OFFICEOFFICE OFOF TECHNOLOGYTECHNOLOGY ASSESSMENTASSESSMENT ATAT THETHE GERMANGERMAN BUNDESTAGBUNDESTAG Arnold Sauter Katrin Gerlinger The Pharmacologically Improved Human Performance-Enhancing Substances as a Social Challenge Final Report Technology Assessment Studies Series, No 5 THE PHARMACOLOGICALLY IMPROVED HUMAN TECHNOLOGY ASSESSMENT STUDIES SERIES, NO 5 The Office of Technology Assessment at the German Bundestag is an independ- ent scientific institution created with the objective of advising the German par- liament and its committees on matters relating to research and technology. TAB is operated by the Institute for Technology Assessment and Systems Analy- sis (ITAS) at the Karlsruhe Research Centre. In executing its working pro- gramme the Karlsruhe Research Centre cooperates with the Fraunhofer-Institut für System- und Innovationsforschung (ISI), Karlsruhe. TAB’s task is to design and implement technology assessment (TA) projects and to monitor and analyse important scientific and technological trends and the associated social developments (Monitoring, Future- and Innovation Reports, Policy-Benchmarking Reports). Arnold Sauter Katrin Gerlinger THE PHARMACOLOGICALLY IMPROVED HUMAN PERFORMANCE-ENHANCING SUBSTANCES AS A SOCIAL CHALLENGE Report for the Committee on Education, Research and Technology Assessment of the German Bundestag OFFICEOFFICE OFOF TECHNOLOGYTECHNOLOGY ASSESSMENTASSESSMENT ATAT THETHE GERMANGERMAN BUNDESTAGBUNDESTAG NOTE The orientation and content of this report cannot be taken as indicating the po- sition of the German Bundestag or its Committees. The German Bundestag retains the copyright to this publication. Reproduction is authorised, except for commercial purposes, but full acknowledgement is re- quested. A PDF-Version of the report is currently available on the Internet at the address http://www.tab-beim-bundestag.de. This title was first published in German language. The bibliographic informa- tion of the German title is: Arnold Sauter, Katrin Gerlinger: Der pharmako- logisch verbesserte Mensch. Leistungsteigernde Mittel als gesellschaftliche Herausforderung. Berlin: edition sigma 2012, ISBN 978-3-8360-8134-4. Translation: Michael Capone Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag (TAB) (Office of Technology Assessment at the German Bundestag) Neue Schönhauser Straße 10 10178 Berlin Germany Fon: +49 30 28 491-0 Fax: +49 30 28 491-119 [email protected] http://www.tab-beim-bundestag.de/ 2013 THE COMMITTEE’ S PREFACE For some years now, in response to the rising challenges of global socioeconomic competition, both the scientific community and the public have been debating whether the improvement of individuals’ performance with the help of technical or biomedical interventions in the human body – termed enhancement – is a welcome, inevitable or undesirable vision of the future. The report on brain research by the Office of Technology Assessment at the German Bundestag (TAB) (Bundestag printed paper 16/7821) also presented evidence of a growing trend towards the use of pharmaceuticals and other medi- cal interventions to specifically influence mental states and capacities. Following publication of the highly respected TAB report »Gene Doping«, an analysis of physical performance enhancement in sport, the Committee for Edu- cation, Research and Technology Assessment commissioned the TAB to under- take a technology assessment project on »pharmacological and technical inter- ventions to improve performance – prospects for more widespread use in medi- cine and everyday life« (»Enhancement Project«). The TAB’s final report analyzes the areas of development and use with the greatest social and political relevance now and in the foreseeable future, i.e. cur- rent developments and plausible trends regarding the use of psychopharmaceuti- cals and other drugs to enhance performance in working and everyday life. It provides a comprehensive analysis of the current status of possibilities to influ- ence human performance by pharmacological means and of the classification of those agents within the framework of laws regulating medicines, foods and healthcare. This will facilitate a realistic discussion of future developments that clearly stands out from previous hypothetical and visionary descriptions of en- hancement. The report shows that the targeted development and use of pharma- cological substances for nontherapeutic performance enhancement is incompati- ble with the current objectives of the medical innovation system and the remit of doctors. A change in this situation would require a far-reaching public and polit- ical opinion-forming process. At the same time, the systematic analysis of the scientific approach to the doping problem in elite and competitive sport under- taken in the TAB report points to the need for a thorough public debate on how to deal with growing demands for performance and innate differences in abilities among individuals. The report examines the options for action in the fields of research, regulation, healthcare consumer protection and prevention. 