Biomedical research in the USA: at the dawn of a golden age?

Abstract

On Dec 16, 2015, at the request of Congress, the US National Institutes of Health (NIH)—the largest source of medical funding in the world—officially released the NIH-Wide Strategic Plan, Fiscal Years 2016–2020: Turning Discovery Into Health. The plan is framed around NIH's mission of seeking and applying knowledge to enhance health, lengthen life, and reduce illness and disability in the context of future challenges and opportunities. It focuses on four essential, interdependent objectives: advancing opportunities in biomedical research in exploration of fundamental science, discovery of treatments and cures, and advancement of health promotion and disease prevention; fostering innovation by setting NIH priorities; enhancing scientific stewardship; and excelling as a federal science agency by managing results of scientific investments, outputs, training approaches and grant review process.Notably, regarding the traditional, non-statutory 10% set aside for HIV/AIDS research, the report pointed out that “NIH no longer sees the value in this formula-driven approach”, while the future priorities of HIV/AIDS research will centre on ending the AIDS pandemic, developing a cure for HIV/AIDS, taking care of people who are already infected, and achieving an AIDS-free generation.The plan concludes by listing potential advances that the agency will strive to deliver by 2020, such as the application of precision medicine to improve survival for many thousands of cancer patients and the launch of clinical trials for a universal flu vaccine. The plan acknowledges that the NIH needs to capitalise upon recent advances in biomedical research to continue—and to accelerate—its efforts to translate scientific discoveries into better health.However, to realise this vision, the major challenge for the NIH is the budget. The agency's budget has been declining since 2003 after adjusting for inflation, and has lost around 22% of its research purchasing power, which “has been a pretty painful experience for anyone who is depending on the NIH to support their research, including most academic researchers in the USA and a number who are outside our country”, NIH director Francis Collins told The Lancet last year. The shrinking budget slows scientific progress and damages long-term innovation. Additionally, there has been a decrease in NIH-funded trials registered in ClinicalTrials.gov from 2006 to 2014. Against this background, many wonder how NIH's ambitious objectives set in the strategic plan can be attained within the next 5 years.On Dec 18, however, Congress approved a federal spending bill with the biggest funding boost for the NIH in 12 years. The bill gives the agency a US$2 billion increase to $32·1 billion for fiscal year 2016, a 6·6% increase in its 2015 budget. The $2 billion funding increase includes $350 million dedicated to Alzheimer's research, $200 million for the Obama administration's Precision Medicine Initiative, an $85 million increase for the BRAIN Initiative (which aims to produce the revolutionary new dynamic picture of the human brain), and a $303 million increase for programmes to fight antibiotic-resistant bacteria. The boost is largely due to the efforts that Francis Collins has made to keep the NIH as politically neutral as possible, by working with both Democrats and Republicans to impress upon them how important funding is to keep the USA from slipping in research and development: a message that politicians have taken to heart. Aside from the NIH, there is an increase of funding for several other biomedical and public health agencies such as the US Food and Drug Administration (FDA), the National Science Foundation, and the Centers for Disease Control and Prevention (CDC) for 2016.The expansion in NIH's funding, together with the implementation of its strategic plan, will ensure biomedical research continues to thrive and might open a new era of science in the USA in 2016. Furthermore, the new plan and funds will have crucial implications in biomedical research beyond the USA. Some specific research areas highlighted in both the strategy and funding plan, such as combating antibiotic-resistant bacteria, require not only close collaboration between NIH and its domestic sister agencies (eg, the CDC and FDA), but also improved international partnerships, because addressing antibiotic resistance needs global solutions, and resistant strains that arise in one part of the world must be rapidly detected and contained at the source of emergence. The boost for the NIH at the end of 2015 represents a positive development for biomedical research in the USA. What is needed now is political commitment by candidates in the 2016 election campaigns to sustain America's pre-eminence in biomedical research. So far, most serious candidates have been ominously silent. On Dec 16, 2015, at the request of Congress, the US National Institutes of Health (NIH)—the largest source of medical funding in the world—officially released the NIH-Wide Strategic Plan, Fiscal Years 2016–2020: Turning Discovery Into Health. The plan is framed around NIH's mission of seeking and applying knowledge to enhance health, lengthen life, and reduce illness and disability in the context of future challenges and opportunities. It focuses on four essential, interdependent objectives: advancing opportunities in biomedical research in exploration of fundamental science, discovery of treatments and cures, and advancement of health promotion and disease prevention; fostering innovation by setting NIH priorities; enhancing scientific stewardship; and excelling as a federal science agency by managing results of scientific investments, outputs, training approaches and grant review process. Notably, regarding the traditional, non-statutory 10% set aside for HIV/AIDS research, the report pointed out that “NIH no longer sees the value in this formula-driven approach”, while the future priorities of HIV/AIDS research will centre on ending the AIDS pandemic, developing a cure for HIV/AIDS, taking care of people who are already infected, and achieving an AIDS-free generation. The plan concludes by listing potential advances that the agency will strive to deliver by 2020, such as the application of precision medicine to improve survival for many thousands of cancer patients and the launch of clinical trials for a universal flu vaccine. The plan acknowledges that the NIH needs to capitalise upon recent advances in biomedical research to continue—and to accelerate—its efforts to translate scientific discoveries into better health. However, to realise this vision, the major challenge for the NIH is the budget. The agency's budget has been declining since 2003 after adjusting for inflation, and has lost around 22% of its research purchasing power, which “has been a pretty painful experience for anyone who is depending on the NIH to support their research, including most academic researchers in the USA and a number who are outside our country”, NIH director Francis Collins told The Lancet last year. The shrinking budget slows scientific progress and damages long-term innovation. Additionally, there has been a decrease in NIH-funded trials registered in ClinicalTrials.gov from 2006 to 2014. Against this background, many wonder how NIH's ambitious objectives set in the strategic plan can be attained within the next 5 years. On Dec 18, however, Congress approved a federal spending bill with the biggest funding boost for the NIH in 12 years. The bill gives the agency a US$2 billion increase to $32·1 billion for fiscal year 2016, a 6·6% increase in its 2015 budget. The $2 billion funding increase includes $350 million dedicated to Alzheimer's research, $200 million for the Obama administration's Precision Medicine Initiative, an $85 million increase for the BRAIN Initiative (which aims to produce the revolutionary new dynamic picture of the human brain), and a $303 million increase for programmes to fight antibiotic-resistant bacteria. The boost is largely due to the efforts that Francis Collins has made to keep the NIH as politically neutral as possible, by working with both Democrats and Republicans to impress upon them how important funding is to keep the USA from slipping in research and development: a message that politicians have taken to heart. Aside from the NIH, there is an increase of funding for several other biomedical and public health agencies such as the US Food and Drug Administration (FDA), the National Science Foundation, and the Centers for Disease Control and Prevention (CDC) for 2016. The expansion in NIH's funding, together with the implementation of its strategic plan, will ensure biomedical research continues to thrive and might open a new era of science in the USA in 2016. Furthermore, the new plan and funds will have crucial implications in biomedical research beyond the USA. Some specific research areas highlighted in both the strategy and funding plan, such as combating antibiotic-resistant bacteria, require not only close collaboration between NIH and its domestic sister agencies (eg, the CDC and FDA), but also improved international partnerships, because addressing antibiotic resistance needs global solutions, and resistant strains that arise in one part of the world must be rapidly detected and contained at the source of emergence. The boost for the NIH at the end of 2015 represents a positive development for biomedical research in the USA. What is needed now is political commitment by candidates in the 2016 election campaigns to sustain America's pre-eminence in biomedical research. So far, most serious candidates have been ominously silent.