Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas

et al. (2009) Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas. PLoS ONE 4(9): e7015. doi:10.1371/journal.pone.0007015 Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas E. Ray Dorsey 0 Joel P. Thompson 0 Melisa Carrasco 0 Jason de Roulet 0 Philip Vitticore 0 Sean Nicholson 0 S. Claiborne Johnston 0 Robert G. Holloway 0 Hamilton Moses III 0 Pedro R. Lowenstein, Cedars-Sinai Medical Center and University of California Los Angeles, United States of America 0 1 Department of Neurology, University of Rochester Medical Center , Rochester , New York, United States of America, 2 School of Medicine & Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, United States of America, 3 School of Medicine and Dentistry, University of Rochester , Rochester , New York, United States of America, 4 University Hospitals, Case Medical Center , Cleveland , Ohio, United States of America, 5 Department of Policy Analysis and Management, Cornell University , Ithaca , New York, United States of America, 6 Department of Neurology, University of California San Francisco , San Francisco , California, United States of America, 7 The Alerion Institute, North Garden, Virginia, United States of America, 8 Johns Hopkins University School of Medicine , Baltimore, Maryland , United States of America Background: We estimated U.S. biomedical research funding across therapeutic areas, determined the association with disease burden, and evaluated new drug approvals that resulted from this investment. Methodology/Principal Findings: We calculated funding from 1995 to 2005 and totaled Food and Drug Administration approvals in eight therapeutic areas (cardiovascular, endocrine, gastrointestinal, genitourinary, HIV/AIDS, infectious disease excluding HIV, oncology, and respiratory) primarily using public data. We then calculated correlations between funding, published estimates of disease burden, and drug approvals. Financial support for biomedical research from 1995 to 2005 increased across all therapeutic areas between 43% and 369%. Industry was the principal funder of all areas except HIV/ AIDS, infectious disease, and oncology, which were chiefly sponsored by the National Institutes of Health (NIH). Total (r = 0.70; P = .03) and industry funding (r = 0.69; P = .04) were correlated with projected disease burden in high income countries while NIH support (r = 0.80; P = .01) was correlated with projected disease burden globally. From 1995 to 2005 the number of new approvals was flat or declined across therapeutic areas, and over an 8-year lag period, neither total nor industry funding was correlated with future approvals. Conclusions/Significance: Across therapeutic areas, biomedical research funding increased substantially, appears aligned with disease burden in high income countries, but is not linked to new drug approvals. The translational gap between funding and new therapies is affecting all of medicine, and remedies must include changes beyond additional financial investment. - Funding: Dr. Dorsey was supported by an American Academy of Neurology Clinical Research Training Fellowship, and this publication was made possible by Grant Number KL2 RR024136 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Information on NCRR is available at http://www.ncrr.nih.gov. Information on Re-engineering the Clinical Research Enterprise can be obtained from http://nihroadmap.nih.gov/ clinical research/overview-translational.asp. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: Dr. Moses advises academic medical centers, foundations, and pharmaceutical companies as chairman of Alerion Advisors, and was previously a partner of the Boston Consulting Group. Biomedical research in the United States has been the beneficiary of investment by many public and private sources. This investment reflects its importance to society, whether measured by human suffering and the burden of disease or by commercial and economic terms. Current total annual funding for biomedical research in the U.S. is approximately $100 billion, and over the past decade has tripled in nominal dollars and doubled after adjusting for inflation [1,2]. However, the rise in funding has not been mirrored by an increase in new therapies [2]. Within each therapeutic area in medicine (e.g., oncology, cardiology), the sources of funds, their relationship to disease burden, and the number of recently developed therapies is generally not known. Therefore, we sought to (1) estimate U.S. funding by therapeutic area, (2) determine whether this funding is aligned with disease burden, and (3) evaluate whether this investment has translated into therapeutic advances. Comparing the productivity of biomedical research across therapeutic areas will help guide and inform private investments and public research policy [3,4]. Therapeutic Areas Examined We selected based on available data and defined nine therapeutic areas within medicine (cardiovascular, endocrine, gastrointestinal, genitourinary, HIV/AIDS, infectious disease excluding HIV, neuroscience, oncology, and respiratory) based on U.S. Bureau of Census Industrial Report product codes for pharmaceutical preparations, except biologicals [5]. For neuroscience, we used previously published data [6] but revised the National Institutes of Health (NIH) funding estimates to exclude HIV/AIDS research. With the exception of HIV/AIDS, each therapeutic area was broad and included multiple medical conditions. For example, funding for neuroscience included funding directed at neurological disorders (e.g., stroke, Parkinson disease), mental health (e.g., depression, schizophrenia), substance abuse, and sensory organs besides skin. Biomedical Research Funding by Therapeutic Area National Institutes of Health. We allocated NIH funding by assigning each Institutes annual appropriation to a therapeutic area (e.g. appropriations for the National Cancer Institute were assigned to oncology) [7]. We allocated appropriations for Institutes that covered multiple therapeutic areas based on funding for disease divisions within each Institute, as outlined in each Institutes Congressional Budget Justification. We quantified HIV/AIDS research support from Office of AIDS Research Congressional Budget Justifications (19982005) [8] and its budget office (19951997) (Wendy Wertheimer, Office of AIDS Research Information Dissemination, historical data, 2007). We estimated infectious disease research funding excluding HIV using appropriations for the National Institute of Allergy and Infectious Disease and the J (...truncated)