Washington Post- Next NIH Director Faces Budget Issues

December 15, 2008

The director of the National Institutes of Health may be the least political of a president's political appointments.

The director's job is not to promote administration priorities -- in fact, it's the opposite. The chief, if unwritten, task is to keep the president and Congress from meddling with the agency.

The NIH this fiscal year will spend just under $29.5 billion on basic and applied medical research. More than 80 percent of the funding takes the form of 50,000 grants to 325,000 scientists in the United States and a few overseas. About 10 percent supports research by 6,000 staff scientists, most working at the agency's campus and hospital in Bethesda.

In the past decade, the NIH's budget saw an unprecedented doubling, from $13 billion in 1998 to $27 billion in 2003. In the past five years, however, it has risen only slightly -- and, when adjusted for inflation, has declined. Of the many people inside and outside the agency who were queried about the issues facing a new director, nearly every one said renewed growth of NIH spending is the top priority.

"We are a knowledge economy, we are not a manufacturing economy," said Elias A. Zerhouni, who stepped down in October after six years as NIH director. "NIH provides an enormous opportunity for sustaining economic activity. I am hoping the new administration will focus on this issue."

During the campaign, President-elect Barack Obama released a statement promising to "double the research budgets of key science agencies over a decade," naming the NIH among them. Whether that is still the plan, given the nation's current economic straits, is unknown.

The NIH director's job became a presidential appointment in 1972. In the years that followed, two holders of the position were forced out by the Nixon and Ford administrations for resisting efforts to cut the institutes' budget -- moves that were "not well received at NIH," recalled Victoria Harden, a retired historian of the agency.

To make amends, President Gerald R. Ford appointed Donald Fredrickson, a distinguished scientist who stabilized the agency and solidified the expectation that the director's principal loyalty is to a high-quality research agenda and not to a party or an administration. Still, the post remains a political appointment.

The incoming director will face a number of the same issues that, in different form, have affected NIH activities under President Bush.

The expected repeal of Bush's restrictions on federal funding of embryonic stem cell research will probably create a flood of requests for grants for that field. Almost all of the NIH's 27 institutes and centers get separate congressional appropriations, with the director controlling only a small, but growing, fraction of the budget -- this year it's about 1.8 percent. There may be substantial pressure to direct any increases in that fund to stem cell research in an effort to make up for lost time.

The NIH is also under pressure to strengthen conflict-of-interest rules governing scientists at universities and medical schools who get money from the agency. Stringent rules that took effect in August 2005 limit investments by NIH leaders (and members of their families) in biomedical companies. The rules also effectively bar NIH staff scientists from consulting for private companies. While such restrictions on outside researchers are not likely, there will almost certainly be requirements for much fuller disclosure.

U.S. biomedical science is also facing a demographic crisis that will be one of the new director's more important problems. The average age of NIH-funded researchers rose from 39 in 1980 to 51 in 2006. The average age at which scientists get their first NIH grant is now 42, up from 37 in 1980. Some observers also think the research portfolio is full of overly safe projects.

Addressing these issues was one of Zerhouni's priorities. He used some of the money under his control to create "Pioneer" awards to scientists with unusually risky but promising ideas. He also created "New Innovator" awards to researchers who have not yet gotten an NIH grant, and "Pathway to Independence" awards to postdoctoral fellows.

In his campaign position paper, Obama said his administration would put "special emphasis on supporting young researchers at the beginning of their careers, and backing high-risk, high-return research."

The NIH Reform Act of 2006 gave the director power to fund research that spans the traditional boundaries of the institutes and might otherwise be overlooked. Studies in those areas include determining the three-dimensional shape of crucial proteins (structural biology), determining the genomes of microbes that live in and on human beings (the "microbiome") and the use of nanotechnology for diagnosis and therapy (nanomedicine).

Along the way, the new director may have to deflect congressional efforts to limit certain areas of research or earmark money for specific disorders, such as autism. Zerhouni in 2004 publicly defended several studies of human sexuality after House members tried to defund them. And in congressional testimony this year, he warned that "it would be a grave mistake to go backwards in mandating disease-specific research at a time when barriers need to be torn down, not rebuilt."

There may also be requests from specific groups of researchers. An example is the need for more monkeys for AIDS vaccine studies -- a field that is heading back to the lab after the failure of several human trials.

A major question facing the new administration is what role, if any, the NIH will play in the huge number of cost-effectiveness, comparative-effectiveness, quality-improvement and patient-safety studies that many health-care policy experts say must be done to get the full value of the products of medical research.

NIH institute directors and the study groups that decide what research gets funded have traditionally favored laboratory-based projects aimed at discovering new molecules, pathways and mechanisms. Large, long and expensive clinical studies that answer a few important questions -- the Women's Health Initiative, which tested the effects of hormone supplements and diet in disease prevention, is a good example -- are not generally viewed as the NIH's mandate.

But if the Obama administration is serious about health-care reform, experts say, many such studies are going to have to be done by someone.

There is no leading candidate for NIH director, according to observers. Inquiries to the Obama transition team members leading the search were not answered.