This research agenda should be developed in true partnership with community, researchers, DAIDS
, and many other stakeholders across the globe.
The internal communiques from DAIDS around the time of Hafford's death made it clear that doctors knew she had died of nevirapine toxicity.
During the decade prior to his arrival at DAIDS, Fishbein had overseen and consulted on hundreds of clinical trials for just about every pharmaceutical company.
DAIDS, when Fishbein came to work there in 2003, was running about 400 experimental trials both in the United States and abroad.
A DAIDS project officer close to the HIVNET study closed the door when she had her first meeting with Fishbein.
DAIDS then hired a private contractor, a company named Westat, to go to Uganda and do another preinspection.
In light of the Westat report, DAIDS and Boehringer asked the FDA for a postponement of its inspection visit.
But the ways in which the various players were tethered together made it impossible for DAIDS to condemn the study without condemning itself.
DAIDS was so dismissive of the Westat report that Westat's lawyers eventually put officials on notice that they were impugning Westat's reputation.
In response to the massive failures documented by Boehringer and Westat, DAIDS embarked on a "re-monitoring review" in an attempt to validate the study's results.
Following FDA regulations, she drafted a safety report documenting this finding and gave it to Mary Anne Luzar, a DAIDS regulatory affairs branch chief.
In July, Tramont sent an email to all DAIDS staff instructing them not to speak about HIVNET at all.