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The National Institute of Biomedical Imaging and Bioengineering Establishment Act
Congressional Update: Report from the Academy of Radiology Research
The National Institute of Biomedical Imaging and Bioengineering Establishment Act: An Interim Report1 C. Douglas Maynard, MD, President, Academy of Radiology Research Edward C. Nagy, Executive Director, Academy of Radiology Research
As we reported in the December 2000 issue of Academic Radiology (1), the U.S. House of Representatives passed H.R. 1795, the National Institute of Biomedical Imaging and Bioengineering Establishment Act, in September and sent that legislation to the Senate. Since that time, the Academy of Radiology Research has been working with the Senate sponsor of this bill, Majority Leader Trent Lott (R-Miss), to advance this proposal in the Senate. Unfortunately, at the time this article was written, the Senate had not yet acted on this legislation. The Congress had been expected to complete its work and adjourn for the election by early or mid-October. Instead, the House and Senate remained in session throughout October but were unable to resolve differences on important legislation. Both Houses therefore recessed with plans to return in mid-November after the election to complete work on controversial tax and spending bills. The fiscal year 2001 appropriations bill for the Departments of Labor, Health and Human Services, and Education was among the bills that were not yet passed when the Congress recessed. Funding for the National Institutes of Health (NIH) is included in this legislation. Senate consideration of the proposal to establish an institute was thus postponed at least until mid-November. Acad Radiol 2001; 8:116 –118 1 From the Academy of Radiology Research, 1029 Vermont Ave NW, Suite 505, Washington, DC 20005-3517. Received and accepted November 9, 2000. Address correspondence to E.C.N.
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Because we have detailed the main arguments in support of the proposed institute in recent issues of Academic Radiology, we will focus in this article on the nature of the opposition that has delayed final passage of this proposal. The primary source of opposition thus far has been the NIH itself, which has traditionally opposed virtually all proposals to create new institutes. Although the NIH did not provide a witness for the September 13 hearing in the House Commerce Health and Environment Subcommittee, the agency did submit a written statement to the Subcommittee expressing opposition to the bill. In its printed testimony for the hearing record, the NIH emphasizes that it is already “making a large and growing investment” in bioimaging and bioengineering and that these fields “are proving to be integral to the operations of all of the present Institutes and Centers” (2). Moreover, the NIH takes the position that the present structure, rather than the establishment of a separate institute for imaging and bioengineering, fosters collaboration between engineers/physicists and clinicians/biologists that focuses research attention on “compelling biological questions.” The NIH also asserts that it recognizes that imaging and bioengineering do not fit neatly into a single existing institute and is taking effective steps to coordinate activities across the institutes. These include the Bioengineering Consortium (BECON), which was established in 1997 “to bring all of the Institutes and Centers together to shape the future directions of the NIH” in imaging and bioengineering and to “address problems raised by these scientific communities” (2). Additionally, in response to a
Academic Radiology, Vol 8, No 1, January 2001
congressional mandate, the NIH is currently creating the Office of Bioengineering, Bioimaging, and Bioinformatics (OB3) within the Office of the Director of the NIH “to provide a focus for biomedical engineering, bioimaging, and biomedical computing issues among the institutes and centers at the NIH and with other Federal agencies” (2). This approach, according to the NIH testimony, “will provide a dedicated infrastructure for coordinating bioengineering, imaging, and informatics issues and initiatives at the NIH while maintaining the trans-institute participation and communication that have been successful in the past” (2). The new Office is intended to replace BECON. The NIH statement concludes that Establishment of a separate institute to coordinate communication, management, prioritization, and accountability is premature at this time. Furthermore, removing the bioengineering and bioimaging initiatives from the institutes in which they are currently located could have the unintended consequence of reducing the ability of Institutes and Centers, over the long term, to support the very research that this legislation is designed to promote. Experience with the OB3 will contribute to the evaluation of the need for a separate institute for bioengineering and bioimaging at the NIH.
