{"id":3750,"date":"2017-01-20T11:53:35","date_gmt":"2017-01-20T11:53:35","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Nagel.pdf"},"modified":"2017-01-20T11:53:35","modified_gmt":"2017-01-20T11:53:35","slug":"nagel-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/nagel-2\/","title":{"rendered":"Nagel"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Nagel<\/a><\/p>\n

Dr. Saskia K. Nagel
\nInstitute of Cognitive Science
\nUniversity of Osnabr\u00fcck
\nConsidering research on neuro-
\nenhancement in the next revision of
\nthe Declaration of Helsinki
\n26.06.2012 WMA Satellite
\nOverview
\n\u2022\u202f Trend: Neuro-enhancement
\n\u2022\u202f What is it?
\n\u2022\u202f Prevalence
\n\u2022\u202f Ethical discussion
\n\u2022\u202f Effectiveness and safety
\n\u2022\u202f Relevance for the Declaration of Helsinki
\n\u2022\u202f General concern
\n\u2022\u202f Challenge to weigh risks and benefits
\n\u2022\u202f Discussion
\n26.06.2012 WMA Satellite
\nNeuro-enhancement
\nImprovement of cognitive or emotional
\ncapacities in healthy people without
\ntherapeutic or preventive intention with
\npharmacological or neurotechnological
\nmeans
\n26.06.2012 WMA Satellite
\nNeuro-enhancement
\nWhat and how?
\nGoals: Means:
\nphysical capacities cognitive capacities
\nlongevity and
\nsymptoms of aging
\naffectice functions
\nsocial
\nand moral capacities
\ndeep brain stimulation
\nneuro-
\nprotheses
\nmagnetic
\nstimulation
\npsychopharmacology
\nBrain-machine
\nInterfaces
\nspiritual capacities
\nultrasound
\nJust a small selection
\nTo offer:
\n\u2022\u202f Vinpocetine – a cerebral enhancer;
\n\u2022\u202f Get SmartTM- brain formula: Increase your IQ
\n\u2022\u202f Idebenone – the ultimate anti-aging drug?
\n\u2022\u202f SAMe – the nutrient for mood, liver, heart, joint and brain protection
\n\u2022\u202f Piracetam – the original nootropic
\n\u2022\u202f NADH – the supervitamin body and mind energizer
\n\u2022\u202f Growth Hormone – the real \u00abfountain of youth!\u201c
\n\u2022\u202f 5-HTP – Prozac\u2019s true alternative
\n\u2022\u202f The energy program at a glance – tired of being tired?
\n\u2022\u202f Life Extension Mix – just 14 capsules a day!
\n\u2022\u202f Centrophenoxine – the anti-aging brain
\n\u2022\u202f Galantamines – opens your memory, rescues brain cells: old becomes young
\n\u2022\u202f Pregnenolone – reducing stress and increasing productivity
\n\u2022\u202f Prescription not required … (http:\/\/smart-drugs.com)
\nPrevalence
\n\u2022\u202f Little accurate data available
\n\u2022\u202f Up to 25% of American students use psychostimulants (range
\n3-25% in colleges) (McCabe et al. 2004, 2005)
\n\u2022\u202f 46% increase in ADHD prescriptions from 2002-2010 (Chai et al. 2012)
\n\u2022\u202f Estimates:
\n\u2022\u202f 5% of the working population in Germany use pharmaceutical drugs
\nto enhance their cognitive functions
\n\u2022\u202f 2% of surveyed German students use drugs to compensate for stress
\nand increase performance (Franke et al. 2011)
\n\u2022\u202f Non-therapeutic use and prescription of drugs happens mainly
\noff-label
\n\u2022\u202f Availability of these prescription medications rises -> rates of
\nmedication diversion and misuse rise as well
\n\u2022\u202f Note: Assuming and communicating high prevalence numbers
\nmight lead to a self-fulfilling prophecy
\nEthical debate
\n\u2022\u202f Neuro-enhancement is growing trend that is vividly
\ndebated regarding ethical and social questions
\n\u2022\u202f Justice & fairness
\n\u2022\u202f Coercion & pressure for conformity
\n\u2022\u202f Open and subtle pressures in working and personal life
\n\u2022\u202f Value of the normal
\n\u2022\u202f Personality changes
\n\u2022\u202f Naturalness
\n\u2022\u202f Authenticity
\n\u2022\u202f Rarely considered:
\n\u2022\u202f Effectiveness, safety, side-effects…
\n26.06.2012 WMA Satellite
\nEffectiveness
\n\u2022\u202f Expectations regarding the effectiveness exceed actual
\neffects
\n\u2022\u202f Stimulants (methylphenidate; modafinil)
\n\u2022\u202f Mainly effects on memory, some effects on executive functions in
\nsleep deprived subjects (Repantis et al. 2010)
\n\u2022\u202f Antidepressants (mainly SSRIs)
\n\u2022\u202f Uncertainty regarding size and robustness of effects
\n\u2022\u202f Dependence on dosage, individual differences, specifics of the task
\n\u2022\u202f The claimed and assumed benefits are often exaggerated
\n26.06.2012 WMA Satellite
\nSide-effects
\n\u2022\u202f US FDA warning on the packets of methylphenidate:
\n\u2022\u202f \u00abamphetamines have a high potential for abuse. Administration of
\namphetamines for prolonged periods of time may lead to drug
