Research Subcommittee Minutes

The Subcommittee addressed the role of David Baltimore and the AIDS Vaccine Research
Committee (AVRC). Dr. Burke and the Subcommittee questioned the scope of the AVRC and
saw this lack of clarity as a potential problem. Ms. Miramontes echoed these sentiments and
added that some see David Baltimore's role as head of the NIH vaccine effort and others view his
role as head of the entire vaccine effort. Dr. Baltimore did respond to the PACHA draft and his
comments were discussed during the Subcommittee meeting. He noted that it wasn't necessary
for a 'vaccine czar' to oversee the vaccine effort. Dr. Burke shared the sentiments of the PACHA
draft and thought the coordination and balance between the empirical and basic science
approaches was appropriate. The draft doesn't clarify Baltimore's role and where leadership
comes from. Ms. Miramontes noted that David Baltimore's perception of his role was narrower
than what the public perceived. The Subcommittee needs to state that the lack of coordination is
an obstacle to obtaining vaccine goals.
A critical question raised by several Subcommittee members was that there wasn't consensus on
when to move from basic science efforts to product development and testing. Dr. Weniger noted
that the polio vaccine and Hemophilus vaccine, and trials were controversial as well, but
ultimately successful, and that if all objections to AIDS vaccine trials must be overcome, then the
vaccine goal will be greatly delayed..
Dr. Mathieson clarified that the NIH not only is conducting basic research on vaccines, but also
is conducting clinical trials. Twenty million dollars is being spent on attenuated virus research.
The Integrated Preclinical/Vaccine (?) Development (IPCVAD) (formerly NCVDG) is
supporting animal studies and clinical testing for safety. There are many contracts for phase I
testing, and a phase II trial of 420 individuals should complete enrollment by 12/31/97. DNA
vaccines are being tested in phase I trials. An extramural AIDS Vaccine Evaluation Group
(AVEG) trial with 40 patients is underway as well as an intramural trial sponsored by NIAID
with 18 of 24 patients.
When asked about a breakdown of the NIH budget differentiating basic research from product
development efforts, Dr. Mathieson replied that the AIDS Research Information System (ARIS)
codes all AIDS dollars and a breakdown could be supplied from this information. She remarked
that $58 million out of a total of $146 million was allocated for development (production, animal
studies, and product testing, excluding phase I/II trials and AVEG trials) in FY 1998. OAR has
discretionary fund authority and can take away up to 3% of an Institute's funds at any time. The
AVEG has six sites funded at $1 to 1.5 million each. Dr. Burke expressed concern that the NIH
budget did not reflect the process for moving a product from basic research to development. Dr.
Mathieson replied that certain functional categories would require one to project this process.
The flow for a single vaccine product would be done at the program level.
Scott Hitt asked NIH for comments on the statement that there was no formal coordination
between departments in the Federal government. Dr. Mathieson replied that formal coordination
is between the PHS and HHS, but other coordination was on an ad hoc basis (between CDC and
NIH for example). Although the NIH vaccine meetings have been attended by DOD
representatives there is no formal process of interdepartmental coordination. [Hitt noted that
Whitescarver stated there was an interdepartmental group, but that it had only met once.]