By Jan Bowers, contributing writer, September 03, 2012
Amidst the rancorous clamor that characterizes much of the political discourse on the federal budget, a quieter struggle is taking place among the physicians and scientists who compete for federal funding of biomedical research. With congressional appropriations to the National Institutes of Health (NIH) essentially flat during the past few years, both seasoned and new investigators are finding it difficult to obtain government funding for their projects. “The reality is that these days, the NIH budget is increasing every year at below the rate of inflation, and that’s been happening for several years now,” said Thomas S. Kupper, MD, professor of dermatology at Harvard Medical School, chairman of dermatology at Brigham and Women’s Hospital, and president of the Society for Investigative Dermatology (SID). “To get funded these days to do research, your grant has to score in the top 10th to 15th percentile, and that is making it almost unsustainable. So a number of scientists who have been funded for a good many years are not able to stay funded.”
The physician investigator faces an especially stiff challenge in this environment because “being a clinician, they do need to see patients and generate revenue for the department,” noted Henry W. Lim, MD, chair of the department of dermatology at Henry Ford Hospital and former chair of the American Academy of Dermatology’s Council on Science and Research. “How much time can you protect for physician investigators so that they can continue to develop and be successful, and when you do protect their time, where is the funding going to come from? With NIH funding becoming more competitive, it just makes it more difficult for many departments to do that.” [pagebreak]
A look at appropriations to the NIH, and specifically the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS, one of 27 institutes and centers that comprise the NIH and a major source of funding for skin research), since fiscal year 2007 reveals what investigators are up against. For fiscal year 2007, the NIH budget was $29.2 billion; five years later, the FY2012 appropriation was $30.9 billion, an increase of just 5.8 percent. The NIAMS budget saw a similar increase during the same period, from $508 million in FY2007 to nearly $536 million in FY2012 (about 5.5 percent). From FY2007 to FY2011, NIAMS’ funding of skin biology and skin disease research increased 2.4 percent to $68.36 million.
More telling is the history of competing research project grants (RPGs), which can be measured in two ways. One is the success rate, which is simply the percentage of reviewed RPG applications that receive funding. The second is the payline, a percentile ranking derived from the score awarded a grant application by the study section (a peer-review group) that evaluates the application. In FY2001, the NIH success rate was 32.1 percent; 10 years later it had dropped to 17.7 percent. NIAMS had a 28.6 percent success rate and a payline at the 24th percentile in FY2001; by FY2011, those had dropped to 14.9 percent and the 11th percentile, respectively. This year, NIAMS has set the payline for RO1 grant applications (NIH’s most commonly used grant program) at the 12th percentile for all but new investigators (those who have not yet received a substantial NIH independent research award), who are funded through the 15th percentile. [pagebreak]
NIAMS’ practice of giving an advantage to new investigators reflects an NIH-wide policy, according to Stephen I. Katz, MD, PhD, a dermatologist and immunologist who has served as director of NIAMS since 1995. “Since the doubling [a period of increased funding for NIH lasting from 1998 to 2003], the NIH has made a concerted effort to fund new and early-stage investigators, and we have stuck to that policy,” he said. “We have given a three- to five-point advantage to new investigators over the past five years.” Even with that edge, “scientists who get a first independent award are in their early 40s now,” said Joel M. Gelfand, MD, MSCE, medical director of the Clinical Studies Unit and associate professor of dermatology and epidemiology at the University of Pennsylvania Perelman School of Medicine. “That’s a critical problem — when people can’t become independent until their early 40s, fewer and fewer people will want to pursue that type of career.”
