- Email: [email protected]
Progress toward an institute for imaging: House of Representatives passage of the National Institute of Biomedical Imaging and Bioengineering Establishment Act
Congressional Update: Report from the Academy of Radiology Research
Progress toward an Institute for Imaging: House of Representatives Passage of the National Institute of Biomedical Imaging and Bioengineering Establishment Act1 C. Douglas Maynard, MD, President, Academy of Radiology Research Edward C. Nagy, Executive Director, Academy of Radiology Research
NOTE: At the time this article was written, the Senate had not considered the National Institute of Biomedical Imaging and Bioengineering Establishment Act. The Academy of Radiology Research was pushing for Senate consideration before the adjournment of Congress. An update on this legislation will be provided in the next issue of Academic Radiology.--E.C.N. On September 27, 2000, the U.S. House of Representatives passed H.R. 1795, the National Institute of Biomedical Imaging and Bioengineering Establishment Act. House passage of this legislation represents an important step toward the creation of a new institute for medical imaging, bioengineering, and related fields of research at the National Institutes of Health (NIH). Consideration and passage of H.R. 1795 by the House followed a hearing in the Subcommittee on Health and Environment of the House Commerce Committee 2 weeks earlier. Representative Richard Burr (R-NC), a Subcommittee member and the author of H.R. 1795, had requested that the Subcommittee schedule a hearing on this issue. Three chairs of academic radiology departments--Drs R. Nick Bryan of the University of Pennsylvania, N. Reed Dunnick of the University of Michigan, and Bruce J. Hillman of the University of Virginia--testified in support
Acad Radio12000; 7:1165-1167
Fromthe Academy of RadiologyResearch, 1029 VermontAve NW, Suite 505,Washington, DC 20005-3517. Receivedand acceptedOctober 11, 2000.Address correspondence to E.C.N. ©AUR,2000
of H.R. 1795 at the September 13 hearing. Much of the testimony centered on the structural impediments to an effective imaging research program under the current NIH organizational plan, the shortcomings of recent NIH initiatives in imaging research, and the potential for innovation that the proposed institute would offer. Dr Bryan, who previously served as Director of Diagnostic Radiology and Associate Director, Radiologic and Imaging Sciences Program, at the Warren G. Magnuson Clinical Center at the NIH, highlighted the structural problems. According to Dr Bryan, ...the NIH is not--and under its present structure cannot be--the catalyst of imaging innovation. The various institutes are focused on specific disease processes or organ systems, but imaging cuts across those lines and is broadly applicable to virtually all diseases and organ systems. Consequently, imaging is used as a tool in all the institutes, but there is no home at the NIH for the basic research that is essential to develop new imaging techniques and technologies for the 21st century. The basic science of imaging and bioengineering, it must be remembered, is fundamentally different from that of the existing institutes at the NIH. Imaging is based on mathematics and physics, not the biological sciences that underlie most of the research in the current institutes. Imaging and bioengineering are unique scientific fields at the NIH and are also critical to future advances in the delivery of high quality health care. Dr Bryan also described his own efforts at the NIH to consolidate several departments into the Imaging Sciences Program (ISP). While creating the ISP has raised the visibility and status of imaging at the NIH and laid the groundwork for a more advanced research program, Dr Bryan testified that
1165
4AYNARD AND NAGY
...the ISP could not be wholly successful, mainly because the very structure of the NIH makes such an endeavor problematic. Research authority and resources reside in the institutes, not in programs at the Clinical Center. As a result, the success of imaging research proposals was ultimately dependent on the ability of ISP researchers to convince one or more of the institutes--instituteswhose primary missions and priorities are in areas other than imaging--to divert funds from their main activities and commit those funds to imaging research. Dr Bryan went on to say that his experience convinced him "that the existing NIH organization will not work for imaging" and that his decision to leave the NIH in 1999 "owed much to the inherent obstacles to imaging research that are built into its structure." He pointed out that recent NIH initiatives in imaging, while often constructive, do not address some of the core problems. The expansion of the Biomedical Imaging Program at the National Cancer Institute (NCI) and the creation of the American College