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December 2, 2003

Post-Doubling, NIH Could Face Bumpy Ride

The House and Senate committees charged with overseeing the National Institutes of Health (NIH) held a joint hearing in October that highlighted both the management challenges facing the research agency and the political challenges facing members of Congress as they seek to address those management issues.

The Senate Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Committee scheduled the hearing two days after NIH Director Elias Zerhouni unveiled a new "roadmap" for biomedical research that would maximize opportunities and bridge gaps unlikely to be addressed under NIH's current decentralized structure. The plan offered a series of new initiatives to encourage cross-disciplinary research involving multiple institutes, some of which the agency has already begun to implement. Dr. Zerhouni also made clear at the joint hearing that some elements of the plan call for strengthening the office of the director by providing greater authority over the agency's budget and a better centralized planning mechanism.

The hearing was held amid increasing calls for Congress to step up its oversight of the agency after doubling its budget over the last six years to about $28 billion. In addition to providing Zerhouni an opportunity to present his proposals, the hearing served as a warning that his planned roadmap could encounter some rugged terrain on Capitol Hill. Committee members are contemplating the first reauthorization of NIH since 1993, and a plethora of obstacles could get in the way, from partisan politics to contentious ethical issues to the complex web of patient groups and research institutions with a stake in the outcome.

One such issue, which has recently garnered much attention, is an attempt by conservatives in the House to prevent NIH from funding certain studies that involve behavioral research relevant to drug abuse and HIV/AIDS transmission. Rep. Patrick Toomey (R-PA) proposed an amendment to the Labor-HHS appropriations bill in July that would have blocked funding for four such studies that have already been approved through NIH's peer-review process, and while the amendment failed by a vote of 212-210, three of its backers raised the issue with Zerhouni at the hearing.

This issue caused additional controversy when an Energy and Commerce staff member provided NIH with a list of over 200 grants that had been deemed questionable by the Traditional Values Coalition, a conservative advocacy group. NIH began contacting recipients of these grants apparently to request information to help defend the research, prompting an outcry from scientific organizations. Many in the research community (including AAAS) expressed concern that such an action undermines the peer-review process and could have the effect of deterring researchers from pursuing projects similar to those targeted.

Rep. Mike Rogers (R-MI), who opposed the Toomey amendment, also spoke up at the hearing, noting that his former career as an FBI agent had convinced him of the usefulness of research on sexual behavior, but nevertheless citing a need for NIH to be more transparent.

Among the other contentious issues raised at the bicameral hearing were stem cell research (a perennial favorite), an outsourcing initiative that has rankled NIH staff, and allegations by Rep. Henry Waxman (D-CA) that the Bush Administration has allowed ideology to interfere inappropriately with scientific panels at NIH.

Many members raised additional issues that are less explosive, but nonetheless illustrate the complicated task facing lawmakers who will need to balance a wide array of parochial interests and overarching policy concerns as they craft a bill. For example, Sen. Hillary Rodham Clinton (D-NY) urged NIH to undertake comparative effectiveness studies of existing drugs; Rep. Stephanie Tubbs Jones (D-OH) focused on the need to address health disparities affecting minorities; and Sen. Edward M. Kennedy (D-MA) attacked the fiscal 2004 appropriations bill that awards NIH a much smaller increase than in past years.

Though Zerhouni was flanked at the hearing by two prominent scientists who support the roadmap—Dr. Harold Varmus, a former NIH director who now heads the Memorial Sloan-Kettering Cancer Center and Dr. Harold Shapiro, who chaired an Institute of Medicine study of NIH's organizational structure released last summer—the plan may prove a nonstarter. The 27 individual institutes that comprise NIH face pressure from constituent groups to focus resources on their specific area of concern. This pressure makes it difficult for institute directors to support the centralized research efforts proposed by the roadmap and thus motivated Zerhouni to ask Congress for greater authority. Members of Congress, however, face pressure from these same patient and disease groups, many of whom feel the current highly decentralized structure is working well. It remains to be seen whether Congress will go along with Zerhouni and pave the way for his proposed reforms. •••