Volume 19, Issue 6, June 2019, Page 19-21.

In their paper, “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” Holly Fernandez Lynch and colleagues have present...

In their article “Ethical Issues in Fecal Microbiota Transplantation in Practice,” Ma and colleagues (2017) raise a number of questions related to the development of fecal microbiota transplants (F...

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review (...) the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning. (shrink)

Many diseases and disease symptoms still lack effective treatment. At the same time, certain controversial Schedule I drugs, such as heroin and cannabis, have been reputed to have considerable therapeutic potential for addressing significant medical problems. Yet, there is a paucity of U.S. clinical studies on the therapeutic uses of controlled drugs. For example, people living with HIV/aids experience a variety of disease- and medication-related symptoms. Their chronic pain is intense, frequent, and difficult to treat. Nevertheless, clinical trials of compassionate (...) management for their chronic symptoms, which should be a research priority, are stymied. Stakeholders’ Views on Barriers to Research on Controlled Substances Evelyn Rhodes, Michael Andreae, Tyler Bourgiose, Debbie Indyk, Rosamond Rhodes, and Henry Sacks We employed qualitative methods to develop an understanding of the barriers to research on potential therapeutic uses of Schedule I drugs so that they might be addressed. We elicited the perspectives of key stakeholder groups that would be involved in such studies: people living with HIV/aids, clinicians, and members of institutional review boards. As we identified obstacles to research, we found that all of the stakeholder groups arrived at the same conclusion, that clinical research on the therapeutic potential of these drugs is ethically required. (shrink)

This case raises a number of complex ethical, legal, and practical issues, some of which cannot be resolved by a research ethics consultation. Sam is an adolescent who has end stage manifestations...