The
Number 12
SOUNDING BOARD
Unethical Trials of Interventions to Reduce Perinatal Transmission of the
Human Immunodeficiency Virus in Developing
Countries
Peter Lurie, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen's Health Research Group
Toward a Single International Standard of Ethical Research
Researchers assume greater ethical responsibilities when they
enroll subjects in clinical studies, a precept acknowledged by
Varmus recently when he insisted that all subjects in an
NIH-sponsored needle-exchange trial be offered hepatitis B
vaccine. (27) Residents of impoverished, postcolonial countries,
the majority of whom are people of color, must be protected from
potential exploitation in research. Otherwise, the abominable
state of health care in these countries can be used to justify
studies that could never pass ethical muster in the sponsoring
country.
With the increasing globalization of trade, government research
dollars becoming scarce, and more attention being paid to the
hazards posed by "emerging infections" to the residents of
industrialized countries, it is likely that studies in developing
countries will increase. It is time to develop standards of
research that preclude the kinds of double standards evident in
these trials. In an editorial published nine years ago in the
Journal, Marcia Angell stated, "Human subjects in any part of the
world should be protected by an irreducible set of ethical
standards." (28) Tragically, for the hundreds of infants who have
needlessly contracted HIV infection in the perinatal-transmission
studies that have already been completed, any such protection
will have come too late.
Peter Lurie, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen's Health Research Group
Copyright © 1997 by the