Crown prince of Austria Rudolf’s 1889 murder·suicide over an affair of the heart destablized the Hapsburg line of sucession and was a major factor in the events that lead to WWI and their ultimate downfall. His mother built a monument to her son’s vulnerability, a summer palace on the Isle of Corfu she called Achilleion. […]
With all of this talk of Data Transparency in Clinical Trials, people in-the-know tend to talk in shorthand jargon, and it’s easy to get lost. And since what they’re talking about actually matters, this is a mini tutorial on what the acronyms mean: The Protocol is the nuclear document in a Clinical Trial, an a […]
He’s baaaack! [you can’t keep a good blog down] Europe Does a U-Turn on Trial Data Policy, Says Ombudsman WSJ: Pharmalot by Ed Silverman June 4, 2014 Late last month, the European Medicines Agency circulated a long-awaited draft policy on disclosure of clinical trial data by drug makers. Transparency has been a contentious topic following […]
In Dr. Poses post about recent settlements, I ran across a blurb that I thought deserved special attention [one was a $650 M settlement – hardly trivial]. It’s actually about something I’ve been thinking about in relation to the recent European Medicines Agency U Turn on Data Transparency [the U-Turn…, the end game…, a decision to […]
As a child, I frequently visited my grandparents in a small Georgia town. They lived in an old Victorian house that was filled with wonderful cousins and "show people" – friends from their earlier days as wandering Vaudevillians who passed through town. It was a magical place etched forever in my mind. One of my […]
The Paradox of Parity Director’s Blog – NIMH By Thomas Insel May 30, 2014 … The paradox of parity is that even with the new laws, in the absence of such a framework, some treatments might not be covered even to the extent that they were covered in the past. To address this concern, NIMH […]
The Latin phrase deus ex machina [from deus, meaning "a god", ex, meaning "from", and machina, meaning "a device, a scaffolding, an artifice"] was referred to by Horace in his Ars Poetica, where he instructs poets that they should never resort to a "god from the machine" to resolve their plots "unless a difficulty worthy […]
When I first heard of the U-Turn in the EMA’s data transparency policy [the U-Turn…, the end game…, to be continued…, a decision to reconsider…], I naively thought that it was perhaps a misunderstanding, that they though this view-on-screen-only business was a convenient way to display data and didn’t represent a massive change in policy. […]
There can be little question that Dr. Brooks’ Program [not yet done…] was innovative and successful, considering the cohort he set out to treat [described even after being medicated]: The patients, as a group, were very slow, concentrated poorly, seemed confused and frequently had some impairment or distortion of recent or remote memory. They were […]
One of the nicest things about being retired is that I can think about what I want to think about. And it’s obvious that my response to the Individual Resiliency Training [IRT] component of the RAISE project has hit one of those things that I’ve wanted to muse about for a long time. I realize […]