News & Analysis Medical News & Perspectives ..........p15
Lab Reports.......................................p19
News From the CDC .........................p20
Budget Woes, Sequester Place Researchers in a Bind
Newly Discovered Mechanism Points to Diabetes Prevention Strategy
Alcohol Industry Isn’t Adhering to Limit on Youth Advertising
Physicians Focus on Primary Care for Patients With HIV
Gut Bacteria May Determine Effectiveness of Anticancer Therapies
Too Many US Adults Still Pass Up Colorectal Cancer Screening
news@JAMA: From JAMA’s Daily News Site
Scientists Coax Stem Cells to Form 3D Kidney Structures Stress Affects Expression of Inflammatory Genes in Immune Cells
Medical News & Perspectives
Budget Woes, Sequester Place Researchers in a Bind Young Researchers Hard Hit Bridget M. Kuehn, MSJ
Clinical Research Hit Hard The cuts in funding are coming across all disciplines of science, including clinical research. jama.com
Collins noted that the cuts to research at the clinical center are just the “tip of the iceberg,” as the numbers of patients in other institutions’ clinical trials are dropping by thousands. Additionally, the agency has decided not to issue calls for grant proposals for several areas of research, including sickle cell disease, early autism diagnosis, and asthma. The National Cancer Institute’s Cooperative Group Program has also been hit hard. The program consists of centers across the United States that conduct multicenter clinical trials. Richard L. Schilsky, MD, chief medical officer at the American Society of Clinical Oncology (ASCO), said the program
is “withering on the vine” at 1998 funding levels. The program has capped annual enrollment in its clinical trials at 15 000 adult cancer patients. Schilsky said that is a reduction of about 40% to 50% in patient enrollment compared with 8 or 9 years ago. It also means fewer chances for the 1.5 million US cancer patients to participate in clinical trials each year. With the current cap, fewer than 1% of US cancer patients will have the opportunity to participate in a trial, Schilsky said. It also means higher medical costs for patients whose care would have been partly subsidized if they participated in a trial. It will take years, maybe decades, for basic and clinical research to recover from the
National Institutes of Health Appropriation, 1995-2013 40 000 35 000 30 000
Dollars, in Millions
W
ith 14 000 federal scientists returning to the National Institutes ofHealth(NIH)tosalvageresearch disrupted by the recent government shutdown,theyandtheiracademiccolleaguesface new uncertainties surrounding whether Congress will reach a budget compromise and whether sequester cuts will continue. “It’s a one-two punch,” said NIH Director Francis S. Collins, MD, PhD, in an interview in November.Atpresstime,abipartisandealthat would soften the sequester’s impact for the next 2 years was being considered. In March 2013, the sequester went into effect, requiring $85 billion in across-theboard cuts to government agencies. The NIH was ordered to cut 5% of its 2013 budget, or $1.55 billion, across all of its activities. As a result, key programs have been scaled back. For example, the NIH Clinical Center, which conducts clinical research, is admitting 750 fewer patients in 2013. The cuts are having an even greater effect on scientists outside the agency. Most (approximately 80%) of the NIH budget is used to fund work by more than 300 000 researchers at 2500 universities and other research institutions. The decrease in extramural research funding translates into 640 fewer grants and cuts averaging 4.7% from existing grants. Collins noted that some toptier researchers are finding themselves unable to secure NIH grants. For them, “that’s a 100% cut in funding,” he said.
25 000
Current US $ 1995 Constant US $a
20 000 15 000 10 000 5000 0
1996
1998
2000
2002
2004
2006
2008
2010
2012
aAdjusted for inflation using the Biomedical Research and Development Price Index.
Note: Supplemental funds from the American Recovery and Reinvestment Act of 2009 awarded to the National Institutes of Health in 2009 and 2010 are not shown here. Source: Federation of American Societies for Experimental Biology.
Funding for the National Institutes of Health (adjusted for inflation) has declined in recent years.
JAMA January 1, 2014 Volume 311, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Florida International University Medical Library User on 06/04/2015
15
News & Analysis
current cuts and divestment. It may take a team of researchers years and multiple grants to pursue a particular line of inquiry. If the researchers are unable to get a grant for the next step of the research, they may have to abandon the line of inquiry. Infrastructure used for the experiment may be reallocated elsewhere; key members of the research team may leave if their positions are no longer funded; biological samples may deteriorate over time. Retraining new staff and reacquiring infrastructure and samples can take years. “You can’t just turn research on and off like a spigot,” Schilsky said.
