Well here we are at the part of the story we now know all too well. Maybe we don’t know the Pfizer/Zoloft version so well as some of the others, but the involvement of the professional ghost writing firms was apparently an industry-wide story of a literature filled with ghost-written studies with "guest authors." And […]
When I read the post that mentioned the Pfizer Lawsuit about Zoloft on Pharmalot [Pfizer, Zoloft And The Vexing Placebo Effect], I pursued it because I was intrigued that the suit was unique, "we want our money back because Zoloft doesn’t work and Pfizer knew it didn’t" – pretty bold. But when I read the […]
While there’s more to say about the Sertraline study mentioned in the last post, specifically about the article version published in 1995, I think I’ll first mention the remaining data available in the N.D.A. that was approved in 1991. Recall the F.D.A. reviewer’s comment: The second study mentioned in the N.D.A. Report was a double […]
This is a lot for a blog post. I’ve tried to only show the essence of things, but it’s still a lot of words and some confusing tables. There are a number of sources: a recent lawsuit, a twenty-five year old FDA drug approval, and an eighteen year old journal article. While a lot of […]
sitting quietly doing nothing. spring comes and the grass grows by itself… Zen poem by Basho We think about it more now than we used to, but it still hasn’t thoroughly sunk in – the USA is just a country in a world of many countries. And from a medical perspective, the real overarching organization […]
We shall drink no wine before its time… Orson Wells The DSM-III/DSM-IIIR/DSM-IV series had given the third party carriers, policy makers, and pharmaceutical industry what they wanted – an objective diagnostic system in psychiatry. In some ways, it was trivial because there’s so much more to a given person’s mental illness than signs and symptoms. […]
An aspect rarely commented on is that the DSM-5 leaders didn’t seem enthusiastic about the basic principles of the earlier revisions. In A Research Agenda for DSM-V, they said: Questions have been raised by many critics that the DSM’s descriptive approach may have outlived its usefulness and is in fact potentially misleading. Although there is […]
The Op-Ed: Antidepressants & Controversial Studies Pharmalot By Ed Silverman February 11th, 2013 Several years ago, the Black Box warnings that were added to antidepressants over suicidal thoughts and behaviors for youngsters caused a backlash, as some suggested the language had pushed physicians and parents to avoid usage when the medications could have done some […]
The Human Genome Project was declared complete in April 2003. An initial rough draft of the human genome was available in June 2000 and by February 2001 a working draft had been completed and published followed by the final sequencing mapping of the human genome on April 14, 2003… The Human Genome Project, Wikipedia Abbot […]
I started to list all the links to the bruhaha brewing over the AllTrials petition, but decided to summarize instead. There’s much posturing around the Alltrials petition, and all parties have behaved in an exemplary fashion [except for the other guys]. That’s it, the whole summary – meaning that the games have begun. Meanwhile, there […]