20 September 2010
Dr. Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
31 Center Drive, Building 31, Room 7A03
Bethesda, MD 20892
Dear Dr. Fauci:
The many complications and comorbidities faced by the aging population of HIV-positive people in the United States constitute a rapidly growing medical crisis that has been woefully neglected by U.S. research efforts. According to the Centers for Disease Control, more than half of all HIV-positive Americans will be over the age of 50 by or before the year 2015. Although increasing evidence points to an earlier onset of age- related conditions in people living with HIV little is known about pathogenesis, or proper methods to screen for, prevent and manage these conditions, or anticipate the infrastructure needed to deliver care and treatment for people suffering from these conditions.
We, the undersigned organizations, advocates, and people living with HIV, fear a reversal of recent scientific gains made against HIV may occur if this emergency is not immediately elevated to a top research priority by the NIAID and other NIH institutes and centers. We are extremely concerned that NIAID's current research priorities underplay the potential long-term health impact of dysregulated T cell homeostasis in people with HIV, which in many cases is not addressed by ART-mediated viral suppression. We expect an increase in morbidity and mortality for people living long-term with HIV, particularly those who started antiretroviral therapy with a CD4 nadir below the threshold at which initiation of antiretroviral therapy is recommended—which includes almost everyone in resource-poor settings—and people with additional risk factors, regardless of chronological age.
The complex interactions between HIV infection, premature aging, immune dysregulation, long-term drug toxicities, coinfections, and comorbidites in various organ systems pose an unprecedented research challenge. This challenge can only be met through a coordinated, multi-disciplinary collaboration across research institutes, which has yet to be created. For example, the “Medical Management of Older Patients with HIV/AIDS” Program Announcement released in 2008 has yielded only three grants to date, totaling less than 1.5 million dollars in funding. Unless adequate funding is set aside, and an appropriate grant review process is in place, desperately needed research on HIV and aging will not occur. A business-as-usual approach to research will not work; this issue is urgent.
We urge the NIAID to immediately:
• Provide the necessary leadership to create a new funding initiative on HIV and aging, in partnership with other relevant Institutes and Centers within NIH. This initiative will identify existing funding that can be set aside for RFAs and RFPs starting in FY 2011, and include significant and long-term funding increases for HIV and aging research in the FY 2012 budget request to Congress;
• Issue a Request for Information and Ideas (RFI) and rapidly establish a special review panel on HIV and aging with reviewers that have expertise across all relevant disciplines in order to streamline the grant making process;
• Identify HIV and aging as a new and distinct future HIV/AIDS therapeutics research priority area for the upcoming network restructuring process;
• Establish one or more large-scale, well-characterized longitudinal cohort of people with HIV with matching HIV-negative controls, and seek out innovative approaches to assess AIDS and aging-related issues from within existing clinical trials networks, existing cohorts, collaborative groups, and Phase IV post-marketing trials to help develop and standardize biomarkers, and characterize relevant AIDS and aging events;
• Create a new aging working group within the AACTG, similar to the one created for lipodystrophy more than a decade ago, to spur new studies on badly needed interventions and preventive measures for aging related complications;
• Ensure cohorts of perinatally infected children are supported to investigate the incidence of, and risk factors for, aging-associated diseases. Furthermore, mandate coordination with the AACTG and INSIGHT networks to study therapeutic and preventive interventions in this unique population.
Lastly, we call on NIAID, along with the other institutes and centers, and in collaboration with the Office of AIDS Research, to immediately commit significant financial and organizational resources to develop a detailed and long-term research plan on HIV and aging. We insist upon full and immediate community participation in all stages of planning for this research, utilizing the experience, knowledge and commitment of HIV/AIDS community activists. We hereby firmly request a meeting with the leadership at NIAID, OAR, DAIDS, and all other relevant ICs to discuss the immediate course change in HIV and aging research at the NIH.
Sincerely,
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[List in formation]
Coalition for HIV and Aging Research and Policy Advocacy (CHARPA)
Cc:
Francis S. Collins, M.D., Ph.D., Director, NIH
Jack Whitescarver, Ph.D., Director, OAR, NIH
Carl Dieffenbach, Ph.D., Director, DAIDS, NIAID, NIH
Harold E. Varmus, M.D., Director, National Cancer Institute (NCI)
Susan B. Shurin, M.D., Director, National Heart, Lung, and Blood Institute (NHLBI)
Eric D. Green, M.D., Ph.D., Director, National Human Genome Research Institute (NHGRI)
Richard Hodes, M.D., Director, National Institute on Aging (NIA)
Kenneth R. Warren, Ph.D., Director, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Stephen Katz, M.D., Ph.D., Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Roderic I. Pettigrew, M.D., Ph.D., Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Alan E. Guttmacher, M.D., Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse (NIDA)
Thomas R. Insel, M.D., Director, National Institute of Mental Health (NIMH)
Story Landis, Ph.D., Director, National Institute of Neurological Disorders and Stroke (NINDS)
Patricia Grady, Ph.D., R.N., F.A.A.N., Director, National Institute of Nursing Research (NINR)
Antonio Scarpa, M.D., Ph.D., Director, Center for Scientific Review (CSR)
Josephine P. Briggs, M.D., Director, National Center for Complementary and Alternative Medicine (NCCAM)
John Ruffin, Ph.D., Director, National Center on Minority Health and Health Disparities (NCMHD)
Barbara M. Alving , M.D., Director, National Center for Research Resources (NCRR)
John I. Gallin, M.D., Director, NIH Clinical Center (CC)