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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.
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).
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