6 THE COMMITTEE’S PREFACE This report places in the hands of the Bundestag an up-to-date and highly de- tailed informational basis for parliamentary debate on this important aspect of research, health, legal, economic and social policies. Berlin, November 22, 2011 The Committee on Education, Research and Technology Assessment Ulla Burchardt, Member of the German Bundestag Committee Chairwoman Dr Thomas Feist, Member of the German Bundestag Rapporteur René Röspel, Member of the German Bundestag Rapporteur Prof Dr Martin Neumann, Member of the German Bundestag Rapporteur Dr Petra Sitte, Member of the German Bundestag Rapporteur Hans-Josef Fell, Member of the German Bundestag Rapporteur INHALT THE COMMITTEE’ S PREFACE 5 SUMMARY 11 I. INTRODUCTION 35 1. Background and central aspects of the topic 35 2. Commission, objective, and approach 36 3. Cooperation with reporting experts 39 4. Structure of the report 41 5. Use of the term »enhancement« 42 II. HUMAN PERFORMANCE AND ATTEMPTS TO INFLUENCE IT BY PHARMACOLOGICAL MEANS 45 1. Concepts and biological foundations 46 1.1 Human performance 46 1.2 Human abilities 50 1.3 Possibilities and limits of attempts to quantify performance and abilities 51 1.4 Biological foundations 54 2. Approaches and limits to improvement of human abilities 58 3. Pharmacologically active substances 61 3.1 Psychostimulants 62 3.2 Substances used to combat dopamine deficiency 75 3.3 Antidepressants 78 3.4 Anti-dementia agents 81 3.5 Beta-blockers 83 3.6 Possible neuroenhancers of the future 85 4. Other substances: plant-based substances 86 4.1 Substances from the fields of medicinal plants and natural medicine 88 4.2 B vitamins 90 4.3 Unsaturated fatty acids 93 4.4 Tyrosine 94 8 CONTENTS 5. Cognitive Training and other methods 95 5.1 Psychologically based training techniques 95 5.2 Noninvasive technical methods 96 6. Conclusion 98 III. ENHANCEMENT SUBSTANCES: FOODS OR MEDICINES? LEGAL DEFINITION, REGULATORY TREATMENT, AND ROUTES OF DIFFUSION 103 1. Substance definitions and distinctions 104 2. Regulatory treatment of foods 107 2.1 The principle of abuse 107 2.2 Subcategories, marketability 108 2.3 Proof of efficacy and obligations to provide information 110 2.4 Market players: attitudes and behavior 114 3. Regulatory treatment of medicines 118 3.1 The principle of prohibition subject to exemptions 119 3.2 Pharmaceutical research: standards for the acquisition of knowledge and for marketing authorization 120 3.3 Marketability 130 3.4 Provision of information and advertising 133 3.5 Pharmacists and doctors: key players for placing on the market and use of medicines 144 3.6 Cost bearers and healthcare markets 154 4. The consumption side: findings on use of medicines for performance enhancement 167 4.1 Empirical findings on pharmacological performance enhancement 169 4.2 Dealing with potential costs arising from use of (enhancement) substances 174 5. Conclusion 176 IV. THE DEBATE ABOUT ENHANCEMENT IN ETHICS AND THE SOCIAL SCIENCES 183 1. The ethical debate about enhancement 183 1.1 Definition and demarcation problems 184 1.2 Ethical principles according to Beauchamp and Childress 188 1.3 Concerns about the future of human nature 192 CONTENTS 9 2. Perspectives of the social sciences: enhancement as part of a medicalization process 194 2.1 Boundary shifts in the narrow area of medical science: illness, health, healing, improvement 196 2.2 The subject level: acquisition forms between social pressure and self-determination 202 2.3 Socioeconomic boundary shifts: from healthcare to health market 208 3. Conclusion 211 V. PERFORMANCE-ENHANCING AGENTS OF THE FUTURE – A SCENARIO OF EXPANSION 213 1. Development of performance-enhancing agents in the current research and innovation system 215 1.1 Players in pharmacological researchand development 216 1.2 Current development and diffusion routes 223 2. Elements and implications of a scenario of expansion 226 2.1 Current legal restrictions – necessary changes 228 2.2 Premarketing research and development 231 2.3 Requirements of long-term monitoring 237 2.4 Possible consequences for the healthcare system 238 2.5 Repercussions on the system of innovation 241 2.6 Conclusion: possible triggers of the scenario of expansion 243 VI. DOPING AND ENHANCEMENT: SIMILARITIES AND DIFFERENCES BETWEEN SPORT AND WORKING LIFE 245 1. Discussion of doping: arguments and patterns of justification 246 2. Doping spiral: the quantity law and drop-outs 248 3. Pharmacological