Which new antiepileptic drug for which patient?

UCL INSTITUTE OF NEUROLOGYDCEE

Ethics in Epilepsy

Ley Sander MD PhD FRCPDepartment of Clinical and Experimental Epilepsy

UCL Institute of Neurology, Queen Square, London and

SEIN – Epilepsy Institute in the Netherlands Foundation

Heemstede, the Netherlands

UCL INSTITUTE OF NEUROLOGYDCEEUCL INSTITUTE OF NEUROLOGY

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Epilepsy and Ethics

• Care and Health Care are basic human rights

• All individual and entities have a duty of care in their dealing with other and with the environment • To exercise reasonable care with respect to the

interests of others, including protecting them from harm


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Differing aspects of epilepsy• Seizures – not there most of the time!

– Frequency & severity, unpredictability, safety

• Physical – Impairment of function, mobility, morbidity, co-morbidity

• Emotional and behavioural – Depression, anxiety, adjustment to circumstances

• Social and family functioning– Relationships, dependence, family, leisure

• Cognitive and academic– Schooling, employment, aspirations, expectations


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Ethics:• The Sciences of morality

• In Philosophy, ethical behavior is that which is “good" or “right"

• Concepts such as "good“, "bad“, "right“, "wrong“, "moral“, "immoral” • But these concept may have very different meaning for

different people!


DCEE

Ethics:• The Sciences of morality

• In Philosophy, ethical behavior is that which is “good" or “right"

• Concepts such as "good“, "bad“, "right“, "wrong“, "moral“, "immoral” • But these concept may have very different meaning for

different people!

• Ethically duty of care needs to be exercised properly and impartially


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Ethics:

• Set of moral values that govern interactions of oneself with others, with society and with surroundings encompassing all spheres

• Concerns duties, obligations, and taking the right actions in dealing with others

– Duty of care

• Values, priorities, and morals


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Ethics in Epilepsy

• Multi-faceted condition which affects many domains of people’s life

• As such many aspects to ethics in epilepsy

• Involve relations between people with epilepsy and their carers, family, peer group, health providers, and society as a whole


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Differing Aspects of Ethics in Epilepsy • Clinical Work

• Care

• Research

• Disclosure

• Code of Ethics

• Conflict of Interests

• Treatment Gap


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Clinical Work • Treatment choices

• Decision to treat or not to treat

• People with learning disabilities

• Consent and assent • Treatment procedures • Investigations

• Emergency care

• Terminal care


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Care • Decision making

• Emergency treatment • Calling emergency services• Taking to hospital

• People with learning disabilities• Choices

• Placement• Treatment• Participation in research• Contraception

• Right to privacy


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Research Work I • Detailed study of a subject or issue to discover

new information or reach new understanding

• Must provide benefit

• Should not harm

• Not all “research” is research • service evaluation • audit


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Research Work II • Valid research question

• Appropriate methodology • Well described • Reproducible

• Ethically approved

• Dissemination of results


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Research Work III • Degree of information for consent

• Excluding certain groups from research• Woman in childbearing age• Woman who are pregnant • People with learning disability • People with certain family histories• People with certain co-morbidities• People with previous histories of specific reactions

• People with Learning Disability • Participation in research • Assent or consent


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Research Work II • Scientific integrity• Fraud and misconduct

• Making up data• “Cooking the books”• Plagiarism

• Sloppiness• Cutting corners• Carelessness• Plagiarism

• Animals rights


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Disclosure

• Right to privacy

• Right to confidentiality • Disclosure of medical information• Balancing confidentiality against public interest

• Pilots, drivers, soldiers, bus/train driver with epilepsy


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Conflict of Interest • When someone has more than one interest in

an issue when impartiality is a must

• Dealing with Conflict of Interest • Removal

• Recusal

• Disclosure

• Ethical Code


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Ethical Code • Better think of the issues ahead

• Code of Ethics (institutional, corporate, business)• Sets out general principles on organization's beliefs• Assists making decisions involving 'right' and 'wrong'

concepts

• Code of Conduct (employees ethics)

• Code of Practice (professional ethics)


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Epilepsy in resource poor settings

• Most people with epilepsy in LAMIC

• Usually low health budget • Less than US$ 10/year per capita

• Chronic diseases not a priority• Inoculations, infectious diseases , child health

• Very high treatment gap• High Burden


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Epilepsy in resource poor settings

• Is it ethical for LAMIC to channel limited resources from direct epilepsy care to research?

• In a country with limited resources, when does ignoring the high treatment gap become an ethical issue?

• Do countries with plentiful resources have an ethical responsibility to help relieve the high epilepsy treatment gap of poor countries?

Tan & Avanizini. Epilepsia 2009


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Epilepsy and Ethics: conclusions

• Differing aspects of both epilepsy and ethics

• Best interest of other paramount in care

• Proactive in identifying issues that may raise questions• Need for Ethical Codes

• Ethics, not law or being professional, should provide the ultimate guidance for what we do • The law of least effort should never apply!

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Which new antiepileptic drug for which patient?