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Thanks to long-term vision and commitment such as this, the NIH today is a nationwide republic of science composed of some 50,000 researchers working at 1700 institutions. In the years since World War II, our republic of science has thrived. More important, it has had a long-term, positive effect on the health of every person in the United States. Today Americans enjoy the best health in the world and of all time. And the health that most Americans now enjoy is the direct result of our nation's steady investment in biomedical research. Yet the crucial role of research in bringing better and potentially more cost-effective medicine to the public has thus far been left out of the current debate on health care.
As Thomas Starzl once observed, "All triumphs in medicine are the forgotten sorrows of past days"2. These sorrows include the treatment of polio victims with iron lungs, deaths from uremia without benefit of dialysis, acute myocardial infarction with a mortality rate of 35 to 40 percent, and contamination of the blood supply with the human immunodeficiency virus (HIV). No one would willingly return to those days. Nor should we put a brake on the momentum behind tomorrow's medical triumphs -- curing cystic fibrosis, finding the genes for prostate or breast cancer, and learning to reconstitute a destroyed immune system or regenerate a neural pathway to a paralyzed limb. By broadening our knowledge of the molecular mechanisms of disease, we can employ the powerful tools of modern biology to reverse the progression of two of the cruelest and costliest diseases of the elderly -- osteoporosis and Alzheimer's disease. Indeed, the kind of new knowledge about the molecular bases of disease that is pouring out of the NIH will revolutionize tomorrow's medicine.
But tomorrow's medicine will not come to fruition unless we fully recognize biomedical research as a major national priority today.
In this context, one must compare President Roosevelt's words in 1940 about the importance of biomedical research with this statement from a 1993 report by the Congressional Budget Office:
A reduction in funding for NIH research could be justified by its rapid growth in recent years. . . . If funds for NIH research were reduced by 10 percent, the 1994-1998 savings in outlays would be about $4.9 billion. The NIH could respond by . . . encouraging researchers to find additional sources of support. Alternatively, the NIH could cut the number of grants awarded3.
This recommendation was given additional support when Fortune magazine cited it in "Clintonomics and You," an article outlining the administration's specific deficit-reduction plans4.
Statements such as this may suggest that our nation is taking for granted the fruits of our investment in the NIH and in biomedical research or that it is failing to make the important connections between the work done and supported by the NIH and the health of the American people and, increasingly, our nation's economic health. To quote Vannevar Bush, the science adviser to Presidents Roosevelt and Truman, "Without scientific progress, no amount of achievement in other directions can insure our health, prosperity, and security as a nation in the modern world"5.
In his post-World War II report on civilian science, Science -- The Endless Frontier,5 Vannevar Bush set forth a blueprint for scientific research and identified biomedical research specifically and repeatedly as a high priority for the nation. Scientists and the public alike reaped the benefits of the priority given to the NIH, as budgets for NIH grants grew 500 percent during the 1950s. The agency's high status was also reflected in the open alliance between its director, James Shannon, and a cadre of champions both inside and outside government, including members of Congress Lister Hill, John Fogarty, Warren Grant Magnuson, and Claude Pepper and politically powerful private patrons such as Mary Lasker and Florence Mahoney.
Today, in a very different economic and congressional climate, the endless frontier of biomedical research has narrowed. One unequivocal statement of priority is made by the level of public investment in biomedical research. From 1989 through 1993, funding for the NIH grew at approximately the same rate as total domestic discretionary funding and at rates lower than those of other science agencies, such as the National Aeronautics and Space Administration (NASA) and the National Science Foundation (NSF). From 1988 through 1993, the NASA budget grew by 74 percent, the NSF budget by 59 percent, and the NIH budget by only 32 percent. In constant dollars, with 1973 as a base, from 1983 through 1987 the NIH budget grew at an inflation-adjusted rate of 7.1 percent per year (6.1 percent if research on the acquired immunodeficiency syndrome [AIDS] is excluded), whereas from 1988 through 1992 the annual growth rate fell to 2.4 percent (1.8 percent if research on AIDS is excluded).
For 1993 and 1994, the picture is about the same. In 1994, except for double-digit increases for research on AIDS and breast cancer, the NIH faces a budget that is static or contracting in real dollars. The lower priority afforded the NIH relative to the other science enterprises of the federal government is in large part an outgrowth of the complex political system and processes within which the NIH functions.
