Substitution of lost anatomical structure or physiological function by various devices was one of the earliest technologies in medicine. The wooden leg, the spectacle lens, and the ear trumpet were antecedents of today's powered limb prostheses, pacemakers, valves, vessels, and hearts. Transplantation of tissues or organs from humans and animals represents a further step along the same path. The replacement of deficient organic chemicals such as insulin and coagulation factors might be considered as part of the same continuum. Such substitutes may be wholly external. These include the extension of extremities foreshortened by congenital or acquired abnormality and various communication aids that allow the transmission or reception of information. Replacing the chemical activity of the kidney by dialysis is another external device.

Positron emission tomography (PET) is a new nuclear medicine technique that has recently entered the clinical realm of medicine. Although it is a technique that can be utilized for assessment of biochemical and physiological parameters of any organ in the body, it has particular utility in the investigation of the brain. PET poses unique advantages over previous imaging devices. For the first time, it is feasible to investigate directly various biological parameters of the brain in a noninvasive way. PET allows for investigating the functional, biochemical, physiological, and pharmacological characteristics of various areas within the brains of normal and psychiatric or neurological patients. Although it has already started to give promising results, it is too new a technique to obtain an accurate appraisal of its true potentials. This is a problem that seems always to surface when one tries to evaluate the utility of a new technique in a new area of research. The problem is accentuated in the case of PET where there is no other technique available with which to compare results. This paper will discuss the basic principles of PET, its relationship to other existing imaging devices, and the issues to be considered when making a technological assessment of positron emission tomography.

During the last 12 years, most Middle Eastern countries, particularly those focused upon in this study (Algeria, Egypt, prerevolutionary Iran, Iraq, Kuwait, and Saudi Arabia), have placed increasing emphasis on improved health care. This emphasis has been reflected in both budgetary and public policy plans. The strides made in medical care during this period have been enormous, but much remains to be done. Some of the major health problems today involve diseases that have largely been conquered in industrialized countries, such as infectious and parasitic diseases, respiratory infections, problems related to childbirth, and diarrheal disease. Chronic diseases, such as heart disease, which have become common in industrialized countries and to which much of the newer medical technology is addressed, are, by many accounts, far down on the list of health problems in the Middle East. Many Middle Eastern countries need comprehensive public health programs to help meet their goals.

For several decades, major advances in medicine have increased dramatically our ability to prevent, diagnose, and manage a wide variety of chronic and acute health problems. However, medical innovations also pose significant economic, social, and ethical questions. How do we best utilize scarce medical resources? How do we balance anticipated benefits against the dollar cost or associated risk? What is the impact on total health care spending now and in future years? As concern over these issues grows concomitant with increased health care spending, technology assessment is often promoted as a method for determining whether a biomedical innovation should be encouraged to disseminate rapidly in order to maximize its benefits to individual patients, or constrained to develop slowly in order to minimize collective costs or risks. But, the art and practice of evaluating medical technologies, especially innovations still in the research and development phase, are not well developed (6;8;11;14;16;34;35).

The treatment of End-Stage Renal Disease (ESRD) is one of the most widely debated topics in contemporary medicine. The high cost of the most usual treatment, hemodialysis, has been and still is the topic for numerous discussions concerning priorities in health care on the one hand, and various medical, psychological, and ethical problems of life “on the machine” on the other hand. The other treatment of ESRD, kidney transplantation, raises other, no less complicated questions such as the limits of medical experimentation, ownership of one's body, the donation of organs, organ procurement and allocation, and the definition of life and death. As Fox and Swazey put it “The importance of hemodialysis and human organ transplantation lies as much in their social and cultural significance as in their medical and surgical value” (27,376).

Artificial insemination with donor semen (AID) has recently come into public view—particularly in France—because of its association with a newer technique, the cryopreservation of semen. One of the oldest and simplest of reproductive techniques, used most frequently as a means of compensating for male infertility, artificial insemination was previously confined to the private clinician's office, where maximum confidentiality could be ensured. This shielded all of the parties involved—recipients, donor, and physician—from moral reprobation and the possible legal complications arising from the use of donor sperm. However, in the mid-twentieth century, some physicians and researchers in cyrogenics came up with the idea that the freezing and stocking of donor semen in banks might greatly improve the psychological conditions and facilitate the material arrangements for performing AID. Essentially, the donor's availability would no longer have to coincide with the woman's ovulation, meaning less inconvenience for the donor, more time for screening his medical history and running the necessary tests on his semen, and possibly a certain tempering of AID's adulterous connotations. Although results with frozen semen were not as satisfactory as with fresh (the probability of a pregnancy at any cycle is almost twice as great with fresh semen), the material and psychological benefits were considered greatly to outweigh the lesser efficiency of frozen sperm.

The articles in this issue of the International Journal of Technology Assessment in Health Care are intended to give the reader a bird's-eye view of the ways that different countries approach the regulation of pharmaceuticals.

Do we have the will, the power of innovation, to lift ourselves above our own creations and control them? This is the central question of modern medicine, a question which for some time has dominated current discourse in health care and which gave rise in the early 1970s to the field of technology assessment. The technologic armory that has been developed over the past one and a half centuries is vast, formidable, and expanding. Its presence must be reckoned with, and to do this we must begin by understanding our relationship to it.

