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Subject:  Re: What is to be gained........? Date:  4/26/2007  3:03 PM
Author:  TMFBreakerTinker Number:  30768 of 95189

Wait a minute here, should Provenge be approved?

The median survival from taxotere is 2-3 months with so many side effects and detriment to quality of life that the majority of men choose not to take it. THIS IS THE APPROVED GOLD STANDARD OF TREATMENT.

Provenge shows substantial evidence of efficacy. If the evidence holds up here is what you have (1) 4.5 months median survival advantage, and 34% of patients living more than 3 years vs. 11% on placebo with a log ranked p valued of .0001 or was it .001.

Yes the study was 128 patients, but each and every angle was checked to determine the veracity of these results. The only thing against the results, which measured 100% of the population, not a subset, was that it was the secondary endpoint. There exists some selection bias in the data I suppose, but for crying out loud, are you dead or are you alive? The rest of the selection was ignored.

Oh yes, and no material side effects. Between Provenge and Taxotere, which drug do you choose.

But wait, wait, when Provenge is used prior to Taxotere the survival benefit of 2-3 months is now extended 14+ plus months so as to make the hardships of taxotere possibly worthwhile.

Nah, it is not a cure. Just an improvement in treatment, and an improvement in quality of life. Therefore not worthy of moving forward. Not something we as a nation should make available for our male population to choose to use when there is nothing else available.

Sorry, the logic does not fly. Neither does it fly on a humanitarian basis. There is clear and substantial evidence of efficacy. There is a desperate unmet need. And it is clearly an improvement. No, we cannot say with certain how well it works, but it is very probable it does work. And even if its efficacy is 1/2 that of 9901, that is the same efficacy of taxotere, only without the side effect. ERGO, an improvement in treatment and quality of life.

Sorry, again. You were saying we should just keep the status quo? And btw/ set back research and R&D in this area of cancer research. The only area of cancer research presently showing any promise of improving cancer treatment as chemotherapy has pretty much reached its apex.

I'm just not there, sorry again.

missash, I understant the data issues. We can debate those forever, but it is without doubt they do not meet the standards of traditional cancer drug approval. But outside of that, I cannot understand why a drug that is better than what exists should not be approved.

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