of Radiology Imaging Network (ACRIN) at the NCI, for example, provide new resources for imaging research. Dr Bryan noted, however, that those additional funds are directed solely at cancer imaging, which deserves to be an extremely high priority but represents only one area in which imaging has applications. He observed that other NIH projects, such as the creation of the new Office of Bioengineering, Bioimaging, and Bioinformatics, focus needed attention on imaging but do not provide actual research funding. In the final analysis, Dr Bryan concluded, a National Institute of Biomedical Imaging and Bioengineering is ...essential to promote the development of new imaging techniques and technologies. In order to flourish and grow consistently at the NIH, a scientific field requires an organization with the mandate, the responsibility, the authority, . and the resources to direct and drive investigation in that field. In the NIH structure, only institutes possess those attributes. Dr Dunnick offered a brief historical account, explaining that the radiologists have worked in good faith with the NIH leadership for 3 decades to locate imaging appropriately within the existing NIH structure. He pointed out that the extramural program in imaging was transferred from the National Institute of General Medical Sciences to the NCI in the early 1980s and that the intramural Laboratory of Diagnostic Radiology Research was moved more recently from the Office of the NIH Director to the Clinical Center. Although both realignments were better for imaging research, each left basic problems unaddressed. Recognizing the traditional NIH opposition to new institutes, Dr Dunnick agreed that "the bar to structural change at the NIH should be set high" and argued that the current proposal could meet such a test. He cited the recommendations made by a neutral, expert group, the National Academy of Sciences' Institute of Medicine, in its 1984 report titled
1166
Academic Radiology, Vol 7, No 12, December 200(
Responding to Health Needs and Scientific Opportunity: The Organizational Structure of the National Institutes of Health (1). The Institute of Medicine report, Dr Dunnick explained, concluded that new institutes are justified only when the following five criteria are met: (a) the activity is compatible with the mission of the NIH; (b) it can be demonstrated that the research area in question (defined either as a disease or health problem or as a biomedical or behavioral process related to a health problem) is not receiving adequate attention; (c) there are reasonable prospects for scientific growth in the research area; (d) there are reasonable prospects of sufficient funding for the new organization; and (e) the proposed structural change will improve communication, management, priority setting, and accountability. The proposed institute, Dr Dunnick said, "is consistent with these criteria." In addition, he pointed out that this proposal is also "completely consistent with the NIH's own rationale for the elevation of the National Center for Genome Research to institute status in 1997." Dr Dunnick also discussed the role of the proposed institute in coordinating imaging research programs throughout the federal government and in meeting the mushrooming medical needs of the information age. He concluded by urging the Subcommittee to support H.R. 1795 in order to "create a climate that promotes discovery and innovation in imaging just as the NIH provides such a climate for other fields." In his statement to the Subcommittee, Dr Hillman described the central role of imaging in the emerging molecular revolution. He said that Medical imaging is the "non-invasive biopsy," the method of disease quantitation, the guidance for new treatments still to be developed that will form the underpirmings of molecular medicine. Under this scenario, new medical imaging technologies will detect alterations in the genetic or molecular makeup of cells that have the potential to progress to disease. We then will employ imaging technologies to precisely determine what fraction of cells are so affected. Finally, medical imaging technologies will be integrated with new therapeutic methods to either guide or monitor treatment, so that we can much more precisely than ever before ensure that only diseased cells are treated while preserving normal tissue. The basic knowledge exists to begin to implement this vision. However, for this optimistic and exciting prophecy to come to fruition, we will need to invest in the development and assessment of new imaging technologies. We are ill-equipped to do so under the current NIH organizational structure that focuses the work of existing institutes on specific organ systems and diseases. Dr Hillman also drew on his experience as chair of ACRIN, applauding the NCI for establishing the network for clinical trials and citing the importance of trials of digital mammography for breast cancer screening, computed tomographic scanning for the early detection of lung cancer,
