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Health Technology and Developing Countries: Dilemmas and Applications KENNETH I. SHINE, M.D. President, Institute of Medicine Three caveats, or principles, will preface this look at health technology and developing countries. The first caveat, which distinguishes the health sector from all others, is this sector's special character: the status of human health derives from the dynamics and outputs of every other aspect of society to a unique extent. Not only the level but also the equity of distribution of a society's economic product determine, though not exclusively, health status. This economic product includes the availability of infrastructure clean water and air, safe work envi- ronments, transportation networks to link people and communities to health fa- cilities, communications media to link them to health information, and health facilities themselves. The education sector has a relentless and unequivocal effect on health status. It provides for the education of women, now widely accepted as crucial in child and family health and welfare; the education of health profession- als who know not only how to use health technology but also how to care for people; and the development of a critical mass of individuals who can perform research and analysis in all the areas that pertain to keeping people healthy and making them well. All this being said, health status and economic status and educational status and good roads are not inevitably correlated. Moreover, the poor, the uneducated, and the politically powerless bear a much larger burden of death and disability than their opposites-the wealthier, the more educated, and the enfranchised. The second caveat, or principle, is a converse of the first: health status not only derives from every other aspect of society but also contributes to it. This is so despite the fact that economists like to relegate health and education to the so- called social sector that is, the sector that costs money but produces nothing, 219

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220 Marshaling Technology for Development unlike agriculture and industry which are the bulwarks of the productive sector. This, however, is nonsense. For example, children who grow up in toxic environ- ments are less likely to prosper, educationally or economically; they are, there- fore, less likely to be productive in societal terms. Women who are in poor health are not able to take care of their families as well as healthy women do. They also tend to have infants who are sicker and who die earlier. As a result, they have more babies to replace those who have been lost. The costs of the consequent high morbidity and high fertility are not trivial in development terms. The third caveat is that, precisely because of the intimate and extensive links among health status and every other aspect of human existence, technology is only part of the answer. Very high technology is an even smaller part, whether talking about developed or developing countries. In fact, in itself technology offers little in the way of solutions to many of the factors that affect human health and well-being negatively smoking and other substance abuse, lack of exercise, ruinous diets, sexual carelessness, noncompliance with medical regimens, or wearing a seat belt or fixing the exhaust on a vehicle are matters of behavior. And, other than the case of firearms, where removal of technology could do a lot for human health, there are no technological answers to the problems and conse- quences of all kinds of violence. CHARACTERISTICS AND TRENDS IN HEALTH AND MEDICAL TECHNOLOGY These principles having been established, what then are some of the charac- teristics and trends in health and medical technology, generically and as they apply in the United States? Technology and Fundamental Research The United States plays a commanding role in the development of health and medical technology, in part because most European and Japanese as well as American manufacturers earn more than half of their profits from U.S. sales. Thus even research not performed in the United States is influenced heavily by U.S. requirements. The main reason, however, is the U.S. leadership role in basic research, or what is increasingly referred to asfundamental science. The term is an excellent one because it diverges from the stereotypical view of basic research as remote and somehow irrelevant to daily life in the "real" world. To the con- trary,fundamental science emphasizes that the concept of science in this case, medical science is an integral part of an entire research and development pro- cess that, in theory, leads to better health. By extension, the term suggests that the way to start this process and achieve technological success particularly in the life sciences is to foster new and creative ideas in fundamental science labora tories.

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KENNETH I. SHINE 221 A good example of how "fundamental" becomes "applied" and, therefore, "relevant" is the classic, seminal work of Stanley Cohen and Robert Boyer in bacteria that opened the whole new world of biotechnology. Other areas in which industrial frontiers were opened by fundamental science were the research under- lying cardiopulmonary bypass surgery and the characterization of the metabolic pathways for insulin regulation and cholesterol metabolism, which spawned an- other generation of pharmaceuticals, as well as fresh understandings of preven- tion and clinical management. The open transmission of scientific findings, the ease of communication between industry and fundamental scientists, the avail- ability of capital, and, not least, the reward system in the United States, combined to fuel these development processes. But such processes are not orderly. Health science technology is notable for not following the neat sequence of steps in technology development that often characterizes other fields. The general notion of some kind of fundamental scien- tific discovery that first informs a body of applied science, which then translates it into technology, which then is properly engineered and manufactured for appli- cation to patients, is just plain inaccurate for the health sciences. In the "real life" of medicine, it is not uncommon for basic scientists to identify a gene, construct a gene product, file a patent, obtain an approval for clinical trials, and rapidly characterize a new therapy. Somewhere in the process, there is involvement with the Food and Drug Administration (FDA),~ but that involvement does not always occur at the same point or in the same way. And somewhere in that process a new company may be formed, a pharmaceutical house may enter into a collaboration or even fund some of the trials of the item in question, and, with a demonstration of efficacy through a licensing mechanism or some other strategy, a new product may be born. Or if the environment is right, the usual steps from fundamental science to commercial application may be short-circuited by being carried out by a single researcher or company. One example is the history of the use of fiber-optic techniques to peer into internal organs and blood vessels. In what might be called "unilateral serendipity," a single gastrointestinal physiologist, in pursuit of an- swers about acid secretion in the stomach, designed (with a graduate student) a way to coat optical fibers. This led to the gastroscope. A postscript to this brief history illuminates the complexity and the occasional irony of what happens in U.S. R&D processes: although the technology was created in the United States, the manufacture of fiber-optic instruments was subsequently perfected by Japa- nese companies, and Japan now largely controls the world's market for such tools. The Health Technologies Market and Its Implications The criteria for the approval of instruments, drugs, and treatments in the United States are limited to efficacy and safety. There is absolutely no require

