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Colleagues,

As reported in numerous publications ... "With the exception of the American Recovery and Reinvestment Act (ARRA/Stimulus), funding support for biomedical research in the United States has slowed after a decade of doubling," writes E. Ray Dorsey, MD, MBA, from University of Rochester Medical Center in New York, and colleagues in a study published recently in the Journal of the American Medical Association...

... "Looking back at this period, one of the striking observations is that while research funding increased, the number of novel treatments entering the market remained steady." said Dr. Dorsey ...

... The authors compiled data from government sources, trade organizations, and industry financial reports to create a profile of biomedical research funding from 2003 to 2007...

... The study is a follow-up to a similar analysis published in 2005 by the same authors that showed that biomedical research funding from all sources had tripled in nominal value and doubled when adjusted for inflation between 1994 and 2003...

... The growth in research funding that began in the 1990s fueled a significant expansion in academic research and many universities became engines for economic growth in their communities. Consequently, the deceleration in research funding could have a profound effect on communities where academic research, health care, and biotechnology have become major economic players...

Approval of New Drugs and Devices Stagnant


... While funding has generally increased over the period examined, this growth has not been accompanied by an increase in the number of new drug and device approvals by the U.S. Food and Drug Administration (FDA). For example, the number of new molecular entities, essentially drugs that have not been marketed in the U.S. previously, approved by the FDA in 2003 was 21 and in 2008 was 17. Similar trends were observed for new biologics, as measured by biologic license applications, and devices, as measured by device pre-market application approvals...

... "The current model is not working well if the desire is to approve new novel therapies to improve health. We need to modify incentives to reward risk and increase support for companies pursuing early stage and innovative research", said Dorsey...

... Increasingly, the model for drug development has the pharmaceutical industry devoting a large portion of its spending for late-stage clinical trials as opposed to drug discovery research. The large pharmaceutical companies have largely abdicated the role of early stage research and development to smaller companies that often serve as the bridge between academic research and the market. These smaller companies, in turn, then develop relationships (either through partnerships or acquisitions) with larger companies once they have proven they have a viable product. However, these smaller firms, with limited resources and capital, face considerable risk and increasing pressures to generate promising results in short time frames from impatient markets...

Biomedical vs. Health Services Research

... The analysis also reveals that health services research represents a small fraction of the nation's health care spending. This research – which is funded by foundations and federal agencies such as the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, NIH, and the Center for Medicare and Medicaid Services – is intended to improve health care quality and access and control costs by examining the impact of financial, social, technological, and organizational factors on public health...

... The study's authors contend that ... spending on health services research, which was $2.2 billion in 2008, is inadequate... "We spend almost $5 for every $100 in national health expenditures on biomedical research, but we spend less than a dime on ensuring those treatments reach the right people and the right time," said Dorsey...

Industry Funding Up, NIH Funding Shrinks

... Industry – pharmaceutical, biotechnology, and medical device firms – supplies the largest proportion of total research spending at 58%, followed by the federal government at 33%. Industry research and development funding increased by 25% between 2003 and 2007 with growth in research activity by medical device (59%) and biotechnology companies (41%) significantly outpacing pharmaceutical companies (14%)...

... The study found that funding from the National Institutes of Health – which is by far the single largest supporter of biomedical research – decreased by 12% between 2003 and 2008 when adjusted for inflation...

... Additional authors of the report, funded by the NIH National Center for Research Resources , include: Christopher Beck, Ph.D., Jason Reminick, Benjamin George, Zachary White-Stellato all with the University of Rochester; Jason de Roulet, M.D. with University Hospitals Case Medical Center; Joel Thompson, M.P.H. with the University of Buffalo School of Medicine and Biomedical Sciences; and Hamilton Moses III, M.D. and Ashley Thai with Johns Hopkins University School of Medicine...

Read on at: http://www.urmc.rochester.edu/news/story/index.cfm?id=2736

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