Computers, a many orders of magnitude decline in DNA sequencing costs, big advances in knowledge of how genes, cells, and organisms function, and the growth in microfluidics technology have not increased the rate at which new therapies come to market.
The general public funds the vast majority of biomedical research and is also the major intended beneficiary of biomedical breakthroughs. We show that increasing research investments, resulting in an increasing knowledge base, have not yielded comparative gains in certain health outcomes over the last five decades. We demonstrate that monitoring scientific inputs, outputs, and outcomes can be used to estimate the productivity of the biomedical research enterprise and may be useful in assessing future reforms and policy changes. A wide variety of negative pressures on the scientific enterprise may be contributing to a relative slowing of biomedical therapeutic innovation. Slowed biomedical research outcomes have the potential to undermine confidence in science, with widespread implications for research funding and public health.
This is a problem.
Society makes substantial investments in biomedical research, searching for ways to better human health. The product of this research is principally information published in scientific journals. Continued investment in science relies on society’s confidence in the accuracy, honesty, and utility of research results. A recent focus on productivity has dominated the competitive evaluation of scientists, creating incentives to maximize publication numbers, citation counts, and publications in high-impact journals. Some studies have also suggested a decreasing quality in the published literature. The efficiency of society’s investments in biomedical research, in terms of improved health outcomes, has not been studied. We show that biomedical research outcomes over the last five decades, as estimated by both life expectancy and New Molecular Entities approved by the Food and Drug Administration, have remained relatively constant despite rising resource inputs and scientific knowledge. Research investments by the National Institutes of Health over this time correlate with publication and author numbers but not with the numerical development of novel therapeutics. We consider several possibilities for the growing input-outcome disparity including the prior elimination of easier research questions, increasing specialization, overreliance on reductionism, a disproportionate emphasis on scientific outputs, and other negative pressures on the scientific enterprise. Monitoring the efficiency of research investments in producing positive societal outcomes may be a useful mechanism for weighing the efficacy of reforms to the scientific enterprise. Understanding the causes of the increasing input-outcome disparity in biomedical research may improve society’s confidence in science and provide support for growing future research investments.
If US FDA and NIH policies are a large part of the problem then that is very unfortunate. They are not likely to change, especially not the FDA.
Why does this matter? Our lives depend on the rate of advance of biomedical treatments. We all have an expiration date on our bodies absent some really big advances in methods to rejuvenate aging bodies. How many decades do you have left to live? Not as many as you would have if only increased spending on biomedical research had translated into a more rapid rate of progress in the development of gene therapies, cell therapies, and other therapies needed for tissue repair and rejuvenation.
Update: The US FDA errs far too much on side of avoiding approval of a bad drug and as a consequence it blocks development of good drugs.
|Share |||Randall Parker, 2015 August 17 10:21 PM|