1. Essay submitted to the Hastings Center Report
Piracetam, Neuro Fuel™ and the ethics of ‘cognitive enhancement’
30 May 2009
Jenny Gristock
gristock@me.com
Abstract
The paper investigates the additional requirements of ethical frameworks as nootropics
move beyond medical research and clinical practice. Through a case study of the
nootropic Piracetam and the canned drink called Neuro Fuel™, we highlight four problems
associated with the application of the Belmont principles to cognitive enhancement in this
context. These problems occur because as nootropic use moves beyond medical research
and clinical practice, informed consent systems are absent; incertitudes are disguised as
risks; unintended effects on the healthy may not be the same as known side-effects when
the drugs are used by the sick; and unjust patterns of social relations – perhaps resulting
from baseline dependencies, dose conflicts or trade-offs – may result, not only from
unequal allocation or access, but also from the pharmaceutical mediation of social
relations.
Keywords: Cognitive enhancement, nootropics, bioethics, incertitudes, (neuro)mediation
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2. Introduction
Drugs which are used to modify brain function, sometimes called nootropics or ‘cognitive
enhancers’, have been the subject of much discussion in journals, newspapers and
elsewhere of late. Most of the literature discusses the increasing use of pills - old and new
- to modify brain function [1] , the strategies used by the big pharmaceutical companies as
they pursue new markets [2] and the impact of demand for nootropics on role of clinicians
[3] But whilst scientists and ethicists pondered over what this new ‘cosmetic neurology’
might look like and the ethical frameworks which could help neurologists deal with patient
demand stimulated by multinational corporations, something unexpected happened. Two
graduates from Tennessee quietly launched a new commercial nootropic product, not in
the form of a pill to be prescribed by a physician or neurologist, but as an energy drink in a
can.
The drink, called Neuro Fuel™, contains Piracetam, a cyclic derivative of the
neurotransmitter γ-aminobutyric acid (GABA), a nootropic first marketed by UCB Pharma
in 1971.[4] The enterprising pair are Joe Elmore and Waylon Howell, sports and business
graduates from the University of Tennessee, otherwise known as Utopian Enterprises
2
Fig 1: source: www.d

3. (Knoxville). Each can contains 750mg of the drug which contributes to what the company
call its ‘mood enhancement formula’.
According to an industry-supported manuscript [4], the exact mechanism of action of
Piracetam is ‘a matter of debate’ and ‘appears to be unrelated to the properties of this
neurotransmitter’. Nevertheless, it is also said that the drug “modulates neurotransmission
in a range of transmitter systems (including cholinergic and glutamatergic), has
neuroprotective and anticonvulsant properties, and improves neuroplasticity.” Over time it
has become ‘indicated for use in vertigo, dyslexia, cortical myoclonus and sickle cell
anemia in addition to age-related cognitive disorders’.
Neuro Fuel™ was first sold in student shops and supermarkets the US in November 2007.
The graduates describe their beverage as ‘the smart way to feel better’, slogans which
make their campaign reminiscent of the ‘Brain Tonic’ and ‘nerve stimulant drink’ claims
made for Coca Cola in its early days [5][6]. The drink can be bought at university
campuses, retail outlets and online through Amazon.com (24 cans for $41.99).
The company advertises Neuro Fuel™ through its website [www.drinkneurofuel.com]
social networking media such as MySpace and Facebook, and directly to consumers
through trade show events. The use of new media systems of information provision allow
the company to make the following claims for its product:
Neuro Fuel ... increases dopamine and serotonin in the brain through a mix of
proponents, cofactors, and precursors. Through this combination Neuro Fuel
increases energy, alertness, motivation, concentration, drive, intelligence, memory,
euphoria, and sexual drive and performance [7]
The claims made on the company’s official Facebook Group pages are even grander. “The
active ingredients in Neuro Fuel … [have] been shown to be beneficial for everything from
Alzheimer's, Parkinson's disease, and Autism to ADD, depression, and anxiety” [8].
