HER2 Support Group Forums - View Single Post - Access to T DM-1

phil · 10-24-2011, 11:56 AM

For trials they accept platelets of 100, 000 or above. Normal platelts run btween 150,000 to 400,000. The new " study " Gen. is talking about is an extension, for pts who have done well on the drug, and finished trials, access. So, they allow for a low of 75,000. Lorraine has gone as high as 71,000 this month. She is , as far as we know, the only candidate for this " new study " in Boston. Its a Catch 22, initiated by Gen. and running into a breuacratic repsonse so far from Partners / MGH IRB as well.
Al this highlights the difficulties thta Stage IV pts suffer in the current access/ trial system. I agree w/ Mr. Walker above . This particular T DM-1 issue started w/ Dr. Pazdurs team. I dont feel its personal when you call it as you see it. He and his team want to change the rules of Accelerated Approval. They didnt like what they saw w/ Avastin, and T DM-1 got caught up in that .
I think T DM-1 will be their stumbling block, its only out -performing very apporved drug out there. > And every researcher in the country was shocked when this FDA denied T DM-1. Its Phase II stats of 38% " complete or significant reduction " in Stage IV tumors speaks for itself. You dont havr to be " rocket scientist " to see the meaning of those no's. Those bloggers who defend this FDA about this drug are as " sincerely deluded " as Dr. Pazdur himself. Is that personal ? I dont think so, he sincerely believes that this Acc. Approval Program needs changing. He feels he is keeping Americans safe. Probably is , but not in this case. And he forgets tht we live in a Democracy, where he should not have this type of un-checked power.
Its not personal, when you deal w/ large Govt. agencies, or Global Corporations , its Very Impersonal. They all should spend more time in the chemo rooms, that might help change the System to be more " Stage IV Survivor Freindly " . Right now its causing un-necessary suffering and death. And its not just the FDA. Doctors are silent, Big Advocacy is silent, Big Media is silent Capitol Hill is silent. So we speak up !

10-24-2011, 11:56 AM	#49
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: Access to T DM-1 For trials they accept platelets of 100, 000 or above. Normal platelts run btween 150,000 to 400,000. The new " study " Gen. is talking about is an extension, for pts who have done well on the drug, and finished trials, access. So, they allow for a low of 75,000. Lorraine has gone as high as 71,000 this month. She is , as far as we know, the only candidate for this " new study " in Boston. Its a Catch 22, initiated by Gen. and running into a breuacratic repsonse so far from Partners / MGH IRB as well. Al this highlights the difficulties thta Stage IV pts suffer in the current access/ trial system. I agree w/ Mr. Walker above . This particular T DM-1 issue started w/ Dr. Pazdurs team. I dont feel its personal when you call it as you see it. He and his team want to change the rules of Accelerated Approval. They didnt like what they saw w/ Avastin, and T DM-1 got caught up in that . I think T DM-1 will be their stumbling block, its only out -performing very apporved drug out there. > And every researcher in the country was shocked when this FDA denied T DM-1. Its Phase II stats of 38% " complete or significant reduction " in Stage IV tumors speaks for itself. You dont havr to be " rocket scientist " to see the meaning of those no's. Those bloggers who defend this FDA about this drug are as " sincerely deluded " as Dr. Pazdur himself. Is that personal ? I dont think so, he sincerely believes that this Acc. Approval Program needs changing. He feels he is keeping Americans safe. Probably is , but not in this case. And he forgets tht we live in a Democracy, where he should not have this type of un-checked power. Its not personal, when you deal w/ large Govt. agencies, or Global Corporations , its Very Impersonal. They all should spend more time in the chemo rooms, that might help change the System to be more " Stage IV Survivor Freindly " . Right now its causing un-necessary suffering and death. And its not just the FDA. Doctors are silent, Big Advocacy is silent, Big Media is silent Capitol Hill is silent. So we speak up !