- It is my pleasure to introduce Judy Iles,
who is the Canada Research Chair in neuroethics
at the University of British Columbia.
To give you an idea of how broadly-ranging her interests
and research areas are, she also has affiliate appointments
in Public Health and Population Heath Sciences
and in Journalism, and she came to UVC
from Stanford University, where she had taken her PhD
in Speech and Hearing Sciences.
As she was there, she began to really develop
her abilities and skills in developing centers
and interdisciplinary work, and became very interested
in working with ethical issues,
and came to the Stanford Center for Biomedical Ethics,
where we worked together, lo those many years ago.
She's been absolutely instrumental since then
in developing the area of neuroethics,
and neuroscience and ethical policy issues.
So she co-founded the International Neuroethics Society,
and currently serves as its president,
and she's the Director of Canadian National
Corps for Neuroethics, and was named fellow
of the Canadian Academy of Health Sciences,
the Royal Society of Canada, and is a fellow
of the American of the Advancement of Science.
She has long been interested and done
a lot of work in imaging research,
but she's ranging much more broadly now,
and has also done work on, for example
how neuroscience has been perceived in the media.
And she's just publishing a new book,
which will appear this coming year from Oxford Press,
Neuroethics: Anticipating the Future.
With that, I give you Judy Iles.
(audience applauding)
- Thank you Linda, and Mike, it's pleasure to be
with old friends and new friends,
and I've enjoyed my evening here yesterday
and my day today just so very much.
It's a very short visit and I'm sorry
to be leaving so quickly.
But I'm delighted to be culminating
my 30 hours with you with this lecture,
and to give you a primer of neuroethics,
but through some case examples of some
of the work that we've been doing at UVC and elsewhere,
and give you a sampler from some work
around cells, systems, and communities.
All of the work that I do really stands on the shoulders
of my colleagues and my students and my funders,
and to all of them, and to those who participate with
our studies, and to all of them I'm immensely grateful.
And I also am honored to be giving this lecture.
My own training in the neurosciences
involved many studies that I learned from Paul,
Dr. Paul Bach-Y-Rita, and I'm honored
to be giving this lecture today in his memory.
So let's start with some first principles
around neuroethics.
And Linda was kind enough to tell me
that you are very sophisticated audience,
and to focus on data, and not just on theory,
and I assure you that I will do that.
But nevertheless, a little bit of theory,
just to be sure that we're all on the same page.
The first principle, I feel, is that for the sciences
of the central nervous system,
to be applied for public health, social good,
I think it's really essential to identify
and address ethics challenges at their earliest stages.
Sometimes we can do them entirely proactively,
sometimes we want to get in there a little bit early,
sometimes we actually have to step in
after the horse has left the barn,
and I'll come back to that metaphor in a moment.
But the earlier we can get in and align ethics
and law and social issues and policy considerations
alongside the neuroscience, the better.
And the other first principle,
maybe it's a second first principle,
is that I really believe that the views
and values of all stakeholders are a vital goal
in achieving this goal, and in fact I'm going
to focus a lot of the case examples
that I'm going to share with you, although not entirely,
on what voices and values have brought
to us in the domain of neuroscience and neuroethics.
And this is a slide from Nicole,
who I met with this morning.
And I just want to say that neuroethics
is very pragmatic and practical,
and really has departed from what I believe
are the historical, perhaps adversarial
relationships between bioethics and science.
And I'll just do that again because I paid
a lot of money for this animation,
which is that we really want to put ethics
on the science horse.
And it's not riding the science, that's not the metaphor,
it's really moving ahead quickly and robustly together.
And I think there's good reason for that.
So if we think about the history of neuroscience going,
even way back before the 1940s,
but we think about some of the dark moments
in the history of neuroscience, pre-frontal lobotomies,
some of the atrocities perpetrated
during the second World War by psychiatrists
and neurologists, of all people.
There really is a history of ethical missteps,
if not ethical neglect, that we really responded to today.
And I think about the International
Brain Research Organization here,
the Society for Neuroscience formed in 1969,
and many of the issues, the Social Issues Round Table
that was initiated by the Society for Neuroscience,
and on and on, including the formation
of the International Neuroethics Society in 2006.
And that's a teeny piece of the logo here,
I'll show you a bigger logo of it later.
We are really responding now and growing
as field of people dedicated to thinking
about these issues in public policy
and neuroscience, really hand in hand.