Careers Stalled or Ended Young and established biomedical researchers are finding their careers upended by both an inability to get funding and the political instability in Washington. As a result of the sequester, BethAnn McLaughlin, PhD, an assistant professor in the department of neurology at Vanderbilt University who studies neurodegeneration and how to protect the brain from acute and chronic insults, faced a 20% cut to a National Institute of Neurologic Diseases and Stroke grant she’d been awarded. “This was money that was promised to those of us awarded grants and we had budgeted appropriately—and had the funding taken away,” she said. McLaughlin had a second grant that appeared likely to receive funding before the sequester that was not funded. Additionally, the sequester reduced funding for her institution and contributed to staff cuts at the medical center. Together, the reduced funding and scaled-back institutional resources mean that McLaughlin will be unable to hire the investigators needed for certain projects. She must spend more time grant writing and less time teaching or participating in outside meetings. Additionally, she eliminated positions in her laboratory for undergraduate and high school researchers. “Those were educational opportunities; we can’t afford to do that now,” she said. Jennifer Zeitzer, the director of legislative affairs at the Federation of American Societies for Experimental Biology (FASEB), said scientists across the board are feeling the effects of what she called years of “budget insanity” on Capitol Hill, with Congress failing to pass budgets on time. The political situation has led to delays and inefficiency in funding, failure of budgets to keep 16
up with inflation, and the recent spate of budget cuts. She explained that the NIH is funding just 1 out of every 7 grants submitted. This means that both senior investigators who’ve been funded in the past and young scientists trying to get a foothold are being shut out. A survey sent to 20 929 US-based academic researchers who belong to ASCO found that the sequester is having immediate effects on the research workforce. Of the 345 researchers who responded, 75% said cuts to federal funding have hampered their ability to do research. More than one-third reported laying off or eliminating laboratory or clinical research support staff as a result of the cuts. “People are having to curtail research programs, jettison research trajectories, lay off staff,” said Schilsky. “It’s taking an immediate economic toll on [those being laid off] and their communities.” Some older investigators are opting to retire early, Zeitzer said. Young researchers are also leaving US science. The average age of first-time NIH grantees with a PhD is now 42 to 43 years old (in 1981 it was 37), she said, so many young investigators are finding themselves faced with the choice of doing prolonged postdoctoral work or finding alternate employment. Some who have come from other countries to train in the United States are leaving for their home countries, where they may more easily get funding. Many young US researchers are leaving the field altogether, often after a decade of training. “We’ll probably never know how many promising ideas are not being followed up on by young investigators,” Collins said. McLaughlin, who is also an editor at the Journal of Neuroscience, is among those concerned about the effects the sequester will have on her career. Her laboratory has been cut to about one-third of its peak size, and the cuts to NIH grants may delay her bid for tenure.
Future Advances in Jeopardy The current funding pinch exacerbates the existing problem of stagnant funding levels at the NIH over the past decade, and the combination may have a lasting effect on biomedical innovation. The inflation-adjusted NIH budget is now at its lowest level since 2000. The agency’s budget doubled between 1998 and
2003, but funding levels have been stagnant since then, and inflation has eroded the agency’s purchasing power. Before the sequester, the NIH’s purchasing power was already down nearly 20% compared with a decade ago, and the sequester added another 5% cut. “It’s a discouraging downward spiral,” Collins said. Collins also expressed concern about a “lost generation” of researchers. “We have to get this turned around and get back on a stable funding trajectory or we will see a serious erosion of our future,” he said. Stagnant investment is also jeopardizing the US position as the world leader in biomedicine. Between 1999 and 2009, the nation’s share of global investment in research and development decreased from 38% to 31%, according to a letter from FASEB to congressional leaders in November (http://bit .ly/HTemgM). Schilsky said ASCO and other groups are urging Congress to reverse the sequester cuts and to begin to restore NIH funding to levels that account for inflation. The groups have proposed a budget of $32 billion for the NIH in fiscal year 2014. Zeitzer said such enhanced investment is vital to ensuring future advances in medicine because the federal government funds basic research that industry doesn’t. “If we scale back our commitment to basic research, there will be no pipeline for pharmaceuticals,” she said. “We are sacrificing the cures and breakthroughs of the future.” McLaughlin said the effect of federal budget uncertainties on students is “heartbreaking.” She noted that although faculty members such as herself often can turn to institutional resources and alternative funders for help, graduate students and fellows are “keenly aware that science is not a national priority.” For example, one of the efforts threatened by the cuts to McLaughlin’s funding was a program that provides clinical experience for graduate students so they can learn about the clinical complexities of neurological conditions. McLaughlin said she was able to secure funding from former National Football League player Dan Marino and the Suzanne and Walter Scott Foundation. “Being able to do those kinds of things for students is incredibly important,” McLaughlin said. “To expect private funders to fill in for the long-term is untenable.”
