Esketamine is approved in Europe for treating resistant major depressive disorderBMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l7069 (Published 20 December 2019) Cite this as: BMJ 2019;367:l7069
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The MHRA has responded to my statement in the Mahase article (20.12.19) that we received 'no meaningful response' to our letter to the MHRA, signed by 12 experts, explaining why the evidence on the safety and efficacy or esketamine nasal spray is woefully inadequate. The MHRA spokesperson claims that it did respond to our letter.
At the time of the statement, and the article, this was not true. In the seven weeks since our letter (31.10.19) we had received nothing but repeated, unfulfilled promises to respond in 18 days and guarantees it had been forwarded to the right team, etc.. At no point had our requests for minutes, committee membership, conflicts of interest, etc. been responded to. Only after the EU decision to license esketamine, and within hours of the BMJ article appearing, did the CEO write to us, on the evening of 20.12.19.
We note that in their Rapid Response supporting the decision to license esketamine, they fail to identify a massive institutional conflict of interest. The MHRA is almost entirely dependent for its funding on drug companies.
Competing interests: I was the lead signatory on the letter reported in the Mahase/BMJ article in question
The MHRA has carefully considered correspondence received raising concerns about esketamine and has consulted with independent experts about those concerns.
The letter referenced in the article has been responded to.
Competing interests: No competing interests