Of late, I find myself drawn to how things play out over time in the world of PHARMA. In the January Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP], I ran across some letters about the N.I.M.H. Treatment of Early Age Mania [TEAM] Study which ran from 2003-2008. It compared Risperidone [Risperdal®], […]
Big pharma often commits corporate crime, and this must be stopped by Peter C Gøtzsche professor Nordic Cochrane Centre, Copenhagen, Denmark British Medical Journal 2012;345:e8462 doi: 10.1136/bmj.e8462. When a drug company commits a serious crime, the standard response from the industry is that there are bad apples in any enterprise. Sure, but the interesting question […]
Data Transparency Independent of the outcome of the Baum Hedlund suit [Laura A. Plumlee et. al. v. Pfizer] in the courts, I think their complaint was illuminating, at least to me. I didn’t know that Zoloft was the best seller in the antidepressant market, or the story of its approval and its rise to those […]
And so to what was riding on those decisions along the way? An absolute fortune was riding on every single one of them – on the jury-rigged protocol 103, or the unreplicable protocol 104, on the relapse prevention protocol 320 with its massive drop-out rates, on Paul Leber’s F.D.A. N.D.A. speech, and on the deceptive […]
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. […]