So, picking up from explanation would be welcome… and looking at the enrollments in RAP-MD-01, RAP-MD-02, and RAP-MD-03 that seem so high in those Rapastinel Clinical Trials. The way trialists pick their sample size is to do a Power Analysis. Using the Standard Deviation from a previous similar study, then pick the difference in means […]
I’ve been writing about Rapastinel, an NMDA receptor partial blocker touted to have Ketamine’s antidepressant effects without being a psychomimetic [see a touch of paralysis… and a block-buster-in-training…]. It was developed by a Northwestern University neuroscientist who formed a private company [Naurex], later purchased by industry giant Allergan for $560 M. They’ve recently registered four […]
Psychiatry was obviously ripe for the the medicalization ushered in by the neoKraepelinians and the DSM-III released two years after this article. Changes in reimbursement schedules, a burst of new psychotropic drugs certified by industry funded clinical trials, and a focus on neuroscience research soon followed. The disappearance of the public mental hospitals was matched […]
[continuing from an interesting read…, Schizophrenia: Science and Practice, Chapter 5: The Evolution of a Scientific Nosology, and Klerman 1978: on the medical model…]. In 1978, criticism of psychiatry was in full bloom. At the radical pole were people like R. D. Laing and Thomas Szasz who questioned whether psychiatry should even exist. In 1974, […]
Some of Gerald Klerman’s comments from 40 years ago [an interesting read…, Schizophrenia: Science and Practice, Chapter 5: The Evolution of a Scientific Nosology] could’ve been written yesterday, and you wouldn’t see any difference. After reviewing the oft told history of diagnosis and treatment of psychotic illness and discussing the neoKraepelinian Credo, he turns to […]
I came to psychiatry from practicing Internal Medicine with something specific in mind to learn about – and it wasn’t psychiatric patients. It was the subset of medical patients whose problems were clearly mental – and there were plenty of them. But in a psychiatry residency, that’s not where you start. It’s on the wards […]
We say that the reason that new drugs are given such a generous period of patent-exclusivity is to compensate the pharmaceutical company for its long and expensive research and development process taken at great risk. But ever since the Bayh-Dole Act of 1980, universities and/or their faculty can be granted unencumbered patents even if federal […]
Looking through the December American Journal of Psychiatry, there was a small study in the Letters section, Effect of a Novel NMDA Receptor Modulator, Rapastinel [Formerly GLYX-13], in OCD: Proof of Concept. They had given intravenous Rapastinel [GLYX-13] an NMDA receptor partial blocker to seven patients with severe OCD. Remember Rapastinel [GLYX-13]? It’s the Ketamine-like […]
With media watchdogs on the sidelines, pharma-funded advocacy groups pushed Cures Act to the finish line HealthNewsReview by Trudy Lieberman December 6, 2016 hat tip to AA… A Frenzy Of Lobbying On 21st Century Cures Kaiser Health News By Sydney Lupkin November 28, 2016 hat tip to Mark Wilson… Excellent summaries of the problem. My […]