ARRA and You (Part IVb): Challenge Grant Research Priorities. Currently, science administrators at NIH are allocating grant funds favoring proposals that have a high impact in biomedical or behavioral science and/or public health. Invariably, the 15 areas of priority that NIH has identified will influence the heath sector for years, so I present and discuss them around the nature of this influence.

1. I’ll address Behavior, Behavioral Change and Prevention research first, not only because it doesn’t fit neatly into the categories
   

   pdf available at www.jgi.doe.gov/education/posters.html

   that follow, but also because prevention is the beginning of health care. The question: Which has the greatest impact on health and disease? Nature or nurture? Inspires an argument that may be as old as time, itself. (Okay, I exaggerate, but only a little). As scientist have forged ahead making great strides in their understanding of nature through the sequencing of the entire human genome and the burgeoning discipline of genomics which has sprung forth as a result. They continue to struggle to elucidate the factors that influence behavior. Since the main diseases that plague us today (think heart disease, diabetes and cancer) are exacerbated by our behavior, this path of inquiry is truly worthy. The aim of this research is to better understand the factors that influence behavior, as well as the methods that have the most robust impact, changing behaviors to those that promote health and prevent disease. To date, prevention is still the most efficient and cost-effective option for alleviating the burden of suffering and disability brought on by disease.

Prevention through biomedical interventions has progressed well through this first decade of the new century. In fact, the next six research disciplines operate in concert. I believe the application of these cutting-edge 21st century technologies will transform the way we diagnose and treat disease bringing them to a personal and molecular level.

1. Let’s turn our attention to those highly debated Stem Cells. They
   

   Colour-enhanced scanning electron micrograph by Annie Cavanagh and Dave McCarthy. Winner of 2006 Biomedical Image Award (Wellcome Trust Medical Photographic Library)

   are simple, undifferentiated cells in the embryo or adult that have the potential to become any specialized cell in a living organism under the chemical influence of specific compounds and hormones. The aim of this research is to better understand the abnormal structure or function that causes disease. Cells with normal structure and function can be generated to replace diseased cells, through the process of culturing or growing them in the laboratory.

2. The area of Genomics aims to examine the entire DNA sequence (the instruction book, if you will, of all life processes) from the number of genes in a living organism to the function of specific genes. The goal is to see how they interact with one another and influence the biological processes of the body as a whole. Ultimately, genomics examines this genetic information to determine biological markers predisposing an individual to disease.
3. The aim of Biomarker Discovery and Validation research is to identify biomarkers (measurable biological molecules found in body fluids such as blood, or tissues that serve as a sign of a normal or abnormal biological processes). The presence or absence of a biomarker indicates a specific disease or response to a treatment for a disease.
4. The scientists at the McGowan Institute of Regenerative Medicine eloquently define regenerative medicine as “a new way of treating injuries and diseases that uses specially-grown tissues and cells (including stem cells), laboratory-made compounds, and artificial organs.” The aim of research in regenerative medicine is to examine these “approaches for ways to amplify the natural healing process in the places it’s needed most, or take over the function of a permanently damaged organ.”
5. The aim of research involving Smart Biomaterials and Theranostics (a term which combines the medical activities of diagnosis and therapy) is to elucidate the process of diagnostic therapy for individual patients. It involves testing them for possible reactions to a new medication and tailoring the treatment for the patient based on those test results. According to Daniel G. Anderson, a research scientist from MIT “such smart biomaterials are revolutionizing the design of medical devices and drug delivery systems. Gone are the days when medical devices had to be manufactured from off-the-shelf materials.”
6. Enabling Technologies are new technologies such as rapid point-of-care genotyping, computational and statistical methods for DNA sequencing and epigenetic molecules, that enhance the capabilities and performance of biomedical research.  The aim of this research is to use these technologies to improve diagnosis and treatment of disease.

These next five disciplines of research operate to improve the biomedical and clinical research enterprise overall.  Specifically, information technology and these older research methodologies will combine to increase health care system efficiency.

