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Regulation of Pharmacological
Substances Enhancing
Cognition: Policy Proposal
Alma LINKEVICIUTE
PhD stude t i Fou datio s of Life
Sciences and their Ethical
Co se ue ces P og a e
OUTLINE
Usage and attitudes to pharmacological
cognitive enhancement (PCE) among
Lithuanians (food supplements).
PCE usage and attitudes in other countries.
Reasons for and against the use of PCE.
Values to be protected.
Policy proposal.
PCE usage among Lithuanians
2008 2011
N=531
Paper questionnaire
Students of 7 universities
3 non-university higher
education colleges
40,9% used food
supplements
Only 2 respondents used
prescriptions drugs
N=61
23 students
Online questionnaire
30 academics
8 physical work/unemployed
34,4 % used food supplements to
enhance cognition
Substance 2008 (%)
Food supplements, vitamins
Medicinal drugs under prescription
Energy drinks
Coffee, tea
Recreational drugs
Over the counter drugs
Alcohol, nicotine
Other
61
54,4
36,3
29,8
26,2
18,6
13,2
1,9
What respondents considered to be pharmacological cognitive
enhancement (N=531). Respondents could choose few answers.
Food supplements, vitamins
Medicinal drugs under prescription
61
54,4
Effect 2008 (%) 2011 (%)
My concentration became better
I felt more awake
I could memorize new information faster
I had energy boost
I did not notice any effect
I experienced some side effects
I could finish my tasks faster
39,7
35,8
30,9
29,1
26,5
14,8
14,7
33,3
42,9
33,3
28,6
28,6
9,2
28,6
Effects respondents experienced while taking food supplements which were described
as enhancing cognition by distributor (N=217 in 2008; N=21 in 2011). Respondents
could choose few answers.
My concentration became better
I felt more awake
I could memorize new information faster
I did not notice any effect
Both surveys at glance
2008
NEUROZAN, GERIMAX,
MEMOREX, BILOBIL
Using or used in the past:
40,9%
Main source of information:
TV adverts – 80,4%
PCE is cheating – 5,6%
2011
NEUROZAN, GERIMAX,
MEMOREX, BILOBIL
Using or used in the past:
34,4%
Main source of information:
Scientific articles 66,6%
TV adverts – 60,7%
Consultation with doctor/pharmacist
49,1%
PCE is cheating – 14,7%
Situation 2008 (%) 2011 (%)
Degenerative illness affecting cognition
During the exams
During intensive work
Being in a job requiring attentiveness
Going for an important interview
Serving at the military
60,6
57,1
54,6
28,4
3,4
2,6
67,2
39,3
50,8
19,7
3,3
4,9
Situations in which respondents would justify the usage of pharmacological
cognitive enhancement (N=531 in 2008; N=61 in 2011).Respondents could
choose few answers.
Degenerative illness affecting cognition
During the exams
During intensive work
Expectation 2008 (%) 2011 (%)
Effectiveness in short time
Limited side effects
Safety
Self-confidence
70
37,4
27,1
17,2
85,7
33,3
49,9
28,6
Expectations influencing the decision to use cognition enhancing food
supplements (N=217 in 2008; N=21 in 2011). Respondents could choose few
answers.
Effectiveness in short time
Key points:
• Confusion in distinguishing medicinal drugs
and food supplements (advertising violations)
• Liberal attitude to usage (especially among
individuals doing intellectual work)
• Scepticism about the effectiveness (emphasis
on effort)
• Only small numbers agreed that the usage of
PCE is cheating or promotes social inequalities
PCE usage in other countries:
• US estimates of PCE usage differ between
1.5% and 31% which makes research
techniques questionable (Hall et Lucke, 2010).