Another trend noted by a leading investigator is that the quality and sophistication of the research projects that are funded has increased significantly because only the best survive the intense competition. “That’s both good and bad because it means that everything that’s funded is of supremely high quality, but we’re leaving some on the table that are very good as well,” said Kevin D. Cooper, MD, professor and chairman of dermatology and director of the NIAMS Skin Diseases Research Center at Case Western Reserve University and University Hospitals Case Medical Center, and chair of the Academy’s Council on Science and Research. “The problem is that the quality is so high, it’s a struggle for people to stay in the field. We may be losing some very creative young people who choose not to face those challenges. And we do need a pipeline of young people, because they have the new technologies and the new thinking to create the discoveries for our specialty in the future.” Both Dr. Cooper and Dr. Gelfand pointed out that the costs of conducting biomedical research, such as technologist salaries, animals, technology, and supplies, are outpacing inflation, adding another layer of difficulty in a tight funding environment. [pagebreak]
Regarding the type of research funded by NIH, one prominent researcher perceived a shift occurring in the recent past. “I think there has been more of a focus toward clinical research, epidemiologic genetic research, and looking at patient outcomes,” said Maria K. Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota. “There has been a greater emphasis on soliciting and requesting projects that are clinical and translational research. And that’s very different from maybe a decade ago, when the focus was still on hard-core science.” During the doubling period, NIAMS “made a concerted effort to support a bit more translational research than in the past, and we also made a commitment to support more clinical studies. That commitment has continued,” Dr. Katz said. “If they’re trials, they have to make a difference, ultimately, in the practice of medicine. They have to have impact.”
How NIH review works
Dr. Kupper, who recently finished a stint as chair of NIAMS’ Arthritis, Connective Tissue, and Skin Study Section, explained that the process of reviewing NIH research grants has “undergone a transformation” in the past four or five years, and that reviewers now adhere to five criteria. “The first is significance: is this work worth doing? Is this something that someday may help patients with disease? Another is, can the investigator do it? For young investigators without a track record of funding, do they have some good preliminary data? A third criterion is innovation — is the idea, or are some of the proposed techniques, new? The final two center on the approach you take: did you set up the appropriate controls, is what you say you’re going to do actually feasible? And, is the environment conducive and supportive to doing this research?” [pagebreak]
The grant application initially goes to the NIH’s Center for Scientific Review, which determines which study section will review the grant and what institutes might be most appropriate to fund it. The applicant can suggest which institute is most relevant to the research project. “I try to get investigative dermatologists to remember that what they’re doing is relevant and potentially fundable to many different institutes,” not just NIAMS, Dr. Kupper said. “My skin immunology research is almost exclusively funded by the National Institute of Allergy and Infectious Diseases. We also have investigators funded by the National Cancer Institute, the National Heart Lung and Blood Institute, and the National Institute on Drug Abuse.”
Dr. Katz noted that the institutes vary greatly in terms of their funding plans. “Some institutes have enormous plans in infrastructure, so they do less in the way of RO1 or R21 [research grant] funding,” he said. “It is an emphasis of mine, and of this institute, that we support investigator-initiated research. I think it’s the bright minds of individuals who make these discoveries.” Dr. Katz also emphasized the distinction between funding for research into skin biology and skin disease — part of NIAMS’ mission — and funding for dermatology programs. “The public doesn’t care whether research is done by a dermatologist or a non-dermatologist,” he said. “We as a society, in my view, should be interested in supporting any kind of research that goes to improve the skin health of the nation and the world.” (For basic information on applying for NIH grants, visit http://grants.nih.gov/grants/grant_basics.htm.) [pagebreak]
Derm societies’ support
In an era of intense competition for funding, dermatology societies can play a key role in promoting skin disease research, the experts agreed. The Dermatology Foundation targets aspiring investigators early in their career, providing funding that helps bridge the gap between a residency or fellowship and qualification for federal funding. “I think the Dermatology Foundation plays a major role in helping new investigators through a stepping-stone process toward federal funding,” Dr. Hordinsky said. “The roles of all the dermatology organizations will probably have to be more focused and specific as time passes, and [early career support is] where the Derm Foundation has been solid.” In 2012, the Dermatology Foundation awarded $3.2 million in research funding to 70 recipients. NIAMS, also a strong supporter of young investigators, awarded more than $2.5 million in individual and institutional training grants in FY2011.
