Biosect,
I completely agree with you on politics, it's time for the people to remind the politicians that they're supposed to work for us, not their party. Both sides have become almost totally loyal to their parties, rather than their country. The Senate, which was supposed to be the worlds best deliberative body doesn't deliberate at all any more. If one side opposes a measure it simply won't be discussed at all.
I have friends who were practicing medicine before abortion was legalized, they know how many women lost their lives to botched abortions. After all this time we cannot frame legislation that's a minimum that can be applied to all. There are so many issues we can't arrive at fixes for, so we just keep applying new band-aids, but won't permanently solve the problem.
I frankly have no idea if the FDA, German's, or anyone else actually received the unblinded data during the halt. If they did, I don't know if the DSMB brought it up with them based on what they were seeing, or the regulators themselves demanded it. I believe that if they did see it they couldn't help but see the benefits, but sadly that's not enough. I believe when you have a close call, refining the numbers to determine whether goals were met is needed. In our case, it should have been clear that at 3 years, 4, or 5 the numbers alive were not just a percentage above what would be expected, they were a multiple. Such an improvement ought not to require a trial to run to it's full duration and then be backed up with paperwork that takes a year or more to assemble. The DSMB ought to be empowered to recognize that so many people are alive and call the trial a success without having to debate with the various regulators. I know that's not how it is, I just believe that it's how it should be.
Personally I believe that there is a great deal of truth in the expression, "I'm not a member of an organized political party, I'm a Democrat." We shoot ourselves in the foot all the time.
Gary
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