American Journal of Bioethics.

Compassion and Research in Compassionate Use

In this issue of American Journal of Bioethics, Walker and colleagues (2014) discuss the issue of expanded access programs, or “compassionate use” that makes it possible for patients to get access to unapproved drugs. This is a timely topic for several reasons. First, demand by patients has never been louder. Social media and the free availability of information through the web makes it possible for desperate patients to find out about promising drugs and treatments much earlier in the development process. It also makes it possible for them to launch campaigns to try to pressure companies into providing access to those drugs. Second, lawmakers have been responsive to these public campaigns. Three states (Colorado, Missouri, and Louisiana) have passed “right to try” laws that attempt to bypass FDA regulation and allow patient access to unapproved drugs (if companies are willing to provide them), and Arizona will soon be voting on a referendum to become the fourth state to try to “guarantee” access. Third, the recent discussion of the controversy over access to ZMapp by health care workers has shined a spotlight on this issue. […]

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Volume 14, Issue 11
November 2014