خطرات ناشی از آینده مواد مخدر: کارشناسی دلفی دانمارکی

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.

At the fin de siècle, we are facing what has been called the “second medical revolution” 1 and 2, which includes an entirely new generation of drugs1 3, 4, 5 and 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].

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 healthy conditions becomes the primary target point. In this respect, it came as a surprise that the study so clearly illustrated the ongoing paradigmatic conflict in the pharmaceutical world: prevention versus cure. We did not expect this old conflict to surface and affect thinking about the future, because most new literature speaks in favor of the prevention paradigm 65, 66, 67, 68 and 69. However, by performing drill-down analysis with the professions or organizational relations as a determinant, it became clear that there is no evidence to conclude that the preferred paradigm is linked to any specific profession or organization. The study agrees with the latest reports in the pharmaceutical field, namely, that biochemical, indirect, and direct gene therapy are the main approaches to pharmaceutical targeting therapies 6 and 65. It came as a surprise that the study lacked suggestions about nano medicine [70] and pharmacogenomics, and expected impact on pharmaceutical discovery and targeting therapies in the future. 6, 65, 69, 71, 72 and 73. The recognized need for new administrative forms and the lack of new approaches also indicate a serious potential bottleneck in drug discovery and development, which is also suggested in the literature by Sam and Fokkens [74]. Overall, the study indicates optimism about the established consensus for targeting therapies in the pharmaceutical world. However, this optimism might show its shortcomings in the long term because it is based on prediction, rather than vision. We find that the focus on old discussions and the lack of vision in new and emerging fields, such as nano technology and pharmacogenomics, is an indicator of limited visionary thinking by the experts and therefore a validity problem in the study. The fact that experts are not always the ones able to envision opportunities and future trends is a recognized drawback of the Delphi method, which some aspects of this study support. Risks of future drugs To consider drugs in themselves as a source of danger sounds almost counter-intuitive for a health professional. In fact, the ethics of medical practice has always been to do no harm [75]. It is evident that the terms risk and drugs go hand in hand in the mind of the public and, indeed, in the mind of the pharmaceutical scientist. The study shows an average of approximately 40% of time focused on risks by scientists, compared to other research activities. Despite the considerable intensive focus on the risk issue in drug discovery and development, the experts agree that the main driving force is the effect of the drugs, rather than the risks. The experts also agree that the focus on risks will become an even more important part of the drug discovery and development pipeline in the future. Risks on all levels, namely, physical, administrative, economic, environmental, ethical, and societal must be discussed openly at the very beginning—and with increasing intensity towards the end—of the process. As in the past and present, future drugs will have physical—as well as administrative—side effects, but these are expected to become increasingly less important for several reasons: 1. the pharmaceutical organization has a genuine interest. 2. Registration procedures today focus heavily on this type of side-effect. 3.Minimization of side effects is a marketing feature in itself. Indeed, new drugs often enter the market with less effect, but also with fewer side effects, than the drug of first choice at the moment. 4. Future drugs are expected to become even more target specific, thereby minimizing unwanted effects. Thus the study suggests a wide range of new physical side effects, largely associated with gene therapy: auto immunization in the use of DNA vaccines, change of cell expression in the use of genetic manipulation, and chemical “burnout” (the degeneration of brain tissue) in the extensive use of CNS drugs. Overall, the study indicates that the concept of no physical side effects in the future is utopian. Side effects on other levels, however, will be experienced in the future. The results of the study show that the societal and ethical consequence of the use of drugs will increase in the future, as reflected in: the increasing expenses in drug discovery and development, seen in the increasing health care budgets around the world, as well as drug abuse, social inequalities, and the quest for pharmaceutical enhancement such as anti-aging, mood enhancement, etc. These results support the Prozac case study presented in Møldrup and Morgall [8], and the concept of “Medically Enhanced Normality” (MEN). On this basis we stress that the risk, to some extent, of future drugs will move from the individual level (e.g., physical and administrative side effects) to a societal level (e.g., economic, social problems, and ethics). The pharmaceutical world has to include this shift in risk profile of future drugs in the drug discovery and development process. To neglect the societal, economic, and ethical levels could ultimately mean the production of a drug that will be used inappropriately, thereby adding costs to society. Or it could mean the production of a pharmaceutical that cannot be accepted for economic or/and ethical reasons. Generally, the questions of the future will be based on economical priorities, social inequalities, and ethical controversies—this focus is indeed illustrated by Figure 9. In the name of openness, the experts suggested inclusion of sub-political groups, such as patient groups, representative citizens' groups, ethical councils, and health economists as part of drug discovery and development. However, the participation of politicians and lawyers was not considered a useful part of drug discovery and development. Perhaps the reasoning behind this can be found in the direct power of the political groups. Opinions by politicians and lawyers might affect the drug discovery and development process itself through new policies and laws. In contrast, the opinions of patient groups are considered to only affect the outcome of the drug discovery and development process, not the power of the industry. Following this line of thought, the inclusion of political groups is based on the level of power, rather than the level of information that might be useful to the drug discovery and development. If this is the case, it could present a problem to future drug discovery and development, involving societal and ethical issues that might require the scope and knowledge of politicians and lawyers.