc, to help you argue your case. All docs tend to be conservative, its in their training. Even the nice ones, you need to give them a push. And they are all busy, what? 18 pts a day ?

08-06-2011, 05:51 PM	#7
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel Went to DC last wk. Got dose # 9. Latest Ct, counts look great. Still hearing that we will be able to transfer tx. to Boston in about a month. Access will close Sept. 6th. Have heard of at least more women from NYC who have enrolled out of state, Va. Mich. Because the access is closing. After Sept. 6th, there will only be trials, w/ extra requirements, 30 day wash-out vs. only 2 weeks for access. Closing of access is due to this FDA 's obstinate refusal to see whats right in front of their eyes. No respect for Stage IV Survivors, no compassion. They have decided to make you guinea pigs for thier new , more rigid regs. " Overall Survival " stas. harder to prove, and definitely morally wrong w/ this drug. Until this FDA's ruling on T DM-1 is investigated, overturned. Only way is to bring it to the Publics attention, again, and again. All of you on taxanes, tyk/xel., this FDA is extending your suffering . Denying you a low s/e , even better drug. Call your Congr. Reps. have they called the FDa ? Their own HELP Committee ? Asked Dr. Sebelius in HHS to investigate ? If you are metastatic Her2 , this drug has to be checked out. If you are suffering w/ s/e of tyk./xel. , and have already progressed on taxanes. You may qualify based on intolerance of tyk./xel. You need an assertive doc, to help you argue your case. All docs tend to be conservative, its in their training. Even the nice ones, you need to give them a push. And they are all busy, what? 18 pts a day ?