And I think it's an extremely exciting time for us.
The Society itself, the Neuroethics Society
itself just celebrated its 10th anniversary,
and we're actually looking at the 15th anniversary of the
field itself, formalized in 2002, this coming November.
So here's today's journey, and I hope
that I can get through it in time
that we have plenty of time for discussion.
What I'd like to do is talk a little bit
about my work with my colleagues on stem cells
and spinal cord injury as an example
of where neuroethics and cellular science
actually intersects and has an impact on autonomy.
I'd like to talk with you a little bit
about neuroimaging and disorders of consciousness,
and some of the work that I think
has evolved towards understandings of the self,
particularly under the case of brain trauma
and neurologic conditions.
And I'd like to talk with you a little bit
about neuroethics and dementia.
And so what's the rationale for these
three very different kinds of case examples?
Well I think they share narratives,
and I will bringing forward the voice
of stakeholders in each of them,
but they do represent values and a range of technologies,
I feel that they are really timely and relevant.
And for each of these, although they're not the only ones,
they've had some substantial impact
on the policy and regulatory communities,
and have led to future directions
that I'm very excited to share with you today,
including some hot off the press results
and publications that we have coming out.
So in general, this is the framework
that we're working through, at least in my lab
and with other groups in neuroethics,
which is a very practical one, a very pragmatic one,
and we really enter the field by identifying,
prioritizing areas for discovery.
My work, and again those of many of colleagues
really is very empirically based.
We collect data using both quantitative
and qualitative methods, and use a lot of social sciences
methods that I bring together with hard sciences.
We engage and embark usually on a high degree
of deliberative consultation to experts
to really take the data and interpret it,
and bring that forward and bring it
in consultation with stakeholders, both lay and expert,
and then to deliver guidance, whether it's in
the form of best practice or policy recommendations.
And overall, our goal, as Ann Glover wrote,
or was written about Ann Glover in 2013
is to inject science into policy-making.
And really our philosophy, and it's one
that very much we spoke about when Linda
and I were at Stanford, is that it's much more
meaningful to have guidance and regulations
and public policy that are promulgated
from inside the science rather than
by the external community, where its relevance,
where its accuracy might not be as great as if put forward
in an evidenced and expert way, and informed way.
So our analytic approach, and this is just to show you,
for those of you who are here from the hard neurosciences,
that our analytic approach is every bit
as rigorous as collecting fMRI data,
it's just a little bit kind of, different kind of data.
So this would be our analytic approach,
for example, to interview our focus group data,
where we actually collect the data,
so this would be narratives, for example,
we manage the data through a very rigorous process
of coding and iteration and checking
and science field notes.
We might engage in a phase of descriptive accounts
where we start to pull themes out
from what we're hearing from interviews,
focus groups, for example, we'll start to compare the data,
and then develop explanatory accounts.
And all of this goes on in an iterative
process throughout the analysis.
And, in fact, unlike some of the quantitative methods
that are more familiar to you in the neurosciences,
we actually start analyzing narrative data
like interviews from the moment we start collecting it,
and it evolves through the analytic process,
it's very iterative.
We don't wait to collect a lot of data
and then put it through an analytic statistical
step or another approach.
So, let's talk about stem cells
and spinal cord injury first.
This work actually stems back to
when I was still at Stanford, and we'll just start
by giving you some data, some statistical data.
There's 12,000 cases, new cases of paraplegia
in the United States, and quadriplegia
in the United States alone each year.
80 percent are spinal cord injury patients
who are young males, and you can see the kinds
of trauma through the images I put up on the slide.
I think in the area of stem cells and regenerative medicine,
there are very few examples, except maybe imaging,
which we'll talk about in a moment,
where the science and society divide
has either been so great or so hotly debated.
And I just want to call out my collaborators
Dr. Kwan and Marlene Eikholt, who work with me
at UVC on some of these studies of stem cells,
both at the bench, the ethics of stem cells
at the bench, and for clinical trials.
And so this work, this case study
that I'm going to share with you now,
has had three phases involving the individuals
you see up on the slide here.
Experts in the laboratory and the medical community,
affected individuals, as well as the people
who care for them.
And so the very first phase of work was conducted
when I was still at Stanford in 2007,
and we reached out to stem cell scientists,
and think about the era of stem cell science in 2006, 2007,
we were just kind of rolling,
and people were barely thinking about
the ethics of the area except for embryos.