The Society for Investigative Dermatology does not make awards, but rather acts as a catalyst to facilitate skin disease research in a number of ways, according to executive director Rebecca Minnillo, DM, MPA. In the research funding arena, the SID communicates to members the range of funding opportunities and resources for obtaining funding available to them through the NIH, “and we also seek out volunteers from among our community to serve on the study sections that review the grants.” She noted, however, that some of the patient groups offer grants for their disease. “They also collaborate to pursue common research interests,” she said. “For example, some of the members of the Coalition of Skin Diseases are in the early stages of development for a research project that focuses on itch’ — a significant burden that cuts across many skin (and other) diseases.”
The Academy’s efforts to develop a focused research agenda, which culminated in a dermatology research agenda consensus conference in June, are partly a result of the funding environment, according to Dr. Lim, who chairs the Research Agenda Committee that organized the conference. “The purpose of the conference was, knowing that funding is tight, what can the Academy do to help investigators be more competitive; what are the areas that would be most appropriate and feasible for the AAD to help facilitate their efforts, given that it is not a funding agency?” [pagebreak]
NIH representatives who attended the conference were very supportive of the idea of dermatology undertaking a data collection effort, Dr. Lim said, “because that’s something that the NIH is not going to fund, but once you have it, any investigator who wants to do studies can easily use the data to propose a hypothesis or ask grant questions.” Citing the Academy’s “many needs” for research, Dr. Cooper noted that “once we establish infrastructure, we’ll have a robust mechanism” for determining where research is needed. “We need performance measures, quality and safety measures, and clinical questions for multi-center studies.”
Funding in the future
None of the experts expected the federal funding environment for biomedical research to improve significantly in the near future. It could, however, get a great deal worse if Congress takes no action to avert the looming “fiscal cliff” — broad tax hikes and $1.2 trillion in automatic spending cuts (known as “sequestration”) scheduled to take effect in January. The Federation of American Societies for Experimental Biology has calculated that sequestration would deliver a 9.1 percent reduction in the NIH budget, or $2.8 billion. Further, because much of the NIH internal budget consists of salaries, which would be difficult to reduce quickly, the FASEB estimates that as much as $2.6 billion of the reduction could come from extramural funding of research across the nation. (Lobbying for medical research funding is a key legislative priority for the AADA; it has worked with groups like the One Voice Against Cancer Coalition, the Ad Hoc Group on Medical Research Funding, and others in pursuit of this.)
Regardless of whether sequestration occurs, federal research funding reductions pose “an existential threat to our specialty,” Dr. Gelfand said. “If academic institutions lose research funding, there will be fewer discoveries and fewer people available to teach others to do research. There’s a real need to expand our workforce, and expand our ability to understand diseases and demonstrate the quality of our services — that’s a big issue with health care reform.” [pagebreak]
Dr. Kupper said that sequestration would be “a disaster” for the NIH, but predicted that the unpopularity of the proposed cuts would prevent them. He expressed guarded optimism for the future, predicting that “NIH will come back again because it has strong bipartisan support. Both parties agree that the money is spent well and responsibly; this is an organization that is the envy of the world in terms of scientific excellence and usable scientific results. You can look at every drug on the market today and trace it back to an NIH-funded experiment that shed light on this pathway or that mechanism and allowed that drug to ultimately make it into use. I don’t think we can look at the world through rose-colored glasses, but I think we can try to say to our young investigators that the best research can get funded, and it’s just a question of figuring out how to do that, and riding out some of these storms of low funding.”
Dr. Katz maintained that while sequestration would impose “devastating” cuts, in his 40 years at the NIH, “there’s never been a more opportune time or better research being proposed than there is right now. There are fantastic discoveries being made that have already had a tremendous impact on people with skin diseases. Investment in research is the future of every specialty that we support.”
Federal funding for selected skin diseases (in millions of dollars)
All figures provided by the National Institutes of Health. Does not include psoriasis research funded through the American Recovery and Reinvestment Act in 2009 and 2010.