Monday, November 14, 2011

I was part of a meeting with a handful of noted cardiologist researchers discussing the development of a clinical trial using a medical technology to reduce pain from and incidence of angina.  We have already run a pilot trial that should very good outcomes for treated patients.  The strongest opinions of the group were that the endpoints of the study should be on angina frequency and exercise capacity, as that is the only thing FDA accepts as valid outcomes.  Lots of discussion about how debilitating the condition can be and how there are not good alternatives for folks failing medical management (love that, 'patients failing.'  In my world, medicine is failing the patients, not the inverse - yes, inverse).  Within our technology company, we have always been enamored of imaging, so originally divined to get some kind of imaging for the trials, but that was deemed both unnecessary and potentially pointless, as the images are highly variable, even among symptomatic patients.  A late-arriving cardiologist/researcher, quite young, gave an animated, even slightly angry, defense of images.  Of course, she is an imaging specialist, so did have a dog in the fight, so to speak.  Her argument met the harshest of academic fates, it was simply ignored and the meeting adjourned shortly thereafter.  While we got organized for dinner, she spoke to me under her breath, while looking sharply at the others, "There has to be an objective measure of change, you can't just rely on patient reports, they are just subjective."  I did not push her on this, as I might otherwise (like invoke Roshaman), simply because I wasn't sure she wouldn't get really upset, even as we went to dinner.  I thought about the two 'camps' in this clinical debate.  The older, seasoned clinician researchers were happy to rely on patient reports, because, after all, that is what constitutes the disease itself, is the patient complaint.  The
young researcher seeking objectivity as some kind of 'truth,'
can do so as long as she doesn't examine things too closely.
She might end up making the argument that patients should
be treated on the basis of 'objective' data, independent of
complaints.  That is the basis of lots of therapies, and lots
of unnecessary treatment and side-effects.  But more
interesting is this notion of 'objectivity,' in that even in
mathematics we find, at the core, a subjectivity that cannot
be resolved.  For example, the law of trichotomy lets me
state that any number is odd or even or zero.  Seems pretty
straight-forward.  So is Pi even or odd, as it is clearly not zero? Guess we have to take it on faith that it is one or the other. 

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