• Ragan et al., 2013; provides an international
PCE prevalence overview for prescription
drugs: Germany <2%, Belgium – 4%, Denmark
– 7%, the UK – up to 10%, Iran – 7,7%
Attitudes towards PCE in other
countries:
Australia and Canada (student surveys): could lead to
unfair advantage, coercion to take enhancement if
majority is doing that and limit individual freedom to
choose how to study (Bell et al., 2012; Forlini et
Racine, 2009).
Sweden: general public finds it acceptable to enhance
human capacities by using natural remedies but only
small minorities of general public and medical
practitioners agree to allow the use of
pharmaceuticals (Bergstrom et Lynoe, 2008).
What are broader attitudes?
Not clear what public opinion on PCE is
(individual trends, societal tendencies,
institutional promotions)
No unity in the regulations across EU
(enhancement tourism)
No solid scientific evidence that PCE really works
Laissez-fair approach in Europe
What are recommendations?
2004: enhancement projects suggested to be
blocked politically (HLEG)
2007: healthcare concerns must be met first
(EGE, Opinion 21)
2008: research aiming for non-therapeutic
enhancement should not be undertaken (EC
Recommendation)
2009: STOA study; 2012: Discussion in EP (CSC)
Institutional policies:
Universities and business are reportedly
ignoring the ethical challenges posed by the
use of cognitive enhancement. The use of
cognitive enhancement drugs is not discussed.
Majority of university codes speak of drugs in
a light of compromised work performance
(Goodman, 2014).
Arguments for PCE:
• Usage would reduce personal losses: lost keys,
forgotten passwords, flooded bathrooms, etc.
• Make work more effective, learning process
faster.
• Help to create welfare and avoid poverty.
• Contribute to individual and society wide
benefits.
Arguments against PCE:
SAFETY: side-effects, addiction, too risky
COERTION: pressure to perform better
FAIRNESS: advantage in the competition
INEQUALITY: not everybody can assess
ALTERED PERSONALITY: boosted self-confidence
HUMAN NATURE: changed radically
PURPOSE OF MEDICINE: treat, prevent, enhance?
ACCOMPLISHMENT ARGUMENT: pride of own work
What do European societies value?
HUMAN RIGHTS and HUMAN DIGNITY
Autonomy, justice, equality, bodily integrity,
health, solidarity, freedoms, beauty...
European values is political and ethical but not
geographical concept.
When and if values clash, they can be ranked
(Hermeren, 2008).
Are we putting ban on PCE?
REASONED PRO-ENHANCEMENT APPROACH
REASONED RESTRICTIVE APPROACH
CASE-BY-CASE APPROACH
Economic Disincentives Model (Dubljevic, 2012)
Temporary committee/working group (Coenen
et al, 2012)
Reasoned pro-enhancement
approach
Meets demands and desires for individual life
choices but not at public expense.
Reflects on changing socioeconomic framework.
Does not necessarily promote the use of PCE but
encourage open public debate.
Shifts from tacit PCE use to a culture of open
use.
Allowing research sets foundations for safety
and quality standards.
Individual Institutions Society
Research Safety
Efficacy
Quality
Knowledge
Clarified
expectations
Transparency
Communication
Public discussion Limits coercion
Helps to establish
fairness in usage
and access
Openness about
usage
Institutional PCE
usage culture
Addresses
inequality issues
Deliberation
about the costs
The points to address when
drafting a policy on PCE:
Why clearer stand is beneficial?
Ensures equal access for all Europeans
Avoids enhancement tourism
Sets up unified safety standards
Safeguards safety and quality of technology
Protects vulnerable (children, students, elderly)
Helps to make informed choice
Defines misuse and abuse
Acknowledgements:
• P of. D . Osvaldas Rukšė as, D . G ita “kujie ė
and Dr.Saulius Noreika at Vilnius University,
Lithuania
• Law, Philosophy and History Department at
Mykolas Romeris University, Lithuania
• Erasmus Mundus Master of Bioethics
Programme at K.U.Leuven, Belgium
• FOLSATEC team at European Institute of
Oncology in Milan, Italy
Thank you for your enhanced
attention!