Politics and the NIH
In fulfilling its mission, the NIH is quintessentially political, but we hope it embodies politics at its best: the use of public resources and power for the public good. The NIH is political in another, more mundane sense as well. It is an agency of the federal government, supported by public funds, housed within the executive branch, and interacting with a number of other political bodies, including the rest of the Department of Health and Human Services (DHHS), Congress, and the Office of Management and Budget. In recent years, however, the ability of the NIH to fulfill its mission has been eroded by relentless partisan politics.
In the Shannon era, the NIH enjoyed a standing that gave it de facto authority to deal with members of Congress, influence directly the design of its budgets, and manage its day-to-day affairs. From the outset, its legislative mandate was broad and flexible, as defined simply by Section 301 of the Public Health Service Act:
The Secretary shall . . . 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 of man . . . [and] make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects. . . .6
To understand how sharply this situation has changed, particularly in the past decade, one must understand three developments: changes in the NIH's position within the ballooning federal bureaucracy, changes in the way in which agency budgets are formulated, and the evolution of legislation to reauthorize the NIH. All three have changed the life of the NIH and of biomedical research, moving the agency relentlessly away from the good old days. Much as we might mourn those days, we must accept the fact that this is no longer the same NIH7. If we are to address our problems and build a better agency and a better biomedical-research enterprise, we must develop solutions within the context of the situation today.
At one time, the NIH was without peer and with little competition. We were the prima donnas of the scientific frontier, if you will, and no one questioned our intrinsic value or that of our work. Today, we compete for resources as never before. As part of the Public Health Service, which in turn belongs to the mammoth DHHS, we compete, often anonymously, with school lunch programs, Head Start, the Indian Health Service, subsidies for home heating fuel, and programs such as childhood immunization that deal with health emergencies. In a similar vein, the NIH budget comes under the purview of the Health and Income Maintenance Branch of the Office of Management and Budget, not the Energy and Science Division, which oversees the other scientific agencies, including NASA and the NSF.
Let me relate a telling anecdote. About a year ago, I visited the associate director of the Office of Management and Budget, responsible for the budgets of the DHHS and NIH, and expressed great concern about a lean 5 percent increase in the proposed budget for 1993. My comment surprised the official, who contended that he had been generous to the NIH. He recounted the meager and sometimes reduced funding of many other health and welfare programs. When I pointed out that NASA and the NSF were seeing double-digit increases, he was speechless and finally admitted that he was not aware of such largess for other areas of science. The NIH had become lost in the federal labyrinth.
In the past, our lowly status in the executive branch did not matter in creating a favorable budget, because the President's figures for the NIH would be generously reshaped and increased by Congress. Today, ballooning federal budget deficits have resulted in expanding, competing priorities for discretionary spending. We have felt the impact of rigid budget constraints for the past three years and have lost many of the most vocal champions of the NIH from both sides of the congressional aisle. Hence, the final NIH appropriation has been about the same as or worse than the President's budget submitted to Congress. Clearly, the scientific community can no longer ignore the President's budget, as was the habit during the previous four decades.
The effect of the reduction in growth of the NIH budget is exacerbated by the increasing loss of flexibility once the budget is issued. The inflexibility is in part caused by the fact that our budget is appropriated piecemeal, institute by institute, across some 23 organizational units. This establishes in law 23 budgetarily independent fiefdoms -- hardly a republic of science. Moreover, we are currently facing proposals to carve out large, independent budgetary units for AIDS research and possibly one for AIDS prevention. At a time when the NIH is increasingly called on to address critical health priorities and emerging scientific opportunities, the rigid budget becomes a straitjacket. Incredibly, any scientific judgment that would necessitate reallocating more than 1 percent of an institute's budget requires an act of Congress. In fact, even the modest director's discretionary fund of $10 million, which represents a mere 0.1 percent of the total NIH budget of more than $10 billion, is not always discretionary. I discovered, for example, that I needed rather elaborate congressional approval, forwarded through several layers of the DHHS bureaucracy, to use this discretionary fund to recruit a new scientific team to the NIH campus.
