I have no interest in whipping a dead horse, but this one won’t die. In February, Robert Gibbons, a Biostatistician from Chicago published a meta-analysis online saying that SSRIs were not associated with suicidality in children and adolescents – in opposition to the FDA’s black box warning of 2004: Suicidal Thoughts and Behavior With Antidepressant […]
ACA, FDA, PDUFA V, CDER, NME, NBE? It’s a lot of alphabet soup to me and a bit too big for my limited tolerance for understanding policies and agencies. Everywhere I went this morning, there were TVs with excited pundits and politicians either smiling or frowning. I retreated to the back porch for the afternoon […]
Barry Becher, co-creator of the Ginsu knife TV commercials, dies at 71 Washington Post By Matt Schudel June 27, 2012 Barry Becher, the co-creator of the classic over-the-top Ginsu knife commercials of the 1970s, and who, with his business partner Ed Valenti, helped develop television infomercial marketing, died June 22 at a hospital in Deerfield […]
DSM-5 Draft Criteria Draws Nearly 2,300 Responses Mental health diagnostic manual closes final public comment period June 26, 2012 The final public comment period for the draft diagnostic criteria of the upcoming Diagnostic and Statistical Manual of Mental Disorders [DSM-5] drew 2,298 responses from across the country and abroad. The six-week comment period ended June […]
UPenn Whitewashed Ghostwriting Probe: Professor Pharmalot By Ed Silverman June 26th, 2012 Three months ago, the University of Pennsylvania denied allegations made by one of its professors that several other academics – including his own department chair – allowed their names to be added to a medical journal manuscript, but gave control of the contents […]
Ark. judge says no new trial in J&J Risperdal case The Associated Press June 20, 2012 An Arkansas judge has denied a request for a new trial after he fined Johnson & Johnson and a subsidiary $1.2 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal. Judge Tim Fox ruled earlier this […]
DSM 5 Continues to Ignore Criticism From Petitioners Huffington Post by Allen Frances 06/20/2012 The petition to reform DSM 5 speaks with the powerful voice of more than 50 mental-health associations. Perhaps more important to APA’s publishing ambitions and budgetary needs, it represents a significant percentage of the potential customers who eventually will have to […]
That picture at the top of the last post was a shot from my phone on Friday fishing in Apalachicola Bay. We left Saturday morning with blue skies and had a sunny drive home [100° when we went through Columbus Georgia]. I wasn’t even aware that there was a Tropical Storm in the Gulf. Sunday, […]
Three professional organization responses to third and final DSM-5 stakeholder review dxrevisionwatch by Suzy Chapman June 21, 2012 No publication of field trial data Following posting of the third draft on May 2, it was anticipated APA would publish full results from the DSM-5 field trials “within a month”. [Source: Deborah Brauser for Medscape Medical News: interview with […]