John Read - UK Esketamine Approval - Not so Fast

This week on MIA Radio we chat with Professor John Read of the University of East London. John worked for nearly 20 years as a Clinical Psychologist and manager of mental health services in the UK and the USA, before joining the University of Auckland, New Zealand, in 1994, where he worked until 2013. He has published over 140 papers in research journals, primarily on the relationship between adverse life events (e.g. child abuse/neglect, poverty, etc.) and psychosis. He also researches the negative effects of biogenetic causal explanations on prejudice, the opinions, and experiences of recipients of antipsychotic and antidepressant medication, and the role of the pharmaceutical industry in mental health research and practice.

John 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 about esketamine.

We Discuss:

• Concerns about the basic concept of using derivatives of hallucinogenic, addictive street drugs to address complex human problems.
• The particular details of the clinical trials that raise concerns about treatment with esketamine.
• How the US Food and Drug Administration approved Spravato in January 2019 and the European Medicines Agency recommended that member states approve it on October 17, 2019, giving 67 days for member states to comment.
• That the Medicines and Healthcare products Regulatory Agency approved esketamine for UK use.
• That there have been no trials of the efficacy of esketamine in the medium or long term, with most trials being only four weeks duration.
• That only one of the trials found a benefit for esketamine over placebo, yet this was deemed sufficient for licensing by the USA's FDA.
• That there were deaths and suicides recorded during the esketamine clinical trials.
• The relationship between the drug regulators and funding from the pharmaceutical manufacturers.
• How there was no response from the MHRA to the concerns raised by John's group.
• In addition, no reply was made to concerns raised by Sir Oliver Letwin writing on behalf of the All Party Parliamentary Group on Prescribed Drug Dependence as well as letters from independent researchers from Kings College London and a group of service users.
• A recent response to the approval by the UK National Institute for Health and Care Excellence.
• A response to the NICE announcement from the Science Media Centre.