Finally, as Congress has reduced operating funds for government agencies, an ever-increasing share of the operating funds appropriated to NIH have actually been taken away from it ("tapped") to finance other programs within the Public Health Service and the Office of the Secretary. Despite its own budget of $600 billion, which goes mainly to entitlement programs such as Social Security and Medicare, the DHHS views the NIH budget as a pool of flexible discretionary money that can be tapped without our consultation and with little notice by the outside world. In 1992, the DHHS initiated 49 individual "taps" that totaled more than $50 million, an increase in taps of 18 percent over the previous year. This happened at a time when our budget grew by only 3 percent. These taps translate into some 200 grant applications that went unfunded.
As we deal with the realities of one year's budget, we are also defending the next year's proposed budget before Congress and simultaneously preparing a budget for the years after that to submit to the DHHS. Developing a budget that extends so far into the future, with little opportunity for ongoing involvement thereafter, would be problematic for any science agency, but it is especially so for an agency involved with human health. The temporal and geographic distance between the NIH and its preliminary budget grows steadily greater once the budget leaves the NIH in the spring, two fiscal years before its issuance. That preliminary budget winds its way through an elaborate vertical and horizontal maze of deputy assistant secretaries, assistant secretaries, and deputy secretaries before it reaches the secretary of the DHHS. Decisions are made at each of these levels, but as the budget moves through the labyrinth direct involvement in the decision making by the NIH leadership is gradually eliminated, as are the scientific bases on which decisions should be made.
This remote and cumbersome process is especially inappropriate because the NIH budget represents 54 percent of the discretionary dollars in the Public Health Service and 30 percent of the discretionary resources of the DHHS. As an indication of the problem of remoteness, a high-ranking DHHS official recently said that the NIH had not fared well in fiscal year 1994 because the new people formulating the DHHS budget "forgot" about the NIH. Imagine a bureaucracy so big, so unwieldy, that an agency such as the NIH, with a budget larger than those of six cabinet-level departments, could be overlooked in the budget process. Among the 30 or so largest independent agencies, such as the Federal Reserve Board, the NSF, the National Research Council, the Securities and Exchange Commission, and the Small Business Administration, only NASA has a budget larger than that of the NIH8.
Clearly, the NIH is at a disadvantage because it is a highly dependent agency, low in the DHHS bureaucracy, and not only in a budgetary sense. Virtually all decisions go through the same vertical and horizontal bureaucratic maze as those affecting our budget. Thus, we are hindered equally with regard to administrative and programmatic authorities. We routinely face long delays, sometimes of more than a year, in gaining approval for senior-level appointments of scientists and administrators; we cannot employ our own legal staff; we must seek agreement and formal approval on relatively minor decisions of operational policy; and we are often denied permission to publish routine health-information materials for the public.
The NIH Reauthorization Process
The NIH clearly has very limited administrative authority within its present structure. What about programmatic authority -- that is, the legislative mandate to pursue our research mission? Although the authority contained in Section 301 of the Public Health Service Act gives us what we need -- namely, a permanent warrant to do research -- Congress has embraced the practice of writing periodic reauthorization bills to refine our programs and provide more detailed directives. In an ideal setting, such legislation would allow Congress to validate the agency's mission and, in collaboration with it and the scientific community, provide a forum for setting priorities and programs and introducing changes that reflect the will of the American public.
In recent years, however, the NIH's reauthorization process has been derailed by partisan politics over issues ranging from abortion to research on fetal-tissue transplantation to immigration policy for people with AIDS. Because of the political tussles of the past 13 years, before 1993 only three reauthorization bills had actually passed Congress -- in 1980, 1985, and 1988 -- which testifies to the overall irrelevance of such bills to the agency's continued operations. Far from validating our mission, reauthorization has served mainly to provide a forum for making political points that are often remote from science.
Since, unlike many other federal programs, the NIH does not need to be reauthorized to do its business, the entire process sometimes becomes a sort of existentialist drama in which characters pursue their own ends and assign their own meaning to the action as it unfolds. A common myth, or misunderstanding, is that the reauthorization process establishes programs and priorities for which resources have been allocated. Although the NIH receives detailed directives from reauthorization bills, the agency is given not a dollar to carry them out. Since the reauthorization is conducted independently of the annual appropriations process (which provides our yearly budget), the reauthorization directives are all, in essence, "advice without a check." In fact, they are worse than advice, insofar as we are legally bound to carry them out, which sometimes requires us reluctantly to redirect resources from other programs.
