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Dora Wynchank

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Should we be worried? Increasing numbers getting stimulants Children Adolescents Adults Stimulant use increased fourfold from 1987 to 1996 0.6% to 2.4% Among under 18 year olds in the U.S.A Approx 2.8% US youths, aged 5 to 18, on methylphenidate in mid-1995 (Safer et al, 1996)

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Should we be worried? 1990-1995: 2.5x increase in stimulant treatment This steep increase in under 18 year olds levelled out until 2002 For very young children, stimulant use has remained stable

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Ethical Dilemma Request for stimulant medication by many patients who do not meet the criteria for ADHD

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in your practice?

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First step: defining normal Normal patients defined as those with insufficient signs, symptoms, or abnormal test results to satisfy criteria for mental health condition Boundary between disease and non disease often unclear If normal adults request neuroenhancement, they are not patients because they do not require treatment

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First step: defining normal However, what defines a doctorpatient relationship? It depends on the mutual decision of the patient and doctor to enter into the relationship Thus, the adult requesting neuroenhancement becomes a patient when the psychiatrist/ neurologist evaluates or prescribes treatment

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Defining normal Assuming doctor patient relationship exists patient requests neuroenhancement Doctor still has full ethical and professional responsibilities to the patient These responsibilities to the patient continue until the relationship is ended

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Who are the non diagnosed users? University students acquire drug illegally (Babcock et al, 2000) Up to 33% of college students misuse stimulants to cope with stressful academic demands http://www.sciencedaily.com/releases/2008/04/080407195349.htm http://www.sciencedaily.com/releases/2008/04/080407195349.htm Prevalence rates 5 38%

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Who are the non diagnosed users? Recent study of university students 38% used stimulants at least once by Year Four (Arria et al, 2012) Non medical use of stimulants associated with academic difficulties alcohol and cannabis use disorder declining Grade Point Average

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Who are the non diagnosed users? Children with pushy parents DSM criteria too vague Teachers accused of insisting on stimulants for disorderly children Weight loss Vigilance during night shift (Israeli Medical Association) Military personnel Alzheimers (American Academy of Neurology 2009) use of cholinesterase inhibitors (e.g., donepezil) to treat normal age-related memory changes

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Why use stimulants? To improve alertness, wakefulness and concentration better retention of information Similar to athletes doping In students, higher tolerance for alcohol (Babcock et al, 2000)

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Ethical questions Do stimulants work in people who do not have a diagnosis of ADHD? Do stimulants cause harm when given to normal people? What are the duties of the physician when facing parents who want medication for a child who is underperforming for reasons other than a diagnosis of ADHD?

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Discussion

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Do stimulants work in normal people... No Literature divided Stimulants improve alertness and cause insomnia Cognitive effects of stimulants on normal people not clear despite the volume of research carried out But no improvement in concentration or fluency on cognitive testing (Safer et al, 1996) Stimulants cause impairment in previously learnt spatial tasks (Elliott et al, 1997)

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Do stimulants work in normal people... No Effects on the executive functions working memory cognitive control are not reliable Metanalysis: no consistent evidence for neuroenhancement effects of MPH (Repantis D et al, 2010) MPH not found to enhance attention Effects are complex, not be uniformly positive across all dose levels or age groups, and do not enhance all aspects of executive function or memory (Turner et al 2003) Long-term use of off-label medications for neuroenhancement in normal patients are not known and may not be known for many years

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Do stimulants work in normal people... No Stimulants improve alertness and cause insomnia Are longer hours spent awake and cramming helpful? What improves memory is repetition Revising and reviewing the material Last minute cramming is not the best way to consolidate long term memory

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Do stimulants work in normal peopleYes Stimulants do improve cognitive function in normal subjects Low doses of stimulants focus attention and improve executive function in normal and ADHD subjects Improvement measured on a learning task in normal boys and men with amphetamine definite increase in learning (Rapoport et al, 1980) Ability to focus attention, manipulate information in working memory flexibly control their responses is improved (Sahakian et al, 2007)

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Do stimulants work in normal people...yes Spatial working memory and planning improve (Elliott et al, 1997) More vigilant and shorter response times Novel problem-solving and planning also improved (Elliott et al, 1997) Metanalysis: positive effect on memory of healthy individuals was found (Repantis D et al, 2010)

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Discussion

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Do stimulants cause harm when given to normal people? Research not fully conclusive No detailed long term studies in normal subjects Methylphenidate increases activity levels, arousal, talkativeness, and mood in normal subjects (Chait et al, 1994) Some people have increased levels of anxiety, dysphoria and fatigue (Clark et al, 1986)

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Do stimulants cause harm when given to normal people? In summary, the effects of stimulants on normal individuals are mild but helpful Drugs with the fewest side effects are methylphenidate and modafinil prescribed mostly for narcolepsy and also ADHD

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Patient has extreme side effect What is your legal position?

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Discussion

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Should cognitive enhancing drugs be prescribed? We undertake many activities to enhance attention Common sense The following improve brain function exercise (Erikson et al, 2009) nutrition (Almeida et al, 2002) adequate sleep (Boonstra et al, 2007) teaching (Draganski et al, 2004) reading (Schlaggar et al, 2007) Are drugs morally equivalent to other familiar enhancements?