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222 Marshaling Technology foil Development ment to show cost-effectiveness or improved productivity. The market and health implications of this aspect of the approval process are enormous. In an environ- ment in which technology is applied by physicians and paid for by third parties, there is little role for consumer (patient) choice. In other words, the large universe of patients really has little to do with the diffusion and rate of application of health technologies; these factors are controlled by the "prescribers" of medical technology and their "reimbursers." It is not surprising that an imperfect, "un-free" market in which the consumer carries so little weight would become very high priced and, consequently, would play what many consider to be an inordinately large role in overall health sector costs-costs that in 1995 will approach $1 trillion annually. Indeed, between 25 and 50 percent of the rate of increase in health care costs in the United States stems from the way in which technology is diffused. The costs of technology diffusion include not only those for production, distribution, and marketing, but also the amount that the producing company calculates it has spent on research and development, as well as what it calculates provisionally for the costs of liability. And then there is profit: for most major European, Japanese, and Ameri- can manufacturers, one-half or more of their net profits comes from sales of medical technology in the United States alone. By extrapolation, each of the components of health technology economics has a big dollar amount attached to it. For the R&D component, one current estimate is that the U.S. national invest- ment in health and medical research is about $25 billion.2 In macroeconomic terms, the amount of growth in health sector technology is gratifying. Given the figures alone, it is not surprising that the United States has been the driving force behind technology development worldwide. But these figures are not necessarily gratifying in human terms: there is relatively thin evidence that this technological burgeoning has, in fact, improved the health of the population as a whole. Technological Disappointments and the Dilemma of "Social Products" Will the developing world benefit from what is going on technologically in the United States? Despite the enormous size of the investment in and the indis- putably high caliber of the U.S. health and medical technology subsector, it gets mediocre marks in terms of generating new products that are critically relevant to the needs of the developing world. Vaccines are a good example. While it is true that success in immunizing the world's children over the past decade has been dramatic, this success has not stemmed from any new, quantum leap in technol- ogy but from the achievements of the Expanded Program on Immunization (EPIJ, which is administered by the World Health Organization. Yet despite EPI, 20 percent of the world's children remain unvaccinated and immunization gains are slipping in a number of places, including the United States. Better childhood vaccines are needed everywhere. Ideally, such vaccines would be given near birth

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KENNETH I. SHINE 223 as a single dose, would contain multiple antigens and protect against diseases not currently targeted, and would be heat stable and affordable. But development of such a "dream vaccine" is likely to take a long, long time, not just because the technology is complex but also because presently the commercial aspects of such a product do not seem enticing to industry. With the cost of new drug development in the range of $200-$250 million, the financial motivation for pharmaceutical companies to make substantial investments in development of a vaccine for which a consumer requires only one, two, or three doses is limited. Along the same lines, a consortium of American pharmaceutical companies recently decided to jointly develop antiviral agents against the human immunodeficiency virus (HIV). Such therapeutic interventions characteristically require repeated doses over a prolonged period, entailing greater sales volumes and thus more profit. This reveals clearly why a joint effort to develop an AIDS vaccine was not the focus of such a consortium. A related example is the development of contraceptive technologies. There is growing consensus that the menu of options available to individuals and couples for planning the spacing and number of their children is deficient. Each method presently available has limitations; only one male contraceptive is reversible; only one contraceptive protects against both impregnation and infection; and most methods have side effects for at least some women women everywhere? not just in the developing world. Based on recognition of this state of affairs and wider recognition of the intimate dynamics among population growth, the environment, and poverty,3 a consortium of funders asked the Institute of Medicine (IOM) to explore what new leads emerging from contemporary science would offset the various disincen- tives associated with such contraceptive products and would attract young scien- tists and motivate industry to come back into the field.4 Among the disincentives are the complexity of the science itself, the costs of R&D, issues of liability, and a cluster of political considerations. In the IOM study, one area of focus was the possible development of a contraceptive vaccine. One of the great misconceptions of policy makers is that fundamental scien- tists are motivated primarily by curiosity and a passion for science. While scien- tists surely are driven by both, the motivation for an individual basic scientist to dedicate substantial effort to the development of any kind of new and novel vaccine seems constrained. The efforts of scientists are determined by the prob- lems perceived as commanding within their fields and by the likelihood of sig- nificant other rewards. In summary, the United States has produced a vast amount of very high technology, yet the economic costs of that progress have been great and the payoff in terms of overall, improved health status has not been commensurate. Over the last two years, a great deal of thought has been dedicated in the United States to reshaping the role of medical technology, as well as the physical infra- structure in which it resides, so that they are less financially burdensome and

