Anas Al-Janadi, MD, and Jennifer Carter-Johnson, JD, PhD, presented at the Bioethics for Breakfast event on November 17, 2016, offering perspective and insight on the topic, “Compassionate Use: What Is in a Name?”
Jennifer Carter-Johnson notes that The United States has a history of dangerous unregulated “medicines” that led to today’s drug regulations. Indeed, no drug is completely safe, and drug effects must balance safety against efficacy to win market approval for patients. Today’s drug regulatory process, in which 90% of drug candidates fail during clinical trials, and the potential desperation of end-stage patients requires that compassionate use balance protecting the public, encouraging new drug development and respecting patient autonomy. But Dr. Al-Janadi believes that we should think of this issue as an “early/expanded access opportunity” rather than “compassionate use.” One of his concerns is that there are presently lengthy delays in drug approval when drugs have shown some promising efficacy, thereby depriving patients of their benefit.
How do you believe a balance ought to be struck? Should there be public policies that reflect this balance? Or should this be left to the judgment of clinicians and patients, or the pharmaceutical industry? Does the current “right to try” legislation in many states need to be amended? These and other questions were addressed by the speakers and guests, creating a respectful and thoughtful discussion.
Anas Al-Janadi, MD
Anas Al-Janadi is Associate Professor and Section Chief of the Division of Hematology and Oncology in the Department of Medicine at the Michigan State University College of Human Medicine.
Jennifer Carter-Johnson, JD, PhD
Jennifer Carter-Johnson is an Associate Professor of Law at the Michigan State University College of Law and holds both a JD and a PhD in Microbiology. Professor Carter-Johnson uses her interdisciplinary training to study the intersection of law and scientific research.