Protecting Academic Psychiatry PsychiatricNews Paul Summergrad, M.D. January 2015 [full text on-line] It was APA, along with NIMH and academic psychiatry leadership in the latter part of the last century, that helped the field to develop to its current prominence. It is incumbent upon us to focus our attention on these issues so that our […]
The Relationship Between Antidepressant Initiation and Suicide Risk Special Reports, Psychopharmacology, Suicide Psychiatric Times By Robert D. Gibbons, PhD and J. John Mann, MD December 31, 2014 [full text on-line with free registration] There has been much debate about whether certain classes of medications [eg, antidepressants] increase the risk of suicidal behavior and whether that […]
University of Chicago Statistician Robert Gibbons was a voting consultant on the 2004 FDA Pediatric Advisory Committee that elected to add the Black Box Warning to the labeling of the Antidepressants: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children and adolescents in short-term studies of major depressive disorder […]
"After about two years on the job, the plans for change were becoming clearer in my mind. Some ideas about the Diagnostic and Statistical Manual of Mental Disorders [DSM] had begun to be formulated just before I came to the APA, as discussed in Chapter 10 ["Evidence Based Diagnosis and Treatment"]. The awareness of how […]
Sometimes, I’m asked why I keep looking at studies long passed – like GSK’s Paxil Study 329 [2001] or AstraZeneca’s Seroquel Study 15 [1993-1995: still unpublished]. The usual answer is that the only way I know to aim for a better future is to thoroughly understand the misadventures of the past. But there’s another simpler […]
During my forty years of an active medical career, I don’t recall thinking about the Food and Drug Administration [FDA] or, for that matter, the Clinical Trials of medications – even though they became obligatory about the same time I started medical school [1962] in the wake of the Thalidomide problem. Whenever there was a […]
I’m obviously not writing about this because I’m conflicted about the Black Box Warning. I’ve seen enough adolescent patients with the Akathisia syndrome from SSRIs to know it’s a real thing. And I know of completed suicides that I am convinced were SSRI induced. In addition, I am underwhelmed with the claimed efficacy of SSRIs […]
Earlier, I said, "I was not aware that the American Psychiatric Association [APA] had been so active in its opposition to the Black Box Warning in 2004 and going forward" [a restrictive interpretation…]. What a naive guy I am! A search of PSYCHIATRICNEWS reveals the history of APA opposition from before it was even decided. […]
From the beginning, and in the decade since, APA has protested the warning, predicting that it would prevent parents from seeking care for their children – and clinicians from prescribing antidepressants – and insisting that by far the greater danger was untreated depression. “We are concerned that the publicity surrounding this issue may frighten some […]
The campaign against the Black Box Warning has been relentless since it was added to the labeling of antidepressants in 2004. Here are a dozen major articles along the way opposing the Warning: The relationship between antidepressant medication use and rate of suicide. Gibbons RD, Hur K, Bhaumik DK, Mann JJ. Arch Gen Psychiatry. 2005 […]