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DEPARTMENT OF HEALTH & HUMAN SERVICES Oct. 31, 2003
Public Health Service Dear Dr. Darling: On behalf of Dr. Elias Zerhouni, I am responding to your letter of September 8, and your offer to serve on a panel to study changing the method of allocating research funding to specific diseases. NIH has given a tremendous amount of thought to research priority setting over the years and much has been written about the process. I know that in May 2001, Susan Quantius, former Associate Director for Budget, NIH sent you a copy of the pamphlet Setting Research Priorities at the National Institutes of Health and summarized a number of points regarding the NIH priority setting process and the burden associated with HIV/AIDS. The NIH research priority setting system has been the subject of considerable Congressional scrutiny. Ms. Quantius also sent you a copy of the Institute of Medicine Report, Scientific Opportunities and Public Needs, prepared at the request of Congress. The 10M committee concluded that the major criteria that NIH uses in its overall priority setting "...are generally reasonable and useful both for allocating research resources and for enabling organized interest groups, members of Congress, and members of the public to understand and evaluate NIH's programs." The 10M also made a number of recommendations to improve the priority setting process which NIH has implemented. Consequently, NIH has no immediate plans to formally evaluate and reshape the priority setting process. We recognize that some people share your belief that there should be more of a correlation between the allocation of funding by disease and the distribution of disease burden. Without repeating much of what Ms. Quantius said in her May 2001 letter, I would like to emphasize a few points. I assure you that NIH does consider the burden of illness as it considers research priorities. Empirical evidence of this correlation was documented in an article published in the New England Journal of Medicine, 1999.[1] However, there is no simple formula for allocating funds to disease-specific research. Page 2 - Richard Darling, DDS Research and the NIH priority process are inherently dynamic. They develop and adjust to new public health challenges and opportunities. The distribution of funding for any year is but a snapshot of an evolving process. The manifest relationship between scientific opportunities, burden of illness and disease-specific funding is multifaceted and not always straightforward or linear. Once an emerging health problem is identified, the amount of disease-specific funding is largely determined by the state of the science. If previous basic research or related disease-specific research suggests promising hypotheses to explore, more disease-specific research, development and clinical evaluation may be proposed and, ultimately, funded. The relatively rapid advance of research on HIV / AIDS built on extensive knowledge of retroviruses and the immune system is a recent, striking example of capitalizing on findings from previous research. If more gaps in knowledge than opportunities are identified, the most productive next step may be to initiate more targeted basic research until new scientific opportunities are identified. Hence we must continually evaluate what is known, what is not known, and what we need to know to solve the problem before us - identifying knowledge gaps and developing the roadmap to solutions. The amount of NIH funding identified with a particular disease incompletely indicates the attention paid to that condition. Disease-specific funding fails to reflect the potential benefits of basic research or research coded to other conditions. Approximately half of the total NIH budget is devoted to basic science, which can potentially have benefit for many diseases and areas of investigation. New scientific opportunities often flow from NIH-sponsored research on broad scientific themes (such as genome projects, development of instrumentation, training in clinical research, or developments in basic science). Historically, support of these themes has often yielded unique insights and capacity to stimulate research to address specific diseases. I emphasize that disease burden includes more than a count of the number of deaths during a single year. NIH must also consider the incidence, severity, and economic costs of a disease as it judges the burden of a specific disorder, or we would never study chronic, non-life threatening conditions such as blindness, deafness, or arthritis. For priority setting, the major contribution of measures of burden is to identify trends, rather than to rank different conditions. Is there an emerging problem? Will it grow in the future? Has there been any progress in preventing a disease or managing a condition? As you have repeatedly focused your premise t on the statement that "allocations are grossly biased towards AIDS" compared to other diseases, I would like to address that issue directly. Your "proration" in that regard is problematic both in the numerator and denominator. You have chosen to use only deaths of Americans to determine your equation. To do so ignores the critical fact that AIDS is a global public health crisis that has already killed more than 22 million people around the world, and more than 42 million are currently living with HIV / AIDS. It is an infectious disease that is continuing to spread and, in some cases, to mutate, devastating communities and crucial socioeconomic infrastructures around the world. It has been declared a Page 3 - Richard Darling, DDS threat to our national security, and the United Nations General Assembly declared it "a global emergency and one of the most formidable challenges to human life and dignity...which undermines social and economic development throughout the world and affects all levels of society - national, community, family and the individual." As a new CIA report states, "The HIV / AIDS pandemic continues to spread around the world at an alarming rate, and the number of people with the disease will grow significantly by the end of the decade, as it becomes more geographically diffuse." ("Intelligence Community Assessment: The Next Wave of HIV/AIDS: Nigeria, Ethiopia, Russia, India, and China." CIA, 2002). The AIDS pandemic has an impact on business enterprises, households and families, agricultural production and famine, military preparedness, healthcare systems, education, economic growth, and political stability of nations around the world. A recent article in Foreign Affairs magazine states: "The spread of HIV/AIDS through Eurasia, in short, will assuredly qualify as a humanitarian tragedy - but it will be much more than that. The pandemic there stands to affect, and alter, the economic potential- and by extension, the military power - of the region's major states...... Over the decades ahead, in other words, HIV / AIDS is set to be a factor in the very balance of power within Eurasia - and thus in the relationship between Eurasian states and the rest of the world." ("The Future of AIDS," Foreign Affairs, November/December 2002.) Dramatic