This is how Trudo Lemmons ended his commentary on the recent EMA U Turn on Data Transparency [see a crushing setback…, repeal the proprietary data act…]: EMA’s Proposed Data Release Policy Promoting Transparency or Expanding Pharma Control over Data? PLoS Blogs By Trudo Lemmens May 30, 2014 [full text on-line] In short, EMA’s approach is […]
I got to wondering recently, how Clinical Trial Data got to be proprietary in the first place, the personal private property of the sponsor of the study, their intellectual property. In 1962, the Kefauver·Harris Amendment added proof of efficacy ["in the form of ‘adequate and well-controlled investigations’"] to the FDA’s mandate for drug approval [see […]
Well, I didn’t know it when I wrote in the details… and achilles’ heel…, but I wanted to end with a conclusion before talking about the current controversies. It might be presumptuous of me to sound off about such things being just a retired doctor, but the Clinical Trials world has gotten itself in such […]
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 […]