JAMA January 1, 2014 Volume 311, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Florida International University Medical Library User on 06/04/2015
jama.com
Lab Reports.......................................p19
News From the CDC .........................p20
Budget Woes, Sequester Place Researchers in a Bind
Newly Discovered Mechanism Points to Diabetes Prevention Strategy
Alcohol Industry Isn’t Adhering to Limit on Youth Advertising
Physicians Focus on Primary Care for Patients With HIV
Gut Bacteria May Determine Effectiveness of Anticancer Therapies
Too Many US Adults Still Pass Up Colorectal Cancer Screening
news@JAMA: From JAMA’s Daily News Site
Scientists Coax Stem Cells to Form 3D Kidney Structures Stress Affects Expression of Inflammatory Genes in Immune Cells
Medical News & Perspectives
Budget Woes, Sequester Place Researchers in a Bind Young Researchers Hard Hit Bridget M. Kuehn, MSJ
Clinical Research Hit Hard The cuts in funding are coming across all disciplines of science, including clinical research. jama.com
Collins noted that the cuts to research at the clinical center are just the “tip of the iceberg,” as the numbers of patients in other institutions’ clinical trials are dropping by thousands. Additionally, the agency has decided not to issue calls for grant proposals for several areas of research, including sickle cell disease, early autism diagnosis, and asthma. The National Cancer Institute’s Cooperative Group Program has also been hit hard. The program consists of centers across the United States that conduct multicenter clinical trials. Richard L. Schilsky, MD, chief medical officer at the American Society of Clinical Oncology (ASCO), said the program
is “withering on the vine” at 1998 funding levels. The program has capped annual enrollment in its clinical trials at 15 000 adult cancer patients. Schilsky said that is a reduction of about 40% to 50% in patient enrollment compared with 8 or 9 years ago. It also means fewer chances for the 1.5 million US cancer patients to participate in clinical trials each year. With the current cap, fewer than 1% of US cancer patients will have the opportunity to participate in a trial, Schilsky said. It also means higher medical costs for patients whose care would have been partly subsidized if they participated in a trial. It will take years, maybe decades, for basic and clinical research to recover from the
National Institutes of Health Appropriation, 1995-2013 40 000 35 000 30 000
Dollars, in Millions
W
ith 14 000 federal scientists returning to the National Institutes ofHealth(NIH)tosalvageresearch disrupted by the recent government shutdown,theyandtheiracademiccolleaguesface new uncertainties surrounding whether Congress will reach a budget compromise and whether sequester cuts will continue. “It’s a one-two punch,” said NIH Director Francis S. Collins, MD, PhD, in an interview in November.Atpresstime,abipartisandealthat would soften the sequester’s impact for the next 2 years was being considered. In March 2013, the sequester went into effect, requiring $85 billion in across-theboard cuts to government agencies. The NIH was ordered to cut 5% of its 2013 budget, or $1.55 billion, across all of its activities. As a result, key programs have been scaled back. For example, the NIH Clinical Center, which conducts clinical research, is admitting 750 fewer patients in 2013. The cuts are having an even greater effect on scientists outside the agency. Most (approximately 80%) of the NIH budget is used to fund work by more than 300 000 researchers at 2500 universities and other research institutions. The decrease in extramural research funding translates into 640 fewer grants and cuts averaging 4.7% from existing grants. Collins noted that some toptier researchers are finding themselves unable to secure NIH grants. For them, “that’s a 100% cut in funding,” he said.
25 000
Current US $ 1995 Constant US $a
20 000 15 000 10 000 5000 0
1996
1998
2000
2002
2004
2006
2008
2010
2012
aAdjusted for inflation using the Biomedical Research and Development Price Index.
Note: Supplemental funds from the American Recovery and Reinvestment Act of 2009 awarded to the National Institutes of Health in 2009 and 2010 are not shown here. Source: Federation of American Societies for Experimental Biology.
Funding for the National Institutes of Health (adjusted for inflation) has declined in recent years.
JAMA January 1, 2014 Volume 311, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Florida International University Medical Library User on 06/04/2015
15
News & Analysis
current cuts and divestment. It may take a team of researchers years and multiple grants to pursue a particular line of inquiry. If the researchers are unable to get a grant for the next step of the research, they may have to abandon the line of inquiry. Infrastructure used for the experiment may be reallocated elsewhere; key members of the research team may leave if their positions are no longer funded; biological samples may deteriorate over time. Retraining new staff and reacquiring infrastructure and samples can take years. “You can’t just turn research on and off like a spigot,” Schilsky said.