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224 Marshaling Technology for Development better adapted to the kind of health care system to which Americans might well aspire. The fact that U.S. health reform is on hold does not mean that these thought processes have been or should be arrested; they will continue and will be tested, especially at the state and local levels. In this connection, great care must be taken not to seduce the developing countries, particularly through misguided "sharing" of technology, into making precisely those mistakes Americans are trying, with great difficulty, to correct another caveat. HEALTH CARE AND TECHNOLOGY A number of new medical technologies and approaches to health care deliv- ery are likely to have significance for all countries, developed and developing. Strategy Shifts: The Expansion of Outpatient Approaches The proliferation of diagnostic and therapeutic technologies is allowing a growing proportion of health care to be provided on an outpatient or ambulatory basis. Even such demanding procedures as cardiac catheterizations, as well as a rising number of surgical procedures, are increasingly being performed in outpa- tient settings. Furthermore, the average lengths of hospital stay are falling steadily. Even in institutions that perform the very major surgeries (which drive up aver- ages) for example, organ transplants average hospital stays are less than six and a half days. In many tertiary care institutions the average length of stay is under five days. As for specific procedures, 10 years ago observers were impressed by the capacity of the medical community to perform vasectomies and tubal ligations on an outpatient basis; five years ago they were impressed by the capac- ity to perform breast biopsies and plastic surgeries on an outpatient basis. Now it is feasible to remove a gall bladder using a fiber-optic technique with, at most, an overnight stay. In the near future, no hospital stay whatsoever will be required. U.S. hospitals, then, are eliminating beds and building ambulatory facilities, "surgi-centers," and satellite clinics. A recent review of the intramural programs at the National Institutes of Health (NIH) recommended that the capacity of the clinical center at this highly research-intensive institution be reduced by 50 per- cent. More and more centers are building hotel and motel accommodations so that patients from outlying areas can stay nearby with their families for a day or two while undergoing ambulatory procedures. This quite massive change not only is a function of changing technology but also is intimately connected with the urgent need to control health costs. Furthermore, staying out of the hospital has other benefits for both human and financial health. The potential for noso- comial infections is dramatically reduced in outpatient settings, as are many of the other complications that can result from inpatient treatment and case manage- ment. All of this, of course, saves money: the costs of nosocomial infections were recently estimated to be $5-10 billion annually.

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KENNETH I. SHINE 225 Thus in the near term, in developed and developing countries alike, the most appropriate health care delivery model will be ambulatory diagnostic and proce- dure rooms with nearby, low-cost hotel accommodations and a relatively small number of very high-tech hospital beds. Investments in ambulatory services, together with an emphasis on comprehensive primary and preventive care, clearly will be the best investments in health care in all parts of the world. Information In an era of cost containment, information is everything. One of the most important types of information is data on outcomes of encounters with the health care system, produced by so-called medical effectiveness research. This research encompasses existing clinical practices, the development of practice guidelines, technology assessment, and cost-effectiveness analysis. It also includes research on the effectiveness of health promotion and disease prevention programs and interventions. All of these areas are highly relevant to the focus of this symposium and the work of the World Bank. The Bank already has moved in significant ways in this field of inquiry through the preparation of the World Development Report 1993: Investing in Healthy The Bank's development of the disability-adjusted life year (DALY) offers a quantitative approach that permits researchers to calculate the burden of disease in a given societal setting by measuring the number of disabil- ity-adjusted life years produced by a certain illness, and permits policy makers to make those investments that, for a given expenditure, will maximally reduce the number of DALYs in that setting. Assessment of the outcomes of technological applications are intensely perti- nent to these calculations. In considering the potential power of such assessments, one need go no farther than vaccines, which are among the most cost-effective interventions available. A 1985 Institute of Medicine study6 demonstrated that, in the United States, a dollar spent on vaccine development saved 10 dollars in health care costs; that ratio is now thought to be about 1:12. The 1985 calculation did not include the accrued long-term benefits to patients and the associated pro- rated savings. Recent work on the impacts of infectious diseases in adults in developing countries suggests that ratios in those contexts might be even more favorable.7 Clearly, then, health care systems that provide outcome and effectiveness information are of utmost importance to any government. They already are piv- otal in the United States where, increasingly, the rising number of managed care organizations must justify expenditures with good outcomes data that enable planners and managers to draw conclusions about the merits of technologies applied, quality of care, effectiveness of case management alternatives, and the relative cost-effectiveness of each. But the U.S. health care community does not have all the answers. While