1. Research of Information Technology for Processing Health Care Data aims to make patient health care data readily available to providers in the health care setting enabling them to provide safe and appropriate medical care.
2. Translational Science aims to optimize the process that moves biomedical research findings discovered in the lab to a clinical setting where they are used safely and ethically to further translate those research results into a practical application for patients and communities that need them.
3. The aim of Clinical Research is to determine the safety and effectiveness of medications, medical devices and medical diagnostic interventions.  It generally relates to the entire research life of a chemical compound or device from its initial development in basic research through its final testing in the four phases of human clinical trials.
4. By Enhancing Clinical Trials (which are a part of the broader Clinical Research discipline), the aim is to use pre-defined protocols to measure the results of medical interventions in assigned patient groups or to measure the results observed in defined patient groups.
5. Comparative Effectiveness Research as defined in a Congressional Budget Office study aims to ensure that interventions used in a clinical setting are indeed the most effective for patients.  This involves research comparing the effectiveness of various treatments for any given condition.
6. The aim of Science, Technology, Engineering and Mathematics (STEM) Education research is to develop and identify the most effective methods for teaching these subjects.  Innovative and effective methods of teaching STEM subjects are essential to sustain the biomedical research and health care delivery enterprises.  We must continue to inspire new generations to pursue careers in science and medicine, as well as foster a community that has sufficient science and health literacy to create policies that foster the biomedical research and the health care sectors.

Finally, research in the areas of health disparities and bioethics will work to increase the integrity of the health care system for all users.

1. Health Disparities as defined by the Health Resources and Services Administration (HRSA) refers to the “population-specific differences in the presence of disease, health outcomes, or access to health care.”  The aim of research in the area of health disparities among ethnic
   

   The Basics of Stem Cell Research (from NIH)

   minorities and medically under served populations is to elucidate and then alleviate the causes of increased burned of disease and poorer health outcomes for specific disease conditions, as well as bring greater parity for access to care among all populations.  This research ensures that the gains made in the aforementioned research disciplines such as biomarker discovery, genomics, theranostics and regenerative medicine truly benefit the entire population.

2. The aim of Bioethics research is to protect patients’ rights throughout the biomedical research and health care delivery enterprises. The verve of technology must always be tempered by sound ethics to guard against the unforeseen consequences of the new (as are many of the research areas previously described).  Framed around four principles that promote patient well-being (beneficence), protect them from harm (non-maleficence), respect their right to accept or deny treatment (autonomy) and generally promote the pursuit of what is right (justice), bioethics provides safeguards in medical research and medical practice.

These are the fifteen research areas upon which the nation’s premier clinicians and biomedical research scientists will focus their investigations.  As a result, passage of the Recovery Act has not only managed to rehabilitate the proximate future but most certainly transform our distant future, as well.  I believe there will be gains in health and medicine that heretofore could have only been imagined.  What do you think?  Are there research focus areas that excite you? Perhaps, you know someone suffering from a disease that will benefit from these areas of research.  Or are you a pessimist awaiting the apocalyptic signs of a Brave New World, concerned that we made the wrong decision by restoring funding to embryonic stem cell research?  Either way, leave me a comment voicing your hopes or concerns.

Sources:

What is Regenerative Medicine. In McGowan Institute for Regenerative Medicine. Cited April 10, 2009.  Available at <http://www.upmc.com/Services/MIRM/RegenerativeMedicine/Pages/default.aspx>

Anerson, D.G. Burdick, J.A. and Langer, R.  (2004).  Materials Science. Smart Biomaterials. Science. September 24;305(5692):1923-4.

Re-engineering the Clinical Research Enterprise: Translational Research.  In NIH Roadmap for Medical Research.  Cited April 10, 2009.  Available at <http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp>

Skeen, J. (Ed.). (2007, December). Research on the Comparative Effectiveness of Medical Treatments:  Isuues and Options for an Expanded Federal Role [Electronic Version]. Available from the Congressional Budget Office, Ford House Office Building, 4th Floor Second and D Streets, SW Washington, DC 20515.

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ARRA and You (Part IVa): Challenge Grant Research Priorities. The impact of the American Recovery and Reinvestment Act of 2009 on the health sector is so broad ultimately, it will touch all our lives. From COBRA insurance premium assistance and funding to the states for Medicaid and SCHIP to improved funding for research in the health and biomedical sectors, there appears to be no area left unaffected by the comprehensive legislation. As part of the Recovery Act, NIH has designated no less than $200 million, in the upcoming fiscal year, to fund research in areas that “address specific scientific and health research challenges in biomedical and behavioral research.” Science administrators hope to take advantage of opportunities to fill gaps in knowledge, develop new technologies, refine research methods and generate data. These areas of priority to which challenge grant funds will be awarded will influence this sector for years to come in the following three ways.

