Some information I came across through subscriptions to HHS and Office of Inspector General (OIG) mailing-lists that may not have been released elsewhere. It would appear that whether in their accounting standards or health statistics, a lax culture with regard to numbers and record-keeping is beginning to encroach on NIAID, and they are seeking to make this laxity the new standard. Please forward to anyone who may be interested in further pursuing or making use of this information.
"Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-15416 With the University of California at San Francisco Audit (A-03-10-03120)". Link to OIG report:
http://oig.hhs.gov/oas/reports/region3/31003120.pdf (PDF file, 4.9M)
'NIAID initially funded only $35.3 million of the $134.8 million Contract obligation with fiscal year 2001 appropriations. NIAID obligated a total of $99.5 million in violation of the bona fide needs rule: $19.5 million of fiscal year 2002 appropriated funds, $22.4 million of fiscal year 2003 appropriated funds, $23.4 million of fiscal year 2004 appropriated funds, $22.7 million of fiscal year 2005 appropriated funds, and $11.5 million of fiscal year 2006 appropriated funds. In addition, when it awarded a fiscal year 2007 Contract modification for nonseverable services, NIAID initially funded only $40.3 million of the $220.5 million contract obligation with fiscal year 2007 appropriations. Because the Contract was a nonseverable service contract, which represents a single undertaking and provides for a single outcome, NIAID was required to record the full amount of the Contract using fiscal year 2001 or fiscal year 2007 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. NIAID complied with the purpose requirements of appropriations statutes.
In written comments on our draft report, NIH agreed that an Antideficiency Act violation had occurred but did not concur with our findings and recommendations regarding the characterization of the Contract as a nonseverable service contract. While the Contract may contain severable elements, we maintain that, on balance, the Contract is nonseverable. We determined that the Contract was overall nonseverable based on the language describing the tasks included in the statement of work.'
NIAID announce dangerous changes to clinical trial protocols in search for HIV vaccine (and will continue advocating for more circumcision regardless):
'To speed the pace at which promising HIV vaccine candidates become viable for evaluation in large clinical trials, NIAID is exploring the use of innovative or adaptive clinical trial designs that let scientists quickly modify ongoing trials in response to data acquired during the study. Such flexibility in trial design will allow the research community to maximize efficiencies in studying vaccine candidates.
No matter how effective a preventive HIV vaccine is, however, we will need to evaluate and administer it in combination with other biomedical and behavioral HIV prevention tools. No single HIV prevention strategy will control and ultimately end the HIV/AIDS pandemic. That is why it is important for NIAID to continue supporting promising research on vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded HIV testing with linkage to care. That is also why public health workers will continue to advocate and implement scientifically proven HIV prevention strategies such as condom use, medically supervised adult male circumcision, harm-reduction strategies for injection drug users and the prevention of mother-to-child transmission of HIV.'