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226 Marshaling Technology for Development health services research and technology assessment are a rapidly growing area in the United States and in Europe, there is much more work to be done. A recent congressionally mandated study by the U.S. Office of Technology Assessments concluded that the U.S. federal government's efforts in medical effectiveness research have fallen short of expectations. The reasons include excessive opti- mism, insufficient funding, and a timid mandate for the lead implementing orga- nization, the Agency for Health Care Policy and Research (AHCPR). One con- clusion of the OTA study relevant to the international concerns of this symposium is that large administrative databases, which were the cornerstone of AHCPR's Patient Outcome Research Team (PORT) program, have not proven to be as useful as was hoped in answering questions about the comparative effectiveness of medical treatments. The report notes that, despite the fact that they are poten- tially powerful sources of information, prospective comparative studies, particu- larly randomized controlled trials, have been underused. The report suggests that investment in community-based research infrastructure for clinical trials might be well placed. Behavioral Research and Nontechnological Challenges Health services research encompasses the way in which health care, health promotion, and disease prevention services are provided at the clinic level and in the community. Within health services research is behavioral research, a growing area of inquiry but a very difficult one. Yet there is substantial pressure to under- stand better the factors that influence individual and community behavior and how to encourage healthy decisions about behavior about smoking, drug and alcohol abuse, diet, and exercise. Another challenge is violence, not only as a matter for law enforcement but also as a public health problem and as a focus for science. As scientific debates go, the war of words over what has been called "the genetics of violence" has itself been marked by violence. This "violence about violence" is a function of frustration about a lack of remedies: law enforcement is daunted; social strategies have met only limited and erratic success; and science and technology have produced no cures. A recent conference sponsored by the National Research Council and Harvard University's John F. Kennedy School of Government con- cluded that, under the prevailing circumstances, "prudent public officials must respond to violence more like medical researchers following promising leads in a search for a cure than like physicians confidently prescribing a proven therapy."9 The price of present inabilities is huge: over $450 billion annually in the United States in direct costs and such indirect costs as the loss of economic activity in high-crime areas.~ The "referred" costs in human distress are not included. Another daunting and partially related area is biobehavioral medicine and mental disorder. Knowledge of these subjects in the developing world always has been very scattered and weak, but this situation should be substantially remedied

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KENNETH I. SHINE 227 by the imminent publication of a study that is the first to explore systematically what is known about mental health, necrologic disorders, and behavioral prob- lems in developing countries. This study's premise is that, as infant mortality continues to decline and life expectancy grows longer in developing countries, chronic illnesses will exert the most pressure on the health systems of those countries. Already half the burden of disease in the developing world stems from injuries, unintentional and intentional, and from noncommunicable diseases. Of the latter, the largest category is "cardiovascular diseases," closely followed by "neuropsychiatric illness." The total mortality and morbidity figures attributable to some composite of neurological and behavioral disorders, intentional injury, internal civil strife, war, and refugee status are presently incalculable. Indeed, the costs of such conditions, for individuals and communities and for developing country economies and health systems, are simply unimaginable. The Genetic Revolution in Health and Its Implications The genetic revolution in health offers glorious prospects for human health- as well as not-so-glorious ethical and practical dilemmas, and substantial costs. Eventually it will be possible to eliminate certain diseases at the gene level-that is, at the source rather than when they manifest as illness and symptoms to be treated or palliated. But, although nearly 100 gene therapy experiments have been approved by the U.S. government, they are still just experiments. Researchers have been humbled over the past few years by the complexities of converting knowledge about genes and disease into practical solutions for people who are sick. Thus despite progress, genetic treatment has a long way to go and is not likely to become a standard of care anywhere for many years, allowing time to consider its implications thoroughly. Genetic screening the capacity to identify an individual's genetic predispo- sition to illness will be a ready tool by the end of this decade. Screening is especially promising in situations in which therapies or mechanisms are available that may postpone onset or prevent "disease X" in individuals predisposed to develop it. At the same time, there are risks and costs. First, the initial impact of screening will be an escalation in health care costs because every positive test will require confirmation and reconfirmation. In addition, prevention or contain- ment of some diseases may require lifelong treatment and monitoring. Second, extraordinary moral and ethical issues are related to how much individuals should or would want to know about their genetic future. Carrying out screening without extensive genetic counseling would be irresponsible. Third, there is heated de- bate within the U.S. medical scientific establishment about whether any genetic information should be provided to individuals, absent the availability of any clear and beneficial response to that information. Finally, the impact of genetic screen- ing on abortion rates could be profound, and there are obvious implications that fall under the heading of eugenics.

