Financing of U.S. biomedical research and new drug approvals across therapeutic areas

• Published in: PloS one Vol. 4; no. 9; p. e7015
• Main Authors: Dorsey, E Ray, Thompson, Joel P, Carrasco, Melisa, de Roulet, Jason, Vitticore, Philip, Nicholson, Sean, Johnston, S Claiborne, Holloway, Robert G, Moses, 3rd, Hamilton
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 11.09.2009; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; AIDS; Biomedical Research - economics; Budgets; Cardiovascular Disorders; Communicable diseases; Correlation; Disease - classification; Disease - economics; Drug Approval - economics; Evidence-Based Healthcare/Health Services Research and Economics; Federal Government; Financing; Financing, Government - statistics & numerical data; Funding; Government Agencies; Health aspects; HIV; Human immunodeficiency virus; Humans; Income; Infectious diseases; Infectious Diseases/HIV Infection and AIDS; Innovations; Investment; Mathematical analysis; Medical research; National Institutes of Health (U.S.) - economics; Oncology; Productivity; Public Health and Epidemiology/Health Policy; Research funding; Research Support as Topic - statistics & numerical data; Science Policy; Time Factors; United States; United States Food and Drug Administration; United States; New York; San Francisco California; California; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0007015

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. 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 (rho = 0.70; P = .03) and industry funding (rho = 0.69; P = .04) were correlated with projected disease burden in high income countries while NIH support (rho = 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. 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.