It made headlines worldwide when the “revolutionary” ketamine-based antidepressant nasal spray drug handed FDA approval in March.
Esketamine was to perform an environment friendly treatment for folks by way of which completely different antidepressant therapies did not present to be helpful.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” talked about Dr. Tiffany Farchione, showing director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research in the group’s announcement of the drug’s approval.
On Thursday, however, Vice revealed a fairly scathing opinion piece from three psychiatrists — Dr. Marco A. Ramos, a psychiatry resident at Yale University; Dr. J. Wesley Boyd, a psychiatrist and affiliate professor at the Center for Bioethics at Harvard Medical School; and Dr. Michael D. Alpert, a psychiatrist and medical school at Harvard Medical School — who provided a differing view on the widespread drug.
Here are their particulars in opposition to the new psychedelic drug:
The doctors discover of their Vice opinion piece that the esketamine nasal spray costs virtually $900 per dose — that’s about $7,000 for the first month of treatment. Generic ketamine, they are saying, is obtainable for a “fraction of the price,” and has been confirmed to be environment friendly in medical trials.
SUCCESS IS QUESTIONABLE
Ramos, Boyd and Alpert discover that esketamine didn’t perform any larger than placebo in two of the three analysis submitted to the FDA. They write:
The actuality is that we don’t know whether or not or not esketamine is sort of environment friendly than widespread ketamine because of there have been no head-to-head trials between the two. Johnson & Johnson solely examined esketamine in opposition to a placebo, in all probability because of they feared esketamine might actually perform worse than the generic mannequin.
The doctors argue that the largest disadvantage with esketamine is not esketamine nevertheless its misrepresentation as a “revolution in mental health treatment.” They write:
While Johnson & Johnson rakes in the revenue from esketamine, victims dealing with despair and making an attempt to navigate our struggling psychological effectively being system will bear the value. Fostering the development of psychological effectively being therapies that are novel, environment friendly, and cheap would require an important examination of the undue firm pursuits that drive drug approval in American psychiatry at the second.
Read Ramos, Boyd and Alpert’s full argument in opposition to esketamine for Vice proper right here.