Compassionate Use of Experimental Therapies: Who Should Decide?
EMBO Molecular Medicine, Vol. 7, No. 10, 2015.
4 Pages Posted: 26 Jul 2015 Last revised: 10 Oct 2015
Date Written: July 22, 2015
In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise.
Keywords: bioethics, administrative law, regulation, agencies, compassionate use, regenerative medicine, food and drug law, science and technology, stem cell therapy, experimental therapy, experimental medicine
JEL Classification: I10, I28, I29, K00, K32, K23
Suggested Citation: Suggested Citation