Testimony

Statement by
Elias A. Zerhouni, M.D.
Director
National Institutes of Health
U.S. Department of Health and Human Services

on
The Search for a Better Way: Reauthorization of The National Institutes of Health
before
Committee on Energy and Commerce
United States House of Representatives

Tuesday, July 19, 2005

Introduction
Mr. Chairman and Members of the Committee, today is my seventh appearance before the Energy and Commerce Committee or one of its Subcommittees. I have testified about a variety of topics, including research priorities, the organization of Institutes and Centers, scientific peer review, the shift of the Nation's health care burden from acute to chronic diseases, and the need to revolutionize the methods and systems we use to conduct and manage biomedical research.

Each time I testified, I noted the remarkable achievements made in the course of biomedical research, ranging from mapping the human genome to reducing mortality from cancer, AIDS, and heart disease to the rapid progress in the development of vaccines. But I tempered the stories of success by describing the daunting journey that lies ahead of the scientific community as we grapple with the remaining obstacles impeding progress towards the prevention, diagnosis, or treatment of the many causes of human suffering. Much more needs to be learned about human biology and behavior. Emerging and reemerging infectious diseases continue to threaten the world. Chronic diseases are growing in terms of their impact on quality of life and the economic future of America and other countries. The threat of bioterrorism continues to loom. Health disparities remain a widespread problem.

As the Institute of Medicine (IOM) has observed, "While NIH's success is to be celebrated, success alone does not answer fully the question of whether there is a better way to proceed, particularly as one faces a future where the world of biomedical science is being rapidly transformed in virtually all its dimensions."

This quest for the "better way," as the IOM describes it, is also at the core of insuring continued scientific progress in an era when the scale and complexity of the problems we are facing require constant innovation, increased interdisciplinary efforts, and a balanced portfolio of basic, translational, and clinical research investments across all NIH Institutes and Centers. Based on my own interactions with the Members of this Committee, I know you too strive to find the "better way."

The IOM had several key recommendations worth recalling in the context of today's hearing. It recommended that the "Director of NIH should be formally charged by Congress to lead a trans-NIH planning process to identify major crosscutting issues and their associated research and training opportunities and to generate a small number of multi-year, but time limited, research programs." The IOM proposed that NIH present the justification for trans-NIH budgeting to Congress and that the funding for such research should be held in an escrow account. It recommended that such research be included in the President's budget request to Congress for NIH.

The IOM suggested that NIH have a formal process for reorganizing offices and programs.

The IOM also recommended standardizing data and information systems at NIH to enhance management, accountability, and transparency.

The IOM report was followed by three years of analysis by the Committee and its staff. I think it is noteworthy that the IOM and the Committee reached similar conclusions about NIH. Many of these conclusions are manifested in the reauthorization concepts offered by the Chairman and Ranking Member.

In thinking about NIH reauthorization, I want to begin with the core research authorities embodied in Title III of the Public Health Service Act, which authorize the Public Health Service to "encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments…."

I believe this core authority is the fundamental reason why NIH has been so successful in its mission. I applaud the Chairman and Members of the Committee for maintaining these and other vital authorities, such as peer review, the pursuit of scientific opportunity through investigator-initiated grants, human subjects protections, and the requirement to disseminate research findings to the public. In its own search for the better way, I think the Committee is correctly focused on organizational efficiency and effectiveness, which is the principal challenge for an increasingly large and complex organization.

I agree with the Chairman that we should first and foremost carefully reconsider how the organizations of NIH can collectively and effectively support the core missions of the agencies. The challenge is to accomplish this goal through enhanced coordination and partnerships across the NIH Institutes and Centers while avoiding the pitfalls of centralization or top-down research. Achieving the right balance between the necessary autonomy and diversity of approaches represented by the various Institutes and Centers while avoiding the silo effects that can reduce the effectiveness of the whole Agency is the central question. How can the whole be greater than the sum of the parts? As I said in the past, twenty-seven fingers without a palm is not a strong hand. Likewise a strong palm without strong fingers is also ineffective.

I agree with the Chairman that NIH needs an organization, such as the proposed division of program coordination, planning and strategic initiatives, that will serve as a coordinating office for evaluating on a regular basis the progress of science in the context of public health priorities. It will be responsible for analyzing and reporting with consistent methods the portfolios of NIH research that cross the boundaries of multiple Institutes and for identifying trans-NIH research needs that no single Institute can address but that all of NIH needs to support. This structure should be able to conduct appropriate strategic planning for emerging areas of scientific opportunities or challenges and to develop important data and intelligence to support a more comprehensive and informed priority setting process. As you know, the Administration has proposed such an office. I support the concept that this office be able, through a codified process that includes participation from all of the Institutes and the scientific community at large, to allocate resources to initiatives that serve the common good, subject to review by an advisory committee. However, I do not think this office should actually conduct the research resulting from any initiatives it identifies. I believe that this research is more appropriately conducted by the existing Institutes and Centers.

The Chairman also proposes to clearly define the roles of NIH Institutes and Centers. I agree that each Institute and Center should have a defined purpose in support of the overall mission of NIH. The Chairman has proposed categorizing Institutes and Centers into either mission-specific or science-enabling responsibilities. This has resulted in the perception that one category is more significant than another. I understand that this is not the intent. All of the Institutes and Centers support vital research. Some engage in broader areas of science that are useful to all of NIH's organizations while others are involved in more specific areas of research, focusing, for example, on cancer, heart disease, or infectious diseases. Their research is of equal value to the scientific community.

I will work with the Committee to clarify the roles of each of NIH's Institutes and Centers. I agree with his goal of clearly defining how each of these organizations serves the overall mission of NIH and ensuring that the Agency does not consist of 27 silos that do not work in coordination.

In further pursuit of the "better way," the Chairman has proposed consistent coding and reporting of research and a more transparent, efficient mechanism for reporting the results of NIH research to Congress and the general public. I agree that these steps are necessary, and I will work with the Committee to accomplish these goals in a way that will enhance the public's understanding of how NIH works, while not unduly inhibiting the Agency's ability to conduct and translate research quickly.

Conclusion
In conclusion, I pledge my cooperation to work with the Committee as it considers reauthorizing the NIH provisions of the public health Act. I look forward to answering any questions that you might have.

Last Revised: July 20, 2005