Potential nootropic users read these claims with interest. In the words of one reader from
Alabama: “I suffer from Depression and Anxiety and this product is suppost [sic] to help
with these problems. I would love for this to work for me so I don't have to rely on meds
and doctors”.[9]
Thus, Neuro Fuel™ has been welcomed by hundreds of its fans; as a party drink, and,
perhaps rather alarmingly, as an alternative to medications from physicians. But not
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4. everyone is so enthusiastic. Quoting the Neuro Fuel™ website’s claims concerning
Alzheimer's, Parkinson's Autism, ADD and depression, another consumer, - a member of a
transhumanist community forum - writes:
Yikes! what are they thinking? They are in way over their head…I think this will
ruffle the feathers of the feds and they will take this down and potentially all other
Piracetam on the market. [10]
This user is not alone. A user from Texas says: ‘I can see this causing a stir that might hurt
supplement availability’. A third concurs: ‘If we feel strongly enough about the negative
impact of their marketing, perhaps we should alert them to this thread, or have a "sit down"
with them’. Others question Utopian Enterprises’ choice to describe Piracetam as a dietary
supplement (see ref 11). ‘Come on, its not a dietary supplement by current FDA rules. I
mean seriously, Piracetam is a drug…I would think the FDA would have something to say
about a drug being put into an energy drink’. [10] Yet Piracetam is not on the FDA’s list of
approved drugs, nor are any of the other nootropics. “The FDA doesn’t regulate dietary
supplements so we don’t have a list of those products” [12].
Other sources of Piracetam
When ImmInst Forum members say they are concerned that the Neuro Fuel™ marketing
campaign is ‘endangering all other Piracetam on the market’, they refer to companies that
are supplying Piracetam in capsule and powder form, to be purchased over the internet.
Without regulation, users are vulnerable. For example, one user has captured his
experiences of this drug on video, and has shared his experience by posting a number of
films on Youtube. Readers of this article who take the time to watch the video footage
available online under the name, ‘The Piracetam Experiment’ [13] may note the user
becomes ill when he takes too much of the drug (1400mg three times daily), despite
apparently following the suppliers’ instructions carefully. Later on the user claims that the
seller’s instructions recommend a much higher dose than most. “I think this company is
just trying to make you burn through your supply more often so you’re gonna buy more,”
he says ruefully. ‘I took way too much’.
Thus we see that early nootropics are becoming available, not only in capsule and powder
form through small companies selling the drugs through the internet, but also through
mainstream channels, both online (such as Amazon) and offline, such as traditional
supermarkets and grocery stores. Citizens gain their information about these products
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5. through social networking sites and word-of-mouth recommendations. Some of the most
vocal supporters of these products in online fora are teenagers, other young people and
people who suffer chronic illness.
Nootropics and the Belmont Principles
Much of the published literature on ethics and nootropics draws, either explicitly or
implicitly, from Beauchamp and Childress [14] and the principles of the Belmont report:
[15] respect for persons and autonomy, beneficence, non-maleficence, and justice.
Although these principles emerged out of concerns about the (un)ethical conduct of
medical research, they have also ‘permeated clinical medicine’ [16]. If one relates ‘safety’
to beneficence and non-maleficence, and ‘coercion’ to autonomy, these four principles are
highlighted in Chatterjee’s [3] ‘seminal article’ [17] and Farah’s [18] thoughtful and highly
cited work. They are also used by Strech [19] and Synofzik [20], who argue for a ‘context-
and case-sensitive approach’ to nootropics.
But the drugs called cognitive enhancers have moved beyond research and beyond
clinical practice. Because of this, there are a number of problems with the application of
these four principles to the use of nootropics. The overlooked issues are as follows.
Issue 1: Nootropics, autonomy and informed consent.
The principles of the Belmont Report stress the importance of informed consent in medical
research. If being ‘inadequately informed… is detrimental to your autonomy’ [21] then
informed consent is vital to autonomy [14]. Some argue that informed consent ‘comprises
three elements: relevant information is provided to a person who is competent to make a
decision, and who is situated to do so voluntarily’ [22]. But in medical research informed
consent is the result, not only of a process but also of one or more systems: dedicated
communication systems which attempt to: mediate the provision of information in a form
suited to the potential participant; test understanding; and provide the ethical and legal
basis for participation. Thus, there is a relationship between: the effectiveness of these
systems; the information that is available and presented; the meaning that is created from
it; and a participant’s autonomy. In other words, the communications systems which
mediate informed consent also mediate autonomy in medical research and clinical care.
