Like so many other federal agencies, the National Institutes of Health (NIH) has struggled under the Bush Administration, and today, it needs to be revitalized. Not long ago, I wrote about what we can expect for the FDA when president-elect Obama comes to office; now I’d like to turn the NIH. But to understand the agency’s future, one needs to recognize its recent past.

The Bush Years: Starving the Beast

From 1998 to 2003, the NIH enjoyed a golden age. Over that span, the agency’s budget doubled to $ $27 billion, an increase that Harvard University president Drew Faust has called a "transformative force for biomedical research.” But since 2003, NIH funding has remained essentially flat and, when adjusted for inflation, it has actually declined.

This has caused concern within the medical research community While 10 percent of the agency’s budget funds in-house research, a whopping 85 percent supports biological and medical research at universities and medical centers. When the NIH has less money, it has less money to give—and more researchers on the cusp of biomedical breakthroughs miss out on the funding they need.

Last year, the Group of Concerned Universities and Research Institutions (GCURI)—an association of seven top-tier universities including Harvard, Duke, Johns Hopkins, and Brown—issued a report arguing that reduced funding for NIH means “slowing the pace of medical advances, risking the future health of Americans, discouraging [the country’s] best and brightest researchers, and threatening America's global leadership in biomedical research.”

Indeed, as the NIH budget has shrunk, researchers have had a harder time securing grants: according to GCURI’s report, the agency funded 32 percent of proposed research projects in 1999, but only 24 percent in 2007. Researchers who are awarded NIH grants also have to jump through more hoops than they did in the past. In 1999, 29 percent of grant proposals were approved upon first submission; in 2007, only 12 percent of projects were given the same first-time approval.  These days, 88 percent of researchers who end up with NIH funding do so after applying multiple times. According to GCURI “this trend represents a clog in the system that is causing researchers to abandon promising work, downsize labs, and spend more time searching for other financial support. Meanwhile,” the report continues, “Americans wait longer for cures.”

There’s no reason to think that the quality of grant proposals between 1999 and 2007 has dropped precipitously enough to warrant a stingier NIH. Good scientists are being left high and dry. The agency’s primary research grant—the so-called R01 grant—is generally regarded as the “gold standard” in science: when the government grants an R01 to a project, that research is officially legitimated as important, ground-breaking work. In fact, GCURI claims that “a scientist is not considered established and independent until he or she is awarded an R01, which…enable[s] scientists to hire staff and buy [the] equipment and materials necessary to conduct experiments.” Or, as Dr. Denis Guttridge, Associate Professor at The Ohio State University, puts it: “assistant professors cannot get going in their careers until they get their first R01.” Thus allowing federal grant money for medical research to shrink puts our country at risk of “los[ing] a generation of committed scientists” and the medical breakthroughs that they can provide.

Blame Bush and Congress for this troubling trend: the NIH is funded through annual Congressional appropriations which legislators base on a funding request submitted to them by the president. In other words, the NIH has less money because President Bush has been asking Congress for less money—and Congress has consistently obliged his request.

The Bush Years: Leadership

From 2002 through this past September, the NIH was led by Elias Zerhouni,  a noted radiologist.  Unlike so many other presidential appointees during the Bush years, Zerhouni was by all accounts a skillful manager and conscientious director. Even the most hard-line Democrats respect him: in March 2008, Ted Kennedy told Government Executive magazine that "Dr. Zerhouni leads the National Institutes of Health with extraordinary skill, vision, and integrity” and California Rep. Henry Waxman acknowledged that “[Zerhouni has] been a very good leader for the NIH.”

Managerial prowess notwithstanding, Zerhouni’s tenure at the NIH was a rocky one. While he introduced some ambitious initiatives—such as a special grant program for young researchers and an initiative to identify under-funded fields—he also raised the ire of NIH stakeholders when he centralized his authority over the various 27 NIH research centers. His conscious goal in doing so was “to destroy points of veto” and exercise greater control over the agency. Administrators, researchers, and patients associated with the various centers—each of which specializes in a particular medical field, such as cancer, aging, and mental health—expressed concern that their respective entities were being marginalized from the NIH decision-making process.