1. Application of cutting-edge 21st century technologies will transform the way we diagnose and treat disease to a more personal and molecular level.
2. Information technology and older research methodologies will combine to increase health care system efficiency.
3. Research in the areas of bioethics and health disparities will work to increase the integrity of the health care system.

In what ways do you think ARRA funding will impact biomedical research and the health care system on the whole?  Keep an eye out for the next post, in which I’ll discuss each priority research area further.

Source:

NIH Challenge Grants in Health and Science Research. In Office of Extramural Research. Cited on April 6, 2009.  Available at <http://grants.nih.gov/grants/funding/challenge_award/>

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by Gary Markstein, originally uploaded by the Health Advocate.

Here’s your latest dose of laughs. While this piece by Markstein made me laugh, I really don’t agree with the politics behind it. Those of you who read Monday’s post will understand since that post was a response to this cartoon. After you’ve enjoyed this piece of satire and read my response to it, be sure to drop me a comment telling me just what you think about ARRA provisions for research funding and the like.

Science is a wonderful thing if one does not have to earn one’s living at it.  ~Albert Einstein

ARRA and You (Part III):  Employment, Economic Recovery and the Research Sector. As I continue to discuss the broad impact of the American Recovery and Reinvestment Act of 2009, I must take issue with Einstein’s observation quoted above.  In fact, there are critics of the ARRA who make light of the idea that one part of the American economy that the Act is stimulating is the science and research sector.  Denying the significant contribution of this sector to the economy is simply a refusal to face facts.  This is an observation I also made in an previous post.  There is serious labor economics at work here.   The National Science Foundation’s (NSF) biennial report Science and Engineering Indicators, 2006 (the most current available) concluded,

“Although workers with science and engineering skills still make up only a fraction of the total U.S. civilian labor force, their effect on society belies their numbers. These workers contribute enormously to technological innovation and economic growth, research, and increased knowledge. Workers with S&E skills include technicians and technologists, researchers, educators, and managers. In addition, many others with S&E training use their skills in a variety of nominally non-S&E occupations (such as writers, salesmen, financial managers, and legal consultants), and many niches in the labor market require them to interpret and use S&E knowledge.”

This sector is so vital that more countries have created their own science and technology infrastructure to attract investment dollars and talent. (For some scientists, that has meant returning home to India, China, or southeast Asia after having remained in the US upon earning a PhD in a science or engineering discipline.)

In one example, during 2004, the South Korean government sponsored a greater percentage of research than the US (see 7-11 above).  More importantly, these trends reinforce one another. The resulting impact on the US economy has been significant.  Because research and development spending has been crossing borders internationally, business and investment spending has also crossed these borders.  Talented scientist have crossed borders internationally in search of intellectually and financially fulfilling work, which has been less and less available within the US in the face of the 8 year hiatus on federal funding for stem cell research and decreasing trends in federal funding of research, in general.  It makes good economic sense to refuel American investment in research and development, to retain or reclaim that business and investment spending that has wandered internationally.

The science and engineering sector continues to grow (see 3-05 below) and continues to be the place where jobs will be found.  The NSF report noted, “employment in S&E occupations in the 1990s continued to grow by 3 to 4 times the growth of other jobs.” Like, manufacturing, scientific research is a solid foundation upon which an economy can be built.  The financial industry must ultimately be based upon something tangible like the products yielded from science and research, such as computers, medical diagnostic equipment, or genetically engineered insulin.  Another reason the ARRA investment in the science and research sector makes good sense can be found within the trends describing scientists’ age.  The number of people with science and engineering degrees currently living and working in America expected to reach retirement age is  increasing substantially.  At the same time, the number earning these degrees and entering the workforce has slowed.  The result could be diminished US success against the increasing international competition discussed earlier.  Hopefully, the capital infused into the American science and engineering sector will stave off this threat for a generation while we improve our science, technology, engineering and math education and convince more American youth just how rewarding careers in science and technology can be.

