No. of Recommendations: 9
The improvement in quality of life is in comparison to using taxotere or in comparison to using nothing at all.

As to the amount of improvement in quality of life that has still to be fully explored. As admittedly the trial data is minimal from what we would like to have.

But for those 34% of patients vs. 11% placebo, p value no greater than .001, and could be .0001, those patients have not been living in pain, in hospices, under massive doses of opiate pain killers. They have been out living their lives.

Within that survival number is implicit and drastic improvement in quality of life vs. what taxotere alone offers and what doing nothing alone offers.

What remains to be seen is how well it works, for whom it works, and how it works best. As with any medication, not all patients will take to it, but the data indicates that those who do take to it some amazing things have resulted.

Will it be all we can hope it will be? I don't know. I am on the record as stating we can't really know if 9901 was a false positive or not, other than when you look at the data in depth, there are a lot of supporting evidence that indicates it is not just a false positive. Even when looking at 9902A you can see it through the data. It just does not appear to be a typical false positive.

But the real decision is whether or not the United States is better or worse off by offering this option to this indication of patients, at this time and the answer as I mathematically laid if out a few weeks ago comes down to the following:

.95 xcost of withholding for 3 years if drug indeed works as substantia evidence indicates <> .05 x cost of drug not working despite substantial evidence that it does but okaying now.

Or something like that, I'll hae to go back and check the equation. But it was utterly and overwhelming in favor of present approval.

Whether it turns out to be like penicillin or not in the end, this much I do know. It is highly probable that it is better than the existing gold standard in this indication for most patients.

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