Antidepressants’ Black-Box Warning – 10 Years Later by Richard A. Friedman, M.D. New England Journal of Medicine 2014 371:1666-1668. [full text on-line] The core of this seemingly endless debate about the Black Box Warning revolves around a more fundamental question about the source of medical knowledge – observations made on the collective? or on individual […]
In case it’s not apparent in these last two posts [sleep on it…, we’re all out of drugs…], I’ve had a change of heart. I’ll admit that my earlier interpretation of PHARMA pulling out of CNS Drug Development was that they were taking so many hits in the courtroom that they decided to throw in […]
I’m sure we’re not out of drugs forever, but we’ve sure picked the low fruit, and then worked our way pretty far up the tree. A bit of mold on a petri dish kills staphylococcus; a new TB drug perks the depressed guys on the Chest Ward; a tweaked antihistamine that shuts down psychotic symptoms […]
Disclaimer: In early high school, my teacher returned a theme paper with a big red mark followed by red question marks. I had spelled the word business wrong. I’d put busyness. She thought I’d had a slip of the pen, but she was wrong. That’s how I thought it was spelled. One thing – it’s […]
One way to be boring is to become too detailed on a topic, and I’m there right now. The topic is obviously the European Medicines Agency Data Transparency policy released in early October. I did a timeline [European Medicines Agency: a timeline…], but it keeps on going and growing. Here are a couple of pieces […]
FLASH – I just found this! Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned in-PharmaTechnologist By Gareth MacDonald 22-Oct-2014 DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned. Juncker u-turn puts […]
Our news is filled with the shooting in the Canadian Parliament on Wednesday, overshadowing something pretty important that happened there on Thursday. Bill C-17 passed its third and final reading in the Canadian Senate and will become Vanessa’s Law after receiving Royal Assent. In case you don’t know or have forgotten this story and sponsor […]
It’s impossible to make sense of the timeline in the last post [European Medicines Agency: a timeline…] based only on the facts as presented. What started as an open commitment to full Data Transparency for the Clinical Trials submitted for approval to the European Medicines Agency [EMA] ended with restricted access to redacted partial Clinical […]
I was getting ready to write some things about a few new developments in the saga of the European Medicines Agency’s Data Transparency policy, and it occurred to me that the story has gone on so long and become so convoluted that I ought to do a rough timeline. I’d like to say it was […]
from AllTrials Dear Friends We have a chance to get the most influential health body in the world – the World Health Organisation [WHO] – to say something strong on the need for the results of all clinical trials to be publicly reported. Following all of our pressure, the WHO has decided it needs to […]