NEW YORK (GenomeWeb News) - Politicians in Washington, DC, proclaim to love biomedical research. They even like to pay for it with federal tax dollars. Most of the lawmakers on Capitol Hill say so openly, most vociferously when it is invested in their states or districts. A succession of recent US presidents also have lauded the National Institutes of Health as an example of the government investment done the right way.
There are occasional grumbles from fiscal conservatives pointing to how taxpayer dollars are being used to study, for example, the effects of cocaine on the sexual habits of Japanese quail, and others as examples of wasteful spending. However, when NIH Director Francis Collins sat before the Senate Appropriations Committee in June and talked up the Institutes' role in funding research that has led to new cancer treatments, the Human Genome Project, and rising life expectancy, the scene was a relative love-fest compared to many agency hearings.
Yet NIH funding has been weakening steadily during the past decade; its budget has been nearly flat for the past three years, and when biomedical inflation is factored in, the agency has lost an estimated 22 percent of its spending power over the past decade, according to the Federation of American Societies for Experimental Biology.
That slow-motion slide has led to fewer competing research project grants being awarded, smaller grants when they are awarded, budget cuts to ongoing projects, and longer wait times for awards. It has put pressure on investigators, who are writing more applications and waiting longer to hear about their awards.
This fiscal year, NIH estimates that it will fund around 20.3 percent fewer research project grants than it did in 2003, and between 2003 and 2012, the number of investigator-initiated R01 awards funded each year fell by 27 percent.
And so, the national biomedical research engine that NIH funding helps fuel was already feeling the pinch when the federal across-the-board sequestration budget cuts hit earlier this year and plucked another $1.55 billion out of the agency's coffers.
The pressure to compete for funding is filling some young investigators with trepidation about their career choices and established scientists with worries about their futures.
Jessica Clague DeHart, an assistant research professor at City of Hope's cancer research hospital outside of Los Angeles, is one of these young scientists who are scrambling to gain a footing in an academic research career as she peers toward an uncertain future.
DeHart submitted her first R01 proposal a couple of weeks ago. As a molecular epidemiologist who studies breast and ovarian cancer, she wants to look at biomarkers such as DNA repair capacity, gene expression, and inflammatory markers that have been linked to cancer to find out how they respond to exercise.
"In a nutshell, I am looking at whether exercise can change your DNA. And whether —hopefully — that in itself can prevent cancer," she told GenomeWeb Daily News on the day she was submitting her investigator-initiated application.
Although this is her first investigator-initiated proposal — her first "big-kid grant," as she called it — in her brief career at City of Hope and at MD Anderson Cancer Center before that, she has been surrounded by NIH-funded career scientists for some time.
A cultural shift has occurred since her predoctoral days at MD Anderson in a lab that was "vibrant and fully funded and exciting," a shift that she attributes to the weakening of NIH awards.
"That excitement has turned into anxiety. Back in the day, it used to be that if you worked hard and you had a good idea then you got funded," she said. "Now, it doesn't matter how hard you work and how great your idea is; the funding is scarce and that is scary. And if you don't have funding, you don't have a job."
NIH funding's long, slow slide
Carrie Wolinetz, president of the advocacy group United for Medical Research, said her group's members have been worried about slowly tightening fiscal belts over the past half-decade. "We are seeing historically low success rates build to a crescendo with the enacting of the sequestration.
"You are talking about people essentially shutting their labs down, or shutting down particular areas of research," she said.
And many researchers are frustrated that the US political climate is largely to blame for the NIH's funding woes, despite politicians' statements of support for the Institutes.
"There is no battle in Congress when it comes to NIH. There is a lot of bipartisan support," said Wolinetz. "NIH is an agency that speaks for itself in terms of its positive benefit on the health side and on the economic side, [and] in terms of its ability to drive innovation in the life science industry."
The problem, she and others who have followed research funding for decades say, has nothing to do with NIH.
Since the financial crisis in 2008, the US political system has been in the throes of a non-stop wrangle over the federal budget deficit. The failure to agree on the best approach has resulted in what many consider to be remarkably poor governing by Congress, which has been essentially paralyzed from performing its central annual duty of passing a budget.
"The bipartisan support [for NIH] becomes lost in this larger, macro battle," and NIH has been the "unfortunate casualty of some of these bigger picture budget battles," Wolinetz said.
What affects the federal budget for discretionary spending at large has also impacted the funding lines for specific agencies, even popular ones like NIH.
Those were the days
If you look at NIH appropriations, its cut of the approved budget of the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, or LHHS, has remained "remarkably consistent over the last 15 years," said Dave Moore, senior director of government relations at the Association of American Medical Colleges.
Generally, that number hovers around 19 percent or 20 percent. "We say roughly one out of every five discretionary dollars in the [LHHS] subcommittee go to NIH," Moore said.
That LHHS budget includes other government programs that have been much more controversial in the halls of Congress, such as funding for the implementation of the Affordable Care Act, among others.
Moore, who has tracked NIH funding since the 1980s, told GWDN that the agency's budget has essentially been in a state of plateauing since 2003.
That year marked the end of a period — a halcyon time in the memory of biomedical research advocates — known as the 'doubling', when the NIH budget rose from $13.7 billion in 1998 to $27.2 billion in 2003.
"There was never an expectation during the time of the doubling that that 14 or 15 percent rate of annual growth was going to continue indefinitely," Moore said."But I don't think that people felt we were going to go from that level of growth to really a flattening of the budget, to where we couldn't even keep pace with inflation."
Stanford University investigator Christopher Gardner has seen the highs and lows of both periods. In the late 1990s and early 2000s, Gardner had several large projects land NIH funding. An associate professor focused on diet, nutrition, and health, Gardner's run of million dollar-plus awards culminated in a roughly $2.5 million project to study popular weight loss diets, the oft-cited A to Z Study.
"By the time 2002 rolled around, I had so many grants that I couldn't even write any more. I was running five studies at once and I had 17 staff members," Gardner recalled.
Not long after the A to Z study wrapped up, the spigot ran dry. Gardner told GWDN recently that he doesn't know for sure if his ideas were bad, or if it was something else, but from 2007 to about 2012, he "limped along," piecing together small R21 grants that never made it to full R01 awards. He also had to lay off all but one of his staff members during that phase.
While Gardner may never know the reasons for his difficulties in getting grants in recent years, he does know that the funding environment has changed and that has affected many of his colleagues as well.
When he landed his first and second grants, the payline was in the 15th percentile to 20th percentile range, but today he hears that investigators say they need to be in the 7th percentile to land funding. To think that "you were better than 92 percent of all the other applications, and you weren't going to get funded or you were on hold or you just didn't know — it is certainly a different environment than we have been accustomed to."
Overall, NIH grant success rates have been waning. Although these rates may vary widely among agencies, across all the institutes success rates hovered around 20 percent between 2005 and 2010 — but in 2012, they had dropped to 17.6 percent. The rate at the National Human Genome Research Institute has been quite robust, at 23.9 percent last year, while NCI's success rate last year was 13.6 percent.
Stiffer competition and the dropping success rate has changed the way the research community sees itself in terms of what it means to land a grant and be a funded investigator, Gardner said.
Ten years ago, if he had missed out on a grant he applied for and his colleagues knew about it, he "would have been a little embarrassed" and thinks that he would have looked bad compared to his peers, Gardner said.
But today, he added, it has become the norm to hear conversations along the lines of: "'I didn't get funded.' 'I didn't either.' 'Oh my gosh, you got funded! Holy cow!'"
"It is the norm now to get rejected. It's unusual to get accepted," Gardner said. "That definitely seems to be a shift in the culture of acceptance. It has made everybody more nervous — wondering how they're going to keep their labs going."
The budget process: 'A real mess'
Another contributor to the erosion of NIH funding has been the turbulence of the budget process itself in recent years, according to the Association of American Medical Colleges' Moore. When lawmakers in Washington, DC, fail to pass a budget by the time a fiscal year begins — as has become the norm in recent years — government agencies automatically receive flat funding under a stopgap measure called a continuing resolution. In this fiscal year, for example, NIH and all the other government agencies received flat funding under a CR until late March, nearly halfway through FY 2013.
The other problem with CRs, Moore said, is that they jam up the planning process of government agencies.
"Trying to figure out what the impact is going to be on existing grants, as well as the potential for new grants to be funded" is a frustrating endeavor under a CR and creates a "huge amount of uncertainty," he said.
That uncertainty can work its way down the pipeline, like a jam in the plumbing, from the agency-level planning rooms all the way to the university lab.
"It's difficult for the agency and difficult for the institution and the scientist to plan when you don't know what the budget's going to be three, four, five months into the fiscal year," Moore said.
Zeitzer at FASEB said that the political situation in Washington this summer suggests that the 2014 budget process will be just as choppy as it was last year, and regardless of the possible funding numbers, NIH will again be a casualty of the stalemate.
"It's a real mess," she said, noting that the majority leadership in both the House and Senate have staked out positions on the 2014 budget that the other chamber most certainly will not pass.
House Republicans have passed an overall spending limit of around $967 billion, which assumes that the sequestration will be in place next year. The Senate, meanwhile, has passed a budget limit of $1.06 trillion, which assumes that the sequestration will end. That leaves a $90 billion gulf, and those who have seen the process repeat year over year have a hunch how it will go this year.
"Essentially, the appropriations process is underway, but what does it matter?" Zeitzer said, adding that appropriations committee members, regardless of their intentions, are "just going through the motions."
"We're sort of hurtling towards that inevitable CR. It's like hurtling toward the sun," she said.
She expects Republicans in the House of Representatives will continue pushing for more cuts to discretionary spending, while the White House and Democrats in the Senate will continue to tack vaguely toward a broader deal to reduce the deficit.
Zeitzer also anticipates that House Republicans will try to force Democrats and the White House to agree to another round of cuts to discretionary spending when the government needs to raise the debt ceiling, which likely will be this fall, possibly bringing up another last-minute showdown over a government shutdown. The last battle over the debt crisis resulted in the US credit rating being downgraded, it nearly shut down the government, and it set in motion the falling dominos that led to the sequestration.
"We're sort of in the same loop that we've been in for the last few years; except it's getting more insane," said Zeitzer.
But CRs that retain flat funding may be preferable to budget cuts, and certainly are much better than the deep cuts of sequestration, she added.
Concerns over deeper cuts
Created as a last-ditch effort to force Congress and the Obama Administration to reach a deficit deal, the sequestration was not supposed to happen. Now that it has happened, and has already cut $1.55 billion out of NIH's budget, the big questions swirl around how long it will last and how bad could it get for those who want to see federal biomedical research spending go up, rather than down.
For them, the answers may not be heartening. Sequestration could last another eight years, and the cuts could get deeper.
Under the discretionary spending total that the House has passed for next year, the LHHS subcommittee budget would be around 20 percent, or around $28 billion, below what it was this year, which means NIH could see as much as a 20 percent cut next year, Zeitzer cautioned.
Although passage of the House appropriation appears unlikely, if anything near the House budget numbers are enacted then "there is no way NIH escapes unscathed," Zeitzer said.
It is hard to tell just how much pain the sequestration has caused so far in terms of grants not being funded or budgets being cut, particularly because funding had been tightening for several years.
NIH has already estimated that it will fund around 700 fewer competitive research grants this year compared to 2012, and that existing noncompeting research project grants will have their budgets trimmed by around 4.7 percent, on average.
UMR's Wolinetz guesses that in the next few months that more specific tales of woe will begin to trickle out about the direct impact of the sequestration cut at NIH.
"We're starting to think of sequestration as almost a slow burn. We didn't expect to see an immediate impact," she said.
"The concern you have now when the budget constraints are this severe is how you maintain ongoing projects," AAMC's Moore added.
"For example, there is some discussion about [whether] NIH might have to cut back on resources like the Framingham [Heart Study] project, a national resource that has been going on since the late 1940s and has really been one of the major contributors to the advances in cardiovascular health in this country. But we're at a point now where we're beginning to think about scaling back a resource like that. Or not being able to take full advantage of the data being generated, as a result," he said.
There has been some talk in Congress about finding a way to protect NIH funding from the sequestration. Both Senator Barbara Mikulski (D-Md.), who chairs the Appropriations Committee, and the committee's ranking member Sen. Richard Shelby (R -Ala.) said at the NIH funding hearing last month that they wanted to do whatever they could to save the agency from sequestration.
But it would not be an easy task to spare one agency while others in HHS and across the government hemorrhage funding, both Zeitzer and Wolinetz noted.
"In the ideal world, in which you have a normal appropriations process, you would see efforts to try to bump up NIH, but I think we're far from a normal appropriations process," Wolinetz said.
"We've got to get Congress to agree to abandon sequestration and come up with a broader budget deal that has a deficit reduction target and then a way to get there that doesn't just rely on cuts to discretionary funding," said Zeitzer.
Wolinetz added that she fears that the long-term funding wane and the sequestration — should it last — could lead to the potential loss of a generation of scientists and the weakening of the US's standing as a science leader. But she also worries about something bigger.
"Ultimately, I think that we never want to forget that the existence of NIH in the first place is to improve human health," Wolinetz said. "I think there is a real fear, in talking with our partners in patient advocacy, that all of this … discouragement of the next generation of scientists, the relative decrease in competitiveness, will at the end of the day, impact negatively our ability to move medicine