and other technologies. Despite the benefits that will result from these trials, however, Dr Hillman explained the shortcomings of an approach based in an institute dedicated to a single disease: ...these same technologies that ACRIN will study, and many other current and future technologies, are broadly applicable to diseases other than cancer. There is no counterpart to ACRIN at the National Heart, Lung, and Blood Institute, or the National Institute for Neural Diseases and Stroke--institutes whose purview includes organ systems and diseases where imaging plays a large and critical role--nor, for that matter, at any of the other institutes. Even if there were, the fragmentation of imaging technology assessment on such arbitrary grounds would be wasteful, inefficient, and leave important gaps. Taken together, the statements by Drs Bryan, Dunnick, and Hillman constituted a compelling and comprehensive rationale for the establishment of a National Institute of Biomedical Imaging and Bioengineering. For its part, the NIH, although invited by the Subcommittee to testify, declined to provide a witness for the hearing. Instead, the NIH provided a written statement for the hearing record. In its testimony, the NIH stressed its substantial and growing investment in imaging and bioengineering, the prominence of these fields of research in the existing institutes, and the importance of such recent initiatives as the Bioengineering Consortium and the new Office of Bioengineering, Bioimaging, and Bioinformatics. The NIH contended that the current structure promotes close collaboration between physical scientists and biological scientists to address specific biological issues and that the creation of a new institute is "premature at this time." University of Arkansas for Medical SciencesMoreover, the NIH statement suggested that establishing the proposed institute could have the longrange effect of decreasing support for imaging and bioengineering research from the current institutes. Finally, the NIH recommended that the question of creating a separate institute be deferred until the new Office of Bioengineering, Bioimaging, and Bioinformatics can be evaluated. One day after the Subcommittee hearing, the House Commerce Committee approved H.R. 1795 by voice vote and sent
it to the full House of Representatives. Two days before the House considered this bill, Secretary of Health and Human Services Donna Shalala sent a letter to Representatives Tom Bliley (R-Va) and John Dingell (D-Mich), the Chairman and Ranking Democrat on the Commerce Committee, opposing H.R. 1795. Secretary Shalala's letter repeated several of the arguments already set forth in the NIH hearing testimony and contended that the "establishment of another NIH Institute would require an expensive administrative structure, for which additional resources would be required, so as not to rob the existing NIH ICs [Institutes and Centers--author's note] of their expertise and funds." Mr Dingell himself had raised similar concerns during the September 14 Commerce Committee markup of H.R. 1795, but he did not object to its approval by the Committee. Despite this opposition from the NIH and the Secretary, the House passed H.R. 1795 by voice vote on September 27 after only brief debate. The two principal sponsors of the bill, Representatives Burr and Anna Eshoo (D-Calif), along with cosponsor Diana DeGette (D-Colo), were the only House Members to speak. No Representatives spoke in opposition. The National Institute of Biomedical Imaging and Bioengineering Establishment Act was thus sent to the Senate with an extremely strong endorsement from the House of Representatives. House passage of this bill over the opposition of the NIH was achieved through a 5-year campaign led by the Academy of Radiology Research with strong support from its member societies and the approximately 3,000 radiologists, technologists, imaging scientists, bioengineers, and equipment manufacturers who contacted their Representatives and Senators to express support. This success, which will not be complete until this legislation is approved by the Senate and signed into law, clearly demonstrates the importance of constituent opinion and the effectiveness of a grassroots effort in the legislative process. At this writing, the Academy is working with the Senate sponsor of this bill, Majority Leader Trent Lott, to push for Senate passage before the Congress adjourns for the year. tEFERENC!
Institute of Medicine Committee for a Study of the Organizational Structure of the National Institutes of Health. Responding to health needs and scientific opportunity: the organizational structure of the National Institutes of Health. Washington, DC: National Academy of Sciences, 1984.
