A surprising court decision this past May has advanced an effortto allow terminally ill people to purchase experimental drugsafter initial safety testing but before they have been shownto work. A three-judge panel of the U.S. Court of Appeals forthe D.C. Circuit was considering a lawsuit by the Abigail Alliance,a patient-advocacy group, against the Food and Drug Administration(FDA). Two members of the panel ruled that patients with life-threateningand otherwise untreatable diseases have a constitutional rightto seek experimental treatments for which efficacy is not yetestablished and that the government cannot interfere unlessit . . . [Full Text of this Article]
Source Information
Dr. Okie is a contributing editor of the Journal.
An interview with Mr. William Schultz, a partner at the law firm Zuckerman Spaeder and a former deputy commissioner for policy at the FDA, can be heard at www.nejm.org.
This article has been cited by other articles:
Schuklenk, U., Lowry, C.
(2009). Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments. Br Med Bull
89: 7-22
[Abstract][Full Text]
Peppercorn, J.
(2009). Off-protocol Therapy in Oncology. Am Soc Clin Oncol Ed Book
2009: 177-181
[Abstract][Full Text]
Peppercorn, J., Burstein, H., Miller, F. G., Winer, E., Joffe, S.
(2008). Self-Reported Practices and Attitudes of US Oncologists Regarding Off-Protocol Therapy. JCO
26: 5994-6000
[Abstract][Full Text]
Mayer, M.
(2008). Swimming Upstream: An Advocate Reflects on Cancer Research and Social Realities. JCO
26: 2783-2786
[Full Text]
Yates, J. W.
(2006). Food and Drug Administration, Partner in Drug Development. CA Cancer J Clin
56: 321-322
[Full Text]