And we reached out to scientists on the West Coast,
and we said think about what might be the
ethics priorities for this field as we go forward.
Help us understand where we need to be taking
the sort of, ethical, legal, and social issues.
And this is what they shared with us, through again,
interviews analyzed in the rigorous way
that I showed you before.
And the importance of truly informed consent.
And I have to tell you that this is taking me
down the path now, after a number of years,
to start thinking about models of informed uncertainty,
rather than informed consent,
and I'll just leave that little seed with you.
And patient vulnerability, the importance of public trust,
the importance of scientists having expertise not only
in the science but also in the ethics, and vice versa.
Again, anticipation of risk and consequences
to prevent setbacks and backlash,
as we've seen for example in other areas of science.
And also criteria for moving from pre-clinical
to clinical studies.
So those were the early days, in my world of ethics,
and I moved to UVC in Vancouver in 2007.
I quickly embarked on some studies with my colleagues there.
And one of the things we did is we went with our clipboards,
I don't think we had iPads at the time,
to the large meeting of the Society of Neuroscience,
where there's sometimes 30,000 attendees, and we said,
"Tell us what you think should be the optimal
trial time window for clinical studies.
Just what do you think?"
And so you see the, I show you on the slide
what most of the respondents said, that it should be,
you know most of them said between six weeks
and three months post-injury.
Can any of you make a wager of actually
where the majority of clinical trials are
in terms of post-injury time-point now?
Can anybody call out an answer?
Where do you think it is, do you think it's in this window?
Do you think it's earlier or later?
I'm seeing heads shaking.
Sorry?
Say it, out loud.
Later, you think later?
Okay, interesting, later.
Anybody else want to make another guess?
Okay, well you, like we in other studies
that we've done, are dead wrong.
This is when the clinical trials are going on.
150 of 161 registered trials in clinicaltrials.gov
are taking place in the immediate post-acute window,
seven to 14 days post-injury.
Very interesting, and so we'll come back
to this window in just a moment,
because we have learned through our further studies
that it is really sub-optimal from
the patient and caregiver point of view.
And the question will be, can we do anything about that?
So we embarked on some studies to find
out the answer to that question.
We worked with 24 post-injury participants who were chronic,
that is 18 months post-injury, and a smaller,
necessarily smaller number of sub-acute post-injury,
who were one to seven months post-injury,
and there's a big gap between the immediate post-injury,
and let's say longer-term post injury, sort of
to try to mitigate any blurring effects there.
And we ran both focus groups and one on one interviews,
and many of these are actually in hospital
or in rehabilitation units.
And now we embarked on interviews with them,
developed from well-developed and piloted coding guides,
to ask them about their views on stem cells
and clinical trials.
I won't show you all the data,
just a little bit of a sampling,
but here are two I think key points
that we learned from these two groups.
First, that the chronic post-injury group
very much varied in their perception of risk.
So if I go back here, these are the thoracic-injured
individuals, so these are the individuals who have lost
the use of their lower limbs,
but not necessarily their upper limbs, thoracic.
And these are the far more severely-injured individuals,
those with cervical injuries, who likely lost
also the use of their upper limbs, okay?
So we've learned, in fact, that in the chronic
post-injury group, those with thoracic injuries,
who have more mobility, weighed benefits
over risks in terms of their tolerance
to stem cell interventions, and those are open to change,
whereas the cervical individuals are quite change-averse.
Also, in terms of knowledge, although we shouldn't
have been surprised by this,
those who were immediately post-injury shared a lot
about how little they know about stem cell interventions.
Although we know anecdotally from the clinicians
that people, if not the patients themselves,
their caregivers are immediately
on the phone or on the internet searching
for information about stem cell interventions,
because this is what's been in their world,
and sometimes are ill-equipped to ask the questions,
and our clinicians are ill-equipped to answer them.
But, you know, our hypothesis in going into
this study is that it would be the individuals
who were most severely affected would be
the most prone to risky interventions,
and those who were least-affected
would be the most risk-averse.
And like the audience in incorrectly predicting
when the timing of clinical trials is going on,
we were actually dead wrong.
And it turns out that those individuals
with the most severe injuries, shown here on the left
of this cartoon, are most risk-averse,
not most risk-prone.
And we were very surprised by these data.
Our hypothesis was rooted in the fact
that the more severely off you are,
the most affected you are, we expected
that they would be most receptive to any kind
of intervention, and in fact what we learned
is that the limited function that they retain
is so precious that they are actually really afraid
for any sort of experimental intervention
that might mitigate any retained function that they have.