1 167
Progress toward an Institute for Imaging: House of Representatives Passage of the National Institute of Biomedical Imaging and Bioengineering Establishment Act1 C. Douglas Maynard, MD, President, Academy of Radiology Research Edward C. Nagy, Executive Director, Academy of Radiology Research
NOTE: At the time this article was written, the Senate had not considered the National Institute of Biomedical Imaging and Bioengineering Establishment Act. The Academy of Radiology Research was pushing for Senate consideration before the adjournment of Congress. An update on this legislation will be provided in the next issue of Academic Radiology.--E.C.N. On September 27, 2000, the U.S. House of Representatives passed H.R. 1795, the National Institute of Biomedical Imaging and Bioengineering Establishment Act. House passage of this legislation represents an important step toward the creation of a new institute for medical imaging, bioengineering, and related fields of research at the National Institutes of Health (NIH). Consideration and passage of H.R. 1795 by the House followed a hearing in the Subcommittee on Health and Environment of the House Commerce Committee 2 weeks earlier. Representative Richard Burr (R-NC), a Subcommittee member and the author of H.R. 1795, had requested that the Subcommittee schedule a hearing on this issue. Three chairs of academic radiology departments--Drs R. Nick Bryan of the University of Pennsylvania, N. Reed Dunnick of the University of Michigan, and Bruce J. Hillman of the University of Virginia--testified in support
Acad Radio12000; 7:1165-1167
Fromthe Academy of RadiologyResearch, 1029 VermontAve NW, Suite 505,Washington, DC 20005-3517. Receivedand acceptedOctober 11, 2000.Address correspondence to E.C.N. ©AUR,2000
of H.R. 1795 at the September 13 hearing. Much of the testimony centered on the structural impediments to an effective imaging research program under the current NIH organizational plan, the shortcomings of recent NIH initiatives in imaging research, and the potential for innovation that the proposed institute would offer. Dr Bryan, who previously served as Director of Diagnostic Radiology and Associate Director, Radiologic and Imaging Sciences Program, at the Warren G. Magnuson Clinical Center at the NIH, highlighted the structural problems. According to Dr Bryan, ...the NIH is not--and under its present structure cannot be--the catalyst of imaging innovation. The various institutes are focused on specific disease processes or organ systems, but imaging cuts across those lines and is broadly applicable to virtually all diseases and organ systems. Consequently, imaging is used as a tool in all the institutes, but there is no home at the NIH for the basic research that is essential to develop new imaging techniques and technologies for the 21st century. The basic science of imaging and bioengineering, it must be remembered, is fundamentally different from that of the existing institutes at the NIH. Imaging is based on mathematics and physics, not the biological sciences that underlie most of the research in the current institutes. Imaging and bioengineering are unique scientific fields at the NIH and are also critical to future advances in the delivery of high quality health care. Dr Bryan also described his own efforts at the NIH to consolidate several departments into the Imaging Sciences Program (ISP). While creating the ISP has raised the visibility and status of imaging at the NIH and laid the groundwork for a more advanced research program, Dr Bryan testified that
1165
4AYNARD AND NAGY
...the ISP could not be wholly successful, mainly because the very structure of the NIH makes such an endeavor problematic. Research authority and resources reside in the institutes, not in programs at the Clinical Center. As a result, the success of imaging research proposals was ultimately dependent on the ability of ISP researchers to convince one or more of the institutes--instituteswhose primary missions and priorities are in areas other than imaging--to divert funds from their main activities and commit those funds to imaging research. Dr Bryan went on to say that his experience convinced him "that the existing NIH organization will not work for imaging" and that his decision to leave the NIH in 1999 "owed much to the inherent obstacles to imaging research that are built into its structure." He pointed out that recent NIH initiatives in imaging, while often constructive, do not address some of the core problems. The expansion of the Biomedical Imaging Program at the National Cancer Institute (NCI) and the creation of the American College of Radiology Imaging Network (ACRIN) at the NCI, for example, provide new resources for imaging research. Dr Bryan noted, however, that those additional funds are