The NIH testimony is unconvincing for several reasons. First, the current structure of the NIH provides research support mainly for investigations that relate directly to the specific disease processes or organ systems that constitute the primary missions of the existing institutes. It does not promote basic research in imaging science to develop new techniques and technologies with broad applications. The growing NIH investment in imaging is a positive development but is directed primarily toward cancer imaging. The present organization does not maximize the potential value of imaging research dollars. Second, by focusing solely on its efforts to improve coordination among the institutes, the NIH is obscuring the more fundamental problem—support for basic research that does not yet have an application to a disease process or organ system—that has motivated the campaign to establish a new institute. Neither BECON nor OB3, as the NIH acknowledges, has the resources or authority to make research grants. These are coordinating entities that can offer little incentive to the existing institutes to divert resources to imaging research from areas that are perceived to be more directly related to the missions of those institutes. There is little in the history of the NIH to suggest that organizational units without re-
ACADEMY OF RADIOLOGY RESEARCH
sources will be successful in directing the activities of the institutes that control those resources. Third, by asserting that the proposed institute will remove all imaging-related research from the existing institutes and is thereby likely to reduce support for imaging from those institutes, the NIH is raising a false alarm. The proposed institute is not intended to consolidate all imaging research at the NIH. Instead, the new institute would provide a home for basic investigations while leaving most research with specific disease or organ-system applications in the appropriate institutes. While there is likely to be a period in which responsibilities relating to imaging and bioengineering are sorted out, that transition does not need to be of extended duration. In the long run, the current institutes can be expected to maintain their interest in, and support for, research that seeks to develop and improve the applications of existing imaging modalities. Because of the wide applications of imaging technologies, the proposed institute is also particularly likely to collaborate extensively with the current institutes in areas of overlapping responsibility or common interest. Finally, the NIH suggests that consideration of an institute should be delayed until the impact of OB3 can be assessed. In fact, there is no need to await the results of an experiment that does not address some of the primary problems plaguing imaging research at the NIH. These are not new concerns; the radiology community has been working with the NIH leadership to locate imaging research appropriately for more than 2 decades. Marginal improvements in interinstitute coordination that can be provided by OB3 do not offer a solution. An institute is needed to support basic imaging science. Despite the flaws in the NIH case, these arguments were adopted by Secretary of Health and Human Services Donna E. Shalala, who sent a letter opposing H.R. 1795 to the senior Republican and Democrat on the House Commerce Committee, Chairman Tom Bliley (R-Va) and Ranking Democrat John Dingell (D-Mich), on September 25. Secretary Shalala restated the arguments relating to the size of the NIH investment in imaging and bioengineering, the importance of the current structure in fostering collaboration between imaging and biological scientists, and the advantages of evaluating OB3 before considering this proposal. She wrote further that establishing a new institute would require either new resources or a reduction in support for the current institutes (3). Secretary Shalala’s focus on the cost of creating institutes echoes arguments that have been made in the past when new institutes were proposed and were offered by
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Representative Dingell in connection with the current bill. In this case, however, the legislation to establish the proposed institute has been crafted to maximize the use of existing NIH resources for administrative functions such as personnel and procurement. In addition, the bill does not authorize any new appropriations. The arguments offered by NIH and the Department of Health and Human Services did not prove to be compelling to the Commerce Committee or the full House of Representatives. Nevertheless, the continuing opposition of the NIH to all proposals for new institutes appears to have contributed to the delay in the Senate. Despite this delay, momentum for the proposed institute