[Report of Proceedings, Government Investigation of GP160]

SECTION IV - FINOINGS wmaJ.-O0. AR 15.6)
Sr *nuesaanu ofierf,.I havn car uily consaderea the evidence. inds:
1. Regarding Letter of Appointment, paragraph 2a: Did the actions of
Lieutenant Colonel Robert Redfield, or any other Command personnel, in
performing duties associated with the Army or Tri-Service HIV Program,
amount to scientific misconduct (to include fabrication or falsification
of research results)? Evidence does not support the allegations of
scientific misconduct (fabrication of results, deception or misrepresentation of data) by LTC Robert R. Redfield, based on the following
facts:
a. The decision to apply the quantitative Polymerase Chain Reaction
(PCR) assay for Human Immunodeficiency Virus (HIV) DNA and RNA to
specimens obtained from patients in the Phase I gp-160 vaccine safety and
immunogenecity trial was made in November 1991.
b. The deadline for submission of the abstract for the Amsterdam
meeting in July 1992 was 2 March 1992. It stated that 7 of the first 11
patients for whom the assay had been completed had a reduction in viral
burden.
c. Preparation of slides and material for presentation in Amsterdam
(21 July 1992) occurred as late as 12-15 July 1992. During this
interval, data provided to LTC Redfield were 18 patients in the natural
cohort and 6 patients in the vaccine trial.
d. Criteria used for presentation of data were the first 15 patients
who sequentially entered the Phase I trial and who had been in the study
for a minimum of 18 months. Criteria for the 19 natural history cohort
patients were patients seen in the Infectious Disease Clinic at the same
point in time that the vaccinees were seen in the Immunotherapy Clinic,
Walter Reed Stages I-III, and had bloods drawn at the same time as the
vaccinees to minimize processing error.
e. Data analysis on 15 July 1992 was assisted by LTC John Brundage
(Chief, Department of Epidemiology, WRAIR) who instructed LTC Redfield on
SECTION V - AECOMMENDATIONS (oar J. I..A R IS.6)
In vtew ot the aoove iainm. s, the rnuvesngann oficer, iA, recommenas:
1. There is no requirement for adverse actions.
2. In fairness to LTC Redfield, the HIV Research Program, the Army and
the scientific community, a press release correcting the record is
warranted.
3. Measures to enhance the effectiveness of communication are warranted.