Anthony S. Fauci, M.D.
Dr. Fauci opened the Monday afternoon, January 29th, session of Council by welcoming visitors to the 137th meeting.
He announced the appointment of four new Council members: Dr. William Bertrand; Dr. Fred Jones, Jr.; Dr. Gerald Mandell; and, Ms. Charlotte Collins.
Dr. Fauci welcomed ad hoc Council members: Dr. Ann Arvin, Lucile Salter Packard Professor of Pediatrics, Stanford University; Dr. James Kazura, Chief, Division of Geographic Medicine, Case Western Reserve University; Dr. Paul Kincade, Head, Immunology and Cancer Program, Oklahoma Medical Research Foundation; and, Dr. Savita Pahwa, Professor of Pediatrics, New York University School of Medicine.
Consideration of Minutes of Previous Meeting:
The minutes of the September 25-26, 2000 meeting were considered and approved as written.
Staff and Organizational Changes:
Dr. Fauci welcomed new staff to the Institute and acknowledged the appointment of several current staff members to new positions. The new staff to NIAID are Dr. Lydia Falk, chief of the Office of Regulatory Affairs, DMID; Dr. Michael Gross, chief, Prevention Sciences Branch, DAIDS; and Mr. Abe Mittleman, associate director for Management and Operations, Vaccine Research Center. New appointments of current staff include: Dr. Pamela McInnes, as deputy director, DMID; Dr. Ann Ginsberg as chief, Respiratory Diseases Branch, DMID; Dr. Steve Rose as director, Office of Clinical Applications, DAIT; and Dr. Edward Schroeder as chief of the Microbiology and Immunology Review Branch, Scientific Review Program, DEA.
Review of Operating Procedures for FY 2001:
Operating procedures had been sent to Council members for review. No modifications were suggested and they were approved.
Budget Update:
Because of budget negotiations NIH once again received a very favorable increase for FY 2001. Dr. Fauci is grateful to the Congress and the Administration for providing NIH a budget that will double by 2003. NIH received an increase of $2.5 billion over the FY 2000 budget, which is a 14.0 percent increase. NIAID received a 13.7 percent increase.
Two percentage changes are not in line with the rest of the NIH. The NCRR's increase of 21.1 percent is largely due to receiving $100 million for the Institutional Development Awards (IDeA) program. The IDeA program is designed to build biomedical research capacity at institutions in the 23 states that do not traditionally receive much NIH funding. The NIH Office of the Director's budget decrease of 24.8 percent is largely due to the replacement of the Office of Research on Minority Health with the new National Center on Minority Health and Health Disparities ($130 million).
Other
Winter Program Review:
Two issues discussed at the Winter Program Review were conflict of interest and ethics and clinical trials. These issues have been the subjects of recent attention in the biomedical community as well as in the popular press.
Dr. Zeke Emanuel, chief, Department of Clinical Bioethics, NIH Clinical Center, presented the issue of ethics and clinical trials. He provided a comprehensive overview of the evolution of the concept of "ethical justification" over the last century. In particular, he focused on the seven ethical requirements. He also provided a detailed review of the major changes included in the 2000 revision of the Declaration of Helsinki. DAIDS Director Dr. Jack Killen will take the lead in developing a framework for implementing the revised Helsinki document.
Ms. Karen Santoro, the NIAID special assistant for ethics and conflicts of interest, presented on conflicts of interest in research. Ms. Santoro provided an overview of the relevant regulations that address management of conflicting interests for investigators as well as for institutions and reviewed conflict of interest policies in place for several NIAID programs, including the Immune Tolerance Network, the AIDS Clinical Trials Group, and the Vaccine Treatment and Evaluation Units. Ms. Santoro will consider who in the Institute can most effectively review conflict of interest issues for NIAID sponsored networks.
World AIDS Day:
On World AIDS Day, President Clinton announced the first NIH plan for international AIDS research. Dr. Fauci gave an update on areas of critical importance, including the upcoming directions in the study of global health, the relation to NIAID's mandate on infectious diseases, and the role NIAID will play in the total global health effort.
At the end of last year, there were 36 million people living with HIV worldwide, over 20 million who have died; therefore a total of over 50 million people have been affected by HIV/AIDS. Of particular concern was the prevalence rate of HIV in adults in South African nations.
If there is stabilization in new HIV infection rates, and that is a matter of some debate, such stabilization has occurred at an unacceptably high level. Morbidity and mortality is increasing, over 2.4 million deaths in 2000 compared to 2.2 million deaths in 1999.
The situation is not restricted to Southern Africa. The epicenter of the epidemic will very likely be in Asia, in the 21st century, in the first couple of decades. In Russia and Eastern Europe, there were exponential increases in cases over the last few years.
In response, NIAID is becoming more intensively involved in the area of international programs, which necessitates an emphasis on ethical considerations and partnerships. The Vaccine and Prevention Trial Network is going to become a growing part of the NIAID research endeavor.
Council Materials:
Copies of the Legislative Update, which describes hearings and bills of interest to the Institute, were distributed. The NIAID Office of Communications provided Council members with several publications and press releases. back to top |