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Truth in Doubling
The biggest and longest-running story in current science policy annals is the essentially unanimous decision by Congress to pour buckets of big money into the National Institutes of Health. The saga of doubling the NIH budget is a major story because the phenomenon has been a “no-kidding-it’s-really-happening” proposition that has generated immeasurable surprise, delight, anticipation, and communal backslapping all around the country’s academic health centers. Congress is now more than two-thirds through this doubling process—indexed by the $13.6 billion appropriated for Fiscal Year 1999 and proceeding to a projected $27.2 billion for FY 2003. NIH never asked for such munificence when Bill Clinton was President. The job was done by Congress in its unquestioned belief that the best way to understand and cure disease in the cheapest way is to do more and more research on it. Clinton went along because he and Congress knew that support for basic and clinical health research was good politics. Also, the lobbying effort was well organized and powerful. Is doubling the NIH budget really good health policy? Or to modify the question toward a fuller if fuzzier answer, what in the larger sense does doubling a health research budget really mean for the nation’s health? After a few weeks of digging around, SPP concludes that no one really knows. A good medical success story here, a bad one there, do not equate to good or bad policy. But the question should force deep thinking about what a research system should really be all about in terms of ultimate costs and outcomes. Doubling generates a lot of good research. It also probably generates more research that goes absolutely nowhere, or leads to treatments that managed care cannot or will not afford. The most important exercise is to learn how to talk about the whole thing in the widest possible context, to talk intelligently about the nature of policy, which one forgotten observer once defined as sets of goals accompanied by means of implementation. Not easy. And the research community is of little help in criticizing its own way of doing work. The biomedical research community loves the doubling. Right now, medical schools are reveling in the increase in the sizes of grants, the gung-ho momentum generated by the colossally expensive human genome project which promises miracles of historical grandeur throughout the 21st century, more money for the training of young researchers, ambitious reform of a neglected clinical research system, purchase of new, expensive, and sophisticated equipment and instrumentation, plans for stronger emphasis on the behavioral aspects of disease, more effective connections between research labs and health services, and reaching out to diverse populations notoriously neglected by a system historically oriented toward males and well off-Caucasians. These are all to the good if you accept the prevailing—or as the sociologists would put it, normative—way of thought about NIH research: that there are huge and important problems begging to be solved, many talented people around to attack them, but too little money to go around. Researchers can not only expand the exploration of basic questions that have been bugging them, but also expand the knowledge they produce into more creative ways of reaching out to patients. But what has all the new money gone for? The answer is everything a researcher can dream of and ask a question about, even research on polio, which has essentially been defeated. The one quickly readable document that attempts to give a rundown of just what and why NIH has spent its extra money on is something called “Investments, Progress, and Plans,” which contains examples of program expansion between the doubling period of FY 1999 to 2003. It is available on the NIH website. You can’t call it scholarly; it is anything but quantitative. But it is a start. This list attempts to lay out the new NIH as a reflection of all those “astonishing” opportunities presented to biomedical science. NIH says that “there are several new lines of research that are changing the way biomedical research is done.” It ticks off fields such as proteonomics (the study of the critical proteins produced via each genome), combinatorial chemistry, advanced imaging techniques, computer power, and robotics, all of which have “required a shift in how medical research is conducted.” Take that to mean, “expensively.” NIH says research now involves “vast and complex teams,” rather than individual investigators, that there are now great needs “for specialists in areas other than biology, including imaging, chemistry, computer science, mathematics and informatics.” It adds, “Projects comparing the human genome to the genomes of nonhuman primates and other organisms such as the rat, fruit fly, and yeast will require much larger teams to achieve success. Moving discoveries in basic research into clinical trials now requires setting up teams to design protocols, recruit participants, conduct trials, and analyze the data.” In this context, the doubling can be seen as a massive assault on disease akin to the World War II planning and execution of the Normandy invasion. A lot of planning went on at NIH when it became obvious that the agency’s budget would begin taking off. When SPP asked a few Institute directors what the doubling has meant to their respective efforts, their tendency was to reel off various needed programs, projects, and initiatives. “My institute,” says Stephen I. Katz, who heads the Institute for Arthritis, and Musculoskeletal and Skin Disorders, “has invested heavily in clinical research, which is far more expensive and more complex than lab research, in osteoporosis in men through generating a longitudinal cohort of patients, in clinical research without therapeutic intervention, surgical versus non surgical interventions for low back pain, combined treatments for osteoporosis, and novel approaches to the treatment of rheumatic and skin disease. These are the types of many studies we would never have been able to afford in the past.” Marvin Cassman, head of the Institute for General Medical Sciences, which sponsors only the most basic of biomedical research and funds its infrastructure, says he organized in 1998 a series of “bull sessions” involving researchers who already were being supported. “We simply asked them what we should be doing, what they needed more of, what were the major issues, what were the big developments. So we identified a series of areas that we felt were essential. The list included computational biology at the cellular and organ level. Another was large-scale collaborative research such as in cellular genomics. A third was equipment, databases, and material resources. The tools of modern biology have become much more pervasive and expensive.” More or less the same types of answers come from other NIH directors. The question bothering everyone is how