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228 Marshaling Technology for Development TECHNOLOGY NEEDS OF DEVELOPING COUNTRIES The development of seven technologies or approaches would meet the ur- gent needs of developing countries, although priorities among the following tech- nologies can be argued and, indeed, will vary from among and within countries and regions: 1. New reproductive health technologies, especially technologies for male and female contraception 2. Cost-effective approaches to making crucial micronutrients available to populations requiring them 3. Vaccines that protect more efficiently against the usual childhood dis- eases, as well as against diseases that carry large, unaddressed burdens of mor- bidity and mortality 4. Expanded and strengthened capacities for the provision of primary care and outpatient clinical care, including the use of cost-effective diagnostics and appropriate therapeutic responses to the diseases identified 5. Cost-effective interventions to prevent and manage the growing preva- lence of chronic illness heart disease, cancer, stroke, lung disease, and diabetes 6. Pharmaceutical and information technologies. Pharmaceutical technolo- gies should anticipate or compensate for problems of drug resistance, and infor- mation technologies would make possible the early identification of emerging infections. 7. Protection against infection by the human immunodeficiency virus (HIV). New Reproductive Health Technologies The term reproductive health technologies is used to broaden the concepts of contraception. Because the contraceptive methods presently available are all lim- ited in some aspect, the principal objective of trying to reinvigorate research and development in this area is to expand the array of good technological options available to couples and individuals in different situations in different cultures at different points in their life cycles. This broader term also embraces an utterly compelling scientific requirement: the need for technologies that protect against infection, whether or not they protect against conception. The over 50 classic sexually-transmitted diseases (CSTD) presently identified produce an enormous burden of morbidity and, in some cases, mortality. To these must be added the acquired immune deficiency syndrome (AIDS) and its causative agent, HIV, and its inevitable mortality. For most populations of the developing world, the greatest burden of CSTD (with the exception of syphilis) and HIV/AIDS falls on females. Because women are the reproducers, in contrast to the male role of progenitor, their reproductive health is directly linked to the health of their offspring, with the consequent epidemiological and public health impact. Thus, while there is a compelling need

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KENNETH I. SHINE 229 for contraceptives for use by males so that they can share the responsibility for conception, there is perhaps an even more urgent need for methods that are controlled not by males or by health care providers but by women themselves. Finally, whatever the political dimensions of the issue, it is a social and medical fact that in the armamentarium of reproductive health technologies there is a transcendent need for postcoital agents, particularly for situations in which intercourse is relatively infrequent and unpredictable. The question of whether the biotechnology and large pharmaceutical indus- tries, and ultimately the private sector investment community, can be motivated to engage in this area of research and development remains moot. However that evolves, the demand for capital at any point in the R&D trajectory will remain high. Micronutrient Research and Technology Development Micronutrient deficiencies appear to be widespread in the developing world, with the impact of certain deficiencies (such as vitamin A' extremely large and meaningful in developmental terms. It is feasible to redress these deficits, but in some cases it is not yet technologically straightforward. Some interactions among micronutrients and between micronutrients and certain toxicants (such as lead) are synergistic in ways that might be deleterious, but they remain poorly under- stood.~3 For example, given the fairly clear causal relationship between high blood-lead levels and cognitive impairment, the insult of lead exposure for an iron-deficient child might be significantly greater than in a child not deficient in that particular micronutrient. Similar questions have been raised in connection with calcium and zinc, but they remain unresolved. Science may have to ask these potentially large questions before technology can be developed or appropriately applied. Science also may have to question the trade-offs between the applica- tions of pesticides, fungicides, and fertilizers and risks to human health in devel . . Oplng countries. With the exception of vitamin A technologies, which have had some success, the transfer of technologies that could redress other micronutrient deficits at the country level seems to be somewhat turgid and certainly uneven. Vaccine Development Lewis Thomas has described the immunization process as one of the genu- inely decisive technologies of modem medicine.~4 Indeed, it is highly cost-effec- tive in public health terms, but it has little appeal in the domain of commercial research and development. Any change in this pattern in recent years seems to be mainly associated with vaccines that are potentially lucrative in the developed world (such as the hepatitis vaccines) rather than vaccines whose main applica

