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

Abstract

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

Big Science vs. Little Science: How Scientific Impact Scales with Funding

“…Further, our study ignored aspects of scientific impact such as books, patents, training of students, etc. However, Dorsey et al [16] found similarly weak relationships between funding of biomedical research and new drug approvals, presumably another measure of impact.…”

The Commercialization of Research and the Quest for the Objectivity of Science

“…The pharmaceutical industry is the biggest sponsor of biomedical research in all therapeutic areas, except for research on HIV, infectious disease and oncology (Dorsey et al 2009). Wyatt and Midkiff (2006) and Musschenga et al (2010) have argued that this fact has contributed to lack of epistemic diversity in psychiatry, where the dominant approach is based on the assumption that mental illnesses are caused by genetic defects, chemical imbalances and other biological phenomena.…”

Empirical Philosophy of Science

“…Pharmaceutical companies fund approximately 60 % of medical research (Musschenga et al 2010). In a study conducted by Dorsey et al (2009), the industry was found to be the biggest sponsor of biomedical research across all therapeutic areas, excluding the research on HIV/AIDS, infectious disease research and oncology. Therefore the field is highly influenced by the decisions made by industry.…”