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Archive for October, 2016

a requiem for a lost tradition…

( OPINION )

` Tradition is forgetfulness of origins… Edmund Husserl It must be kind of fun to be a philosopher, thinking about the nuts and bolts of something like "Tradition." I’m not constructed for that kind of fun – only an observer from afar. But fortunately for me, there’s always another philosopher that comes along to explain […]

accountability IV…

( OPINION )

"He who controls the narrative, controls the debate." It was after retiring when I first became aware of how unreliable the information I had about the psychiatric medications I was being asked to prescibe as a volunteer physician had become. So I went to the medical resources traditionally available to me. I bought the latest […]

accountability III…

( OPINION )

"He who controls the narrative, controls the debate." So why insist that the FDA certify the a priori declarations and analysis plan entered into ClinicalTrials.gov prior to beginning the study? That one is easy. The FDA is the only agency that can. Usually, the a priori Protocol and Statistical Analysis Plan have been filed with […]

accountability II…

( OPINION )

"He who controls the narrative, controls the debate." I’ve always had something of a love affair with the medical literature. I think I was awed that so many physicians contributed, and felt proud to be in a profession where there was such a rich community dialog among us. And for whatever reason, I was drawn […]

accountability I…

( OPINION )

"He who controls the narrative, controls the debate." In this particular American political season, one would have to be close to stage four Coma to doubt the veracity of those words. But we have plenty of examples in American medicine that make the same statement. One version that still amazes me is the notion that […]

bru  bach  beck, 1956…

( OPINION )

starting the ball…

( OPINION )

There’s Such a Thing as Too Much Neuroscience New York Times By JOHN C. MARKOWITZ OCT. 14, 2016 The United States government recently announced its new director of the National Institute of Mental Health, Dr. Joshua Gordon. If you think that’s just bureaucracy as usual, think again. Mental health research, under the leadership of the […]

congressional action time, redux…

( OPINION )

IF … at the time of Registration [before the study started], the ClinicalTrials.gov database defined the a priori Primary and Secondary Outcome Parameters and the methods by which they were to be analyzed. AND IF … at the end of rhe study [after the blind was broken], the ClinicalTrials.gov results database were populated with the […]

richard twardzic 1954…

( OPINION )

congressional action time…

( OPINION )

This article [Schwartz et al] compares the results found in the ClinicalTrials.gov Results Database with those in Drugs@FDA for 100 drugs up for approval between January 2013 and June 2014. It makes little sense to look at it outside the context of a whole series of articles focusing on ClinicalTrials.gov going back in time. At […]