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230 Marshaling Technology for Development lion is in the developing world (such as a vaccine for malarial. This seems to be the case whatever the dimensions of the burden of disease. For these and other reasons, the IOM committee charged with studying the impediments to U.S. participation in the international Children's Vaccine Initia- tive (World Health Organization) saw real merit in fact, necessity in the es- tablishment of a National Vaccine Authority (NVA). The NVA would have both the capacity and the budget to support vaccine research and to engage in joint ventures with the private sector in the development, manufacture, and clinical trials associated with vaccine development. In this way, some of the development costs would be borne by government, yet the private sector would have the opportunity to realize profits. There have been stirrings of interest in some form of this model within the biotechnology community and stirrings of opposition in the few large integrated pharmaceutical companies currently engaged in vac- cine manufacture. An alternative strategy might be the establishment of a consortium of phar- maceutical houses that would be encouraged to engage in this area of activity through some form of subsidy. But the subsidy proffered would likely have to be big enough to overcome industry perceptions of a less-than-attractive market. This is not solely a matter of perception: "new-tech" vaccines will not be inex- pensive in the early phases of market launch, and it is not likely that developing country markets can demonstrate an ability to pay or levels of demand that would be realistic, never mind attractive, for pharmaceutical companies and their inves- tors. Both the NVA and the consortium strategy would require additional outside capital, whether for vaccine development in the developed world or for creation of production facilities in developing countries. Indeed, what about vaccine development in the developing world? Most efforts to promote local vaccine research, development, and production in devel- oping countries have been flawed where they have not failed outright. This has stemmed in part from an inadequate indigenous technical capacity and in part from what have been, in some instances, massive problems in quality control. There also have been some quite vexing issues surrounding international prop- erty rights. All these issues could be addressed in some way by the international development community by making a serious, coordinated attempt at capacity- building and thoughtfully tackling the intellectual property right issues. Any such efforts thus far appear to have been scattered and tormented by a variety of institutional angsts. in. . . ~. . ~ Expanded Primary Health Care lnere IS a tendency to think of primary care as somehow nontechnological or, at most, low tech. In fact, integrated systems of health care delivery are explicitly subsumed in the definition of technology that has been used by the Institute of Medicine in its fairly extensive body of work on medical technology,

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KENNETH I. SHINE 231 its applications, and its assessment. The evolution of primary health care in the developing world after the international meeting at Alma-Ata has provided the structural "shelter" for the development of some rather remarkable technologies. Oral rehydration therapy (ORT), a quite elegant technology firmly rooted in a great deal of basic and applied science, heads that list. Despite that fact, ORT has not been particularly well integrated into protocols for diarrhea case management in the United States. But this is not surprising given the driving role of "high" technology in U.S. health care. Analogously, the U.S. patient population generally prefers a personal physician over other types of health care provider. Yet it is extremely unlikely that the desire to have a physician in every small town in the United States can ever be achieved. The developing countries have learned this faster and dealt with it more creatively and consistently than Americans have. In fact, as managed care inevitably expands in the United States, so will the use of a variety of health care providers, including nurses, nurse practitioners, physician assistants, technicians of different types, and community workers. This does not imply the absence of technology; it means only that the hands that apply it will not necessarily be those of a physician. A number of the technologies already being developed in anticipation of this shift in the hierarchy of health care delivery will be nicely transferrable to devel- oping countries. For example, "telemedicine" now allows health care providers in rural communities to communicate with an academic health center so that a patient can be seen, heard, and even partially examined by a consultant at a distance. More futuristically, research under way by medical device manufactur- ers and the Department of Defense's Advanced Research Projects Agency (ARPA) is seeking to apply virtual reality in ways that will actually permit the surgical procedures themselves to be carried out at a great distance. Indeed, the same fiber-optic techniques that surgeons now use to remove a gall bladder can be employed to transmit images over thousands of miles and actually manipulate medical equipment in distant settings through robotics. But one cannot be naive about the immediate potential of these technologies; they will require not only the installation of the corresponding technology in situ, but also its meticulous main- tenance, excellent antisepsis, and a quality of patient care commensurate with the intervention and illness in question. Chronic Diseases Many developing countries are now undergoing a demographic change in which the population is aging and many of the chronic illnesses associated with developed countries, such as cancer and heart disease, are becoming disconcert- ingly prevalent. Critical to the management of these illnesses are cost-effective strategies for their prevention and their large burdens of mortality and morbidity. None of these strategies is more important than informed tobacco policies. In

