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WASHINGTON – Senator Joe Lieberman (D-CT) today expressed concerns about proposed reforms to the organization of research at the National Institutes of Health (NIH). In a letter sent Friday to Health and Human Services Secretary Tommy Thompson and NIH Director Dr. Elias Zerhouni, Lieberman said he supported many of the goals of “NIH Roadmap” but the vague outline leaves unanswered many critical questions about implementation and funding that could jeopardize the proposal’s feasibility.
“I believe we will need to establish a new organization focused on translational research that includes scientific and industry leaders together with leaders of other federal government agencies to facilitate coordination and communication,” the letter said. “Your proposal appears to try and accomplish these goals through the existing NIH structure. I have questions about whether NIH can realistically accomplish the goals of the Roadmap with its existing authority and organization.”
The NIH Roadmap was proposed by Dr. Zerhouni in September and suggests several reforms in NIH’s structure and research organization to turn around the Institutes’ weak performance on translating research into tangible benefits for the treatment and cure of diseases. In his letter, Lieberman cited the criticisms of the NIH outlined in the October 2003 Report of the National Academies of Sciences Institute of Medicine including problems with the current organizational structure and budgetary limitations on crosscutting research. Given these shortcomings, Lieberman called for more information about how the NIH roadmap proposal would be implemented and funded. He asked HHS and NIH for further details, including:
- Specific organizational and structural changes needed at NIH, including reforming its weak central management and disconnected institutes-specific budgetary authority and funding requirements to implement the Roadmap;
- Specific proposals for implementing the new public/private partnerships the Roadmap calls for;
- Specific organizational and funding mechanisms for increasing interdisciplinary research collaborations, long recognized as a problem at NIH;
- Specific proposals for supporting the professional development of young scientists and clinical researchers;
- Specific proposals for restructuring NIH grants and programs to meet the Roadmap’s acknowledgement of the need to better speed advances into medicines.
Below is the full text of the letter.
November 7, 2003
The Honorable Tommy G. Thompson
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dr. Elias Zerhouni, M.D.
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Dear Mr. Secretary and Dr. Zerhouni,
I am writing to commend you for your decision to establish the NIH Roadmap for Medical Research and to seek more information on it. I agree that a renewed focus on translational research will help transform basic research discoveries into tangible benefits for the treatment and cure of diseases.
Although I believe establishing a new entity to focus on this stage of the innovation process is required, I strongly support, in a manner similar to your proposed “NIH Roadmap”, a plan under which goals, priorities, and milestones for desired future biomedical discoveries would be established, and research and development alternatives or means for achieving those goals, priorities, and milestones would be identified and analyzed in order to guide decisions on resource allocation and investments. I am pleased to see that many of your proposals are similar to approaches that I support. For example, we both support the development of tissue and genetic database libraries, collaboration among different disciplines, renewed focus on translational research and rapid funding mechanisms for innovative promising treatments. Your proposal, however, is extremely general and I would like more information about the specifics of how you intend to accomplish your “NIH Roadmap”.
ORGANIZATIONAL STRUCTURE
I believe we will need to establish a new organization focused on translational research that includes involvement of scientific and industry leaders together with leaders of other federal government agencies to facilitate coordination and communication. Your proposal appears to try to accomplish these goals through the existing NIH structure. I have questions about whether NIH can realistically accomplish the goals of the NIH Roadmap with its existing authority and organization. The October 2003 Report of the National Academies of Sciences Institute of Medicine, “Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges”(“National Academies Report”) points out that the existing structure of NIH “is the result of a set of complex evolving social and political negotiations among a variety of constituencies” and is “imperfect” and has not been solely dictated “with a concern about promoting health-related research and advanced biomedical training”(page 3). In addition, the National Academies Report refers to the fact that NIH’s “complex and decentralized organizational structure” makes it “difficult for the NIH director to mobilize significant resources to focus on new programs of strategic importance that should engage all the institutes and centers, to support broad based interdisciplinary efforts, and to cooperate in other ways across existing organizational and bureaucratic boundaries”(page viii). Given the findings of the 2003 National Academies Report, I have the following questions:
1. How do you plan to accomplish the goals of the NIH Roadmap within the structure of the NIH? What specific organizational and structural changes will be required? What legislative authority will be needed to reorganize the agency to meet the goals?
