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Archive for October, 2012

past time…

Spinal Tap: Medtronic And Manipulated Studies Pharmalot By Ed Silverman October 25th, 2012 There is nothing like a stack of internal documents to tell a story. And so, the US Senate Finance Committee has released a wad showing Medtronic employees were secretly involved in drafting and editing favorable journal articles about its spinal fusion product […]

a mere catalogue?…

The Classification of Insanity by John Turner MB British Journal of Psychiatry. 1912 58:9-25. BEFORE attempting a classification, it is desirable to define what we exactly mean by insanity. It is not an easy matter. Who is to say where the dividing line is to be drawn between the sane and the insane ? The […]

suggests that such variants do not exist…

In a seemingly endless string of attempts to make the modern antidepressants more potent than they are, we went through algorithm·izing, sequencing, combining, and augmenting with little to no improvement in efficacy. That was followed by personalized medicine [fool me twice… etc], the notion that the response to antidepressants is genetically linked/determined. While I can’t […]

bet you didn’t know…

[click the graphic to see Dr. Nemeroff’s presentation] hat tip to Nancy 

vote for marketing…

While I kvetch about legalese and matters legal, my actual experience has been that in cases I’ve been involved in personally, the courts have usually gotten it right, even in situations where they ruled in a direction I wasn’t headed. The legal decision in Kaiser v. Pfizer [Nov 3, 2010], the case mentioned in the […]

a symptom…

When Clinical Trials are Meant for Marketing, not Science Healthcare Renewal by Roy Poses October 19, 2012 The development of the randomized controlled clinical trial (RCT) was one of the major scientific advances in clinical medicine.  RCTs provide a major part of the evidence underlying evidence based medicine.  RCTs provide a major source of data […]

bucket list…

*** This is an automated message. Please do not reply to this email. *** Reference: FDA******* Dear Requester, This is to acknowledge receipt of your request for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act. Don’t get me wrong about this. I’m very appreciative of the Drugs@FDA web site. […]

on comments…

This blog has been randomly [I thought] holding comments. I have looked in the comments settings many times, trying to figure out what’s going on. Today I noticed something called "discussion" in the settings. Sure enough, the item "email me when a comment is held for moderation" wasn’t checked. And there was a setting that […]

without trust, it’s no idea at all…

Drug firm to share raw trial data Full disclosure could improve health care and restore trust Nature by Declan Butler 16 October 2012 The secrecy that has long surrounded drug-industry trials is crumbling. Scientists are applauding drug giant Glaxo­SmithKline [GSK] for its announcement last week that it will make the trove of detailed raw data […]

we, three kings…

The story that lead GSK to the settlement table paying a $3 B fine for past sins is a long and winding road, a lot of it having to do with the Paxil antidepressant and the Department I was affiliated with at Emory. But even practicing a mile or so from the University, I only […]