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2014_06_10_Regulation of Pharmacological Substances Enhancing Cognition_Helsinki

  • 1. Regulation of Pharmacological Substances Enhancing Cognition: Policy Proposal Alma LINKEVICIUTE PhD stude t i Fou datio s of Life Sciences and their Ethical Co se ue ces P og a e
  • 2. OUTLINE Usage and attitudes to pharmacological cognitive enhancement (PCE) among Lithuanians (food supplements). PCE usage and attitudes in other countries. Reasons for and against the use of PCE. Values to be protected. Policy proposal.
  • 3. PCE usage among Lithuanians 2008 2011 N=531 Paper questionnaire Students of 7 universities 3 non-university higher education colleges 40,9% used food supplements Only 2 respondents used prescriptions drugs N=61 23 students Online questionnaire 30 academics 8 physical work/unemployed 34,4 % used food supplements to enhance cognition
  • 4. Substance 2008 (%) Food supplements, vitamins Medicinal drugs under prescription Energy drinks Coffee, tea Recreational drugs Over the counter drugs Alcohol, nicotine Other 61 54,4 36,3 29,8 26,2 18,6 13,2 1,9 What respondents considered to be pharmacological cognitive enhancement (N=531). Respondents could choose few answers. Food supplements, vitamins Medicinal drugs under prescription 61 54,4
  • 5. Effect 2008 (%) 2011 (%) My concentration became better I felt more awake I could memorize new information faster I had energy boost I did not notice any effect I experienced some side effects I could finish my tasks faster 39,7 35,8 30,9 29,1 26,5 14,8 14,7 33,3 42,9 33,3 28,6 28,6 9,2 28,6 Effects respondents experienced while taking food supplements which were described as enhancing cognition by distributor (N=217 in 2008; N=21 in 2011). Respondents could choose few answers. My concentration became better I felt more awake I could memorize new information faster I did not notice any effect
  • 6. Both surveys at glance 2008 NEUROZAN, GERIMAX, MEMOREX, BILOBIL Using or used in the past: 40,9% Main source of information: TV adverts – 80,4% PCE is cheating – 5,6% 2011 NEUROZAN, GERIMAX, MEMOREX, BILOBIL Using or used in the past: 34,4% Main source of information: Scientific articles 66,6% TV adverts – 60,7% Consultation with doctor/pharmacist 49,1% PCE is cheating – 14,7%
  • 7. Situation 2008 (%) 2011 (%) Degenerative illness affecting cognition During the exams During intensive work Being in a job requiring attentiveness Going for an important interview Serving at the military 60,6 57,1 54,6 28,4 3,4 2,6 67,2 39,3 50,8 19,7 3,3 4,9 Situations in which respondents would justify the usage of pharmacological cognitive enhancement (N=531 in 2008; N=61 in 2011).Respondents could choose few answers. Degenerative illness affecting cognition During the exams During intensive work
  • 8. Expectation 2008 (%) 2011 (%) Effectiveness in short time Limited side effects Safety Self-confidence 70 37,4 27,1 17,2 85,7 33,3 49,9 28,6 Expectations influencing the decision to use cognition enhancing food supplements (N=217 in 2008; N=21 in 2011). Respondents could choose few answers. Effectiveness in short time
  • 9. Key points: • Confusion in distinguishing medicinal drugs and food supplements (advertising violations) • Liberal attitude to usage (especially among individuals doing intellectual work) • Scepticism about the effectiveness (emphasis on effort) • Only small numbers agreed that the usage of PCE is cheating or promotes social inequalities
  • 10. PCE usage in other countries: • US estimates of PCE usage differ between 1.5% and 31% which makes research techniques questionable (Hall et Lucke, 2010). • Ragan et al., 2013; provides an international PCE prevalence overview for prescription drugs: Germany <2%, Belgium – 4%, Denmark – 7%, the UK – up to 10%, Iran – 7,7%
  • 11. Attitudes towards PCE in other countries: Australia and Canada (student surveys): could lead to unfair advantage, coercion to take enhancement if majority is doing that and limit individual freedom to choose how to study (Bell et al., 2012; Forlini et Racine, 2009). Sweden: general public finds it acceptable to enhance human capacities by using natural remedies but only small minorities of general public and medical practitioners agree to allow the use of pharmaceuticals (Bergstrom et Lynoe, 2008).
