Re: BCA fighting to keep tdm1 off market
Hmm. The point is, that if it becomes too easy, the big Pharma companies can just fast-track meds that are no better than the old meds at high prices.
If they really wanted to prove that TDM-1 works, they should have complied with the rules and should have organised a large double blind phase 3 trial. Lots of people who desperately needed the med would have had access to it. Ofcourse, that would mean that some would have gotten a placebo, and when you think you found the magic bullet, that's a hard thing to do. But we have thought we had the magic bullet before, and sometimes we were wrong. There have to be some safeguards in the system.
So I think if they want to market the new combo, they will have to invest in giving it to a lot of people, even as compassionate use. That way there will be enough data.
But who am I? U dont even live in the US.
Love
Jacqueline
(wishing everybody would get the right drug to keep them dancing with NED)
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Diagnosed age 44, January 2004, 0.7 cm IDC & DCIS. Stage 1, grade 3, ER/PR pos. HER2 pos. clear margins, no nodes. SNB. 35 rads. On Zoladex and Armidex since Dec. 2004. Stopped Zoladex/Arimidex sept 2009 Still taking mistletoe shots (CAM therapy) Doing fine.
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