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Old 02-27-2013, 06:20 AM   #44
phil
Senior Member
 
Join Date: Nov 2010
Posts: 393
Re: T DM-1 Approved !!

we can agree to disagree. i saw this article before, not impressed. he has not worked with t dm-1. researchers who have , and the t dm-1 responders , are your best source of info. writer reminds me of Dr. pazdur and his FDA t dm-1 analysis team , tunnel vision on piles of stats , and they were biased against drug , wanting to punish pharma. authors statement at end about " possibly " prescribing t dm-1 is ridiculous , if i were one of his her2 + metatstatic pts i'd find another doctor immediately. at least he sees pts . FDA bureaucrats are too far from chemo rooms .
I do not see myself as a luddite, wanting to dismantle trial structure, actually i think it just needs re-structuring to reflect 21st century advances in tx. more flexibility .
i am not impressed with curent NBCC leadership who are too close to fda , trying to make " points " , distinguish themselves from other advocacy grps. they talk about stopping transplants yrs ago , as justifying thier current pro fda , pro prolonging testing. those transplant pioneers had no options, showed us it was not right path , now move on.
I want special tx for this special drug. like herc back in 90's, given to all stage iv her2 + now. The TDM-1 trial pioneers had progressed on many, many nasty combos , ALL HAD PROGRESSED ON TAXANES, Lorraine twice , on 2 different ones. so, instead of this biased article, tell me why we need to compare taxanes to t dm-1 in a trial that takes another 3 yrs ? or pert ?
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