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Archive for May, 2014

the end game…

No matter how often I’ve thought about the analogy between the board game of chess and the world of politics and business where the moves people behind the scenes make have an enormous impact on the lives of real people, it’s never hit home so poignantly as when it’s something that affects me personally. The […]

whew!…

I lay down for a nap this afternoon, but was jerked awake in a cold sweat by a nightmare. I dreamed I was captured in the PhRMA [Pharmaceutical Research and Manufacturers of America] web-site being forced to read an article entitled Mental Health Medicines in Development Report, 2014 that said: "Biopharmaceutical research companies are currently […]

its effectiveness…

The signature novel of the Civil War, The Red Badge of Courage, was written by a young man who wasn’t even born when it was fought and had never seen combat. It’s the story of a young recruit who was marching into his first battle obsessed that he would run – would be a coward. […]

a mockery…

At first, it seems an odd candidate as a symbol for problems with the current clinical trial culture. It’s a trial at an academic center rather than one run at some commercial clinical trial center. The Principle Investigator is the Chairman of Psychiatry at Columbia, the P.I. of the widely quoted NIMH C.A.T.I.E. trial, and […]

International Clinical Trials Day…"> International Clinical Trials Day…

Flash: see the press release from the Nordic Cochrane center et al: Backpedalling on EMA’s “proactive publication of clinical-data” draft policy… Well, today is International Clinical Trials Day once again – celebrated from all sides of the controversies.The AllTrials campaign has a new video about Data Transparency: … while Clinical Research Organizations have many things […]

feels that way…

Howard Brody has an interesting post based on his junk mail: Are KOLs drying up? Praise be Hooked by Howard Brody May 14, 2014 Back in 2011 I heard from Cutting Edge Information on the subject of key opinion leaders [KOLs]: http://brodyhooked.blogspot.com/2011/06/keeping-kols-fat-and-sassy-these.html I figured that once I outed them on this blog, they would know […]

the U-Turn…

It’s a bit hard understanding quickly why this complaint is a big deal. Originally, the EMA proposed to simply release the raw data from Clinical Trials to qualified requesting parties. AbbVie and InterMune sued and held things up for a time, but AbbVie dropped their suit and things seemed to be on track. Now this. […]

lucky…

How Being a Doctor Became the Most Miserable Profession The Daily Beast April 14, 2014 A former student of mine, a cardiologist, was seeing me on a consultation because of an abnormality in a test. The question was, "Did I need a cardiac catheterization?" I knew I didn’t. I expect the referring doctor knew I […]

why bother?…

So what’s a nice guy like me doing in a place like this? PhRMA.org? Google got me there when I was looking up something with Insel’s name in the search. But this is what greeted me: What needs to happen to ensure that ‘treatment’ is front and center in america’s ongoing conversation on mental illness […]

out of the loop…

I realize that nosing around the NIMH RAISE Project is a little different than many of the things I write about here. Usually, I’m rooting around looking for corruption peeking out from behind the spin. But here, I’m looking for something else. I want these early psychosis programs to work. A career of seeing what […]