Neuro - To continue our Yahoo conversation in this more convenient forum, I humbly disagree:
The Stroop was one of six tests given
Not according to their pre-results charts which listed 4 computerized tests (which the recent press release says the Stroop is not part of) and 4 different pieces of MMSE (another 4 parts - again we know Stroop is not part of MMSE). So they analyzed more than six tests.
if I had to choose one domain where a trend would have been expected (given post-CABG pt complaints of slowed decision making and information processing), this is it
My gut says the same, but my brain has been burned too many times by retrospective data fitting orchestrated by my (or others) gut instincts. Past CABG trials have found very varied areas of decline - e.g. memory, attention, ... .
Had they come out with some third-order 'finding' like (I'm making this up):
'male CABG patients over 62 but under 64 showed improvement on the Stroop at six weeks, significant at .049', where there are a host of covariates thrown in, your criticism would be justified. But they didnt. If it's data mining, they did not have to dig deep to find something of value.
We know they ran at least 10 different tests (the 8 listed pre-results, an extra computer test and Stroop) at least twice each. And they used MANOVA to combine/separate data items. The combinations are large. I'll suggest again that the chance of them not 'finding' something would be stellar - I personally would have been swayed by an overall MANOVA or an improvement in a composite where they used the one area of most decline as a marker.
So far as I am aware, no previous CABG trial did pre-post comparisons using the Stroop
A quick search of Medline confirms this, but this should not, IMO, be comforting. After a confirmatory Ph IIb, then I might consider it very strong data, but given its largely retrospective nature (i.e. not mentioned, much less highlighted prospectively and not an 'industry standard') coming out of this trial, ... .
in fact I am not aware of any drug producing a positive neuroprotectant effect in CABG
Ok, but there are lots of CABG trials that are erratic in their results at best. This is a very very hard thing to measure (based on the erratic results of previous trials) and thus this trial had to accomplish two things - come up with a measurement technique and determine if their was drug efficacy at the same time. Very hard - thanks Heizenberg!
Certainly it is not ready for PhIII, but Phase IIb is a viable option.
On this we agree absolutely. In fact I would say more strongly that short of disaster a Ph IIb was always in the cards.
In closing I'll repeat what I said on the Yahoo boards:
if, two years from now I have CABG and Dex is on the market for TBI I will be having a long long conversation with my surgeon to ensure I get Dex off label. The evidence for ministrokes is very very strong. I personally like my brain the way it is.
BTW - Need to do some more research into MANOVA.
BTW2 - It is possible that I missed some reference to Stroop in the earlier releases and that would change my mind somewhat, but clearly they were not considering it the pre-eminent test.
Thanks for the feedback. Debate is useful (and interesting).
Clark |
