The perception and management of therapeutic risk
Technology has enhanced our ability to harness our environment, eradicate dread diseases, and fashion a life of comfort and leisure. But it has become apparent that these benefits are accompanied by a variety of hazardous side effects. Hardly a day passes that does not reveal some new danger in our foods, our homes, our places of work, our leisure activities, our environment or our medical treatments. In a world where more and more people are coming to see themselves as the victims rather than the beneficiaries of technology, it is not surprising that the control of hazards has become a major concern of society and a growing responsibility of government. Massive regulatory bureaucracies have been created and charged with answering myriad forms of the question “How safe is safe enough?” Yet despite this enormous effort, people in many industrialized nations feel increasingly vulnerable to the risks from technology and believe that the worse is yet to come. Regulatory agencies have become embroiled in rancorous conflicts, caught between a fearful and dissatisfied public on one side and frustrated technologists and industrialists on the other. Nuclear power was the focus of public concerns during the decade of the 1970s. During the eighties, there has been great concern and increasing dissatisfaction with the production, use, transport, and disposal of chemicals. When the people in the US are asked to report the first thing that comes to mind when they hear the word “chemicals,” the dominant response is “dangerous” or some closely related term (toxic, hazardous, poison, harmful, deadly, pollution, risk). Beneficial aspects of chemical technologies are rarely mentioned. Manufacturers and users of industrial and agricultural chemicals are virtually at war with the public and the regulatory authorities in many places. At the same time, manufacturers of other important products of chemical technology, pharmaceutical medicines, are also concerned about what appears to be a changing social and political environment. The preface to a book reporting the proceedings of an international conference on the prescription and management of drug safety risks summarized these concerns as follows: 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 accident or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulatory 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. At this same conference, Dr. Walter von Wartburg elaborated these concerns: Drug risks . . . constitute a major anxiety today . . . If we look only at the 1980s, we see a phenomenon which was and still is difficult to explain. A number of old, established drugs have suddenly disappeared. We find quite a number of newly introduced “wonder” drugs being withdrawn after a promising start. The number of drug issues has been rising rather dramatically. And both manufacturers and drug regularity authorities have come under increasing public criticism. In part, von Wartburg argued, this change can be attributed to the emergence of new actors in the management of drug risks — patients, the public at large, politicians, the media, consumer organizations, and special interest groups. Working effectively with these new publics brings issues of perception and communication into prominence. Knowledge of perception has been shown to be vitally important in understanding how individuals and societies manage the risks of daily life. In medicine, perceptions of drug risks are likely to influence patients’ treatment choices, their compliance with treatment regimens, their views on the acceptability of adverse reactions and the drugs that cause them, and their attitudes toward government regulation of drugs. Understanding perceptions is a prerequisite for designing better communication materials for patients and the public.