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Risks of Future Drugs: A Danish Expert Delphi

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Abstract

This study adopts the prospective perspective in an attempt to explore and define the risks of future drugs. The use of the Delphi method in this study is substantiated by its psychological, financial, and (in the case of the pharmaceutical field) relevant advantages. This study is one of the first Delphi studies to fully utilize Internet (also referred to as the worldwide web [www]) html technology to collect and process data. The two rounds of questionnaires seek both qualitative and quantitative data through Likert-scale questions with mandatory open-ended questions for argumentation. Thirty (round 1) and 22 (round 2) top-level experts drawn from all of the pharmaceutical research and development organizations in Denmark participated. This study concludes that risks of future drugs expand and develop beyond our existing assessment and perception mechanisms. They have the ability to transform side effects from the traditional individual physical level to a societal level with economic, political, and ethical consequences. The study identifies several serious bottlenecks in drug discovery and development in the future; paradigm conflicts and, more important, the assessment of risks associated with future drugs need new and alternative methods and assessment procedures. This is essential in order to capture and cope with the unseen and new side effects that the emergence of the “informational paradigm” within the field of drugs will undoubtedly bring about.

Introduction

At the fin de siècle, we are facing what has been called the “second medical revolution” 1, 2, which includes an entirely new generation of drugs13, 4, 5, 6. Drews [7] argues that, after having developed within the “chemical paradigm,” drug research is now under the influence of a radically different approach, the “informational paradigm.” The term “informational” refers to the information provided by our genes. In that respect, modern drug discovery and development is on a journey that is moving deeper into the secrets of the human being. This journey draws parallels to the “first medical revolution” from nature compounds to the chemical paradigm as primary drug approach. We now know that this “first medical revolution” produced risks: we only have to mention the Thalidomide scandal. As a result, drug discovery and development dramatically changed away from an euphoric belief in chemical structures, once it was learned that chemistry can also cause harm to human beings. Today, the “second medical revolution” may produce new types of risks and harm in the future. We had to learn from our mistakes in the first medical revolution and look deeper into the future of risks. Therefore our concern in this study is with the unseen and new side effects that the emergence of the informational paradigm within the field of drugs will undoubtedly bring about [8].

Section snippets

Objective

This study attempts to explore and define the risks2

The delphi method

The Delphi method is perhaps the best known prospective research method in use today [10]. It aims to collect and distill knowledge from a group of experts by means of a series of questionnaires based on a structured process with controlled opinion feedback [11]. According to Lang [12], the development of the Delphi method had its main genesis in two major findings:

  • 1.

    The “MacGregor effect,” saying that predictions made by a group of individuals are more likely to be right than predictions made by

Response rate and expert demography

A total response rate of 15% in round 1 and 11% in round 2 on the Internet is somewhat lower than the expected response rate for a conventional postal questionnaire (Table 1). Taking into account that the possible expert group was selected as broadly as possible, one might expect that some of the potential experts did not regard themselves as experts on this particular issue. Indeed, this was the argument among those who did not wish to participate.

A relatively low response rate might be a sign

Future drugs

Strategies in future drug discovery and development tend to focus on rational knowledge-based research, rather than on multiple synthesis and the screening of possible lead structures. The optimism about the knowledge-based approach illustrates the trend that the pharmaceutical world has experienced in recent years [6]. Indeed, this approach shows its value because modern diagnosis is able to deal with complex and detailed situations on a molecular level. Information about pathogenesis or

CLAUS MØLDRUP was trained as a pharmacist at The Royal Danish School of Pharmacy, where he is now enrolled as a doctoral student at the Department of Social Pharmacy. His research interests include risk perception, future drugs, prospective research methods, and medical technology assessment.

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    CLAUS MØLDRUP was trained as a pharmacist at The Royal Danish School of Pharmacy, where he is now enrolled as a doctoral student at the Department of Social Pharmacy. His research interests include risk perception, future drugs, prospective research methods, and medical technology assessment.

    JANINE MARIE MORGALL was trained as a sociologist and received her doctorate at the University of Lund, Sweden. She is the author of the book Technology Assessment—A Feminist Perspective (1993). She is now an Associate Professor at The Royal Danish School of Pharmacy, Department of Social Pharmacy. Her research interests include the sociology of science and technology, medical technology assessment, health care policy, international health care, and risk perception.

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