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Hill Hearing Airs NIH Needs, Congress' Concerns

By Rich McManus

On the heels of the debut of NIH's new Roadmap initiative and release of an Institute of Medicine report on the structure and vitality of NIH, a hearing was held Oct. 2 at which director Dr. Elias Zerhouni reported to joint Senate and House committees on how closely the two visions merge as NIH faces its post-budget-doubling future. The director also heard a host of lawmakers' concerns, ranging from A-76 to stem cells to studies of human sexuality.

Zerhouni was joined at the witness table by his predecessor, Dr. Harold Varmus, and by Dr. Harold Shapiro, who chaired the IOM committee on NIH revitalization; all three offered brief opening statements, then took questions from members of both the House energy and commerce committee and the Senate health, education, labor and pensions committee, who cosponsored the rare joint oversight hearing.

Zerhouni presented past evidence of NIH success in such areas as prevention of coronary heart disease, life-prolonging AIDS therapies and record-breaking speed in discovery of the SARS agent, then outlined his roadmap plan.

Varmus, now head of Memorial Sloan-Kettering Cancer Center in New York, had three major points: a need to "counter the deleterious effects of the proliferation of institutes and centers"; find ways to augment the NIH director's authority; and "NIH is a fragile flower in government and a remarkable creation — it needs to be insulated from partisan politics."

Shapiro, who is president emeritus of both Princeton and the University of Michigan, and who now is a professor in the economics department at Woodrow Wilson School of Public and International Affairs, applauded Zerhouni's roadmap as "extraordinary, innovative, helpful and consistent with our [IOM] recommendations." He argued that NIH needs a number of enhanced capacities (improved clinical research, less conservative portfolio, more trans-NIH projects, enhanced directorial authority), but cautioned that "widespread consolidation of existing institutes and centers is not the best strategy to deploy at this time."

Sen. Judd Gregg (R-NH), who chairs the Senate committee, set the goal of the hearing: "We recognize that NIH is an extraordinary resource for our nation." He wanted to know if the 100 percent increase in the NIH budget over the past 5 years was having its intended effect. "Are those dollars being effectively used, and how can we assist NIH attain its goals?"

While virtually all of the legislators preceded personal and constituent concerns with kind remarks about NIH, there were thorns amid the roses. Rep. John Dingell (D-MI) wanted to know about outsourcing at NIH. "I am unaware of any reason it is taking place, or any benefits to be realized," he began. "[A-76 review] has caused great concern among employees, stakeholders and patients, whose hopes and fears rest on the outcome of this process. Is [A-76] serving science or is it serving right-wing ideology? What jobs are being outsourced? Why? In what time frame? Outsourcing causes disorganization, fear, concern and difficulty. Successful organizations don't embark on these kinds of risks." He called for a "candid assessment of the damage A-76 review has done."

During their questioning of the three panelists, lawmakers learned of the natural tensions that exist between the NIH director and the directors of institutes and centers. Varmus pointed out that IC directors need more incentive and flexibility to pursue such trans-NIH projects as the zebrafish initiative and the sequencing of the rat genome.

Both Sen. Edward Kennedy (D-MA) and Rep. Sherrod Brown (D-OH) expressed dismay about the modest increase in President Bush's FY 2004 budget for NIH; Brown called it the "smallest in decades" and added, "We can't afford to drop the ball now — too many lives are at risk," and Kennedy offered two posters: "Shortchanging Vital Medical Research" and "Stifling Scientific Invention."

A number of congressmen, including Reps. Joseph R. Pitts (R-PA), Mike Ferguson (R-NJ), John Shimkus (R-IL) and Mike Rogers (R-MI), took issue with grantee studies involving sexual activity. Zerhouni emphasized that NIH tries to balance, in all studies that it funds, the needs of science, public health and society. Rep. Henry Waxman (D-CA) took the opposite tack of his more conservative colleagues, calling for Congress to lay off second-guessing the scientific expertise of the NIH.

The 2 ½-hour hearing ranged broadly and included: earmarked funding for anthrax vaccine development (Sherrod Brown); health disparities (Rep. Michael Bilirakis, R-FL, wanted assurances that minorities won't be left on the "off-ramp" of the roadmap initiative, and Rep. Stephanie Tubbs Jones, D-OH, pleaded for more studies of uterine fibroids, which affect many African American women); head-to-head studies of the effectiveness of comparable drugs (Sen. Hillary Clinton, D-NY); the health risks of silicone breast implants (Rep. Gene Green, D-TX); pressure to pursue more aggressive stem cell policy (Reps. Lois Capps, D-CA and Diana DeGette, D-CO); a need to bolster pain research (Mike Rogers); portfolio management and cost-effectiveness (Rep. Tom Allen, D-ME); and concerns about the plan to restructure the Commissioned Corps (Waxman).

On many of the above topics, Zerhouni promised written responses in more detail than he could provide at the moment. The session ended cordially with Bilirakis concluding, "Let us know what improvements we can make to enhance the NIH enterprise."

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