long the salad days will lasts. The economy is already in a serious and perhaps prolonged slump, which means the huge budget surplus will begin melting down and research budgets, even medical research budgets, will once more become tight. Cassman points out that the out-year projection for NIH in FY 2004 calls for a mere 2.2% increase, “Sure we’re concerned,” he says. “We’re doing a lot of talking about it.” They are. Congress has said they better and to report back what they are thinking. What they are talking mostly about is building such a strong and steady infrastructure that by the time the gusher diminishes to a mere flow the big expensive instruments will have been bought and laboratories built. “We are worrying because we have created these research consortia, instrumentation systems, and clinical trials that demand substantial resources,” says Duane Alexander, director of the Child Health and Human Development Institute. “We also increased the number of grants, grantees, and the capabilities of the whole research community. Once this doubling stops, depending on its abruptness and degree of stopping, you bring this whole creative enterprise to a static situation. You lose your ability to fund new concepts and new ideas that capitalize on the things you just invested in, or even keeping going the kinds of big science activities that you have invested in. That eats up an enormous part of the resources that are ordinarily going to the investigator. And if you don’t have continuing capability to invest in those, you wind up losing the capability to keep this basic part of the scientific process going.” With all that said (and what hasn’t been said is that only about 30 percent of grant applicants to that enormous research enterprise are in fact funded), the issue of NIH doubling remains bothersome in the larger sense because the whole medical establishment cries out for reform today, reform that would include a study of outcomes directly from the research lab to the bedside. In other words, if one steps outside the immediate research establishment and looks around the entire medical landscape, the context begins to expand and one can begin to at least wonder about the sorts of cost/benefit trajectories of different research paths. A primary source to turn to is a current Institute of Medicine review (Informing the Future: Critical Issues in Health) of all the major problems confronting biomedicine today. It says the health care system is subject to “destabilization” across a whole range of issues.” It is essential to be familiar with these broader issues of health care because the overall conclusion to be gathered is that of a medical system more and more remote from public understanding and even from a sense of community. There’s a great translational challenge here. NIH knows it and realizes that news of medical advances from the labs must go beyond the NIH press release, promotional brochure, and journalists friendly to the existing way of thought about research. The troubles described in the IOM report stretch for typewritten yards. Anger against managed care; inadequate attention to prevention; shortages of clinical researchers; poor clinical research design; insufficient numbers of skilled clinical researchers; ethical lapses if not outright scandals; privacy of medical records; outcomes that don’t appear commensurate with the money paid for research; gaping disparities between the well off and poorer segments of the population when it comes to quantity and quality of health care; commodification of research; intellectual property policies driven by drug companies; conflicts of interest in the research labs; the soaring expenses of doing research. What all of this boils down to is that the public policy issue around NIH doubling isn’t really about money. It is about the search for solutions to all of the above. Money is a serious enough matter to the academic health centers, mired in their own fiscal crises. Therefore they can think of little else. But the issue is really one of federalism and its ability to create a research system that does the best job possible in generating new, useful knowledge and transferring it from the laboratory to the patient. What, then, should be the role of academia in all this? One academic, Fred L. Bookstein, who does imaging research at the University of Michigan under NIH support, has an answer. Back away from the current commercialization craze. Writing in the July 30 Washington Post, Bookstein said that, after teaching, the role of universities “is to determine and set forth what the consequences of current understanding will be for future scientific and social developments.” “Bodies vary one from another,” he writes, “and they fail and die. But the life science institutes arise from a ‘medicalization’ of health that would deny this. They would perpetuate our overinvestment in an unending, unproductive extension of severely damaged lives.” And he concludes: “The goals of today’s life science institutes are economically, intellectually and academically incoherent. Universities need to return to their accustomed distance from economic fashions in the pursuit of knowledge and speak out against these developments.” So to sum it all up, a comprehensive look at the broad problems of connecting research to health services and the rest of the system is needed. Daniel Callahan of the Hastings Center for Bioethics will soon be publishing a book that will delve into the whole matter of why the research establishment has apparently been so reluctant to assess its outcomes. The book, to be issued by the University of California Press, will be called The Research Imperative: At What Price Better Health? In the book Callahan describes his attempt to understand the way in which NIH sets its priorities and concludes that the process “rests on no clearly articulated view of the health needs of the nation.” “I remember when NIH used to publish an annual data book,” he tells SPP. “Near the front it would chart over 25 years the rise in health research funding. Alongside that it would also chart the steep rise in health costs. I thought it odd that they never commented on the correlation. So I decided to look more carefully at the relationship between research and health care costs and there’s simply no doubt in my mind that medical research does drive up health care costs. A quote from Callahan’s forthcoming book essentially sums up the challenge.
“Once it is recognized that there are other social goods, many of which
can make a more direct contribution to health than medicine (such as education
and decent jobs), then a more nuanced approach to biomedical research will
be needed. The fact that much, even if not all, research increases health
care costs but provides only a marginal gain to population health has yet
to be taken into serious account in setting research priorities; that day
of reckoning will surely come.”
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