Careers Stalled or Ended Young and established biomedical researchers are finding their careers upended by both an inability to get funding and the political instability in Washington. As a result of the sequester, BethAnn McLaughlin, PhD, an assistant professor in the department of neurology at Vanderbilt University who studies neurodegeneration and how to protect the brain from acute and chronic insults, faced a 20% cut to a National Institute of Neurologic Diseases and Stroke grant she’d been awarded. “This was money that was promised to those of us awarded grants and we had budgeted appropriately—and had the funding taken away,” she said. McLaughlin had a second grant that appeared likely to receive funding before the sequester that was not funded. Additionally, the sequester reduced funding for her institution and contributed to staff cuts at the medical center. Together, the reduced funding and scaled-back institutional resources mean that McLaughlin will be unable to hire the investigators needed for certain projects. She must spend more time grant writing and less time teaching or participating in outside meetings. Additionally, she eliminated positions in her laboratory for undergraduate and high school researchers. “Those were educational opportunities; we can’t afford to do that now,” she said. Jennifer Zeitzer, the director of legislative affairs at the Federation of American Societies for Experimental Biology (FASEB), said scientists across the board are feeling the effects of what she called years of “budget insanity” on Capitol Hill, with Congress failing to pass budgets on time. The political situation has led to delays and inefficiency in funding, failure of budgets to keep 16
up with inflation, and the recent spate of budget cuts. She explained that the NIH is funding just 1 out of every 7 grants submitted. This means that both senior investigators who’ve been funded in the past and young scientists trying to get a foothold are being shut out. A survey sent to 20 929 US-based academic researchers who belong to ASCO found that the sequester is having immediate effects on the research workforce. Of the 345 researchers who responded, 75% said cuts to federal funding have hampered their ability to do research. More than one-third reported laying off or eliminating laboratory or clinical research support staff as a result of the cuts. “People are having to curtail research programs, jettison research trajectories, lay off staff,” said Schilsky. “It’s taking an immediate economic toll on [those being laid off] and their communities.” Some older investigators are opting to retire early, Zeitzer said. Young researchers are also leaving US science. The average age of first-time NIH grantees with a PhD is now 42 to 43 years old (in 1981 it was 37), she said, so many young investigators are finding themselves faced with the choice of doing prolonged postdoctoral work or finding alternate employment. Some who have come from other countries to train in the United States are leaving for their home countries, where they may more easily get funding. Many young US researchers are leaving the field altogether, often after a decade of training. “We’ll probably never know how many promising ideas are not being followed up on by young investigators,” Collins said. McLaughlin, who is also an editor at the Journal of Neuroscience, is among those concerned about the effects the sequester will have on her career. Her laboratory has been cut to about one-third of its peak size, and the cuts to NIH grants may delay her bid for tenure.
Future Advances in Jeopardy The current funding pinch exacerbates the existing problem of stagnant funding levels at the NIH over the past decade, and the combination may have a lasting effect on biomedical innovation. The inflation-adjusted NIH budget is now at its lowest level since 2000. The agency’s budget doubled between 1998 and
2003, but funding levels have been stagnant since then, and inflation has eroded the agency’s purchasing power. Before the sequester, the NIH’s purchasing power was already down nearly 20% compared with a decade ago, and the sequester added another 5% cut. “It’s a discouraging downward spiral,” Collins said. Collins also expressed concern about a “lost generation” of researchers. “We have to get this turned around and get back on a stable funding trajectory or we will see a serious erosion of our future,” he said. Stagnant investment is also jeopardizing the US position as the world leader in biomedicine. Between 1999 and 2009, the nation’s share of global investment in research and development decreased from 38% to 31%, according to a letter from FASEB to congressional leaders in November (http://bit .ly/HTemgM). Schilsky said ASCO and other groups are urging Congress to reverse the sequester cuts and to begin to restore NIH funding to levels that account for inflation. The groups have proposed a budget of $32 billion for the NIH in fiscal year 2014. Zeitzer said such enhanced investment is vital to ensuring future advances in medicine because the federal government funds basic research that industry doesn’t. “If we scale back our commitment to basic research, there will be no pipeline for pharmaceuticals,” she said. “We are sacrificing the cures and breakthroughs of the future.” McLaughlin said the effect of federal budget uncertainties on students is “heartbreaking.” She noted that although faculty members such as herself often can turn to institutional resources and alternative funders for help, graduate students and fellows are “keenly aware that science is not a national priority.” For example, one of the efforts threatened by the cuts to McLaughlin’s funding was a program that provides clinical experience for graduate students so they can learn about the clinical complexities of neurological conditions. McLaughlin said she was able to secure funding from former National Football League player Dan Marino and the Suzanne and Walter Scott Foundation. “Being able to do those kinds of things for students is incredibly important,” McLaughlin said. “To expect private funders to fill in for the long-term is untenable.”
JAMA January 1, 2014 Volume 311, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Florida International University Medical Library User on 06/04/2015
jama.com