A few examples from recent reauthorization bills will illustrate my point. The NIH Revitalization Act of 1992 called for the establishment of an office of research on women's health -- an office that had already been established, had a substantial budget appropriation, and had been functioning well at the NIH since 1990. The bill mandated that the NIH impose scientifically flawed sex quotas on clinical trials, and its many requirements would have turned the staff of the Office of Research on Women's Health into bureaucratic bean counters. The bill also called for the creation of other offices and established several new oversight mechanisms both within and outside the NIH, augmenting our already exhaustive systems of oversight.
The NIH has seen a relentless increase in the number of such congressional directives contained in reauthorization bills. The 1984 bill contained 122 directives; the 1985 bill, 166; and the 1991 bill contained a whopping 269 directives, including 92 directives for expanded efforts, 62 for new programs, and 50 for new research areas. That bill also required 20 new reports, and again, it provided no resources with which to carry out any of the 269 directives. Such detailed directives shrink the already narrow margin of funds for research into new areas and drown the NIH in bureaucratic requirements that hinder administrative and programmatic flexibility.
The 1991 reauthorization bill would also have imposed a number of new advisory committees on the NIH, including an ethics board, which would have been costly and unnecessary and would have duplicated existing committees. At present, the NIH has the largest advisory system in the entire government. Ironically, along with all other government agencies, it has recently been given a presidential order to cut its committees by one third9.
In 1992, the portion of the proposed legislation that took center stage was a provision that would have allowed the NIH to fund research involving the transplantation of fetal tissue derived from induced abortions. The Bush administration vetoed the bill because of the fetal-tissue provision, but the NIH opposed the bill because of its endorsement of intrusive micromanagement and flawed science. The 1992 bill never passed. Its failure was touted by some as a failure for women, for research on Parkinson's disease, for cancer research, and for the NIH. The committee chairman pledged that the bill was so important that it would be the first to be passed in the new Congress. This did not happen.
The next version of the reauthorization bill, the NIH Revitalization Act of 1993, resembled the preceding year's bill in lifting the ban on funding for research involving fetal-tissue transplantation (or "relifting" it, since it had already been lifted by the Clinton administration in February 1993). The political debate around this bill now centered on AIDS, not abortion. A new part of the 1993 bill mandates much-expanded authority for the Office of AIDS Research, including central control of all AIDS-related appropriations to individual institutes. This measure has been staunchly opposed by institute heads, as well as by many in the scientific community. The bill was also held up several months, not because of issues related to biomedical research, but because of the political debate on another provision added to the bill, which concerns the immigration of persons who are HIV-positive. One might well ask what immigration policy has to do with NIH revitalization. After five years and in a somewhat different political form, the reauthorization bill was finally passed and signed into law by President Clinton. Clearly, the entire reauthorization process for the agency has gotten out of hand.
Strengthening the NIH
I have described some of the realities that may account for a large part of the unease that many in science are feeling. No doubt, understanding the pathophysiologic aspects of this process is crucial to crafting an intervention that will improve the health of the NIH. But amid this analysis we must not lose sight of the truly magnificent enterprise that is the NIH -- the dedicated and creative talent that both ennobles the effort and enables it to succeed -- and the public that so desperately depends on the NIH for one of its most prized possessions, health. But not losing sight of that means crisply articulating a vision for the present and the future. Developing a clear statement of the NIH's strategic importance to the nation and of the strategic issues that must be embraced successfully if the NIH is to thrive, rather than just survive, is crucial to our continued success, especially in times of stress.
The health of the NIH is vital to American science, the American public, and parts of the American economy. Thus, the most important outcome of our new strategic plan, entitled Investment for Humanity, may not be the document itself, but rather a broadening of our thinking. Through strategic thinking, many in the scientific and academic community have come to recognize that the fates of the NIH, its network of research institutions, and the public we serve are truly intertwined. We all sink or swim together. And our joint endeavor must be seen as a national priority. If that goal seems unattainable given the current political environment, I would paraphrase something that Derek Bok once said: "If you think seeking new medical knowledge is expensive, try ignorance."
The NIH's strategic plan goes a long way toward defining the environment in which medical research can flourish, but it can never be a panacea. One factor that hinders the NIH must be engaged directly at some point. Let me state it plainly: The problem for the NIH is not that it has become too political, but rather that it is so far down in the bureaucracy of the executive branch and the DHHS that it lacks the political clout needed to confront inappropriate political pressures.