directed solely at cancer imaging, which deserves to be an extremely high priority but represents only one area in which imaging has applications. He observed that other NIH projects, such as the creation of the new Office of Bioengineering, Bioimaging, and Bioinformatics, focus needed attention on imaging but do not provide actual research funding. In the final analysis, Dr Bryan concluded, a National Institute of Biomedical Imaging and Bioengineering is ...essential to promote the development of new imaging techniques and technologies. In order to flourish and grow consistently at the NIH, a scientific field requires an organization with the mandate, the responsibility, the authority, . and the resources to direct and drive investigation in that field. In the NIH structure, only institutes possess those attributes. Dr Dunnick offered a brief historical account, explaining that the radiologists have worked in good faith with the NIH leadership for 3 decades to locate imaging appropriately within the existing NIH structure. He pointed out that the extramural program in imaging was transferred from the National Institute of General Medical Sciences to the NCI in the early 1980s and that the intramural Laboratory of Diagnostic Radiology Research was moved more recently from the Office of the NIH Director to the Clinical Center. Although both realignments were better for imaging research, each left basic problems unaddressed. Recognizing the traditional NIH opposition to new institutes, Dr Dunnick agreed that "the bar to structural change at the NIH should be set high" and argued that the current proposal could meet such a test. He cited the recommendations made by a neutral, expert group, the National Academy of Sciences' Institute of Medicine, in its 1984 report titled
1166
Academic Radiology, Vol 7, No 12, December 200(
Responding to Health Needs and Scientific Opportunity: The Organizational Structure of the National Institutes of Health (1). The Institute of Medicine report, Dr Dunnick explained, concluded that new institutes are justified only when the following five criteria are met: (a) the activity is compatible with the mission of the NIH; (b) it can be demonstrated that the research area in question (defined either as a disease or health problem or as a biomedical or behavioral process related to a health problem) is not receiving adequate attention; (c) there are reasonable prospects for scientific growth in the research area; (d) there are reasonable prospects of sufficient funding for the new organization; and (e) the proposed structural change will improve communication, management, priority setting, and accountability. The proposed institute, Dr Dunnick said, "is consistent with these criteria." In addition, he pointed out that this proposal is also "completely consistent with the NIH's own rationale for the elevation of the National Center for Genome Research to institute status in 1997." Dr Dunnick also discussed the role of the proposed institute in coordinating imaging research programs throughout the federal government and in meeting the mushrooming medical needs of the information age. He concluded by urging the Subcommittee to support H.R. 1795 in order to "create a climate that promotes discovery and innovation in imaging just as the NIH provides such a climate for other fields." In his statement to the Subcommittee, Dr Hillman described the central role of imaging in the emerging molecular revolution. He said that Medical imaging is the "non-invasive biopsy," the method of disease quantitation, the guidance for new treatments still to be developed that will form the underpirmings of molecular medicine. Under this scenario, new medical imaging technologies will detect alterations in the genetic or molecular makeup of cells that have the potential to progress to disease. We then will employ imaging technologies to precisely determine what fraction of cells are so affected. Finally, medical imaging technologies will be integrated with new therapeutic methods to either guide or monitor treatment, so that we can much more precisely than ever before ensure that only diseased cells are treated while preserving normal tissue. The basic knowledge exists to begin to implement this vision. However, for this optimistic and exciting prophecy to come to fruition, we will need to invest in the development and assessment of new imaging technologies. We are ill-equipped to do so under the current NIH organizational structure that focuses the work of existing institutes on specific organ systems and diseases. Dr Hillman also drew on his experience as chair of ACRIN, applauding the NCI for establishing the network for clinical trials and citing the importance of trials of digital mammography for breast cancer screening, computed tomographic scanning for the early detection of lung cancer,
