Press room ... 2005 archive
Project Inform Applauds Institute of Medicine
Report on HIVNET 012 Study
April 9, 2005
San Francisco, CA—Project Inform today reinforced
its support of nevirapine (Viramune) as a safe and effective treatment
for prevention of mother-to-child transmission (MTCT) of HIV. This
announcement follows yesterday's release of findings from the Institute
of Medicine's pivotal review and audit, which supports the scientific
conclusions of the National Institutes of Health-sponsored HIVNET
012 study in Uganda.
The study was one of several that consistently demonstrated that
the use of a single dose of the drug nevirapine could cut the rate
of mother-to-child transmission (MTCT) of HIV in half. Critics of
the study, including a short-time NIH employee, had claimed that
the study violated ethical standards and procedural rules, endangered
patients and failed to provide proper informed consent. As a result
of the accusations made against the study, the use of nevirapine
was stopped or threatened in many resource poor locations where
it was the only practical means of reducing MTCT to slow the spread
of AIDS. The primary purpose of the IOM review and audit was to
determine whether the study's results were reliable and accurate
and whether proper ethical and procedural protections had been applied
on behalf of patient volunteers.
The IOM study soundly rejected the critics' accusations, strongly
supported the scientific conclusions of the study and dismissed
accusations of ethical and procedural misconduct. The IOM Committee
"found no reason to retract the publication or alter the conclusions
of the HIVNET 012 study" and concluded that the data presented
"are sound, presented in a balanced manner, and can be relied
upon for scientific and policy-making purposes." The Committee
also concluded that "there is no reason based in ethical concerns
about the design or implementation of the study that would justify
excluding its findings from use in scientific and policy deliberations."
Several other chapters of the report addressed issues of informed
consent, record keeping, IRB review, and local and international
ethical standards. The review found no fault in any of these or
other areas other than minor problems of record keeping.
Martin Delaney, Founding Director of Project Inform, commented,
"Given the serious nature of the charges that were made against
the study and NIH officials, and the damage done by them, you have
to wonder whether the accusers should somehow be held accountable
for their actions. Race-baiting accusations comparing the study
to the infamous Tuskegee experiments at the very least warrant an
apology, as do the many false and damaging charges raised against
individuals at the NIH and among the Ugandan research community.
Good people doing extremely important work have been slandered.
Worst of all, pregnant women struggling to prevent their babies
from becoming infected by HIV in the poorest of countries have suffered
enormously from the confusion and distrust these accusations raised
at a critical moment in their lives."
Shalini Eddens, Director of Women's Programs at Project Inform
added, "I hope that this report now makes it possible for researchers
and government agencies to get back to the work of trying to slow
the spread of AIDS to women and their newborns. The last thing we
wanted was to see women frightened away from using the available
tools for preventing mother to child transmission, but this is exactly
what these accusations accomplished. I applaud the Institute of
Medicine for helping to correct this injustice. We should all go
forth now with a renewed commitment to doing sound, ethical research
on the issues faced by women in developing nations."
