Modern drugs are invented according to medical needs, making use of the latest innovations in technology. They are sophisticated, efficacious, and costly, but are they effective? Are they superior to existing - and cheaper - alternatives, and is this superiority reflected in increased cost-effectiveness? Are they socially more beneficial? These questions, and those related to the intriguing search for better quality of life, are addressed in this book by experts from the fields of medicine, epidemiology, economics, sociology and the pharmaceutical industry. The book describes the environmental situation in the United States and Europe in which pharmaceutical development takes place; it also explores the grounds for agreement as well as disagreement between the social and the economic evaluations of progress. It tackles the problem of outcome measurements, patients' behavior, quality of life, and individual value judgments and describes methodological boundaries in the socioeconomic evaluation of drugs.

In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies executed according to strict protocols and scientifically defined criteria. Drug surveillance activities have gained recognition, and reporting systems to identify drug safety problems have been strengthened. The understanding and management of drug safety is, nonetheless, beset by doubts, disagreements, and disputes. Conflict occurs over the significance of risk, the adequacy of evidence, the methodologies used to evaluate and measure risk, the standards that guide regulation, and the optimal means of communicating risk information to the public.

Over the past decades, health care delivery - once characterized by clearly defined relationships between medical professionals, regulators, and industr- has become much more complex. Traditional roles and relationships are changing and new decision-makers are entering the scene. They bring into the discussion the need for cost containment and the changing perceptions of the public with regard to the risks and benefits of health care outcomes. As benefits of medical care are increasingly questioned and as scepticism and fear of advanced technologies are demonstrated by a growing body of people, decision making must move beyond medical concerns to encompass economic, political, and sociological considera tions. This evolution has also affected the pharmaceutical industry. Public percep tion of responsibility for product safety is no longer limited to regulators and physi cians. Manufacturers, previously unencumbered by social policies, governmental preoccupations, or public expectations, are now held accountable for product safety. As a certain amount of risk acceptance is, however, a prerequisite for the further development of health care goods, it has to be carefully balanced against society'S demand for safety. To weigh risks against benefits, to define acceptable risk, and to exclude what no longer falls within this category remain perpetual challenges. Accordingly, health care outcomes have to be assessed not only from a clinical point of view, but also from an economic and societal perspective. The assessment of drug risks and benefits has become an important political issue world-wide.

As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).

In view of the continuing preoccupation of all industrialized countries with the rising share of national resources devoted to health care, it is valuable to compare the fmanc ing and breakdown of health care expenditure on an international basis. How far should public spending on health care be regarded as a capital investment in the improvement of the health of the population and how far as subsidies to individual consumption? This question is of major importance to policy makers, including the me dical profession, politicians, employers, social security officials as well as to the public at large. In order to obtain some insight into the incentive structures enhancing competition among suppliers which have been built into the health care delivery systems in the various countries, the Interdisciplinary Research Centre for Public Health at St. Gall, in close co operation with the Institute of Insurance Economics and the Institute of Public Finance and Fiscal Law, both afftliated with the Saint Gall Graduate School of Economics, Business and Public Administration, initiated an international seminar held at Wolfsberg, Switzerland, 20-23 March 1979. The purposes of the Seminar were: 1. to review present experience on the development of health care costs and their financing - particularly the role of health insurance and the institutional relationships between public illd private health insurance policies; 2."

