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


RESULTS
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.


CONCLUSIONS
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.
Dorsey
E Ray
ER
Department of Neurology, University of Rochester Medical Center, Rochester, New York, United States of America. ray.dorsey@ctcc.rochester.edu
Thompson
Joel P
JP
Carrasco
Melisa
M
de Roulet
Jason
J
Vitticore
Philip
P
Nicholson
Sean
S
Johnston
S Claiborne
SC
Holloway
Robert G
RG
Moses
Hamilton
H
D035843:Biomedical Research / Q000191:economics*; D004194:Disease / Q000145:classification* / Q000191:economics; D017277:Drug Approval / Q000191:economics*; D035082:Federal Government; D005380:Financing, Government / Q000706:statistics & numerical data; D006077:Government Agencies; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000191:economics*; D012109:Research Support as Topic / Q000706:statistics & numerical data; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration