From the issue dated February 6, 2004
http://chronicle.com/weekly/v50/i22/22a01701.htm
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What the NIH Bought With Double the Money
After five years, $13.6-billion has produced few major new treatments and little spreading of research wealth, but the agency's leaders and supporters counsel patience
By JEFFREY BRAINARD
When Congress started a five-year effort in 1999 to double the budget of the National Institutes of Health, leaders of the agency and many researchers said the money would set the stage for a golden age of biomedical research. Hopes were high that the infusion of cash would lead to new treatments for some of the most serious diseases, like cancer and AIDS.
But last fall, as the $13.6-billion run-up in the NIH budget came to a close, those dreams -- and expectations that the new dollars would be shared by more than a select group of universities -- remained unfulfilled. While the cash infusion expanded the volume of U.S. biomedical research, NIH grants were still concentrated among established researchers and among a small number of the most elite research institutions.
What's more, much of the practical payoff for health may take years to realize. Some experts believe the NIH could have moved faster sooner to push the science envelope, using the new funds to support innovative research that might have cured debilitating diseases like diabetes and Parkinson's.
Now Congress, which approved the budget increase based mostly on faith in the agency and attached few explicit demands, is asking where the results are.
"There's a reason it's the 'National Institutes of Health' and not the 'National Institutes of Science,'" Sen. Tom Harkin, an Iowa Democrat and one of the NIH's biggest supporters in Congress, said at a hearing last month. "We expect the NIH to be actively involved in translational research. Yes, you get the basic science done, but we want to know, how does that help us lead healthier lives?"
The NIH's director, Elias A. Zerhouni, and many outside scientists counter that new therapies often take more than five years to develop and are difficult to predict. The money, Dr. Zerhouni says, helped establish new facilities at universities and other research institutions that will accelerate the pace of discovery.
"We would not have taken the jump that we took in reinforcing the research
infrastructure, building new buildings, recruiting new people, if the doubling had not occurred," he said in an interview last month. "Right now, you'd be in a dire state trying to mount an effective research against bioterrorism, for example."
Now that the giddy budgetary rise has drawn to a close, the agency and the researchers it supports are waking up to a bit of a hangover. With the money have come tough questions about the agency's research grants on sexuality and about outside consulting by its top officials. Those questions have arisen just as Congress and the Bush administration, faced with a rising deficit, are poised to approve much smaller increases for the agency's budget over the next several years. That has scientists alarmed that the expansion in research will be tamped down just as new scientific opportunities made possible by the doubling are taking off.
"If there's a sense of NIH pulling back, that it doesn't have enough money, people get discouraged from applying for grants," says Frederick Grinnell, a professor of cell biology at the University of Texas Southwestern Medical Center at Dallas, and a recipient of two NIH grants. "It takes away from the momentum of the research enterprise."
The Rich Got Richer
The five-year rise in spending on the NIH has been spectacular by federal-government standards, surpassed in recent years only by spending on homeland security. In the 2003 fiscal year, the NIH's discretionary budget, or spending not required by law, was larger than all but 4 of the 15 cabinet-level departments in the federal government. In recent years, a little over half its total budget, which reached $27.2-billion in 2003, has gone to colleges, making the agency the largest single source of funds for academic research.
The NIH has long enjoyed political support, far more than most other agencies that support research, such as the National Science Foundation, which does not have such an obvious connection to ordinary people's lives. Since 1972, the NIH budget has increased by an average of about 9 percent a year, doubling every nine years, on average. That is far better than the growth in money for the physical sciences, which has remained largely flat over the past decade.
When the NIH's latest budget rise started, many universities hoped the new dollars would wind up in their laboratories and help them increase the size of their research operations significantly. Instead, some scientists gripe today that the new dollars merely helped the rich get richer.
Although there is some truth to that, the complete picture appears to be different for institutions than for individual scientists, according to a review of NIH data by The Chronicle.
Institutions that already had a lot of NIH money before the budget doubling began did benefit handsomely from the recent rise in spending. The Johns Hopkins University was the largest single recipient before and after the doubling, and its NIH awards increased by more than two-thirds, to $510-million in the 2002 fiscal year, the last for which the NIH has made available complete data about institutions.
Other top institutions continued to do just as well as they had before the doubling. In 2002, the top 100 colleges receiving the most NIH dollars got 92 percent of all the agency's funds given to higher education -- the same share as in 1998 -- while 415 other institutions got the rest.
While some institutions that had less NIH money before the budget rise began did get more money relative to their peers, for the most part, the new dollars did not shake up the list of institutions receiving the most. Comparing 2002 with 1998, just five newcomers moved up into the list of the top 100 institutions: Howard University, Morehouse School of Medicine, and the Universities of Georgia, Louisville, and South Florida.
And although some members of Congress encouraged the NIH not to overlook institutions in states that had traditionally not received many grants from the agency, the awards remained concentrated in half the states. Twenty-four states that received relatively low amounts of NIH money before the flush times got just 7 percent of all award money for colleges in 2003, up from 5 percent in 1998.
NIH supporters concede that the agency's future budget growth depends partly on increasing its reach. "I think everyone would recognize that if you have only a few institutions doing the majority of the research, you have no political base to support increased funding," said John Edward Porter, a former Republican congressman from Illinois who, as chairman of an appropriations subcommittee, was instrumental in pushing to double the NIH budget.
Among researchers, though, there appeared to be turnover among grant recipients and little concentration of award money among a select few, according to The Chronicle's review. In 2002, only about 50 percent of NIH grantees who applied to renew grants were successful, the same percentage as in 1998. By the end of the increase, the NIH was financing about one in three of the grant applications it received -- about the same rate as before the doubling began -- although the number of applications rose significantly. It appears that more researchers were getting NIH support.
Make Up For Deficits
The new money has brought mostly praise from scientists who received NIH grants. It provided more money for the "R01" grant, the type most commonly awarded by the NIH to individual investigators. The average amount of all such awards rose 24 percent from 1998 to 2002, to $325,924. The total number of awards grew even more, by 34 percent, to 27,568. Growth in the number of new grants had been tighter in the early 1990s, when NIH budget increases were smaller.
With the larger grants, biomedical researchers could finally buy expensive equipment that had been deferred and pay their laboratory assistants more.
"It's not very glamorous to say it was a makeup for past deficits," says David L. Brautigan, a professor of microbiology and medicine at the University of Virginia. "Everyone wants to see new initiatives. But in my mind, that is a very important payoff for the health of the research enterprise in this country."
NIH leaders say the budget doubling had another immediate effect on research at universities: It spurred the institutions to spend their own money to build more research laboratories in anticipation of winning NIH grants to operate them. Construction spending at U.S. medical schools rose to a total of $5.5-billion from 1998 through 2002, compared with $3.3-billion during the previous eight-year period, according to the Association of American Medical Colleges. (Although the NIH provides relatively little money directly for construction, a portion of each research grant partly reimburses institutions for past expenditures on buildings.)
Despite the increase in the size and number of grants, the agency's new money brought disappointment for investigators trying to land their first-ever R01 grants. They tend to be younger scientists hoping for faculty appointments and research careers. The number who got their first-ever grant grew by just 7 percent, to 1,519, between 1998 and 2002. The NIH's data suggest that the increase in the total number of R01 grants between those years went disproportionately to researchers who had previously won agency grants.
Instead, the NIH's improved cash flow helped to increase the number of postdoctoral researchers working as assistants on the projects of established scientists, usually for relatively low pay. "The doubling accelerated the trend, or at least contributed to it," says Howard H. Garrison, director of public affairs for the Federation of American Societies for Experimental Biology.
Mr. Garrison and other science-policy experts worry that the limited prospects for young investigators may, in turn, restrict the flow of new ideas in biomedical research, or cause some people to leave science altogether.
The budget doubling "could have been an opportunity to say, We've got all this money, let's tackle this in some robust way," says Thomas R. Cech, president of the Howard Hughes Medical Institute, who just finished a term on the NIH director's advisory committee. But the NIH and universities did not use their expanded resources to pursue possible remedies, such as creating research jobs for scientists who did not land tenured faculty positions.
Bottom Up vs. Top Down
How the NIH decided to distribute its newfound wealth has also created some resentment among established researchers who get R01 grants. The NIH chose, for instance, to give a larger percentage of the additional funds to other types of awards, especially to pay for research centers and cooperative agreements, as well as for career development and training.
That represents a small but significant shift in control away from researchers and toward the agency. Individual scientists seeking R01 grants submit their own ideas to the NIH, which reviews them. Experts say this "bottom up" approach results in the best ideas being awarded grants. With the research centers, the NIH chooses topics based on where it sees needs and opportunities for research, and then solicits proposals for investigators to do that work.
"The R01 investigator -- the individual scientist working away with a couple of people in a lab -- is the heart and soul of America's biomedical research and has made us the world's leaders in science," says Ralph A. Bradshaw, a professor of physiology and biological sciences at the University of California at Irvine. "I have serious questions whether center grants will replace the grant that has made American science what it is."
Still, the traditional R01 grants did get many more dollars over all than did other kinds of awards. Dr. Zerhouni says the NIH has a bigger role to play today than in the past to provide direction and goals for biomedical research and help translate laboratory discoveries into therapies. "I think NIH has a pretty good balance," he says.
In the years after World War II, as the NIH began its steady growth, the bottom-up approach predominated because researchers understood so little about fundamentals of biology, Dr. Zerhouni says. Today some of the most pressing problems in medicine -- such as understanding how networks of molecules allow cancer cells to grow and spread -- require large teams of researchers working toward a common goal.
"You probably need to identify grand challenges and targets," he told his advisory committee in December. "But you can't dictate necessarily what kind of research will be done, and how."
An Interest in Results
Grant making to university scientists is just one measure of the NIH's achievements during the doubling. Ultimately, Congress provided the money to speed cures, not simply to help scientists indulge their curiosities.
For the most part, Senator Harkin and other members of Congressional appropriations committees have taken a respectful approach to asking the NIH, both publicly and privately, what discoveries the doubled budget produced. But some members have asked more-pointed questions now that the budget rise is complete.
"People are in a sort of Missouri 'show-me' mode up here," says Daniel R. Pearson, an aide to Democratic members of the House Science Committee. "They're thinking, 'We gave you all this money. What are we getting for it?'"
The Bush administration is also developing new ways to try to measure progress in the agency's research.
Dr. Zerhouni notes that Congress has always asked the NIH such questions. He concedes that the agency has struggled to provide concise answers, and he wants that to improve. He ticks off lists of research advances that have accompanied the budget doubling. For instance, NIH-financed researchers last year completed mapping the human genome and decoded the genome of the anthrax bacterium, which could lead to the development of new drugs to defeat it. He also cites last year's finding that a widely prescribed regimen of hormone treatment for older women to treat symptoms of menopause caused more harm than benefit.
In addition, Dr. Zerhouni points to a big drop in deaths from AIDS since 1995 and from coronary-heart disease since 1970. NIH-financed research led to new drugs to treat both maladies, and while healthier lifestyles also contributed to the falloff, Dr. Zerhouni says that arguement is beside the point. "You couldn't have been there without the knowledge that was generated" from NIH research, he says.
Some experts who closely follow the agency argue that the NIH could have used its increased budget to make a bigger push for significant progress toward cures for some major diseases, like diabetes or Parkinson's. The agency "may have made a political mistake by not asking whether there was some low-hanging fruit in terms of a specific disease or affliction that we could pick," said one long-term observer of the NIH, who spoke on condition of anonymity. "Instead, what we did was to raise all boats at the same level" by not picking priorities.
Partly in response to similar comments from scientists who want NIH research to become more ambitious, Dr. Zerhouni last fall proposed a road map for "pioneering" research. It emphasizes filling in the gaps in existing, peer-reviewed science and providing new kinds of research tools. That plan has gotten generally good reviews among scientists, although some worry it will erode support for existing disciplines.
Still, "it's a little frustrating that this is coming when new budget growth is over and we're entering a drought," said a Congressional aide, who spoke on condition of anonymity. "Shouldn't we have been doing that during the doubling?"
It didn't help that NIH was without a permanent director for more than two years in the middle of the cash influx. The agency's former director, Harold E. Varmus, departed in December 1999, and Dr. Zerhouni arrived in May 2002.
Continuing the Momentum
Now, even with more than double the budget it had in 1998, the NIH is pondering its future. During the last five years, the agency's budget rose by about 15 percent annually. Last month Congress approved a budget for 2004 that contains an increase of just 3.7 percent over the previous year. And President Bush is expected to recommend this week an increase of about 2 percent for 2005 fiscal year, which begins October 1.
After so many years of big raises, the NIH has built up a base of multiyear grants that it has committed to continue financing. As a result, a period of slow growth may force the NIH to cut the number of new grants and competively awarded renewals.
The squeeze from the smaller increases will be cushioned somewhat in 2004 because money spent in 2003 for construction of bioterrorism laboratories will be available for other purposes. But that cushion will disappear in 2005. To avoid a crunch then, scientists have been busy lobbying Congress to continue increases for the NIH at its historical average of about 9-percent annually. Still, there appears to be little appetite among lawmakers for increases that large, especially with a growing federal deficit.
That means that the NIH may be set for another round of boom and bust, like what the agency saw from the mid-1980s, when increases were relatively generous, to the mid-1990's, when they flattened out. And if the agency gets annual increases of about 2 percent for the next three years, as the Bush administration has projected, it will bring its budget in 2007 to approximately the same level it would have reached had the doubling never occurred and the agency's budget risen at its historical annual average.
NIH supporters say the ups and downs threaten to dissipate the momentum gained through the doubling. But if the overall federal fiscal picture improves, it's an open question whether the NIH's budget can resume a significantly upward trend or whether it has reached a natural ceiling. Even so, when Congress finally passed appropriations last month for 2004, the NIH was one of the few domestic agencies for which Congress provided a significantly larger increase than President Bush had requested.
Experts have predicted before that NIH funds would level off for good, such as in 1971, after it got a big shot of cash as part of President Richard M. Nixon's "war" on cancer. But they were wrong.
"I think when the budget gets better, the NIH will move back to the top of the Congress's priority list," says Robert M. Cooke-Deegan, a professor of public-policy studies and medicine at the University of North Carolina at Chapel Hill. "I don't think there's anything in the political dynamic that suggests the American people won't continue to think that health research is important."
GROWTH IN NEW AWARDS
Although the NIH's overall budget doubled, the increase was spread unevenly across different kinds of projects. The agency, for instance, gave relatively larger increases to new research centers and training than to individual-investigator research projects (R01 grants), the most common type of NIH award that is given to single investigators.
SOURCE: Chronicle reporting
HOW DOUBLING THE MONEY FOR NIH AFFECTED COLLEGES
As the National Institutes of Health's budget doubled from 1998 to 2003, the ability of individual institutions to tap the gusher of dollars has varied. Here are some of the big movers in the rankings of institutions by amount of NIH money received, from the 1998 to the 2002 fiscal year.
Largest drops (within the top 100)
SOURCE: Chronicle reporting
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Section: Government & Politics
Volume 50, Issue 22, Page A17
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Copyright © 2004 by The Chronicle of Higher Education
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