Research on Controlled Drug Use: A Paradigm for Public Health Research in Sustainable Health

Ketamine treatment for depression: opportunities for clinical innovation and ethical foresight

“…We have already outlined some of the limitations of the conventional RCT pathway. It is also worth noting that, if access to ketamine were restricted to those involved in clinical trials, very few patients would receive it, creating unequal conditions, particularly for patients in low resource settings and those with limited access to clinical trials [58]. Therefore off-label use of ketamine for treatmentresistant depression in single cases can contribute to innovation and to justice, if the harms of ketamine use can be minimized, and the benefits maximized, in the form of systematic and transparent data recording and sharing.…”

Research With Controlled Drugs: Why and Why Not? Response to Open Peer Commentaries on “An Ethical Exploration of Barriers to Research on Controlled Drugs”

“…In the especially informative commentary, “Research on controlled drug use: a paradigm for public health research in sustainable health,” Evert van Leeuwen (2016), explains how the sort of goals that Francis and Francis laid out were actually accomplished in The Netherlands. Recognizing the need for “evidence-based programs for people in vulnerable situations, like those suffering from addiction” (p.2, l.15) and the difficulty of developing them in the context of current research regulations that are designed for idealized populations and a narrow range of circumstances, van Leeuwen cautions that it is important to confront “undue political constraints in performing research” with vulnerable populations.…”