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Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, briefly reported on DMID staff changes, including: 1) the recent departure of Dr. Michael Gerber, who served as a medical officer on vaccine-related issues; 2) the addition of Dr. Holli Hamilton, who will head DMID's Office of Clinical Research Affairs; 3) the appointment of Dr. Ann Ginsberg as Chief of the Respiratory Diseases Branch (RDB); 4) the addition of Dr. Christine Sizemore to RDB, who has assumed the position of Tuberculosis and Leprosy Program Officer; 5) the addition of Ms. Cathy Roberge, who has joined RDB as a technical assistant; 6) the addition of Dr. Walla Dempsey to the Virology Branch (VB), where she will serve as the Clinical Trials Program Officer and oversee the Clinical Antiviral Study Group; and 7) the selection of Terry Greenfield as a technical assistant in VB.
Dr. Heilman reported on several recent DMID activities, starting with an update on vaccine safety issues. She informed the Subcommittee that a joint NIAID and CDC request led to the establishment of an Institute of Medicine Immunization Safety Review Committee to consider a variety of vaccine safety-related topics. Dr. Heilman noted that several members of Congress have a strong interest in this area and their representatives actively participated in the first meeting of this newly-formed group. She also provided an update on two vaccine safety-related research studies that DMID is supporting, in collaboration with the National Institute of Environmental Health Sciences and the Food and Drug Administration, which are entitled: 1) Examination of thimerosal pharmacokinetics and tissue distribution in rodents and non-human primates; and 2) Evaluation of the levels of mercury in the blood of infants vaccinated with thimerosal containing and non-containing vaccines.
Dr. Heilman also reported on the Division's involvement in the development of a Public Health Service (PHS) Influenza Pandemic Plan, and informed the Subcommittee that the PHS Antimicrobial Resistance Action Plan was released earlier in the month. The latter is a joint NIH-FDA-CDC effort; Dr. Dennis Dixon, Chief of DMID's Bacteriology and Mycology Branch, served as the NIH Chair. Ten other Federal agencies also played a role in the development of the Plan, which lays out a comprehensive approach to addressing antimicrobial resistance and identifies a series of related action items, many of which relate to research. Dr. Heilman encouraged the Subcommittee to review the Plan via NIAID's Web site (www.niaid.nih.gov). She also noted a few upcoming meetings, including the annual topical microbicides workshop, a review of the Collaborative Antiviral Studies Group, and an IOM meeting designed to follow-up on their 1992 emerging and re-emerging diseases report. Finally, Dr. Heilman reported on impending changes in the Division's Biometry Program. Current plans would entail the consolidation of all NIAID biostatisians and biometricians into one cohesive group under the Office of the Director, serving all four research divisions.
Following the Director's Report, Dr. Ginsberg presented a new DMID research initiative for the Subcommittee's consideration: Partnerships for Novel Therapeutic and Vector Control Strategies in Infectious Diseases. A key component of this initiative is the development of partnerships among government, academia, and the biotechnology and pharmaceutical industries. All academic applications must have industry partners. Partnerships with EPA, USDA or NIEHS would also be possible. The Subcommittee was interested in knowing whether or not NIH had any history or experience with such partnerships and if so, how they had worked. The best experience with a similar program is the Challenge Grants Program, which is relatively new. The Challenge Grants Program is focused on areas of public health priority but low industry interest. Feedback to NIH from industry is that they see this type of program as important and effective in raising private sector interest in these areas.
The Subcommittee questioned how intellectual property rights issues would be handled. To address this issue a plan for intellectual property rights will be requested as part of the application package. The second part of the initiative that addresses vector control issues comes at a time when there is a great need to find safer control strategies for arthropod vectors. Since this initiative involves partnerships with industry and the conclusion of a recent meeting is that pesticide development requires a stronger public/private partnership, this initiative appears to be a good way to address this need. The Subcommittee expressed enthusiasm for the inclusion of diagnostics development as part of this initiative. The Subcommittee unanimously approved the initiative.
Dr. Phillip Baker, DMID's Lyme Disease Program Officer, then provided the Subcommittee with a report on two DMID-supported placebo-controlled clinical studies under a contract awarded to Dr. Mark Klempner at the New England Medical Center. The studies were testing the safety and efficacy of intensive antibiotic treatment in people with Lyme disease who had developed chronic symptoms despite earlier treatment with antibiotics. Another major objective of the study was to determine whether there is any evidence of persistent infection in patients. Dr. Baker reported that on November 14, 2000 the study's Data Safety and Monitoring Board recommended that NIAID terminate the treatment component of both trials because a planned interim analysis showed no significant difference in the percentage of the patients who felt their symptoms had improved, gotten worse, or stayed the same between the antibiotic treatment and placebo groups in either trial. The Principal Investigator's full report of this study will be published in the near future. Dr. Heilman acknowledged the rich contributions of Lyme disease patients and advocates who have lent considerable assistance to this important research effort and indicated that Dr. Klempner will continue to follow participants to address other study objectives.
Following a brief break, Dr. James Meegan, Program Officer for Acute Viral Diseases, and Dr. Baker, who provided an update on the Institute's bioterrorism research activities. Dr. Meegan provided background on the Institute's involvement in bioterrorism-related research, which currently focuses on smallpox and anthrax, and addresses basic research, development of antiviral drugs, and genomics research. In recent years, the Institute has released four requests for applications (RFAs) to stimulate research in these areas. Dr. Meegan also provided preliminary results of a current smallpox vaccine study being conducted at the St. Louis Vaccine and Treatment Evaluation Unit, in which the investigators are examining the effectiveness of diluted smallpox vaccines. He indicated that the first study considered undiluted, 1:10 dilution and 1:100 dilution vaccines. Discussions are underway to consider other possible ways to learn more about the effectiveness of this approach.
Finally, Dr. Pamela McInnes, DMID's Deputy Director, presented an overview of DMID's clinical research program, beginning with a historical perspective on how the current clinical infrastructure was formed, and addressing DMID's response to the plethora of recent NIH changes related to clinical research activities. As a result of the influx of new standards in clinical research, Dr. McInnes described DMID's recent establishment of a central clinical research core group that will serve as a hub for discussion, debate and development of standard practices. She described the newly-established Offices of Clinical Research Affairs and the Office of Regulatory Affairs, which will work together to coordinate and interface with all of the individual programs within the branches to implement these new guidelines and procedures. Dr. McInnes also briefly reported on the activities of several working groups in the division that were formed to consider a host of clinical research issues and acknowledged staff contributions in this regard. back to top |