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4 IMPACTS ON BIOMEDICAL AND HEALTH RESEARCH
Pages 25-36

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From page 25...
... REVIEWING THE LITERATURE ON HEALTH IMPACTS Bhaven Sampat, Assistant Professor of Public Health at Columbia University, presented a brief summary of a commissioned paper (Appendix D) that discusses representative studies of the effects of publicly funded biomedical research on a range of outcomes.
From page 26...
... Since the Bayh-Dole Act of 1980, these prototypes have tended to be developed in universities and licensed out to firms to turn them into successful products. A third channel includes funding for clinical trials and clinical research that informs clinical practice -- such as the knowledge that doctors should give people an aspirin after a heart attack -- along with funding of other applications-oriented work, such as contracts to fund the development of technologies and to conduct consensus conferences.
From page 27...
... For both forms of research, there are challenges linking R and D to health outcomes, Sampat observed. Another line of research regarding private sector R and D is whether proximity to public sector scientists makes firms more productive.
From page 28...
... Very recent studies have used accounting methodologies to look at, for example, the impact of public sector R and D in producing drugs that are then marketed. In a study of drugs in FDA's Orange Book, about 10 percent of marketed drugs come from universities or public laboratories, meaning that these institutions hold key patents (Sampat and Lichtenberg, 2011)
From page 29...
... THE VOLATILITY OF FEDERAL R AND D SUPPORT Richard Freeman, Herbert Ascherman Chair in Economics at Harvard University, addressed the unintended effects of variability in federal government funding for R and D Using changes in the budgets of the National Institutes of Health as an example, Freeman said that chief among these effects is the damage done to people's careers by changes in grant rejection rates and increased uncertainty about future career prospects.
From page 30...
... Further, basic and applied research tend to be artificially divided, but anything that is an innovation is going to go back and forth between the two categories of research, Freeman observed. MEDICAL DEVICE INNOVATION Many people assume that the development of biomedical devices is similar to drugs, said Paul Citron, retired Vice-President at Medtronic, Inc., and now at the University of California, San Diego; but in fact "they have very different characteristics as they traverse the pathway from bench to bedside." Drugs tend to be more discovery-based and derived from in-house activity.
From page 31...
... Typically thousands of compounds are synthesized to yield just a few potential candidates that enter preclinical study, and for every five thousand to ten thousand synthesized compounds, one approved drug on average may emerge. And for many reasons, the costs to develop new drugs have risen precipitously, which is further complicated by the fact that fewer drugs are commercially successful "Despite all this, we continue to press very hard because we recognize that there is unmet need and there are
From page 32...
... The United States should invest in an infrastructure akin to the Internet or the interstate highway system in which it would be possible to enroll patients in clinical trials much more rapidly, whether for drug trials, observational studies, investigations of medical devices, or other research. Only 3 percent of cancer patients enroll in clinical trials today.
From page 33...
... " RESEARCH AND OUTCOMES CASE STUDY: PEDIATRIC HIV Laura Guay, Research Professor at the George Washington University School of Public Health and Health Services, provided a perspective on research funding and evaluation by a philanthropic foundation. As vice president for research, she spoke about the work of the Elizabeth Glaser Pediatric AIDS Foundation, founded in 1988 to prevent HIV infection and eliminate AIDS among children in the United States and abroad through research, advocacy, and treatment programs.
From page 34...
... This dramatic outcome depended on progress dating to well before that date in human capacity, laboratory capacity, and clinical capacity, Guay observed. It is important to consider "all of the pieces that had to be in place" as "we continue to eliminate pediatric HIV in the rest of the world." Sampat asked how the Glaser Foundation allocates funds among basic studies, vaccine development, and operations research, and Guay said that in the early years the foundation considered its funds unrestricted.
From page 35...
... SOURCE: Guay, 2011 DISCUSSION Given the "exceptional return" of HIV-AIDS research in the United States, "we need more case studies on failures" to figure out why some research avenues have not been more productive, said Sampat. Also, in evaluating the outcomes of public sector health research, it is hard to aggregate across disease areas.
From page 36...
... 36 MEASURING THE IMPACTS OF FEDERAL INVESTMENTS IN RESEARCH the biggest success in preventing cancer has been behavioral, with regulatory, marketing, and other factors all working to reduce smoking. Citron pointed out that that over time the optimal ratio of biomedical research to behavioral change could change.


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