As we move beyond research and clinical care, and more significantly, outside clinical care
to other contexts of nootropic consumption, systems of informed consent are replaced by
other communication systems - packaging and advertising in old and new media – whose
processes have very different ends. The communication systems are designed, first and
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6. foremost, to sell products and encourage consumption. Thus, when we move beyond
medical and clinical research, our first Belmont principle is missing an essential
foundation: something needs to stand in its place.
Consider the many other contexts of nootropics consumption – such as off-label use
(where, by definition, patient information leaflets contain no information pertinent to the
intended use) and the use of lifestyle nootropic products such as Neuro Fuel™, where
health claims are communicated through unregulated media, such as social networking
websites. With respect to the older nootropics, such as Piracetam, some of the information
provided by these communication systems - for example, the dosing instructions read by
nootropic user h8uall66, appears to have been harmful to nootropic users. Similarly the
claims made by Neuro Fuel™ have been questioned, even by nootropic enthusiasts.[23]
Issue 2: Nootropics, incertitudes and risk
When assessing beneficence and non-maleficence of nootropics, ethics authors speak of
risks. But a risk is the probability that a known harmful event will occur. As and Stirling [24]
points out, we do not always know the likelihood of a known event (uncertainty), we are
not always sure what kind of event will happen (ambiguity) and furthermore, some
outcomes are so unknown to us, that we are not even aware of our lack of knowledge
(ignorance). Thus, argues Stirling, it is not only risk, but also the other three components
to our incertitude that are pertinent to our decisions. If we are imprecise, and imagine that
all we need to concern ourselves with are risks then we are labouring under the false
impression that we posses all the information we need to make judgements. Thus, when
Synofzik [20] instructs us to ‘assess the benefit-harm ratio for a specific drug X given to a
specific person Y in the specific context Z’ he also admits that ‘assessment of the benefit-
harm ratio’ can be ‘impossible’, ‘even for a physician’, because ‘data about benefit-harm
ratios are still largely missing.. questionable benefit-harm ratios of psychotropics are often
not published, not adequately interpreted or falsely presented in direct-consumer
advertisements’. To this, we would add the following: First, that it is not that ‘data about
benefit/harm ratios’ are ‘missing’, but rather, potential uncertainties, ambiguities and
unknown unknowns, imply a multiplicity of benefits and harms which make the very
idea of basing decisions around a single benefit/harm ratio questionable at best.
Felt [25] notes that in ethics there is a tendency to defer decisions “to an imagined place
where there would be more facts available to assess possible consequences”. We also
need to recognise that the selection of the ‘benefits’ and ‘harms’ to be put into such
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7. calculations are political processes. Thus, any plans to make decisions about the
‘legitimacy’ of enhancement based on a ‘benefit-harm ratio’ (1) overlook uncertainties,
ambiguities and potential ignorance of nootropics, and (2) dodge the question of which
benefits and which harms we are considering (or not considering) in the first place. These
influence considerations of beneficence and non-maleficence.
Issue 3: Nootropics, side-effects, unintended effects and imbalance effects
Research appears to indicate that the effects produced when a drug acts on a healthy
brain may not be the same as those produced when it is used in illness [26] [27] [28]. To a
greater or lesser extent, the referenced studies consider how ‘memory, attention and
creativity represent three different cognitive domains, which are interconnected and
contribute the ‘mental performance’ of an individual’ [26]. But it is Lanni et al [26] and de
Jongh [27] who reflect most deeply about the implications of the existence of ‘different
cerebral circuits and molecular events regulating memory, attention, creativity and
problem-solving’ and their implications for the use of nootropics. For by drawing attention
to the ‘distinct but heavily intermingled’ systems which contribute towards mental
performance, Lanni (2008) and de Jongh highlight the potential for a nootropic, like any
innovation, to have both enhancing and detrimental effects at the same time.
Thus, some neuroscientists argue that as a consequence of the baseline dependencies,
dose conflicts, trade-offs and other factors [26][27][28], the potential problems associated
with the use of nootropics by healthy people are not at all the same as the ‘side-effects’ of
drugs when used in illness.
The reason for this increased need is that, while targeting a disease process we
may more easily isolate biological targets on the basis of their multifunctions, when
hitting a normal function having in mind to improve it, there is the need to explore in
depth the consequence of an increased (rather than restored as in illness) function
on all the correlate system (26; p209).