continues to build. Even former NIH Director Harold Varmus, an opponent of proposals to create new institutes, recently predicted that the National Institute of Biomedical Imaging and Bioengineering would be established by the next Congress if it is not created this year (4). Writing in the Washington Post on October 4, 2000, Dr Varmus also acknowledges that progress in biomedical research depends on advances in fields other than biology. He asserts that “scientists can wage an effective war on disease only if we as a nation and as a scientific community harness the energies of many disciplines, not just biology and medicine. The allies must include mathematicians, physicists, engineers and computer and behavioral scientists” (5). Dr Varmus’ analysis is accurate, and his proposed solution—larger appropriations for the National Science Foundation, the Office of Science at the Department of Energy, and other federal agencies that support basic scientific research— deserves support. However, increased funding for scientific research at non-NIH agencies should not be viewed as a substitute for an imaging and bioengineering institute at the NIH. The proposed
118
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National Institute of Biomedical Imaging and Bioengineering would allow scientific investigators from different fields to collaborate more directly on medical questions and would also promote critical interaction between scientists and clinicians. Achievement of those goals would be much less likely if medical science is forced to rely entirely on agencies with little or no medical research mission to support the basic research in physics, mathematics, and other fields on which medical advances depend. In the final analysis, the NIH has been unable to offer an alternative to the proposed National Institute of Biomedical Imaging and Bioengineering that would address the principal problems relating to imaging research effectively. In particular, the NIH has not offered a sollution that would answer the core question of how to provide a home for basic research in imaging science. The strong arguments in support of the proposed institute, on the other hand, prevailed in the House of Representatives, and the Academy of Radiology Research is continuing to present that case in the Senate. REFERENCES 1. Maynard CD, Nagy EC. Progress toward an institute for imaging: House of Representatives passage of the National Institute of Biomedical Imaging and Bioengineering Establishment Act. Acad Radiol 2000; 7:1165–1167. 2. Hearing on Securing the Health of the American People before the Committee on Commerce, Subcommittee on Health and Environment, 106th Cong, 2nd Sess (2000) (testimony of National Institutes of Health). 3. Secretary of Health and Human Services Donna E. Shalala. Letter to Representative John D. Dingell. Congressional Record; 106th Cong, 2nd sess; September 27, 2000; p H8268. 4. Fisher K. Imaging institute picks up momentum. Science 2000; 289: 2015–2017. 5. Varmus H. Squeeze on science. Washington Post; October 4, 2000: A33.
The National Institute of Biomedical Imaging and Bioengineering Establishment Act: An Interim Report1 C. Douglas Maynard, MD, President, Academy of Radiology Research Edward C. Nagy, Executive Director, Academy of Radiology Research
As we reported in the December 2000 issue of Academic Radiology (1), the U.S. House of Representatives passed H.R. 1795, the National Institute of Biomedical Imaging and Bioengineering Establishment Act, in September and sent that legislation to the Senate. Since that time, the Academy of Radiology Research has been working with the Senate sponsor of this bill, Majority Leader Trent Lott (R-Miss), to advance this proposal in the Senate. Unfortunately, at the time this article was written, the Senate had not yet acted on this legislation. The Congress had been expected to complete its work and adjourn for the election by early or mid-October. Instead, the House and Senate remained in session throughout October but were unable to resolve differences on important legislation. Both Houses therefore recessed with plans to return in mid-November after the election to complete work on controversial tax and spending bills. The fiscal year 2001 appropriations bill for the Departments of Labor, Health and Human Services, and Education was among the bills that were not yet passed when the Congress recessed. Funding for the National Institutes of Health (NIH) is included in this legislation. Senate consideration of the proposal to establish an institute was thus postponed at least until mid-November. Acad Radiol 2001; 8:116 –118 1 From the Academy of Radiology Research, 1029 Vermont Ave NW, Suite 505, Washington, DC 20005-3517. Received and accepted November 9, 2000. Address correspondence to E.C.N.
