Standardized Evaluation of Mental Health Treatment on the Way Medscape Medical News: Psychiatry by Alicia Ault February 25, 2016 Starting in 2017, the Joint Commission will require the 2300 behavioral healthcare organizations it accredits to initiate standardized measurement of interventions designed to improve patients’ mental health outcomes. "We’re going to put in place a measurement-based […]
Guidance for the publication of clinical data Requirements for industry now available on submission of clinical data for publication 03/03/2016 The European Medicines Agency [EMA] has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. EMA’s pioneering policy entered into force on 1 January […]
Last night, I spent some time writing a letter to the FDA. It was about Vortioxetine [Brintellix®] and their application for an approval for Cognitive Dysfunction in Major Depressive Disorder [see indications… and more vortioxetine story…]. This morning I got a confirmation that it had been passed along to "the Division" [which I suppose is better […]
Some commentaries need no introduction other than the link. Psychiatry With And Without A Conscious State by George Dawson of Real Psychiatry is an example of such a must-read.
It is either fashionable or required to end articles with a few comments about the limitations of the study. In this case, I’m going to start with the limitations; then summarize my previous musings on the topic; then say what the topic actually is that has these limitations and musings: Limitations Several limitations of this […]
In the last post [indications…], I started out by objecting to the FDA Advisory Panel’s endorsement of an indication for Vortioxetine [Brintellix®] in Cognitive Dysfunction in Major Depressive Disorder on the grounds of obvious Indication Creep [the well known marketing strategy of adding indications to allow misleading advertising]. But as I looked into the articles […]
I suppose every discipline has its jargon, words or phrases that have specific meanings that aren’t necessarily found in the general language. If you walk into the waiting room and see someone with bilateral exopthalmos [bulging eyes], you immediately think "Grave’s Disease" [hyperthyroidism]. It’s a pathognomonic sign: pa·thog·no·mon·ic [puh-thog-nuh-mon-ik] adjective Medicine/Medical. characteristic or diagnostic of […]
"Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to be Commissioner of U.S. Food and Drug Administration. Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine. […]
Lawmaker seeks moratorium on consumer drug ads Pharmalot @ STAT By Ed Silverman February 22, 2016 A congressional lawmaker has introduced a bill calling for a three-year moratorium on advertising newly approved prescription drugs directly to consumers, reasoning that such a freeze would prevent consumers from receiving inaccurate information and also hold down health care […]
About six months ago, I saw a patient on an outrageous medication regimen – one that rendered her literally unable to think. I mentioned her first in blitzed…], later in some truths are self-evident…, and most recently in a story: getting near the ending[s]… shortly after Christmas. I obviously had to get her off the […]