June 5, 2017 – Anton Bespalov took part in a meeting in Washington, DC (USA) hosted by Francis Collins, Director of National Institutes of Health, and Nora Volkow, Director of National Institute on Drug Abuse. This meeting was aimed to address the role of science in addressing the opioid crisis (link to the NEJM paper – http://www.nejm.org/doi/pdf/10.1056/NEJMsr1706626) and was attended by representatives from pharma and biotech, SMEs, academic scientists, consultants in the related fields of drug discovery research, as well as officials from FDA / CDER. The goal was to identify efforts that need be prioritized in order to facilitate development of medications for opioid use disorders and overdose prevention/reversal. It was emphasized that the goal is to come up with an action plan (i.e. not a conventional academic / scientific meeting). NIH Opioid Research Initiative suggested three main directions for developing actionable plan: i) pain management, ii) opioid addiction treatment, and iii) overdose reversal. PAASP’s position is that this field of drug development is not much different from others where failures to develop novel and effective medications have complex reasons including poor quality of preclinical data and inappropriate use and interpretation of preclinical data. In support of this opinion, it was confirmed by several meeting attendees (in private conversations) that there are too many novel drugs and mechanisms that are reported at every scientific conference to have miraculous anti-addictive and / or analgesic efficacy in preclinical settings. This high rate of positive results can only be explained by either false positive results due to insufficient research rigor or inappropriateness of the models used.
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