Over the past several years, I have come to believe that the only way to overcome the many difficulties handicapping our noble enterprise is to effect fundamental changes that will give the NIH greater involvement in the appropriations and reauthorization processes. There are many halfway solutions. One might be to elevate the agency within the organizational structure of the DHHS. Another might be to give the NIH so-called "bypass" budget authority, allowing it to make direct budget submissions to the Office of Management and Budget. However, for the few segments of the NIH to which such authority has been granted, it has not been effective, since the Office of Management and Budget ignores it. We could hope for a direct and more productive involvement with Congress and the executive branch in the reauthorization process, but that will not occur until we have substantially elevated the standing of the NIH within the federal bureacracy. Whatever improvements they may effect, such halfway solutions will not solve the core problem of creating a stable environment for science within a massive agency administering welfare and entitlement programs.
I contend that the NIH needs to be an independent agency, separate from the DHHS, with the clout, access, and visibility of the other large science agencies, most notably the NSF. Since its founding 54 years ago, the modern NIH, through its magnificent contributions to American medicine and the American people, has outgrown the organizational structure in which it has lived.
Independent status would define the NIH as a uniquely important health sciences agency, critically relevant to the future of the life sciences, medicine, the environment, and the public. Independence would mean that the NIH could formulate its own budget for presentation to the Office of Management and Budget and the President. Also, the NIH could confront operational and scientific issues more directly, streamline internal systems and personnel management, promote efficiency in decision making, and thereby maximize the resources available to fund research. All this would increase our ability to be responsive to the scientific community, elected officials, and the public. Indeed, the NIH could be a model for reinventing government.
Critics may say that such independence and visibility would inevitably heighten the politicization of the NIH and make us more vulnerable to partisan political ideology. If I thought this would be the outcome, I would never suggest it. It is not the inevitable outcome when independence is properly crafted. Furthermore, I contend that such crafting has already been done in the federal government, albeit on a grander scale and in a different arena: monetary policy.
The Federal Reserve System is the central banking authority of the U.S. government. As such, it has the critical role of determining and implementing U.S. monetary policy. The Federal Reserve System has been designed to function independently of partisan politics, but within a highly political environment. Through the use of term appointments for the chairman and the board of governors and of a nonpartisan peer-review system to select the presidents of the 12 Federal Reserve Banks, stability and political independence have become prized features of the Federal Reserve. Indeed, the very fact that the Federal Reserve Board chairman caused a public outcry by appearing beside the President's wife during the State of the Union address reflects the public's demand that that agency steer a nonpartisan course. Accountability is ensured by a law that requires the Federal Reserve to report to Congress in detail and frequently on its policies and their consequences.
This model is a starting point for developing ways to insulate science from partisan politics and create a more stable environment for research. There are other bodies within the federal system, such as the office of the Joint Chiefs of Staff, that honor an imperative to maintain stability and independence from partisan politics, even though they are on the political firing line.
In the light of the NIH's vital mission and the magnitude of our budget, if independence were achieved the NIH would most assuredly become a highly visible national organization, one from which the American public could and would demand nonpartisanship.
Conclusions
The modern-day NIH was launched during a period of great national hardship. Yet in the midst of domestic uncertainty over the economy and international unrest, President Roosevelt set his sights on the future, on America's posterity. Today we must do the same. Research is medicine's field of dreams -- dreams that have produced tangible benefits for every man, woman, and child in this country since the founding of the agency.
As a society, we must not allow nostalgia to blind us to the truth about the medicine of yesterday. Nor should we allow transitory economic hardship to blind us to the promise of tomorrow's medicine. The only way to ensure that the next generation of physicians will be practicing 21st-century medicine in the years to come is to secure the future of the NIH today.
The purpose of medicine and of all medical research remains constant from one presidential administration to the next: to maintain health, relieve human suffering, and prevent death from disease. As an institution that embodies that goal, the NIH holds a public trust that far exceeds that of almost all other federal agencies. Indeed, to paraphrase the American playwright Howard Sackler, the NIH, by seeking "to intervene . . . between our fellow creatures and their suffering or death, is our [nation's] most authentic answer to the question of our humanity"10. Putting people first must translate into putting the NIH high on this nation's list of priorities.
Source Information
Presented as the 103rd Shattuck Lecture to the Annual Meeting of the Massachusetts Medical Society, Boston, May 15, 1993.
Address reprint requests to Dr. Healy at the Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195.
References
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