Anna Freud’s 1934 book "The Ego and the Mechanisms of Defense" listed a variety of mechanisms the mind uses to deal with the pain of emotions, but she left out one – scientific understanding. I’ve spent months reviewing the story of Seroquel by looking at the science, but what runs the motor is a felt […]
It just seems like every time I have a question about this drug business, I have to go learn something else that I know absolutely nothing about. In this case, I naively begin to thing about patents in my last post, but then I found out that all this talk about patents isn’t the crux […]
Clozipine was approved in Europe in 1971 as the first Atypical Antipsychotic, but withdrawn after 4 years because of bone marrow toxicity in 5% of patients. It was approved under careful monitoring for use in refractory cases in this country in 1989. The parade of Atypical Antipsychotics derived from Clozapine began in 1993 and continued […]
Back at the end of November, Paul Thacker, now at POGO, wrote a letter to Dr. Francis Collins, Director of the NIH, about ghostwriting. His examples included a textbook by Drs. Charlie Nemeroff and Alan Schatzberg. Nemeroff I knew about from my years at Emory, but I didn’t know much about Schatzberg. I ended up […]
Looking over the ACRO [Association of Clinical Research Organizations] web-site, it seems to be standard industry-specific trade organization fare. Their central thrust is Globalization. In fact the policy page seems organized around the topic: ACRO’s global advocacy program is focused around a set of core principles: • Secure a consistent, stable regulatory environment to support […]
Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy “I had to train myself not to get too interested in their problems, and not to get sidetracked trying to be a semi-therapist.” The New York Times By GARDINER HARRIS March 5, 2011 Alone with his psychiatrist, the patient confided that his newborn had serious […]
The CROs [Clinical Research Organization AKA Contract Research Organization] aren’t visible. They’re a mixture of Consultant/Contract Units so they don’t show unless you know how to look for them. For example, Parexel has been all over these posts I’ve been writing about Seroquel, but I didn’t know it when I was writing them [because I […]
I was chasing some leads trying to figure out when Zeneca went from running their own clinical trials to using Parexel, the CRO, and I ran across this editorial. I thought I’d take a look. If I had false teeth, they would’ve fallen out when I read the second sentence [It reminded me of a […]
The Internet is a really big place. Just searching with Google™ or one of its cousins doesn’t always get the job done, so one learns to find people who are ahead of the game. I want to look at how these Cinical Research Center Clinical Trials work, so I started looking at the blogs and […]
There must be two sides to every story, And whose to say whose right and who is wrong… Willie Nelson – Honeysuckle Rose In prehistory, Pharmaceutical Clinical Trials were arranged by the Drug Companies directly – often by contract with academic institutions that weren’t in the running for the more competitive N.I.M.H. research funding. In […]