Viewed in relation to the vast amount of clinical research in the United States, the number of total artificial heart (TAH) implants is so small as to be statistically invisible. And while the results of those implants to date may seem dubious in terms of the recipients' outcomes, theyare in fact very similar to those of many other innovative therapies when they are first tried ondesperately ill patients. Why, then, has the artificial heart been the object and subject of suchextraordinary interest and controversy? It has been the subject of special federal studies, reports, and hearings for 20 years; has been perceived and portrayed as a unique chapter in the annals of human experimentation and therapeutic innovation; has attracted medically unprecedented media attention; and, in the case of permanent implants, has received unusually exhaustive and restrictive regulatory supervision.

There are many ongoing activities in the United States that can be characterized as strategies in technology assessment and implementation. A comprehensive strategy, however, is lacking. The richness and diversity of the groups with a stake in technology assessment is in part responsible for the inability to move to a comprehensive strategy. Important conflicts within and across groups must be resolved before a comprehensive program of technology assessment can be put in place.

For some observers, the artificial heart represents the latest, and perhaps the most flagrant example of the health system's tendency to favor the rapid introduction of expensive but ineffective technologies over efforts to prevent disease and to improve access to care (5;6;19;44;45). Even if it can be perfected, they argue, its opportunity cost in terms of other foregone health benefits would be exorbitant. The ultimate failing of the health care system, it would seem, is its failure to establish mechanisms to select among alternative uses of resources. If such mechanisms had existed, some critics believe that the quest for an artificial heart never would have begun and certainly its premature clinical uses could have been prevented (6;45).

A widely held assumption today is that biomedicine is “scientific” and therefore “objective,” thus, “culture-free.” It epitomizes the objectivism falsely attributed to technology in general. Contemporary Japan is seen to epitomize non-Western modernity with its high development of industrialization and scientific technology. It follows then that biomedicine in Japan today should remain as such without cultural transformations. Yet, in post-industrial Japan today biomedicine takes an almost entirely different form and meaning from biomedicine practiced elsewhere, especially in Western societies such as the United States. The purpose of this paper is to describe the experience of hospitalization in contemporary Japan in order to demonstrate how Japanese culture and society have powerfully transformed the underlying concepts and practices of biomedicine, which was originally introduced from the West and has been highly acclaimed by the Japanese as the epitome of superior Western science and technology. Due to space limitations, however, it will not be possible to engage in an extensive discussion of theories about technological impact, or issues involved in the broader theoretical concern variously referred to as “modernization,” “industrialization,” “rationalization,” “secularization,” etc.

Drug regulation in the United States has been the subject of extensive public literature and has been studied more thoroughly than any other aspect of American governmental regulation. Yet it remains mired in criticism and debate that, over the years, have threatened not only the existing regulatory system but also the stability of the American drug industry itself. This article summarizes the history of drug regulation in the United States, discusses the basic structure of the American regulatory system as it exists today, and relates some of the more important controversies that continue to surround this subject.

In a short story entitled “Second Opinion,” R. K. Narayan, one of India's foremost writers in English, introduces us to Sambu, a young man who spends his days and nights at the “Boardless” coffee shop with friends, avoiding work, marriage, and his widowed mother. One day a local doctor, Dr. Kishen, informs Sambu that his mother is suffering from fainting spells, possibly a heart condition, and is in a “leave-taking” (dying) mood. Dr. Kishen, who knows the family, suggests to Sambu that he marry, thereby easing his mother's anxieties and ill health, and making her last days happy. However, he also gives his usual advice to get a “second opinion.” Sambu does, taking his mother to Dr. Natwar, a foreign-trained doctor, who has a spotless clinic with many rooms housing the latest medical equipment, a contrast to Dr. Kishen's ill-equipped, disorderly clinic. After his mother has undergone tests, Sambu meets with Dr. Natwar. The doctor gives him various documents and states that they show there is nothing wrong with his mother. Thus, armed with irrefutable proof provided by technology, Sambu avoids marriage and responsibility; his mother, afraid of losing her son altogether, acquiesces to his wishes, telling him to do whatever he wants (5).

No European country (as far as the author knows) has a comprehensive strategy for technology assessment and implementation. Many countries undertake some aspects of such a strategy, but none cover all of them. Such a strategy would need to include the technical, clinical, economic and social evaluation of technologies, and the use of this information to set policies and to ensure that they are implemented. Despite the considerable differences in health systems financing and organization there is a surprising degree of similarity in the way we approach technology assessment; more variability exists in the mechanisms used to regulate and control the introduction and use of medical technologies.

It is difficult to determine when drug regulation began. The idea that some kind of control is necessary is very old indeed; it was many centuries ago that apothecaries were first accused of paternalism and secrecy, and it was just as long ago that they found arguments to present their case as guardians of the public interest. It was at least three centuries ago that regulations on the sale of opiates were first devised in order to protect the ignorant, the reckless, and the exploited.

From the perspectives of coverage and reimbursement, heart transplantation has been a serious concern of policymakers in the U.S. since 1980, the year it was decided that a comprehensive study was required before the Health Care Financing Administration (HCFA), the federal agency responsible for the administration of the Medicare program, would be able to decide the status of the procedure (14;15;30;35). It was well acknowledged that the issues surrounding this decision were complex and that initial attempts to resolve the underlying coverage issue seemed to be too narrowly construed. It was at this time that the late Patricia Roberts Harris, then Secretary of the Department of Health and Human Services (DHHS), declared that DHHS would require new technologies to pass muster on the basis of their “social consequences” before “financing their wide distribution” (30). In a very special sense, although not appreciated at the time, a new era of health care technology assessment was ushered in, as Harris proclaimed that the then-conceived study of heart transplantation should serve as the “prototype” of technology assessment.