Using the ARRA to stimulate the research sectors is good for the economy.  But what exactly are some of the areas that scientists in the health and biomedical sectors are researching?  Again, we can look at the ARRA to see what new priorities have been set and we will do so in future posts:

• Challenge Grant Research Priorities
• Comparative Effectiveness Research
• Preventive Health Interventions

Sources:

National Science Board. 2006. Science and Engineering Indicators 2006. Two volumes [Electronic Version]. Arlington, VA: National Science Foundation (volume 1, NSB 06-01; volume 2, NSB 06-01A). Available at<http://www.nsf.gov/statistics/seind06/>

National Science Foundation, Division of Science Resources Statistics
Universities Report Continued Decline in Real Federal S&E R&D Funding in FY 2007. Arlington, VA (NSF 08-320) [August 2008]. Available at <http://www.nsf.gov/statistics/infbrief/nsf08320/>

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ARRA and You (Part II). Statistics serve only to confirm what we instinctively already knew, the Executive Order of 2001 which banned funding for embryonic stem cell research did not reflect the will of the people. (see fig. 7-18) Though we live in a representative democracy, the ignorance and fears of the minority should not overrule the cautious optimism of the majority. My biology background taught me that correlation does not suggest causation, but during 2002 when about 35% favored this research and nearly 50% opposed it, I’m nevertheless, tempted to surmise that the American people second guessed themselves, “perhaps the President knows something I don’t,” they mused. By 2004 however, public opinion had decisively migrated back in favor of supporting this kind of medical research. So the scientific community and the majority of the broader public alike, breathed a collective sigh of relief with the signing of an Executive Order that reverses the ban of federal funding for embryonic stem cell research. The President stated,

“…the potential [embryonic stem cell] research offers is great, and with proper guidelines and strict oversight, the perils can be avoided. That is a conclusion with which I agree. That is why I am signing this Executive Order, and why I hope Congress will act on a bi-partisan basis to provide further support for this research.”

It is the hope of future legislation combined with the Executive Memorandum directing the head of the White House Office of Science and Technology Policy to develop a strategy for restoring scientific integrity to government decision making that go further to prevent future challenges of this kind.

In conjunction with initiatives of the stimulus package (ARRA 2009), the new research agenda should indeed go a long way towards the recovery of the economy.

The changes that the Obama administration is bringing to biomedical research don’t end with this critical executive order. For the first time in the history of the National Science Foundation’s Survey of Research and Development Expenditures at Colleges and Universities (initiated in 1972), in a two year period (2005-7) federal funding decreased when adjusted for inflation. Combine this with a decreasing trend in federal share of overall research and development dollars spent. In light of these statistics, the $8.2 billion allocated to the National Institutes of Health for extramural research via the ARRA is a logical decision, to say the least. While $800 million will be targeted to priority research areas through Challenge Grants (more on this later), another $1.1 billion is allocated for Comparative Effectiveness Research (more on this later). Anyone who wants to deny that science research and biomedical research, in particular are not significant sectors of our economy is simply fooling themselves (further explanation to come). In short, the President has opened a new frontier (by expanding embryonic stem cell research) and provided the funding with which to explore it, responsibly and ethically. All in less than 40 days in office.

I have laid the foundations in this post to for the impact of the ARRA on the health and research sectors and on you. In the following weeks look for posts expanding on:

• Employment, Economic Recovery and the Research Sector
• Challenge Grant Research Priorities
• Comparative Effectiveness Research
• Preventive Health Interventions
• HITECH Act

Sources:

“A debt of gratitude to so many tireless advocates” at The White House Blog on March 9, 2009. http://www.whitehouse.gov/ blog/09/03/09 /A-debt-of-gratitude-to-so-many-tireless-advocates/

American Recovery and Reinvestment Act: Comparative Effectiveness Funding. March 2009. http://www.ahrq.gov/fund/cefarra.htm

Federal Policy. In Stem Cell Information. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2009 [cited March 16, 2009] Available at <http://stemcells.nih.gov/policy/ defaultpage>

NIH’s Role in the American Recovery and Reinvestment Act (ARRA). In From the Director. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2009 [cited Saturday, March 16, 2009] Available at <http://www.nih.gov/about/director/ 02252009statement_arra.htm>

National Science Board. 2006. Science and Engineering Indicators 2006. Two volumes [Electronic Version]. Arlington, VA: National Science Foundation (volume 1, NSB 06-01; volume 2, NSB 06-01A). Available at<http://www.nsf.gov/statistics/seind06/>

National Science Foundation, Division of Science Resources Statistics
Universities Report Continued Decline in Real Federal S&E R&D Funding in FY 2007. Arlington, VA (NSF 08-320) [August 2008]. Available at <http://www.nsf.gov/statistics/infbrief/nsf08320/>

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