©
AUR, 2001
116
Because we have detailed the main arguments in support of the proposed institute in recent issues of Academic Radiology, we will focus in this article on the nature of the opposition that has delayed final passage of this proposal. The primary source of opposition thus far has been the NIH itself, which has traditionally opposed virtually all proposals to create new institutes. Although the NIH did not provide a witness for the September 13 hearing in the House Commerce Health and Environment Subcommittee, the agency did submit a written statement to the Subcommittee expressing opposition to the bill. In its printed testimony for the hearing record, the NIH emphasizes that it is already “making a large and growing investment” in bioimaging and bioengineering and that these fields “are proving to be integral to the operations of all of the present Institutes and Centers” (2). Moreover, the NIH takes the position that the present structure, rather than the establishment of a separate institute for imaging and bioengineering, fosters collaboration between engineers/physicists and clinicians/biologists that focuses research attention on “compelling biological questions.” The NIH also asserts that it recognizes that imaging and bioengineering do not fit neatly into a single existing institute and is taking effective steps to coordinate activities across the institutes. These include the Bioengineering Consortium (BECON), which was established in 1997 “to bring all of the Institutes and Centers together to shape the future directions of the NIH” in imaging and bioengineering and to “address problems raised by these scientific communities” (2). Additionally, in response to a
Academic Radiology, Vol 8, No 1, January 2001
congressional mandate, the NIH is currently creating the Office of Bioengineering, Bioimaging, and Bioinformatics (OB3) within the Office of the Director of the NIH “to provide a focus for biomedical engineering, bioimaging, and biomedical computing issues among the institutes and centers at the NIH and with other Federal agencies” (2). This approach, according to the NIH testimony, “will provide a dedicated infrastructure for coordinating bioengineering, imaging, and informatics issues and initiatives at the NIH while maintaining the trans-institute participation and communication that have been successful in the past” (2). The new Office is intended to replace BECON. The NIH statement concludes that Establishment of a separate institute to coordinate communication, management, prioritization, and accountability is premature at this time. Furthermore, removing the bioengineering and bioimaging initiatives from the institutes in which they are currently located could have the unintended consequence of reducing the ability of Institutes and Centers, over the long term, to support the very research that this legislation is designed to promote. Experience with the OB3 will contribute to the evaluation of the need for a separate institute for bioengineering and bioimaging at the NIH.
The NIH testimony is unconvincing for several reasons. First, the current structure of the NIH provides research support mainly for investigations that relate directly to the specific disease processes or organ systems that constitute the primary missions of the existing institutes. It does not promote basic research in imaging science to develop new techniques and technologies with broad applications. The growing NIH investment in imaging is a positive development but is directed primarily toward cancer imaging. The present organization does not maximize the potential value of imaging research dollars. Second, by focusing solely on its efforts to improve coordination among the institutes, the NIH is obscuring the more fundamental problem—support for basic research that does not yet have an application to a disease process or organ system—that has motivated the campaign to establish a new institute. Neither BECON nor OB3, as the NIH acknowledges, has the resources or authority to make research grants. These are coordinating entities that can offer little incentive to the existing institutes to divert resources to imaging research from areas that are perceived to be more directly related to the missions of those institutes. There is little in the history of the NIH to suggest that organizational units without re-
ACADEMY OF RADIOLOGY RESEARCH
sources will be successful in directing the activities of the institutes that control those resources. Third, by asserting that the proposed institute will remove all imaging-related research from the existing institutes and is thereby likely to reduce support for imaging from those institutes, the NIH is raising a false alarm. The proposed institute is not intended to consolidate all imaging research at the NIH. Instead, the new institute would provide a home for basic investigations while leaving most research with specific disease or organ-system applications in the appropriate institutes. While there is likely to be a period in which responsibilities relating to imaging and bioengineering are sorted out, that transition does not need to be of extended duration. In the long run, the current institutes can be expected to maintain their interest in, and support for, research that seeks to develop and improve the applications of existing imaging modalities. Because of the wide applications of imaging technologies, the proposed