But this hubbub was nothing compared to two other controversies that ended up defining public perception of Zerhouni’s tenure as director. The first was his scramble to clean up a scandal involving NIH researchers signing lucrative, off-hours consulting deals with biotech and pharmaceutical companies. Though these relationships were established in the 1990s, under Zerhouni’s predecessor, news of the misbehavior didn’t break until he became director. After being called before Congress, Zerhouni introduced stricter regulations regarding consulting by NIH staff, but by then it was too late: the scandal had already rocked public respect of the NIH and, as Patrick White, the vice president for federal relations at the Association of American Universities, told GovExec last year, “it practically derailed his directorship."

The second controversy that upended Zerhouni’s directorship surrounded stem cell research. Back in 2001, President Bush banned federal funding for research that required generating new strains of stem cells—self-renewing cells that can transform into other types of cells and are used in developing innovative new treatments. Following Bush’s ban, the NIH was allowed to fund research only if it used the 21 stem cell strains that had already been created. Scientists could no longer generate new types of stem cells.

From the start, Zerhouni disagreed with Bush’s restrictions on stem cell research, but he kept relatively mum about the issue until 2007. In  the spring of that year, Zerhouni testified before Congress on the importance of new stem cell research, declaring that “American science will be better served — and the nation will be better served — if we let our scientists have access to more cell lines that they can study with the different methods that have emerged since 2001.” The press called Zerhouni’s testimony “a high-profile dissent from Bush administration policy,” and indeed it was: Zerhouni insisted that the “shortsighted” stem cell ban limited the NIH to fighting for medical innovation with “one hand tied behind our back.”  A year and a half later, Zerhouni stepped down from his post.

The NIH under Obama

Zerhouni’s tenure at the NIH was undermined by problems that he inherited from others—including President Bush, who consistently kept funding requests for the NIH low and imposed the ban on stem cell research. But now, a new president means new hope for the NIH.

Indeed, both the President-elect and Congressional Democrats want to repeal Bush’s stem cell ban, thus opening funding streams for new research. The sticking point is about how best to do this: progressive leaders are undecided as to whether the restriction should be overturned through executive order or by legislation. As the New York Times noted last week, choosing between these two procedural options is “not [an] academic [exercise].” If Congress tries to tackle the issue, pro-life legislators and voters could put up a big fight that would cause the new Democratic Congress to “stumble out of the box.”  (Pro-lifers oppose stem cell research because stem cells are harvested from human embryos).

According to the Times, one strategy that Democrats may use to reduce the divisiveness of the stem cell debate is “framing the stem cell policy as…a health care issue with the potential to provide new treatments.” Logic suggests that if Democrats were to choose this route—that is, if they were to focus on the medical advances possible with stem cell research and how they relate to public health—then the NIH would find itself with a new Congressional mandate to fund more stem cell research. 

The Obama Administration may also want the NIH to play a bigger role in health care reform. For example, recent legislation co-sponsored by Finance Committee Chariman Max Baucus and Senate Budget Committee Chair Kent Conrad  proposing a comparative-effectiveness research institute called for the Director of the NIH to serve on the institute’s Board of Directors, which would give him (or her) an important role in evaluating the effectiveness of new and existing treatments.

Moreover, since 2000 the NIH has been managing and developing an online data bank of clinical trials, which currently contains 66,730 trials sponsored by the NIH and other public and private bodies. These trials include studies exploring the cost-effectiveness and comparative-effectiveness of various treatments and medications. As health care reform heats up and administrators begin making difficult choices about which treatments should or should not be covered by insurance, the NIH and its work will become a go-to source for information and insight. The math here is simple: if Obama’s health care policies are going to be evidence-driven, then our nation’s primary clearing house of medical research will have to play a more direct role in guiding policymakers’ decisions.

