Bruno Horisberger

The Perception and management of drug safety risks

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Risk Perception Analysis

Background. Drug risks should be viewed in the context of other risks. Recently developed methodology has the power to explain public concerns and to predict reactions to events.

RAD-AR Council Japan

The RAD-AR Council of Japan was founded in May 1989. Its membership has grown from 11 to 19 companies, only three of which are not based in Japan. The Council’s objective is to increase the understanding and credibility of pharmaceutical drugs in society by promoting and supporting research, risk assessment, and communication activities in the area of drug safety. At the head of the Council is the governing board of company presidents, but the work is largely carried out by a steering committee and two committees devoted to pharmaco-epidemiological and communications matters. These committees are supported by a number of expert committees made up of journalists, academics, and medical and pharmaceutical experts.

From Questions to Missions and Actions

The 1990 meeting in Wolfsberg, Switzerland, was neither the beginning nor the end of an international effort to understand the risks and benefits of pharmaceutical products. It was, rather, a further step in a process to improve drug safety and the health of people throughout the world.

Wolfsberg Think Pieces

The 1990 Wolfsberg dialogue conference raised many issues and points that were energetically debated during the working group meetings. The diversity of opinions voiced reflected the range of professions and interests represented. The think pieces are the concentrated essence of these meetings, and summarize the areas in which the participants agreed that change must be effected. The think pieces also propose principles and guidelines for the way in which responsibility for action can be shared.

International Medical Benefit/Risk Foundation -RAD-AR

By the close of the Wolfsberg dialogue conference, many participants had expressed a wish to see the kind of projects generated under the RAD-AR umbrella translated into a broader, more formal structure of an international body. Since April, a great deal of research has been carried out into the kind of organization that would answer current and future needs with regard to medical benefit/risk assessment.

Summary of Part II: Presentations and Discussions

Speakers at the beginning of the session underscored the theme that risk analysis alone is insufficient, that there must be appreciation of both perception and communication of risk. They then discussed the limitations of available data on the safety of prescription drugs: limits both of studies to evaluate efficacy and of the reporting of voluntary postmarketing adverse drug reactions. Attention focused on computer-based medical record linkage systems which could provide rapid access to the information needed to answer safety questions about new drugs. Currently, several medical data bases exist, but their cumulative size is too small to provide answers to critical drug risk questions. (Systems including about ten million people are required for safety studies of newly marketed drugs.) Other problems of current medical data systems are confidentiality, cost, technical organization, and immediate access to records.

Strategies, Designs, Criteria, Tactics and Statistics to be Considered when Evaluating Scientific Evidence

Most accepted definitions of epidemiology in standard textbooks and as taught by leading professors throughout North America are consistent with the following: Epidemiology is the study of the determinants of health and disease in human populations; it subsumes the study of distribution of health-related phenomena in man.

Communicating the Benefit/Risk Relationship

Background. Effective communication is the result of a four — stage process: listening, understanding, formulating a message, and communicating. The pharmaceutical industry currently implements the last two of these stages while paying little attention to the first two. An industry-wide program on drug safety risk management and perception offers a unique opportunity for pharmaceutical manufacturers to step back from parochial issues regarding specific products and to move forward by promoting understanding and candor on all matters relating to the benefits and risks of drugs.

Risk Appraisal on an International Scale

Background. A major concern for drug regulators, academic epidemiologists, and members of the pharmaceutical industry seems to be the development of a generally accepted approach to the assessment of drug-associated risks in the postmarketing phase in order to achieve safety standards that are both objective and rigorous.