AAMC Reporter: September 2005

AAMC Stresses Priorities for NIH Reauthorization

By Gina Shaw, Special to the Reporter

As part of an effort to reauthorize the National Institutes of Health (NIH) for the first time in more than a decade, House Energy and Commerce Committee Chair Joe Barton (R-Texas) released draft legislation in July that would place an increased level of power in the hands of the NIH director. The bill would also organize the NIH's divisions and centers under a two-pronged, overarching structure: one category focused on specific diseases and organs and the other on research technologies and additional resources used across all areas of medical research.

In general, the AAMC supports several of the bill's objectives, including enhancing the capacity of the NIH to undertake cross-institute planning and coordination. But since the initial draft of the legislation was released, the AAMC has been working with committee staff to address concerns about some aspects of the bill.

The additional authority given to the NIH director by the draft legislation is something the association has long supported in principle, said Dave Moore, senior associate vice president in the AAMC's Office of Governmental Relations. "We have talked for some time about the need for the director to have more authority to better coordinate trans-NIH initiatives across institutes."

But current legislative language leaves out two important numbers: what the total size of the NIH budget should be and what percentage of that budget the director would control. "If the NIH budget as a whole is held relatively level, but you give the director more budget authority for trans-NIH initiatives, then institute budgets may fall. We're in favor of the NIH director having more authority, but not if it comes at the expense of ongoing research in the institutes," Moore said.

The issue is one of balance, agreed Philip Pizzo, M.D., dean of Stanford University School of Medicine, who co-chairs the AAMC's ad hoc working committee on the NIH reauthorization. "The amount of discretionary dollars under the director should be notable but constrained and should not come at a cost of funding other critical areas," he said.

There is also a concern that the reauthorization could potentially remove the allocation of funds among institutes and centers from the control of Congress, which has historically guarded that privilege, and place it in the hands of the director. "That's a potential concern, and would require enormous checks to balance that power," Pizzo said.

The position of the NIH director is a political appointment, Pizzo pointed out. "We all have tremendous respect for [current director] Elias Zerhouni, but none of us know what could happen in subsequent years, so we have to be mindful that a political rather than a scientific agenda could emerge from future leaders. While there needs to be a good amount of central control for the director, we don't want it to be so much that the NIH is left vulnerable to political manipulation."

Another key area of discussion: the extensive reporting requirements found in the initial draft of the legislation. The draft calls for research plans that include statements of objectives regarding the research, the means for achieving the objectives, deadlines for the objectives to be met, and justifications for revisions to the plans. The AAMC is concerned that this intensive level of oversight may be more appropriate for a government contracting organization rather than an agency that relies heavily on research grant mechanisms—particularly when it comes to basic research.

"None of us can or should or would speak against the importance of being accountable for what we're doing," said Pizzo. "But the reporting language in the last bill was much more of the kind suited to industry or very applied investigations and would be less satisfactory for basic, fundamental research, which may have a long latency period before anything comes of it." The danger of too rigorous reporting requirements, he said, is that they may truncate some of the most innovative research—which is also the most unpredictable and least easily held to a timeline.

Moore also noted that the draft legislation is silent on just how much the new reporting requirements will cost or how they will be paid for. "It's unclear how much time and resources those reports are going to require. If we're dealing with a static NIH budget, the money and time put into reporting will have to come at the expense of other activities."

That worries Pizzo, who served at the NIH for many years, ultimately as director of pediatrics in the National Cancer Institute. "With the NIH, the U.S. has achieved the greatest biomedical research program in the world," he said. "What's enabled that progress is basic, fundamental, undirected, investigator-initiated research that may not have an application today but explores and develops new opportunities that can subsequently be mined to improve health and life. The clinical progress made today builds on basic science research that began decades ago. As the NIH is reauthorized, it's essential that we ensure our continued investment in basic research."

In a July 19 letter to Chairman Barton, AAMC President Jordan J. Cohen, M.D., emphasized these points and urged the committee to safeguard the NIH's historic autonomy. "…the critical factors underlying the universally acclaimed success of the NIH are merit-based allocation of resources and a carefully balanced approach to addressing scientific opportunity and public health need, as determined by peer investigators and public health officials, and informed by patient and community advocates in deliberation within the NIH," Cohen wrote. "Any modification of the NIH's organization and function must adhere to these foundational principles."

—Gina Shaw, special to the Reporter

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