AAMC Reporter: December 2007

New NIH Office Examines Where the Money Goes

In most organizations, a new office would get noticed only by immediate stakeholders. But if that organization is the National Institutes of Health (NIH)—whose stakeholders include thousands of research scientists, and by extension every last American citizen—it might be safe to assume that a new office might warrant more than a passing glance.

So it is with NIH's Office of Portfolio Analysis and Strategic Initiatives, or OPASI. Formally announced in 2005, OPASI is responsible for overseeing the NIH Roadmap for Medical Research initiative, which funds some of NIH's most innovative—and risky—research projects. In addition, OPASI works, as the official language states, to "establish a transparent and adaptive priority-setting process for identifying areas of scientific and health improvement opportunities."

It is the priority-setting process that has NIH stakeholders sitting up and taking notice. Part of OPASI's charge is to examine NIH's $29 billion research portfolio for efficacy and efficiency. OPASI will scan all NIH grants to account for where money is being spent—disease by disease, for example. According to OPASI officials, the intent is to shed more light on NIH expenditures, and provide stakeholders with data to help them make decisions. But all that, coupled with accompanying talk of "functional integration" and "fingerprinting" of grants, has led to fears that OPASI may eventually draw already stretched funds away from NIH's 27 institutes and centers or from grants to individual investigators.

Wooed away from a successful career in children's health at Stanford School of Medicine, Alan M. Krensky, M.D., was appointed as the first NIH deputy director for OPASI in July.

Krensky said OPASI has three major functions: portfolio analysis, strategic initiatives, and evaluation, each of which "deal with cross-cutting aspects of the NIH." For example, the office will use "new computer technologies to understand what the NIH portfolio is," Krensky said. "We do this by what's called a fingerprint, which is to look at the content of every grant and to say, this is relevant to [a particular disease]. This is really to bring together one transparent, cohesive, reproducible system to look at what we fund."

With this approach, he said, OPASI hopes to answer the critical question, "What is the NIH spending the people's money on?"

The NIH has always analyzed its grants, Krensky said, but generally within institutes and centers, "with their own rules and methodologies." The new approach cuts across the NIH, he said, and "is an attempt to have one

methodology so that you can get the same answer every time, totally transparent." And so that anyone who is interested can "see what the data is that gives rise to the numbers," Krensky said.

"It's not that we are defining the portfolio," Krensky is quick to say. "We are analyzing the portfolio. Once we find out what we fund, then it is up to the various entities— the [NIH] institutes and centers themselves, Congress, stakeholders, foundations, patients—to see the data and decide what they want to do with it."

"Evaluation is really fundamental to the culture of OPASI," Krensky said, "and it's going to be used NIH-wide, in trans-NIH initiatives." Already, for example, OPASI is working to evaluate the Roadmap's Pioneer Awards, which are given to individual researchers who, as Krensky said, "are doing research that might not have gotten funded in the old system, a little more outside the box." OPASI currently is analyzing how the awards are made. The office also wants to study the program's long-term effects—to answer the question, Krensky said, "Did these people do something really special because of this particular award?"

Out in the field, among the bench scientists and those who manage the complex organizations where research takes place, researchers are watching OPASI with what might be characterized as cautious optimism. Neuroscientist Jeffrey R. Balser, M.D., Ph.D., is associate vice chancellor for research at Vanderbilt University Medical Center and an evaluator of NIH's Pioneer Awards. Based on his own experience at a complex organization, Balser said that having an office like OPASI intuitively "makes a lot of sense." Balser thinks that OPASI will help NIH's institutes and centers to share information.

"It just makes sense to me," he said, "to have an organizing structure to make information available, not just to the director but to all the institute directors.

"Where there is more potential advantage to portfolio management," Balser continued, "is the larger grants that may fund big science, where there may be a dozen investigators involved, in a very large budget. I think it makes a lot of sense for there to be a broad understanding of what the goals and objectives of that effort are, as well as the kinds of resources that might be created in developing that fund."

At the University of California, Los Angeles David Geffen School of Medicine, Senior Associate Dean for Research Leonard H. Rome, Ph.D., focuses not so much on what effect OPASI might have but on the bigger picture. Rome, a past chair of the AAMC's Group on Research Advancement and Development, said that "no matter what NIH tries to do…when the federal government doesn't put enough money into basic research, into clinical research, into translational research, everybody starts to suffer."

Thus, with dollars tight overall Rome said that OPASI's scrutiny of NIH grants might be to the good. Still, he worries that too rigid an emphasis on priority setting might result in opportunities missed. He admittedly sides with his fellow basic scientists in suggesting that the best use of NIH's money would be to not do anything that "takes away from the natural process that has made us so successful in the past, which is to encourage the best research to go on." That approach has worked to science's advantage, he said, and "allowed us to do things we wouldn't have anticipated from a more sort of focused approach."

David Korn, M.D., AAMC's senior vice president for biomedical and health sciences research, also pointed to the big picture. When it comes time to allocate money for the NIH, Korn suggests, Congress and the NIH's other stakeholders, including the general public, need to know that the money is being spent wisely.

"That's what I think the purpose of OPASI is," Korn said. "Substantively it will provide a very different approach of analyzing and then thinking about the results of the analyses on a trans-NIH scale of analysis. That is, it will ask questions and maybe provide some answers about how NIH is functioning as a whole.

"But you've got to be very, very careful how one does this," Korn cautioned. "One man's waste is another person's Nobel Prize research."

Korn also hopes that NIH does not stray too far from the heart of its current mission.

"NIH has been responsible for some very important scientific resource investments that would never have been done by any other entity," he said. "It's very, very important to the future that robust basic science continue to be funded."

Korn, as it turns out, knows Krensky: they were colleagues when Korn was dean of Stanford School of Medicine. He thinks Krensky will serve NIH well. "He comes in as an outsider with a very fresh, creative mind," Korn said, and thus has the capacity to "sort of shake things up a little bit."

At OPASI, meanwhile, Krensky half-jokes that his routine since starting in July has been "having 10 hours of meetings a day." In the midst of leadership searches, Krensky said he is "just starting to get the office off the ground in terms of standard operating procedures, personnel, the nuts and bolts."

At the same time, Krensky has been extraordinarily busy managing the Roadmap—reviewing existing projects, picking new individual award winners, and getting ready to fund new projects. With $483 million in funding this year, the Roadmap constitutes about 1.7 percent of the NIH budget.

The Roadmap is a "venture space," Krensky said, "where we are doing science that is hopefully a little more outside the box. We're testing the boundaries of things." Successful Roadmap science gets picked up in individual NIH institutes and centers; if it's not successful, Krensky said, "then we have done an experiment."

Current Roadmap projects focus on the microbiome, sequencing microorganisms that have an impact on health and disease, and the epigenomics, which looks at why certain genes are expressed or not. That kind of cross-cutting research is perfect for the Roadmap, he suggests: "It's not about any one or two [NIH] institutes or centers, it's really about the group as a whole, and where there can be real synergy among the various institutes."

Each of the researchers interviewed for this article voiced the concern that, as Jeffrey Balser said, OPASI receive "plenty of strategic input from the research community at the nation's academic medical centers."

For his part, OPASI's new leader sounded more than open to that.

"Communication is fundamental to research in this country," Krensky said, "and so for this office, and I think for the NIH as whole," communication with the academic community "is of fundamental importance."

—By Stephen Pelletier, special to the Reporter

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