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Archive for November, 2014

a paradigm….

( OPINION )

I just wrote three posts reviewing the case of Dan Markingson, but I’m not going to even post them. We all know that case only too well. Over Thanksgiving, Carl Elliot posted a news video of a new whistleblower [INVESTIGATORS: Nurse questions integrity of U of M drug researchers], nurse Nikki Gjere who was a […]

along the way…

( OPINION )

Thanksgiving special — menus needed at the EMA’s restaurant British Medical Journal by Tom Jeffeson and Peter Doshi 27 Nov 2014 [full text online] … On 24 November 2014, the European Medicines Agency [EMA] released a new “Guide on access to unpublished documents.” The guide follows in the steps of several other policy documents, charting […]

happy thanksgiving…

( OPINION )

ombudding…

( OPINION )

European ombudsman questions European Medicines Agency over AbbVie redactions by Rory Watson British Medical Journal. 2014 349:g6904. The European ombudsman, Emily O’Reilly, has written to the European Medicines Agency asking it to explain by 31 January 2015 the redactions it made in the clinical trial data provided by AbbVie for its best selling drug adalimumab […]

just a thought…

( OPINION )

While it’s not my usual fare, I saw something on Twitter that reminded me of a thought from long ago and I chased it down. When I was an Internist, it was the early days of treatment guidelines. They were beginning to show up frequently. They began to move into areas of preventive medicine – […]

you couldn’t make this stuff up…

( OPINION )

So remember Guido Rasi, head of the European Medicines Agency, the guy who has been the architect of their policy on Data Transparency? [see European Medicines Agency: a timeline…, game on…]: EMA’s Top Drug Regulator, Guido Rasi, Forced to Step Down Regulatory Affairs Professional Society By Alexander Gaffney, RAC 14 November 2014 In a major […]

promises, promises…

( OPINION )

I didn’t know it when I started blogging, but this blog isn’t about psychiatry, it’s about honesty in medical science. And right now, for me that reduces down to what has come to be called Data Transparency. The reason for my sabbatical these last several weeks has to do with a project working with the […]

speaking of about time!…

( OPINION )

I know I said that I was taking something of a sabbatical to finish up a project, but I broke that to post the Newsweek article last week [see about time…]. And I’m doing it again because this just came my way – and it’s huge!: NIH, FDA Toughen Rules on Reporting Medical Trials The […]

about time…

( OPINION )

what it’s for…

( OPINION )

Back in the 1980s when psychiatry [and psychoanalysis, and medicine, and American culture] was undergoing big changes, the trajectory of my life changed and I found a place out of the flow that I really liked. It was more than a refuge or a sanctuary, it was just as interesting as I could’ve imagined. I’ve […]