Das groBte Hindernis, das dem interdisziplinaren Gedankenaustausch im Wege steht, ist haufig der Jargon. Wahrend des Symposiums, des sen Beitrage und Diskus- sionen auf den folgenden Seiten verOffentlicht werden, versuchten wir natiirlich, jede unnotig verschleiernde Fachsprache auszuschalten; gleichzeitig waren wir be- strebt, ein vie! ehrgeizigeres Ziel zu erreichen: die Konfrontation mit den intellektu- ellen Sachverhalten, die mit der Verwendung des Wortes "Evaluation" in der Medi- zin und den Gesundheitsdiensten verbunden sind. Zu diesem Zweck wurde eine sorgfaltig ausgewahlte Gruppe von Experten aus den Gebieten der Medizin, der Epidemiologie und der Gesundheitsokonomie einge!aden, zum selben Thema Vor- trage zu halten. Sie wurden entweder aufgrund ihres Rufs als "Synthetiker" oder als empirische "Analytiker" oder - die seltenste Expertengruppe - als beides in einer Person gebeten, ihren Beitrag zu leisten. Urn den Praxisbezug zu gewahrleisten wurden 3 Verfahren ausgewahlt, fUr die bereits Evaluationen voriagen, von denen jedoch jedes besondere Probleme auf- warf. 1m ersten Fall handelte es sich urn die Behandlung des Nierenversagens durch verschiedene Dialyseverfahren. Die Evaluation dieser Therapiemethoden reicht verhaltnismaBig weit zurUck, und die entsprechende Literatur ist umfang- reich. Insbesondere stellen sich aber weitreichende konzeptuelle Fragen fUr die Ge- sundheitsdienste der Industriegesellschaften sowohl in bezug auf den Umfang der bereitzustellenden Programme, die Art und die Kombination der Behandlungen als auch beziiglich der Auswahl der zu behandelnden Patienten. Die Messung des Er- folgs der diversen Strategien verursacht okonomische und medizinisch-soziale Pro- bleme besonderer Art.

Unter dem Eindruck der Kostenentwicklung im Gesundheitswesen gewinnen oko- nomische Uberlegungen im Gesundheitswesen zunehmend an Bedeutung. Die Notwendigkeit, den Gesundheitszustand effektiv und efftzient zu verbessem, ruft nach einer Auswahl wirkungsvoller Verfahren aufgrund objektivierbarer Kriterien. In der heudgen Situation kann die friiher geauBerte Ansicht, daB Geld keine Rolle spielen durfe, wo Gesundheit und das menschliche Wohlbefinden auf dem Spiel stehen, nicht mehr langer aufrechterhalten werden, da sie bei beschrankten Mitteln unweigerlich zu Ungleichheiten in der Behandlung fuhren muBte. Die vielfaltigen Anforderungen an den modemen Sozialstaat verpflichten vielmehr alle Beteiligten zu einem moglichst rationellen Einsatz der Ressourcen, unter Abwagen der Beurtei- lung der Altemativen. Der Ruf nach Methoden zur Bewertung der Leistungen des Gesundheitswesens und des Nutzens der einzelnen Verfahren ist nicht neu. Es sind jetzt gut 20 Jahre her, seit Fuchs seine Monographie unter dem Titel, Who shalllive?'l veroffentlicht hat und darin das zentrale Thema der Auswahl verschiedener Verfahren auf indivi- dueller und auf sozialer Ebene als Notwendigkeit fUr das Gesundheitswesen ent- wickelte.

Grundsatzlich ist es Aufgabe einer Kosten-Nutzen Analyse, die Vor- und Nachteile eines Projektes, oder allgemeiner eines Vorhabens, im Vergleich mit anderen oder ahnlichen Vorhaben darzulegen und abzuwagen. Zweck der vorliegenden Untersuchung war, zunachst eine geeignete Methode fUr die Beurteilung von Kosten und Nutzen von Heilverfahren im allgemeinen 'und einer Medi kamentengruppe im besonderen zu entwickeln, sodann diese Methode an einem konkreten Beispiel, dem der Antidepres siva-Therapie, anzuwenden. Ein medizinisches Behandlungsverfahren als Gegenstand einer Kosten-Nutzen-Analyse stellt methodisch besonders interessante Probleme. Einerseits sind wirtschaftliche MaBstabe an ein individual-medizinisches Verfahren zu legen und andererseits sind dabei soziale und offentliche Faktoren moglichst gleichwertig in die Rechnung mitein zubeziehen. Die Lasung dieser Aufgabe erfordert eine Betrachtung von verschiedenen Gesichtspunkten aus. Die vorliegende Studie schien uns von aktuellem Interesse, weil nach Ubereinstimmenden Entwicklungsprognosen mit einer zunehmenden Verbreitung psychotroper Pharmaka ge rechnet werden muB, so daB dem Fragenkomplex allgemeln soziale Relevanz zukommt. Die Untergruppe der Antidepressiva stellte sich dabei sowohl aufgrund der Haufigkeit der Depression als auch wegen der relativ gut abgegrenzten therapeutischen Indi kation in den Vordergrund des Interesses."