Indeed, the NIH may also become more involved in producing—and not just evaluating and cataloguing—policy-related research. A recent Washington Post article noted that, while the NIH traditionally funds “laboratory-based projects aimed at discovering new molecules, pathways and mechanisms” rather than “large, long and expensive clinical studies that deal with prevention, effectiveness, and safety,” this dynamic may change under Obama. Not only does the President-elect suppo
rt the creation of a comparative-effectiveness research institute, but his campaign materials also state that “governments at all levels should lead the effort to develop a national and regional strategy for public health and align funding mechanisms” to more directly promote public health and wellness. In other words, the NIH could find itself funding more research on immediate public health issues that it does today. After all, as the Post notes, “if the Obama administration is serious about health-care reform…[studies that inform actionable public health policies] are going to have to be done by someone”—and the NIH certainly seems an obvious choice. The presence of former NIH bioethicist Ezekiel Emanuel inside the Obama White House makes it even more likely that the NIH will take on a more important role within Obama’s policy agenda. 

None of this is definite, of course—after all, Obama hasn’t even taken office yet. But one thing that is almost certain is a budget boost for the NIH. The importance of such an increase can’t be over-emphasized: even if Zerhouni’s directorship had proceeded without political incident, it would have still been crippled by lagging funds. As GovExec put it last year, “in a town that measures success by budget growth [like D.C.], a slowly shrinking budget is a big, black blot.”

Obama has made it clear that he intends to erase that blot. His campaign’s science “fact sheet” notes that, “after a period of growth of the life sciences, the National Institutes of Health (NIH) budget has been steadily losing buying power for the past five years” and promises that as president, Obama will “double budgets of key science agencies such as the National Institutes of Health…over the next ten years.” 

This is great news, but the current economic climate may put a big asterisk on this promise. Indeed, Obama’s team is already backpedaling slightly. Back in October, an Obama adviser told a reporter from the science magazine Nature that the doubling of funds was just for “basic research” and not the NIH’s entire budget. Nonetheless, Democrats do seem serious about significantly boosting NIH funding the economic stimulus bill introduced in November included $1 billion supplemental funding for the NIH, and word on the Beltway is that this provision will find its way into next month’s Obama-supported stimulus package.

The last consideration when mapping out the future of the NIH is leadership: who will succeed Zerhouni as permanent NIH director? Insider reports claim that the top contender for the post is Francis Collins, a geneticist who ran the NIH’s Human Genome Project until this past August. Collins would be a good choice: in 2007 he was awarded the Presidential Medal of Freedom, the nation’s highest civil award, and his research has led to the identification of genetic variants associated with type 2 diabetes and the genes responsible for cystic fibrosis, neurofibromatosis, Huntington's disease and Hutchinson-Gilford progeria syndrome.

Collins also has a good track record as a manager: under his direction, the Human Genome Project completed “all of…[its]…goals…ahead of schedule and under budget,” according to a 2008 interview.  Circumstantial evidence suggests that Collins wants the position and is likely to land it.  In May of last year he told the Washington Post that the NIH is "the most wonderful government organization that I can possibly imagine” and this month has responded with a curt “no comment” to press questions about his possible appointment as director.

All in all, it appears that the NIH is in for a period of revitalization—a welcome respite from the Bush years, when its budget and prestige eroded. There are, of course, important unanswered questions: How will stem cell research play out? Just what kind of budget increase will the NIH see? But at the same time, there’s reason to believe that the agency will play a more prominent role in the Obama Administration than it did under Bush and that it will be in good hands under Collins’ directorship.

Ultimately, the NIH finds itself at the same crossroads as the rest of the nation, between the disappointing Bush years and the promise—and extraordinary challenges—of the Obama Administration.