Health Technology and Developing Countries: Dilemmas and Applications
KENNETH I. SHINE' M.D.
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 environments, transportation networks to link people and communities to health facilities, 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 professionals 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 socalled social sector - that is, the sector that costs money but produces nothing, unlike agriculture and industry which are the bulwarks of the productive sector. This, however, is nonsense. For example, children who grow up in toxic environments are less likely to prosper, educationally or economically; they are, therefore, 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 consequences of all kinds of violence.
CHARACTERISTICS AND TRENDS IN HEALTH AND MEDICAL TECHNOLOGY
These principles having been established, what then are some of the characteristics 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 as fundamental 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 contrary, fundamental science emphasizes that the concept of science-in this case, medical science-is an integral part of an entire research and development process 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 laboratories.
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 fun,damental science were the research underlying cardiopulmonary bypass surgery and the characterization of the metabolic pathways for insulin regulation and cholesterol metabolism, which spawned another generation of pharmaceuticals, as well as fresh understandings of prevention and clinical management. The open transmission of scientific findings, the ease of communication between industry and fundamental scientists, the availability 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 scientific discovery that first informs a body of applied science, which then translates it into technology, which then is properly engineered and manufactured for application 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),¹ 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 answers 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 Japanese 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 requirement to show cost-effectiveness or improved productivity. The market and health implications of this aspect of the approval process are enormous. In an environment 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 American 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 investment 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 indisputably 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 technology but from the achievements of the Expanded Program on Immunization (EPI), 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 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 disincentives associated with such contraceptive products and would attract young scientists 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 scientists are motivated primarily by curiosity and a passion for science. While scientists 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 problems perceived as commanding within their fields and by the likelihood of significant 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 infrastructure in which it resides, so that they are less financially burdensome and 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 delivery 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 outpatient settings. Furthermore, the average lengths of hospital stay are falling steadily. Even in institutions that perform the very major surgeries (which drive up averages) - 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 capacity 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 percent. 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 nosocomial infections is dramatically reduced in outpatient settings, as are many of the other complications that can result from inpatient treatment and case management. All of this, of course, saves money: the costs of nosocomial infections were recently estimated to be $5-10 billion annually.
Thus in the near term, in developed and developing countries alike, the most appropriate health care delivery model will be ambulatory diagnostic and procedure 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.
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 Health. 5 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 disability-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 pertinent 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 study 6 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 prorated 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 pivotal 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 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 Assessment 8 concluded that the U.S. federal government's efforts in medical effectiveness research have fallen short of expectations. The reasons include excessive optimism, insufficient funding, and a timid mandate for the lead implementing organization, the Agency for Health Care Policy and Research (AHCPR). One conclusion 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 potentially powerful sources of information, prospective comparative studies, particularly 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 understand 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 concluded 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. 10 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 by the imminent publication of a study that is the first to explore systematically what is known about mental health, neurologic disorders, and behavioral problems in developing countries. 11 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. 12
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 predisposition 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 containment 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 debate 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 screening on abortion rates could be profound, and there are obvious implications that fall under the heading of eugenics.
TECHNOLOGY NEEDS OF DEVELOPING COUNTRIES
The development of seven technologies or approaches would meet the urgent needs of developing countries, although priorities among the following technologies 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
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 limited 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 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 industries, 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 understood. 13 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 applications of pesticides, fungicides, and fertilizers and risks to human health in developing 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.
Lewis Thomas has described the immunization process as one of the genuinely decisive technologies of modern medicine. 14 Indeed, it is highly cost-effective 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 application is in the developing world (such as a vaccine for malaria). 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 Initiative (World Health Organization) saw real merit-in fact, necessity-in the establishment 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 vaccine manufacture.
An alternative strategy might be the establishment of a consortium of pharmaceutical 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 inexpensive 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 investors. 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 developing 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 property 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.
Expanded Primary Health Care
There 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, 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 developing 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 manufacturers 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 maintenance, excellent antisepsis, and a quality of patient care commensurate with the intervention and illness in question.
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 disconcertingly 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 societies in which cholesterol levels are low, cigarette smoking in itself is not a major predisposing factor toward heart disease. As cholesterol levels rise, however, 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 smoking and public policy interventions that limit the introduction of cigarettes or their accessibility are therefore critical. But this will not be easy; the behavioral component 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 usually perceived as “health technologies.” For example, in many parts of the world unventilated indoor cooking produces emphysema and other chronic lung diseases 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 apparently 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.
For developing nations, no development is more ominous than the globalization of illness, particularly infectious diseases. The recent Hanta virus outbreak and the emergence of resistant tuberculosis in the United States in themselves 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, 15 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 problem. Heading the list of requisite actions is the establishment of a global surveillance system and renewal of pertinent research. The issues that need to be addressed range from low to fairly high technology, and this spectrum of needs, some of them urgent, could be addressed usefully in the development and scientific 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 understand 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 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 nonetheless 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.
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 research and development are carried out in industrial countries and are dominated by the U.S. market will not serve developing countries well, if only because differences in patterns and manifestations of disease, standards of living, environment, and available resources mean that research questions asked in the developed 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 improvements in electronic and computer communications, the need for scientists working 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 confront 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 organize and conduct clinical trials, health service researchers able to assess technologies 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 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.
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 development, adoption, and application.
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