  • 12. What are broader attitudes? Not clear what public opinion on PCE is (individual trends, societal tendencies, institutional promotions) No unity in the regulations across EU (enhancement tourism) No solid scientific evidence that PCE really works Laissez-fair approach in Europe
  • 13. What are recommendations? 2004: enhancement projects suggested to be blocked politically (HLEG) 2007: healthcare concerns must be met first (EGE, Opinion 21) 2008: research aiming for non-therapeutic enhancement should not be undertaken (EC Recommendation) 2009: STOA study; 2012: Discussion in EP (CSC)
  • 14. Institutional policies: Universities and business are reportedly ignoring the ethical challenges posed by the use of cognitive enhancement. The use of cognitive enhancement drugs is not discussed. Majority of university codes speak of drugs in a light of compromised work performance (Goodman, 2014).
  • 15. Arguments for PCE: • Usage would reduce personal losses: lost keys, forgotten passwords, flooded bathrooms, etc. • Make work more effective, learning process faster. • Help to create welfare and avoid poverty. • Contribute to individual and society wide benefits.
  • 16. Arguments against PCE: SAFETY: side-effects, addiction, too risky COERTION: pressure to perform better FAIRNESS: advantage in the competition INEQUALITY: not everybody can assess ALTERED PERSONALITY: boosted self-confidence HUMAN NATURE: changed radically PURPOSE OF MEDICINE: treat, prevent, enhance? ACCOMPLISHMENT ARGUMENT: pride of own work
  • 17. What do European societies value? HUMAN RIGHTS and HUMAN DIGNITY Autonomy, justice, equality, bodily integrity, health, solidarity, freedoms, beauty... European values is political and ethical but not geographical concept. When and if values clash, they can be ranked (Hermeren, 2008).
  • 18. Are we putting ban on PCE? REASONED PRO-ENHANCEMENT APPROACH REASONED RESTRICTIVE APPROACH CASE-BY-CASE APPROACH Economic Disincentives Model (Dubljevic, 2012) Temporary committee/working group (Coenen et al, 2012)
  • 19. Reasoned pro-enhancement approach Meets demands and desires for individual life choices but not at public expense. Reflects on changing socioeconomic framework. Does not necessarily promote the use of PCE but encourage open public debate. Shifts from tacit PCE use to a culture of open use. Allowing research sets foundations for safety and quality standards.
  • 20. Individual Institutions Society Research Safety Efficacy Quality Knowledge Clarified expectations Transparency Communication Public discussion Limits coercion Helps to establish fairness in usage and access Openness about usage Institutional PCE usage culture Addresses inequality issues Deliberation about the costs The points to address when drafting a policy on PCE:
  • 21. Why clearer stand is beneficial? Ensures equal access for all Europeans Avoids enhancement tourism Sets up unified safety standards Safeguards safety and quality of technology Protects vulnerable (children, students, elderly) Helps to make informed choice Defines misuse and abuse
  • 22. Acknowledgements: • P of. D . Osvaldas Rukšė as, D . G ita “kujie ė and Dr.Saulius Noreika at Vilnius University, Lithuania • Law, Philosophy and History Department at Mykolas Romeris University, Lithuania • Erasmus Mundus Master of Bioethics Programme at K.U.Leuven, Belgium • FOLSATEC team at European Institute of Oncology in Milan, Italy
  • 23. Thank you for your enhanced attention!