\ndependence …Misuse of amphetamine may cause sudden death and
\nserious cardiovascular adverse effects.\u201c
\n\u2022\u202f Risk of addiction
\n\u2022\u202f Highly selective, direct effects on dopamine release (e.g. by
\npsychostimulants methylphenidate and modafinil)
\n\u2022\u202f Habitized drug intake (counter-regulatory neuroadaptive processes
\nare induced and strengthened)
\n\u2022\u202f \u201eThe immediate and long-term risks to individuals seeking
\ncognitive enhancement remain unknown.\u201c (Smith and Farah 2011)
\n26.06.2012 WMA Satellite
\nEmpirical studies are needed \u2013 if wanted
\n\u2022\u202f Public interest contrasts with paucity of data on specific enhancement
\neffects of available agents
\n\u2022\u202f Decision of healthy individuals on the usage of enhancement
\nshould be based on exhaustive information provided by
\nscientifically valid studies
\n\u2022\u202f Investigating enhancement usage
\n\u2022\u202f Dosages, length of intake, and risks might differ
\n\u2022\u202f Definition of efficacy of enhancement intervention must be clarified
\n\u2022\u202f Large longitudinal studies
\n\u2022\u202f Large samples
\n\u2022\u202f Comparative designs
\n26.06.2012 WMA Satellite
\nWhy considering this?
\n\u2022\u202f Challenge to the purpose and scope of biomedical
\nresearch and medical practice
\n\u2022\u202f \u00a77 of the current DoH version:
\n\u2022\u202f \u201eThe primary purpose of medical research involving human
\nsubjects is to understand the causes, development and effects of
\ndiseases and improve preventive, diagnostic and therapeutic
\ninterventions (methods, procedures and treatments). Even the
\nbest current interventions must be evaluated continually through
\nresearch for their safety, effectiveness, efficiency, accessibility
\nand quality.\u201c
\n\u2022\u202f Reconsider the basic assumptions of justifying medical
\nresearch
\n26.06.2012 WMA Satellite
\nRisk-benefit balancing anew
\n\u2022\u202f \u201cIn medical practice and in medical research, most interventions involve risks
\nand burdens.\u201c (\u00a78)
\n\u2022\u202f \u201cMedical research involving human subjects may only be conducted if the
\nimportance of the objective outweighs the inherent risks and burdens to the
\nresearch subjects.\u201c (\u00a7 21)
\n\u2022\u202f What are acceptable risks?
\n\u2022\u202f When is it justified to expose human beings to potential harm?
\n\u2022\u202f Risk-benefit balance for research on enhancement
\n\u2022\u202f Which ratio would be acceptable?
\n\u2022\u202f How to weigh societal benefits against individual risks?
\n\u2022\u202f Potentially unfavorable ratio given side-effects BUT high demand given social
\ntrend
\n\u2022\u202f Research on enhancement in the healthy not as essential as research on disease
\n\u2022\u202f Consider prioritization of healthcare; responsible use of finite resources
\n\u2022\u202f Legitimacy of this research needs scrutiny and \u201cregulation\u201d
\n26.06.2012 WMA Satellite
\nVulnerable populations
\n\u2022\u202f Children and adolescents show particularly high increase
\nin usage and acceptance
\n\u2022\u202f Studies on enhancement are lacking
\n\u2022\u202f Off-label use, diversion, and social pressure raise
\n\u2022\u202f Specific regulations for enhancement in pediatric
\npopulations necessary (e.g. for practitioners; Graf et al. in
\nprogress)
\n26.06.2012 WMA Satellite
\nConclusion
\n\u2022\u202f Enhancement is prevalent despite paucity of data on
\neffectiveness and safety
\n\u2022\u202f Empirical studies on enhancement are not covered by
\ncurrent version of Declaration of Helsinki
\n\u2022\u202f Deliberation of general stance and adequate risk-benefit
\nbalancing is needed in the context of regulating biomedical
\nresearch
\n\u2022\u202f Decisions will strongly influence ethical debate
\n\u2022\u202f Suggestion: No ban, but cautious positioning
\n26.06.2012 WMA Satellite
\nThank you for your attention!
\n26.06.2012 WMA Satellite<\/p>\n"},"caption":{"rendered":"

Nagel Dr. Saskia K. Nagel Institute of Cognitive Science University of Osnabr\u00fcck Considering research on neuro- enhancement in the next revision of the Declaration of Helsinki 26.06.2012 WMA Satellite Overview \u2022\u202f Trend: Neuro-enhancement \u2022\u202f What is it? \u2022\u202f Prevalence \u2022\u202f Ethical discussion \u2022\u202f Effectiveness and safety \u2022\u202f Relevance for the Declaration of Helsinki \u2022\u202f General […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Nagel.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3750"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3750"}]}}