2. Have the 27 NIH institutes and centers signed off on this proposal? Will they actively support it and commit resources to it?
3. How will you alter the decentralized and stove-piped culture of NIH to prevent it from interfering with your goals?
4. How will you coordinate with the five other major federal agencies that undertake health related research to meet your goals? What specific coordination mechanisms will need to be established?
BUDGET
In my view, a new entity would require a budget of approximately $15 billion a year, much of which would come from private sector sources, to meet goals of fielding a significant volume of new medical solutions. In my view, industry and investor cost sharing combined with a small percentage of royalties from new drugs could be used as an important source of revenue. The 2003 National Academies Report states that the budget for the Office of the Director of NIH “is inadequate for the effective management of the organization” and that there should be an increase of 5% from the NIH budget for the first year growing to 10% or more over 4-5 years to support trans-NIH initiatives (page 7). Given the findings of the 2003 National Academies Press report, I have the following questions:
5. How do you propose to fund the NIH Roadmap?
6. Will you need an increase in budget authority?
7. How will you ensure multi-year funding for projects?
8. What specific funding levels are you proposing for both the overall budget and the particular program elements for this initiative?
9. How will you prioritize funding among the needs you list in the roadmap?
10. Among those priorities, what will be the process for granting awards?
PUBLIC/PRIVATE PARTNERSHIPS
I believe a workable, improved innovation system requires partnerships between the scientific community and the private sector. I believe we will need a coordination mechanism that includes leaders in the fields of science, medicine, industry, biotechnology, public health and medical ethics.
Your NIH Roadmap proposal calls for “new partnerships among organized patient communities, community-based physicians and academic researchers.” You do not give any specifics on the terms and structure of these partnerships. I have the following questions:
11. Your list appears to reject further private sector R and D partnerships, despite the recommendation to the contrary in the 2003 National Academies Report (page 6). If that is correct, please explain why given that the private sector plays a pervasive role in the life science innovation system and that existing NIH technology transfer programs have not met with success.
12. How would you reorganize NIH to implement the partnerships you propose?
13. What would be the organizational structure to ensure that these partnerships operate effectively?
CROSS-DISCIPLINARY RESEARCH COLLABORATIONS
I strongly support cross-disciplinary research collaborations that will allow scientists from fields such as information and computer sciences, nanotechnology, chemistry, physics and engineering to work alongside top researchers with more traditional biomedical backgrounds. It is, of course, widely recognized that interdisciplinary and crosscutting initiatives are key to future advances. In a similar manner to my approach, your proposal states that NIH wants to stimulate new ways of combining skills in both physical and biologic sciences. You also discuss the promotion of better integration of existing clinical research networks. The 2003 National Academies Report, however, points to a “critical lack of coordination and standardization across NIH in its clinical programs that cause many opportunities for collaboration and data sharing across fields to be lost”(page 62). Therefore, I have the following question:
14. How will you move from the current situation at NIH to the increased crosscutting, interdisciplinary collaboration model that you seem to be proposing? What organizational and funding mechanisms do you plan to create?
15. Is NIH considering expanding its notoriously under funded nanotechnology efforts, perhaps the most important current cross-cutting, interdisciplinary approach to biomedical advances? If so, what funding levels and organizational changes do you plan to implement?
SUPPORT FOR TRAINING
I also have concerns about how you plan to support the professional development of young scientists and clinical researchers. The current structure of NIH allows for funding of the training of physician investigators through special training programs for clinical researchers known as “K awards” and through loan repayment programs (pages 61-62). Nevertheless, the 2003 National Academies Report points to a failure in the training of translational researchers. It states that “the length of training required, the expense and time involved, and the complex regulatory environment of clinical research have depleted the ranks of those willing to engage in clinical research, and many feel that this trend contributes to the inability to translate basic research findings into improved health” (pages 62-63). I have the following question:
16. How are you going to restructure NIH grants and programs to encourage more training for translational researchers?
I would appreciate your prompt and detailed reply to these questions. I strongly support the general thrust of your proposal and would like to know more details about precisely how the ideas will be implemented.
Sincerely,
Senator Joseph I. Lieberman
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