The UK's drug regulator rejected Janssen's esketamine nasal spray. Why did the US FDA approve it?
Peter Simons covers a clinical trial that found lithium ineffective at preventing suicide attempts, an essay by Allen Frances on the overdiagnosis of depression and overprescription of antidepressants, a review of the ineffectiveness and dangers of antidepressants, and an analysis that revealed that esketamine failed five of its six clinical trials.
An analysis of FDA adverse event reports related to esketamine shows the potential for negative effects such as suicidal and self-injurious ideation.
An interview with Professor John Read who joins us to discuss the UK licensing of esketamine nasal spray (Spravato) for so-called ‘Treatment Resistant Depression’. John led a group of 12 academics and professionals who wrote to the UK regulator expressing concerns.
The UK’s Medicines & Healthcare Products Regulatory Agency is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.
A new article documents the “flimsy evidence” behind the recent FDA approval of the party drug esketamine for the treatment of depression.
Several members of the FDA Advisory Committee perceived this new drug as a potential “game changer” in the way depression is treated. I, however, am NOT one of them. I take my role as the Consumer Representative very seriously and want to make sure that any pharmaceutical drug that the FDA approves shows greater benefit than potential harm.