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Objections 2 broad categories: problems for the individual user problems for society

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Are we enhancing patient autonomy by prescribing cognitive enhancers? Could we be limiting it?

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Ethical principles: patient autonomy Patient has right to refuse or choose treatment Does autonomy grant patients the right to try cognitive enhancement?

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Ethical principles: patient autonomy Does cognitive enhancement impair autonomy? Especially children who cannot choose their medication or refuse it

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Doing good for patients Are cognitive enhancers good for us?

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Ethical principles: beneficence Does cognitive enhancement allow us to act in best interest of the patient? If long term adverse effects exist, perhaps prescribing them is not beneficial to the patient May even cause harm

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First do no harm How could we be harming patients?

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Ethical principles: non-maleficence First do no harm Possibility of serious side effects Brain is the most complex and important human organ Perhaps premature memory loss and cognitive decline? Interfering with normal brain function dangerous

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Ethical principles: non-maleficence Which 'limitations' are there for a good reason? Normal forgetting rates is important Irrelevant information designed to be forgotten Synaptic pruning important part of good brain function How damaging is excessive memory? Important in pathogenesis of PTSD

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Ethical principles: non-maleficence Is cognitive enhancement unnatural? How natural are our lives? Also, be aware of placebo effect if prescribing

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Is cognitive enhancement fair?

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Ethical principles: justice Distribution of scarce health resources: distributive justice Who gets what treatment ? If wealthy had sole access unjust Would each dose be cheap? There are many examples of unequal access to benefits in society, including private schools

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Ethical principles: justice Could employers coerce employees into taking enhancers to improved performance? Would the widespread use of enhancers change the standards of what constitutes normal cognitive function? Would this disadvantage those who choose not to enhance?

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Ethics Committee of Israeli Medical Association Traditional role of medicine is to maintain patient's health improve quality of life With request for neuroenhancement if patient healthy inherent risk is marginal Doctor should examine any request professionally, but is not obliged to accept Off label usage of medication requires informed consent from patient Periodic evaluation of treatment effectiveness is necessary

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Ethical principles: justice Use should be regulated and monitored in certain situations use by healthy children no autonomy insufficient information on their effects in the developing brain

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Ethical principles: justice Competitive situations: entrance exams cognitively enhanced have unfair advantage guidelines need to be devised Would cognitive enhancers improve overall learning or simply boost exam performance? With temporarily improved exam performance, exam not a valid measure of the ability of the student Therefore unfair

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Is it truthful?

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Ethical principles: truthfulness Is it cheating? Is it doping? Would it be against the rules? Should the rules be changed?

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Ethical principles: truthfulness Does cognitive enhancement bypass real effort in obtaining results? No gain without pain Emotional component struggle is worth it moral benefit

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Ethical principles: truthfulness Many shortcuts to performing better Study guides and extra lessons Is cognitive enhancement not yet another practice? Who would stand to gain financially?

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Is the doctors dignity compromised if pressured to prescribe in the absence of a medical diagnosis?

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Ethical principles: dignity Is the doctors dignity compromised? Answer depends on the doctors attitude to practice of medicine Healers view prescribing to normal individuals as inappropriate Therapy is about treating disease

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Ethical principles: dignity If regard medicine broadly helping patients have better quality of life More open Enhancement is about improving normal abilities Fukayama says: the original purpose of medicine is to heal the sick, not turn healthy people into gods. Also suggests that public policy should restrict research for enhancement (2002)

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Where does this leave us? In future, with internet, many may purchase scheduled medication Medications may be developed for improving cognition and memory in normal persons (de Jongh R, et al. Botox for the brain: enhancement of cognition, mood and pro-social behavior and blunting of unwanted memories. Neurosci Biobehav Rev 2008;32:760 776) We all need to engage with all the issues

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Where does this leave us? Devise clear guidelines supervised access to safe and effective cognitive-enhancers All stake holders make decisions Dialogue to create boundaries and regulations Restrict in certain competitive situations Regulations similar to those in place limiting doping in sporting events

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Where does this leave us? Dont rely on pharmacology alone to improve memory and attention Use holistic approach psychotherapy, nutrition, good sleep hygiene and exercise Understand more about their advantages and disadvantages Naturalistic setting for research Only once the potential harm of these agents has been clarified, will clinicians be able to decide on their usage

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I believe in an open mind, but not so open your brains fall out.

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Discussion

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Ethical principles: dignity Traditional goals of medicine prevent and diagnose disease or injury cure or treat the disease/injury reduce suffering or, if that is not possible, or help patients to cope educate patients about disease and prognosis help patients to die in peace and with dignity reassure the worried well Cosmetic surgery uses medical skill to enhance the well- being of normal persons

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socially useful practices acceptable to the profession and society Illegitimate Prohibited

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Ethical principles: dignity From this perspective, prescribing neuroenhancement lies outside the core domain of traditional medical practice is not ethically obligatory Is it illegitimate or an acceptable practice? therefore ethically permissible