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232 Marshaling Technology for Development societies in which cholesterol levels are low, cigarette smoking in itself is not a major predisposing factor toward heart disease. As cholesterol levels rise, how- ever, there is a multiplier effect, ranging from two to four, which means that the use of cigarettes multiplies the impact of those rising levels. Thus developing countries that begin to improve their nutrition in a direction that increases serum cholesterol levels also will see rising heart attack rates, which will in turn escalate in the presence of extensive cigarette smoking. Methodologies to minimize smok- ing and public policy interventions that limit the introduction of cigarettes or their accessibility are therefore critical. But this will not be easy; the behavioral com- ponent is central, the incentives to the national and international producers of the raw and finished products are great, and the addiction of nicotine is real. Some of the technologies that can dramatically improve health are not usu- ally perceived as "health technologies." For example, in many parts of the world unventilated indoor cooking produces emphysema and other chronic lung dis- eases and, at a minimum, exacerbates the ordinary respiratory infections that are so prevalent in developing countries. As populations age, the magnitude of that accumulated burden can only increase and accelerate. Over the years there have been experiments with such appropriate technologies as low-smoke stoves and improved ventilation arrangements, as well as different energy sources. But ap- parently no innovations have been well adapted and distributed. This does not mean that the need does not persist or that the returns to health would not be considerable. Microbial Threats For developing nations, no development is more ominous than the global- ization of illness, particularly infectious diseases. The recent Hanta virus out- break and the emergence of resistant tuberculosis in the United States in them- selves have increased public awareness dramatically. A prescient report on this topic, produced in 1992 by an Institute of Medicine committee cochaired by Nobel laureate Joshua Lederberg and Robert Shope,~5 has provided the basis for a well-articulated plan by the Centers for Disease Control and Prevention for addressing the multiple facets of this very real prob- lem. Heading the list of requisite actions is the establishment of a global surveil- lance system and renewal of pertinent research. The issues that need to be ad- dressed range from low to fairly high technology, and this spectrum of needs, some of them urgent, could be addressed usefully in the development and scien . A. . . talc communities. Perhaps the most urgent issue in the area of emerging infections is the virtual collapse of the antibacterial weapons systems. Not only must the battle to under- stand individual diseases and ways to combat them be continued, but it is also necessary to address the worldwide threat of the increasing antibiotic resistance of a number of organisms that produce major disease burdens. Because bacteria

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KENNETH I. SHINE 233 and many other microbial agents reproduce at very rapid rates, there is a high probability that a single bacterium of the millions of descendants of the original infecting agent will undergo a spontaneous mutation, making it resistant to an antibiotic. The antibiotic may manage to kill all of the other organisms involved in an infectious episode, but the single resistant organism could remain nonethe- less and proceed to reproduce in yet another case of the survival of the fittest. A major strategy for dealing with this situation is the use of multiple drugs. The probability that a mutation that occurs in one in a million cell divisions will produce a genetic resistance to two antibiotics is approximated by the product of that frequency that is, a million times a million chances. In some types of tuberculosis, use of three drugs is desirable. This is both a technological and a behavioral matter. One reason antibiotic technology has failed is its overuse by providers and poor adherence to treatment regimens by patients. Designing methodologies by which individuals can take multiple drugs simultaneously and assuring compliance by providers and patients with prescription and case management regimens are major research challenges. HIV Infection Hanging over the entire world is the specter of HIV infection because no easy solution is in sight. A vaccine is not on the horizon. Moreover, it is unlikely that a crash investment in the development of such a vaccine will dramatically decrease the time to its availability in the absence of some new intellectual breakthroughs in the understanding of viral variation or some plain luck. The current $1.2 billion NIH budget is probably more than adequate to assure that reasonably promising leads are followed. In the absence of such a vaccine, the very expensive antiviral drugs available have been shown to be of only marginal value. Modification of behavior continues to be the only hope of substantially decreasing the rate at which the disease spreads. This will require an in-depth understanding of the variations in the cultural, social, and ethical values and mores among the societies in which HIV is prevalent. In the United States, this means the variation among San Francisco, Los Angeles, and New York, all of which have very different scenarios for the spread of infection. The modes of transmission in Africa and in Southeast Asia differ even more. This is an area in which either the technology fails or it is defined inappropriately. INTEGRATED SCIENCE AND TECHNOLOGY CENTERS This cursory view of the kinds of technologies needed to advance health in low-income countries has provided little insight into how these technologies might be more speedily and efficiently developed. A system in which most re- search and development are carried out in industrial countries and are dominated

