Samuel Gershon: Brintellix  -  votioxetine

        My information on Brintellix  (votioxetine) is limited and confusing. I received my initial information from the company advertisements and brief clinical statements about it.
From my scrappy information, it seems that this compound has been approved for sale in the US with an indication that seems to focus on the claim that this compound is uniquely beneficial for postpartum depression. (It has also been approved for sale in Australia.) The claim of very prompt anti-depressant efficacy in this special population provided special interest in early approval. Also, in reading some more advertisements it also appears that Brintellix will prevent the recurrence of subsequent depressive episodes. Additionally, one of the side effects listed is the occurrence of a manic illness. Just at this point it would help if the company might indicate whether it would be contraindicated in bipolar patients altogether.

        Ken Gillman sent me his 2016 article on this substance in which he addresses more clearly than I a number of questions and concerns that I have about the clinical data and how well these claims are substantiated.

        Although I have little information on this compound, some aspects of the story are similar to the questions that have been raised about the Ketamines (Gershon 2019).
There seems to be an indication that the FDA is including in the approval evaluations things like the uniqueness of these compounds and their rapidity of production of a positive outcome.

        So, after just reading Jay Amsterdam’s input to the article published by Edward Tobe (2020), I am offering these other questions with a lot of concern about what is going on with these new wonder drugs. They are spreading into clinical usage very rapidly and I would welcome opinions from my colleagues.

References:

Gershon S. Ketamine, the “new” breakthrough in the treatment of depression. inhn.org.controversies. July 18, 2019.

Gillman K. Vortioxetine: Multimodal or Multi-muddle. https://psychotropical.com/vortioxetine-multimodal-or-multi-muddle/. 2016.

Tobe EH. The Iceberg of Improbity.  Journal of Scientific Practice and Integrity. 2020; 2(1).

May 21, 2020