increases in HIV infection also are occurring in Eastern Europe, Central Asia, Latin America, and the Caribbean. The prorating formula does not account for the international impact of disease nor for the potential epidemic spread of an infectious disease. The Centers for Disease Control and Prevention (CD C) recently reported that more people were diagnosed with AIDS in the U.S. in 2001, the latest year for which reliable statistics are available, than the previous year, or any year since 1998. After years of sharp declines, thanks largely to successful treatment with new antiretroviral therapies (ART), this report indicates a reversal in cases of AIDS in the U.S. While these new drugs are extending the lives of HI V-infected individuals, use of ART has now been associated with a series of side effects and long-term complications that may have a negative impact on mortality rates. The appearance of multi-drug resistant strains of HIV presents an additional serious public health concern. Further, CDC reported that the rate of new HIV diagnoses, which had remained stable since 1990, also appears to be increasing. This means that the overall epidemic is continuing to expand in the U.S. NIH reports the total dollars allocated for AIDS somewhat differently than dollars for other diseases, as Federal law requires all AIDS-related dollars to be tracked across all NIH institutes. At least half of the total spending for AIDS research is actually basic science, which has been determined to be related to AIDS, but it may, in fact, benefit a myriad of other disease research areas. The basic research that underpins most other areas of research at NIH is not reported in the same way. Further, NIH research dollars reported as "AIDS" are actually much broader than that. Because AIDS affects virtually every organ system, with a myriad of associated infections, malignancies, and clinical complications, AIDS research dollars actually fund research on, for example, tuberculosis, Hepatitis, sexually transmitted diseases, human papilloma virus, nonHodgkins lymphomas, digestive diseases, and wasting, to name just a few. AIDS is not just one single disease entity; and AIDS-related research funds support a vast portfolio of research Page 4 - Richard Darling, DDS beyond AIDS. Thus the total NIH spending for "AIDS research" cannot be directly compared to spending for other diseases, such as Parkinson's disease, breast cancer, or autism, as the NIH dollars reported for diseases other than AIDS refer only to the research directly related to that disease. Another problem with the proration is that it fails to acknowledge the fact that spending for research on one disease often has tremendous benefit in other disease areas. Again, AIDS is a perfect example of that principle. Because of the unique nature of HIV - the way the virus enters a cell, causes infection, affects every organ system, and unleashes a myriad of opportunistic infections and cancers - and the pace at which the knowledge base has expanded, AIDS research also is unraveling the mysteries surrounding many other infectious, malignant, neurologic, autoimmune, and metabolic diseases. In addition to its direct and indirect medical applications, basic knowledge of the biology of HIV infection and how it causes AIDS benefits other areas of basic research including immunology, virology, microbiology, molecular biology, and genetics. The study of drugs to treat HIV infection and its complications also has helped to establish new approaches for the design and conduct of more rapid clinical studies, as well as those that address the special recruitment requirements of women, minorities, and other underserved populations. The AIDS drug development experience has not only benefited the development of treatments for other viral diseases, but also will hasten drug development efforts for bacterial, mycobacterial, and fungal diseases. For example, the drug known as 3TC, developed to treat HIV/AIDS, is now the most effective therapy for chronic hepatitis B infection. I note from your letter that you have suffered from hepatitis C. It may be of interest to you that development of combination therapy for HIV infection stimulated interest in utilizing combination therapy to treat hepatitis C virus (HCV) infection. Pegylated interferon, initially tested on HIV-infected patients with Kaposi's sarcoma, later was shown to be effective for the treatment of HCV infection. Drugs developed to prevent and treat AIDS-associated opportunistic infections also provide benefit to patients undergoing cancer chemotherapy or receiving anti-transplant rejection therapy. AIDS research also is providing a new understanding of the relationship between viruses and cancer. The human and economic toll of the AIDS pandemic is profound. It requires a unique response that is complex, comprehensive, multi-disciplinary, and global. The NIH role in this response is fundamental, unprecedented, and appropriate. A relatively recent example of the importance of identifiable trends is the recognition of the growing prevalence of obesity among U.S. adults and children. While not immediately manifest in increased mortality, we know from previous research that obesity is a risk factor for several killer diseases such as heart disease, stroke, and diabetes. Consequently, obesity is receiving more research attention and funding in recent years. NIH remains committed to sustaining and expanding ongoing initiatives and to devoting new resources to our most pressing research problems which capture both promising arenas of science and current and emerging public health need. As a Federal agency we will work to be more transparent about where we are going, how we are getting there, and why. All of this will Page 5 - Richard Darling, DDS [be] more transparent about where we are going, how we are getting there, and why. All of this will lead us to even more dynamic and adaptive management of the biomedical enterprise of our country. You might find the Offices of Public Liaison web site informative (see: http://getinvolved.nih.gov/) It includes information on the Director's Council of Public Representatives (COPR) and links to Public Liaison Office points of contact for each Institute and Center within the NIB. Together, the COPR and the Public Liaison Offices bring important matters of public interest forward for discussion and advises and assists in enhancing public participation in NIB activities and in increasing public understanding of the NIB. I hope this letter responds to your questions and communicates the care with which NIB approaches the complex challenge or research priority setting.
Sincerely,
Lana R. Skirboll, Ph.D. Director [1] ICary P. Gross, M.D., Gerard F. Anderson, Ph.D., and Neil R. Powe, M.D., M.P.H., M.B.A. "The Relation between Funding by the National Institutes of Health and the Burden of Disease" NEJM June 17, 1999 Volume 340, Number 24: 1881-1887. See also: Harold Varmus, M.D. "Evaluating the Burden of Disease and Spending the Research Dollars of the National Institutes of Health.” NEJM June 17, 1999 Volume 340, Number 24:1913-1915 |
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