Lanni et al [26] and de Jongh [27] take this argument no further, but it is suggested here
that if there is a difference between the effects of restoring function, and the effects
produced when acting on a healthy brain, then we need to ensure that when considering
the ethics of nootropics use by healthy people, we are not speaking of ‘side-effects’, which
involve the illness paradigm. At best, we need to speak of ‘unintended’ effects. At worst, if
the ‘intermingling’ of cognitive systems does constitute a ‘balance’ between different
cognitive domains, a more appropriate label might be (im)balance effects. Thus the
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8. regulatory approach to unintended effects of nootropics by the healthy might need to be
different to those which have been created to assess therapeutic pharmaceuticals.
Issue 4: Nootropics, socio-technical systems and distributive justice.
Distributive justice is ‘the fair, equitable and appropriate distribution determined by justified
norms that structure the terms of social co-operation’ [14]; ‘the allocation of the benefits
and burdens of economic activity’ [29]. If theories aim for the equal allocation of resources,
then there is a tacit assumption that an equal distribution of resources will equalise gain.
But it is not only the allocation of technologies which can introduce ‘unjust cultural patterns
of value and hierarchy’ [30]. If having two cars benefits an individual family, it does not
necessarily follow that a society in which every family has two cars is a healthy one; and
neither does it follow that interventions which succeed in equalising the allocation of cars
will benefit everyone in society – equally or otherwise.
Non-allocation issues are particularly important with respect to pharmaceutical
technologies such as nootropics, given the ‘complex and dynamic relationship between
the brain (and its related systems) and social interaction’ [31]. For example, if, as Lanni et
al [26] and de Jongh et al [27] suggest, a drug which improves memory may have a
detrimental effects on attention, it is possible that the use of such a drug may positively
impact memory, but negatively influence interpersonal communication and trust relations.
Under such a scenario, there is no evidence to suggest that an equal allocation of the drug
to all citizens will be, de facto, beneficial: the associated shifts in relationships and social
structure are unknown. It is suggested here that this implies that distributive justice is
insufficient as a value principle to guide the use of nootropics. It also suggests that as well
as requiring evidence of the impact of such drugs on individual healthy brains, we also
need to gather evidence of the impact of nootropics on the ‘complex and dynamic
relationship between the brain (and its related systems) and social interaction’ [31] and
social roles [30]. The question, ‘what sort of society would we become?’ applies not only to
a potential gap between the haves, and the have-nots, but also to the socio-technical
(pharmaceutical) mediation of social relations. These are new questions for ethics and
social neuroscience.
Conclusions
This paper takes neither a transhumanist nor a bioconservative approach to the use of
nootropics, given what they offer those with chronic illnesses for which there are, as yet,
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9. no effective approved treatments. Rather, it argues that attention needs to be paid to the
conditions under which nootropics are produced, the systems through which they are
marketed, delivered and consumed. The cases here demonstrate how, as nootropics
move outside medical research and clinical medicine, the four tenets of traditional
bioethics - which are often used in ethical analysis of nootropic drugs - become
insufficient as guiding principles. This is because outside medical research and clinical
contexts, information and products are provided through unregulated media, driven by
commerce, and thus our principle of autonomy is not underpinned by systems for informed
consent. Furthermore, we may no longer (if we ever could) consider use harm/benefit
ratios to judge beneficence and non-maleficence, because our formula disguise
incertitudes as risks, and thus deny all potential uncertainty, ambiguity and ignorance - nor
indeed, multiplicities in benefits and harms - associated with nootropics use. Furthermore,
because of the interconnectedness of cognitive domains [26], baseline dependencies [26],
dose conflicts [27] and trade-offs [26] associated with the use of nootropics, not all
unintended effects are ‘side’ effects; so we need new ways to discuss how we perceive the
trade-off between potential benefits and harms. In addition, the concept of distributive
justice neglects non-allocation issues, which may lead nootropic use to impact, not only on
individuals, but on social relations. With respect to justice, this requires a focus, not just on
obduracy and allocation, but on the inclusive and exclusive properties of systems of
mediation within innovation systems. [32] In other words, in neurosocieties [33][34] we
require new ethical frameworks to consider the ethics of systems of (neuro)mediation.
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