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Archive for September, 2015

keller responds…

( OPINION )

This is  cross posted from Dr. David Healy’s web site with his permission… The Letter below from Marty Keller and colleagues was sent to many media outlets, to retraction watch, and to professional organizations on Wednesday.  Paul Basken from the Chronicle for Higher Education asked me for a response which I sent about an hour […]

an innovative design…

( OPINION )

It has been quite a week, so I haven’t had much else on my mind outside of our own publication [Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence], but I ran across this paper and thought it was pretty interesting – focused on a topic that’s […]

study 329 x – “it wasn’t sin – it was spin”…

( OPINION )

[Note: the Press coverage of our article is on study329.org, but I wanted to mention the article on Retraction Watch because it has Dr. Martin Keller’s response to our paper with an argument similar to the one below…] We know from this internal memo and position piece that the initial SKB interpretation of the efficacy […]

study 329 ix – mystic statistics…

( OPINION )

Most of us have an incomplete knowledge of Statistical Analysis unless we’ve had formal training and hands-on experience, yet we tend to accept the output from the computer’s statistical packages as if it’s dogma. In academic and commercial laboratories, we count on Statisticians [or trained SAS Programmers] to generate those abstract lettered indices that we […]

study 329 viii – variable variables decoded…

( OPINION )

WARNING AGAIN: Sometimes the devil really is in the details. Here too, we need to get pretty far into the details… The 528 page Full study report acute is an exhaustive narrative of the entire study including the results in much more detail than the published article – filled with charts and tables. It was […]

study 329 vii – variable variables?…

( OPINION )

WARNING: Sometimes the devil is in the details. Here, we need to get pretty far into the details… RATING SCALES HAM-D     Hamilton Depression Rating Scale K-SADS-L Kiddie Schedule for Affective Disorders – Lifetime CGI Clinical Global Impressions Scale AFC Autonomous Function Checklist SPP Self-Perception Profile SIP Sickness Impact Profile It is essential in Clinical […]

study 329 vi – revisited…

( OPINION )

Well, our RIAT article, Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, is finally published online at the British Medical Journal. It’s fairly straightforward. The emphasis is on the harms analysis for obvious reasons – an accurate representation of a drug’s safety is always the first […]

emil kraepelin – born again [again]…

( OPINION )

I’ve always been almost as interested in the history of the scientists as the science they pursued. And one of the pleasures of psychiatry for me was that this was an important perspective, specialty-wide. That was even more true in psychoanalysis where history is really central. So the life and times of Karl Jaspers, Emil […]

ambivalence…

( OPINION )

NIH Director’s Statement Regarding Dr. Thomas Insel’s Departure Dear Colleagues, After serving 13 years as Director for the National Institute of Mental Health [NIMH], Thomas R. Insel, M.D., will step down effective November 1, 2015… While we conduct a national search for a new NIMH Director, Bruce Cuthbert, Ph.D., will serve as Acting Director… Francis […]

time for some pushback?…

( OPINION )

The release of regulatory documents under EMA policy 0070: Now you see them, now you don’t British Medical Journal by Khaled El Emam, Tom Jefferson, and Peter Doshi 15 Sep, 2015 The European Medicines Agency (EMA) has issued its long anticipated new policy (policy 0070) on prospective access to clinical trial data, and is now […]