institute is also particularly likely to collaborate extensively with the current institutes in areas of overlapping responsibility or common interest. Finally, the NIH suggests that consideration of an institute should be delayed until the impact of OB3 can be assessed. In fact, there is no need to await the results of an experiment that does not address some of the primary problems plaguing imaging research at the NIH. These are not new concerns; the radiology community has been working with the NIH leadership to locate imaging research appropriately for more than 2 decades. Marginal improvements in interinstitute coordination that can be provided by OB3 do not offer a solution. An institute is needed to support basic imaging science. Despite the flaws in the NIH case, these arguments were adopted by Secretary of Health and Human Services Donna E. Shalala, who sent a letter opposing H.R. 1795 to the senior Republican and Democrat on the House Commerce Committee, Chairman Tom Bliley (R-Va) and Ranking Democrat John Dingell (D-Mich), on September 25. Secretary Shalala restated the arguments relating to the size of the NIH investment in imaging and bioengineering, the importance of the current structure in fostering collaboration between imaging and biological scientists, and the advantages of evaluating OB3 before considering this proposal. She wrote further that establishing a new institute would require either new resources or a reduction in support for the current institutes (3). Secretary Shalala’s focus on the cost of creating institutes echoes arguments that have been made in the past when new institutes were proposed and were offered by
117
MAYNARD AND NAGY
Representative Dingell in connection with the current bill. In this case, however, the legislation to establish the proposed institute has been crafted to maximize the use of existing NIH resources for administrative functions such as personnel and procurement. In addition, the bill does not authorize any new appropriations. The arguments offered by NIH and the Department of Health and Human Services did not prove to be compelling to the Commerce Committee or the full House of Representatives. Nevertheless, the continuing opposition of the NIH to all proposals for new institutes appears to have contributed to the delay in the Senate. Despite this delay, momentum for the proposed institute continues to build. Even former NIH Director Harold Varmus, an opponent of proposals to create new institutes, recently predicted that the National Institute of Biomedical Imaging and Bioengineering would be established by the next Congress if it is not created this year (4). Writing in the Washington Post on October 4, 2000, Dr Varmus also acknowledges that progress in biomedical research depends on advances in fields other than biology. He asserts that “scientists can wage an effective war on disease only if we as a nation and as a scientific community harness the energies of many disciplines, not just biology and medicine. The allies must include mathematicians, physicists, engineers and computer and behavioral scientists” (5). Dr Varmus’ analysis is accurate, and his proposed solution—larger appropriations for the National Science Foundation, the Office of Science at the Department of Energy, and other federal agencies that support basic scientific research— deserves support. However, increased funding for scientific research at non-NIH agencies should not be viewed as a substitute for an imaging and bioengineering institute at the NIH. The proposed
118
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National Institute of Biomedical Imaging and Bioengineering would allow scientific investigators from different fields to collaborate more directly on medical questions and would also promote critical interaction between scientists and clinicians. Achievement of those goals would be much less likely if medical science is forced to rely entirely on agencies with little or no medical research mission to support the basic research in physics, mathematics, and other fields on which medical advances depend. In the final analysis, the NIH has been unable to offer an alternative to the proposed National Institute of Biomedical Imaging and Bioengineering that would address the principal problems relating to imaging research effectively. In particular, the NIH has not offered a sollution that would answer the core question of how to provide a home for basic research in imaging science. The strong arguments in support of the proposed institute, on the other hand, prevailed in the House of Representatives, and the Academy of Radiology Research is continuing to present that case in the Senate. REFERENCES 1. Maynard CD, Nagy EC. Progress toward an institute for imaging: House of Representatives passage of the National Institute of Biomedical Imaging and Bioengineering Establishment Act. Acad Radiol 2000; 7:1165–1167. 2. Hearing on Securing the Health of the American People before the Committee on Commerce, Subcommittee on Health and Environment, 106th Cong, 2nd Sess (2000) (testimony of National Institutes of Health). 3. Secretary of Health and Human Services Donna E. Shalala. Letter to Representative John D. Dingell. Congressional Record; 106th Cong, 2nd sess; September 27, 2000; p H8268. 4. Fisher K. Imaging institute picks up momentum. Science 2000; 289: 2015–2017. 5. Varmus H. Squeeze on science. Washington Post; October 4, 2000: A33.