Compassionate Use: A Story of Ethics and Science in the Development of a New Drug
Buhles, William C
Perspectives in biology and medicine 2011; 54(3): 304-15
This history chronicles the unusual development of the antiviral drug ganciclovir. The first compound with activity against human cytomegalovirus (CMV), ganciclovir was so clearly efficacious that a placebo-controlled clinical trial could not ethically be done, and the FDA rejected the first application to market the drug. Used to treat a blinding eye infection in patients with AIDS, the story of ganciclovir paralleled the spread of the AIDS epidemic. Both ganciclovir and AIDS caught the federal government off guard. Caught in a Catch-22 situation, the pharmaceutical company developing ganciclovir gave the drug away free for five years under compassionate use guidelines. The problems encountered in the development of ganciclovir provide guidance on how future drugs to treat life-threatening diseases can be developed.
Showing items related by title, author, creator and subject.
AIDS and the Transformation of Biomedicine Book Review of AGAINST the ODDS: THE STORY of AIDS DRUG DEVELOPMENT, POLITICS and PROFITS by Peter S. Arno and Karyn L. Feiden, the INVISIBLE EPIDEMIC: THE STORY of WOMEN and AIDS by Gena Corea, And ACCEPTABLE RISKS by Jonathan Kwitny Epstein, Steven (1993)