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Children being protected from infectious disease in a French institution in 1925.

Children being protected from infectious disease in a French institution in 1925.

Casas-Rodríguez Collection/Flickr

NIH rushes to spend a $150 million pediatric research windfall

The National Institutes of Health (NIH) is scrambling this year to spend a windfall of more than $150 million on pediatric research. And things could get a little hairy, judging from an outside advisory panel’s reaction Friday to the agency’s initial public airing of its plans.

“Given the diffuse nature of what you have described, and its complexity, I don’t want to use the word ‘nuts’, but it’s a daunting challenge,” Lila Gierasch of the University of Massachusetts, Amherst, told Principal Deputy NIH Director Lawrence Tabak after his presentation to a Council of Councils meeting in Bethesda, Maryland. “Thank you for changing ‘nuts’ to ‘challenging,’ ” Tabak replied, tongue-in-cheek. “We’re just trying to do what makes the most sense, and multiply the potential value of the resources available to us.”

The situation is certainly unusual for the $30 billion agency, where a succession of flat budgets has meant plunging success rate on grant proposals. But NIH is just following orders from Congress regarding two separate research initiatives to help children.

Last spring, legislators passed the Gabriella Miller Kids First Research Act, authorizing NIH to spend $126 million over 10 years for pediatric research. In December, they gave NIH its first $12.6 million installment. Taken together, the authorization plus the appropriation represented a kind of belt-and-suspenders approach to making sure that NIH follows through on lawmakers’ interest in having the agency do more to understand and find cures for everything from pediatric cancer and juvenile arthritis to adolescent suicide and obesity.

Simultaneously, NIH pulled the plug on its controversial National Children’s Study (NCS), which was supposed to monitor various environmental and psychosocial factors affecting a cohort of 100,000 children from before birth to age 21. So Congress ordered NIH to find other uses for the $165 million that lawmakers had already allocated in the final 2015 spending bill for the massive study. Some money will go to shutter the existing Vanguard study and related activities, leaving approximately $140 million for new initiatives.

NIH officials have spent the past 6 weeks reacting to that whirlwind of legislative activity and plotting their next moves. Although the two pots of money are distinct, they hoped to use each to capitalize on the rash of new technologies that allow researchers to collect and analyze vast amounts of information. On Friday, they presented their preliminary plans to the council.

Kids First

The money from the Kids First initiative is expected to help enrich any number of children’s studies already under way, said Elizabeth Wilder, head of the Common Fund, which coordinates trans-NIH research programs. “The goal is to mine the information across cohorts to address compelling questions in pediatric research,” she told the council. “We want to develop a rich resource for the pediatric community.”

Some council members were put off, however, by such a generic description of the research plan. “I’m not as excited as I’d like to be,” said one. “I’m trying to imagine what I would do with this database.” Another council member characterized NIH’s plan as “‘we’ve got the capacity for Big Data, so let’s apply it to kids.’”

Wilder admitted that the scope of the research to be covered has not been determined. “We do not have a Kids First definition of when childhood ends,” she said in response to a question on whether studies involving drug abuse and mental illness would be part of the initiative. (Miller, the law’s namesake, died of cancer at the age of 10, and sponsors of the legislation routinely refer to it as supporting research on pediatric cancer.) Another council member wanted to know if studies of adult outcomes of such disorders would also be fair game.

But the initial uncertainty didn’t bother Marlene Belfort, a professor at the University at Albany, State University of New York. “I think there is more enthusiasm for this project than I heard 25 years ago when we started to discuss the Human Genome Project,” she remarked. “And look at how much we learned from that.”

The pediatric research initiative, like the genome project, is expected to be a multiyear effort. And the idea won broad, bipartisan support because it was touted as revenue-neutral: Its funding comes from ending federal support for political conventions for each party’s presidential candidate, now funded through a $3 checkoff on tax returns.

Some $38 million from the election fund was set aside last spring for the NIH initiative, and Representative Tom Cole (R–OK) has introduced a bill to transfer another $88 million to NIH by completely eliminating the checkoff mechanism, which also funds presidential campaigns. However, Congress funds federal agencies on an annual basis, so the money for Kids First must be appropriated every year.

Children's study windfall

By contrast, the money from the canceled children’s study is a one-time windfall. It must be spent, or at least committed, before the 2015 fiscal year ends on 30 September. Congress also attached two strings to the money, Tabak told the council: NIH must “remain true to the original intent of the study, to examine questions at the intersection of pediatric health and the environment, and we must also do a better job of engaging underrepresented communities.”

Moving quickly, a group of institute directors and senior NIH officials have cobbled together three options for spending the NCS money. As Tabak described them, the first would focus on developing and employing new tools, like biosensors, to track the impact of environmental factors on pediatric diseases. The second would study the “seeds” of future diseases by monitoring factors that affect children before and after birth. The third would broaden existing studies to include more environmental factors. The goal, Tabak explained, “is to develop tools and approaches that, if successful, could be applied to many existing cohort studies.”

Tabak acknowledged that he was being vague, which prompted Gierasch’s comment about how much more work NIH needs to do in a very short amount of time. But Tabak said NIH faced an even greater challenge in 2009, when Congress bestowed $10 billion on the agency as part of the government’s stimulus package in the wake of the financial meltdown. “Did we get it perfect then? Maybe not,” he said. “But I think it worked out pretty well in the end.”

Several council members suggested specific areas that NIH should consider in any future solicitation to spend the NCS money, leading Tabak to warn that “we need to strike a balance between trying to be all things to all people and delivering something useful.” He said the advantage of emphasizing the development of new tools is that “you can tailor them” to whatever studies NIH decides to fund down the road.

Tabak didn’t offer a timeline for making decisions on how to distribute the NCS money. Wilder said that she hoped NIH leadership would decide “in early spring” how the first year of Kids First funds would be spent.