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234 Marshaling Technology for Development by the U.S. market will not serve developing countries well, if only because differences in patterns and manifestations of disease, standards of living, envi- ronment, and available resources mean that research questions asked in the devel- oped world are not always or sufficiently responsive to needs in developing countries. Increasingly, it has been recognized that creative research efforts require a critical mass of scientists from different disciplines some pursuing fundamental research and others more clinical applications but all with access to expensive equipment and laboratories to house it. Regardless of the undeniable improve- ments in electronic and computer communications, the need for scientists work- ing together to interact daily is unchanged, if only because science is increasingly cross-disciplinary and thus demanding of team effort. This is no less true in developing countries and may be even more urgent in some respects: efforts to develop and extend technologies in most such countries have often failed as a result of the lack of well-articulated teams of trained personnel to facilitate real technology transfer. Over the years, there has been talk about using the CGIAR (Consultative Group on International Agricultural Research) model for the health sector. That interest has waxed and waned so that, with the exception of a few institutions such as the International Centre for Diarrheal Disease Research in Bangladesh, little has happened. A strategy for the development and continued support of regional integrated science and technology centers located in key sites around the world, financed through public-private cooperation, and challenged to con- front important research and development issues within a given region is more likely to succeed than a large number of decentralized facilities marginally staffed and equipped. Such regional centers can serve as critical training sites for local young people who wish to acquire research and technology transfer skills. If the quality of the centers were comparable to that of establishments in the higher-income countries, then scientists from the industrialized as well as the developing world would be motivated to spend significant amounts of time there. The tenure of developing country scientists would be limited to ensure their return to their countries of origin to continue their work and to serve as agents of technology transfer. In some cases, even entire cadres of researchers and scientists would be trained so that when they return to their own countries they could, properly equipped, carry on research and development and the transfer of technology. Personnel in these centers should include men and women trained to orga- nize and conduct clinical trials, health service researchers able to assess technolo gies for total effectiveness, as well as social and behavioral scientists able to address prevention, ethics, and equity. Facilities for production of materials for clinical trials should be available at the centers or in connection with them. While the costs and the political sensitivities and difficulties associated with siting such establishments cannot be underestimated, and the familiar arguments

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KENNETH I. SHINE 235 about making the strong stronger at the expense of the weak cannot be ignored, these sensitivities and arguments have too often served as an excuse for inaction. The world is changing too fast and the old models of technology development and transfer have been discredited in too many ways to cling to them. It is time to move on to new ideas and new models. NOTES 1. In the United States, FDA, the Environmental Protection Agency, and other health agencies play dominant but varying roles in setting the conditions for acceptance of a new technological innovation. That variation stems from differences in the points at which the agency in question enters the evaluative and regulatory process and the ways its involvement affects an innovation's develop- ment, adoption, and application. 2. National Science Board, Science and Engineering Indicators (Washington, D.C.: U.S. Gov- ernment Printing Office, 1991), 100. 3. The relationships among population growth, environmental degradation, and poverty have been much debated, notably at the recent UN conferences on environment (Rio de Janeiro) and population (Cairo). The population/poverty/environment "spiral" is well articulated in the recent UNICEF report, The State of the World's Children (New York: Oxford University Press, 1994). The accompanying narrative cites better family planning options as a crucial element in arresting the downward momentum of that spiral. 4. Institute of Medicine, Applications of Biotechnology to Contraceptive Research and Devel- opment: New Opportunities for Public-lPrivate-Sector Collaboration (Washington, D.C.: National Academy Press, 1995). Funding for this study was provided by the Rockefeller Foundation, Andrew W. Mellon Foundation, National Institutes of Health, and U.S. Agency for International Develop ment. 5. World Bank, World Development Report 1993: Investing in Health (New York: Oxford University Press, 1993). 6. Institute of Medicine, New Vaccine Development: Establishing Priorities, vol. 1 (Washing- ton, D.C.: National Academy Press, 1985). 7. I. T. Elo and S. H. Preston, "Effects of Early Life Conditions on Adult Mortality: A Review," Population Index 58 (1992): 186-212; D. J. Jamison et al., ea., Disease Control Priorities in Devel- oping Countries (New York: Oxford University Press, 1993); W. H. Mosley and R. Gray, "Child- hood Precursors of Adult Morbidity and Mortality in Developing Countries: Implications for Health Programs," in The Epidemiological Transition: Policy and Planning Implications for Developing Countries, ed. J. Gribble and S. H. Preston (Washington, D.C.: National Academy Press, 1993). 8. Office of Technology Assessment, Identifying Health Technologies that Work: Searching for Evidence (Washington, D.C.: U.S. Government Printing Office, 1994). (Available from Superinten- dent of Documents, P.O. BOX 37194, Pittsburgh, PA 15250-7974. Stock #052-003-01389-4.) 9. National Research Council and the John F. Kennedy School of Government, Harvard Univer- sity, Violence in Urban America: Mobilizing a Response~ummary of a Conference (Washington, D.C.: National Academy Press, 1994). 10. National Research Council, Understanding and Preventing Violence (Washington, D.C.: Na- tional Academy Press, 1993). 11. A. Kleinman et al., World Mental Health: Problems and Priorities In Low-Income Countries (New York: Oxford University Press, 1995). 12. See R. Kaplan, "The Coming Anarchy," Atlantic Monthly, February 1994,44-75 passing 13. K. R. Mahaffey, "Environmental Lead Toxicity: Nutrition as a Component of Intervention," Environmental Health Perspectives 89 (1990): 75-78.

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236 Marshaling Technology for Development 14. See, among other works, The Lives of A Cell: Notes of a Biology Watcher (New York: Bantam, 1975). 15. Institute of Medicine, Emerging Infections: Microbial Threats to Health in the United States (Washington, D.C.: National Academy Press, 1992).