and other technologies. Despite the benefits that will result from these trials, however, Dr Hillman explained the shortcomings of an approach based in an institute dedicated to a single disease: ...these same technologies that ACRIN will study, and many other current and future technologies, are broadly applicable to diseases other than cancer. There is no counterpart to ACRIN at the National Heart, Lung, and Blood Institute, or the National Institute for Neural Diseases and Stroke--institutes whose purview includes organ systems and diseases where imaging plays a large and critical role--nor, for that matter, at any of the other institutes. Even if there were, the fragmentation of imaging technology assessment on such arbitrary grounds would be wasteful, inefficient, and leave important gaps. Taken together, the statements by Drs Bryan, Dunnick, and Hillman constituted a compelling and comprehensive rationale for the establishment of a National Institute of Biomedical Imaging and Bioengineering. For its part, the NIH, although invited by the Subcommittee to testify, declined to provide a witness for the hearing. Instead, the NIH provided a written statement for the hearing record. In its testimony, the NIH stressed its substantial and growing investment in imaging and bioengineering, the prominence of these fields of research in the existing institutes, and the importance of such recent initiatives as the Bioengineering Consortium and the new Office of Bioengineering, Bioimaging, and Bioinformatics. The NIH contended that the current structure promotes close collaboration between physical scientists and biological scientists to address specific biological issues and that the creation of a new institute is "premature at this time." University of Arkansas for Medical SciencesMoreover, the NIH statement suggested that establishing the proposed institute could have the longrange effect of decreasing support for imaging and bioengineering research from the current institutes. Finally, the NIH recommended that the question of creating a separate institute be deferred until the new Office of Bioengineering, Bioimaging, and Bioinformatics can be evaluated. One day after the Subcommittee hearing, the House Commerce Committee approved H.R. 1795 by voice vote and sent
it to the full House of Representatives. Two days before the House considered this bill, Secretary of Health and Human Services Donna Shalala sent a letter to Representatives Tom Bliley (R-Va) and John Dingell (D-Mich), the Chairman and Ranking Democrat on the Commerce Committee, opposing H.R. 1795. Secretary Shalala's letter repeated several of the arguments already set forth in the NIH hearing testimony and contended that the "establishment of another NIH Institute would require an expensive administrative structure, for which additional resources would be required, so as not to rob the existing NIH ICs [Institutes and Centers--author's note] of their expertise and funds." Mr Dingell himself had raised similar concerns during the September 14 Commerce Committee markup of H.R. 1795, but he did not object to its approval by the Committee. Despite this opposition from the NIH and the Secretary, the House passed H.R. 1795 by voice vote on September 27 after only brief debate. The two principal sponsors of the bill, Representatives Burr and Anna Eshoo (D-Calif), along with cosponsor Diana DeGette (D-Colo), were the only House Members to speak. No Representatives spoke in opposition. The National Institute of Biomedical Imaging and Bioengineering Establishment Act was thus sent to the Senate with an extremely strong endorsement from the House of Representatives. House passage of this bill over the opposition of the NIH was achieved through a 5-year campaign led by the Academy of Radiology Research with strong support from its member societies and the approximately 3,000 radiologists, technologists, imaging scientists, bioengineers, and equipment manufacturers who contacted their Representatives and Senators to express support. This success, which will not be complete until this legislation is approved by the Senate and signed into law, clearly demonstrates the importance of constituent opinion and the effectiveness of a grassroots effort in the legislative process. At this writing, the Academy is working with the Senate sponsor of this bill, Majority Leader Trent Lott, to push for Senate passage before the Congress adjourns for the year. tEFERENC!
Institute of Medicine Committee for a Study of the Organizational Structure of the National Institutes of Health. Responding to health needs and scientific opportunity: the organizational structure of the National Institutes of Health. Washington, DC: National Academy of Sciences, 1984.
1 167