EU agency lifts lid on drug data secrets Reuters By Ben Hirschler July 15, 2012 Europe’s medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.The change is a landmark in […]
Some of my friends tell me I’m an optimist, someone who is too naive about the possibility of dark undercurrents lurking in the background of human affairs. I don’t think that’s altogether right. A career as a psychoanalyst/psychotherapist doesn’t create wide-eyed optimists. But I can’t argue that point when it comes to the matter of […]
When I started writing about all this PHARMA/Clinical Trial stuff a year or so ago, I was essentially an illiterate, embarrassingly naive. I didn’t know what clinicaltrials.gov was, how drugs were approved by the FDA, what the Clinical Research Industry or Clinical Research Organizations [CROs] were. All I knew was that there was something […]
I really believe that the only way to insure that the debacle of the recent past with Clinical Trials like GSK’s Study 329 is to require public online posting of the raw data for any study published in any peer reviewed journal or submitted to the FDA. Mathematical and statistical analyses of the data is […]
Back in December, I tried to summarize the algorithmic treatment-by-computer obsession of Madhukar Travedi, a magnificent obsession…, cataloging the benign [IMPACT, an unfinished symphony], the expensive [STAR*D, another unfinished symphony], the negative [CO-MED], and the corrupt [TMAP]. 18 months ago, I had tried to schematize what he seemed to be trying to sell: The idea […]
I revived my interest in Study 329 when I stumbled across the fact that GSK had finally published their raw data earlier in August [a movement…]. I transcribed the Placebo and Paxil HAM-D data into a spreadsheet and ran the statistics on the observed values using Excel [the lesson of Study 329: the basics…]: Dr. […]
In the course of time, there are sometimes moments of clarity that change things forever. An alcoholic decides to finally wander into an AA meeting. A patient who’s had years of therapy realizes something that makes it all worth it. A Rosa Parks has had a long day and just says "no" when asked to […]
Flash forward: Breakthroughs in the Treatment of Child and Adolescent Depression & Anxiety Children grow out of shoes and clothes, but the odds say it is unlikely they will outgrow depression. A depressed child is twice as likely to be a depressed adult, according to Dr. Karen Wagner, a leading child psychiatrist. Dr. Wagner spoke […]