While I haven’t thought about it very much, I made a move from the hardest of medical sciences to the softest without any transition. The first time around was in a lab with scintillation counters printing data to punch cards to feed into Fortran programs that cranked out ANOVA with p values. And then I […]
UK Agency Will Ask Regulators for Trial Data if Drug Makers Refuse Pharmalot: WSJ by Ed Silverman September 11, 2014 In yet another sign of frustration with drug makers that do not release clinical trial data, the U.K. agency that is responsible for recommending coverage of medicines will ask European regulators for data if companies […]
I’ve noticed that there’s a pattern in this blog [and in your responses]. I write a post, and something sticks in my mind, and I chase it in the next. That often goes on for a couple of iterations. It’s apparently how I think. Readers tend to comment the first time around, then run out […]
Ed Silverman reports here on the end of a long story that has appeared in fragments for several years. It’s about Agomelatine, a Melatonin like compound, and a review article published in the Lancet by Ian Hickie and Naomi Rodgers at the end of 2011. Here’s the Pharmalot post: Servier Breached Industry Codes by Not […]
My last post about Zoloft® and it’s approval [an echo that needs to keep reverberating…] got me thinking about a number of things. In the UPDATE, I finally found that Laura A. Plumlee et. al. v. Pfizer had been denied on a technicality for the second time just this week. I also found a Louisiana […]
Dr. Roy Poses of Healthcare Renewal often writes about a concept – the anechoic effect [see themes…]. We all know about it. Some big story comes along and there’s a big reaction, outrage around, but then interest peters out and it’s forgotten – worse, nothing is done about it. It happens all the time. And […]
Irving Kirsch published an article in 2008 [Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration] that concluded: Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is […]
We shall not cease from exploration And the end of all our exploring Will be to arrive where we started And know the place for the first time… Little Gidding T.S. Eliot 1942 I hate being so repetitive with my quotes. This one has had many re-runs here. But I guess that’s the way it […]
I wrote this less than four years ago [selling seroquel I: background…]: This email response to a researcher who was requesting funding from Zeneca several months after the F.D.A.’s approved Seroquel might seem odd or even Machiavellian to a Basic Scientist, a Practicing Clinician, or a patient-to-be, but if your business is selling the product, […]