Must-read: the approval of Zohydro, and more tox on the web

Must-read of the week: Stephen S. Hall’s article “How Much Does It Hurt?” in the current edition of  New York magazine gives the best explanation I’ve seen of how the Food and Drug Administration ended up approving the extended-release hydrocodone product ZohydroER, even though their scientific advisory committee recommended against approval by a vote of 11-2. According to the article, Dr. Robert Rappaport, Director of the FDA’s Anesthesia, analgesia, and Addiction Products section, “reminded that advisory committee that it had to consider the Zohydro application within the narrow regulatory framework that legally governed all FDA decisions: Was the drug safe and effective for the ‘intended population’ — that is, for chronic-pain patients?” Although I would argue that evidence suggests that the drug would not be safe and effective even for this tightly defined group, it is interesting that the FDA was mandating the general public health ramifications not be considered.  The article quotes @LNelsonMD, @DavidJuurlink, and @JMPerroneMD. Meanwhile, USA Today reports that in recent years prescriptions for  opioid analgesics and anxiolytics such as alprazolam have increased radically among seniors covered by the Medicare prescription program. Ayahuasca — it’s not just for the Amazon any more: In an article in today’s New York Times “Fashion & Style” section, Bob Morris describes how the psy...
Source: The Poison Review - Category: Toxicology Authors: Tags: Medical ayahuasca FDA new york magazine zohydro Source Type: news