A very big surprise to us, a very big surprise
to our clinician colleagues as well,
who always thought that this was really
the group that we needed to be focusing on.
And then, of course, we always want
to have a balanced approach, and we very much recognize
and respect those people who fall
in the middle of this cartoon, as represented by this quote:
"Need scientific evidence that stem cell therapy
is safe on humans."
Now, we also did some other studies
with healthcare providers and carers.
We really wanted to understand the support networks
around the affected individuals.
Again, we ran focus groups and interviews with them,
and we found another fascinating result,
which is that adequate decisions support is difficult
to achieve, and there are really three obstacles.
There's the personal dimensions of risk,
and that is respecting the self in this story,
the self of each affected individual.
I'm not talking about statistics,
I'm talking about young people, mostly men,
who have suffered a traumatic brain injury,
who are living different contexts of their life.
Very limited insights into pathophysiology and recovery,
particularly in the early group.
And this was just shocking to us,
deferring attitudes of support networks.
And what we found is that the physicians were telling us
that it's actually the families and caregivers
who should be supporting the affected individuals
in their decision making around clinical trials.
And it was the families who were telling us
that it really should be the clinicians who should
be supporting the affected individuals in their decisions
about whether or not to enter a clinical trial.
And they were each deferring to each other.
And again, a sub-optimal situation
for an affected individual whose life has truly changed
in almost all respects, especially in the early phases.
So the deliverables from this case study
were actually twofold.
One is that we recommend, and there's some data in here
that I didn't show you, but we actually recommended
that in the research setting, there starts
to be a shift in the clinical set,
in the experimental setting, there starts to be a shift of
the time-points of intervention for stem cell therapeutics.
Some of my colleagues, including Brian Kwan,
and Wolf Teslak Are starting to run studies
with stem cell interventions, particularly oligodendrocytes
in animal models six weeks out from injury,
rather than in that very acute time-point,
to see if, in fact, there is re-myelination
or restoration of some sort of function
that is as effective as it might be at earlier time-points,
with the idea that if we could demonstrate
the efficacy later out, that would give patients
who are affected with the spinal cord injuries time
to recover and to gain a little bit
of the psycho-social footing,
knowing what questions to ask,
and to actually bridge that stability,
that psychological social stability
with a pathophysiological stability,
and that the two combined might be more beneficial
than just trying to intervene physiologically
at those very early time-points.
The jury is still out, we'll see if that works.
But that, right now, is the theory.
And the other deliverable we have from this particular
study is around new models of consent and resources.
And this really bears on this sort of pointing fingers
at each other for decision support.
We have suggested both network supported, that is,
people in the network around people affected
with spinal cord injury, as well peer support consent,
where affected individuals who are in the chronic phases
are paired with people who are in the early
sub-acute stages, to learn more about the potential
for recovery, recovery of life and quality of life
as well as experimental interventions.
And we're hoping to be able to enjoy some funding support
to be able to test some of those models in real life
with some of our participants as we go forward.
So in our continuing neuroethics directions,
this led to some very exciting follow-on work,
some work by Chris Scott, who was also with Linda
and me at Stanford, and who is now at Baylor College,
who has done some very nice studies on the ethics
of starting and stopping clinical trials.
Some work by one of my students, Kim Sharpe,
and others who looked at how people,
parents with children with neurodevelopmental disorders,
including autism and cerebral palsy,
seek information about stem cell interventions.
And we actually learned from them that many of them,
and many of us, perhaps, race to the internet
for information, but in fact we trust it very little.
And so we are actually allowing convenience
to trump our accessing more trustworthy sources,
such as researchers and clinicians.
And I think that is very important,
particularly for affected children
and the whole movement towards medical tourism
of countries that are offered stem cell interventions
or supposed stem cell interventions,
where we really don't know what
is actually being offered abroad.
And now, Shelly Benjaminy and others
and I are worked on timeframes of whether
patients actually understand, translational
timeframes around stem cell therapeutics,
in particular for neurodegenerative disorders
like Parkinson's and multiple sclerosis,
and also accessing their understanding
about accessing off-label interventions
using regenerative medicine interventions.
So that closes that case study, and we're going
to make big shift now from cells to systems.
And again, we've sort of moved from autonomy to the self.
And so this is a story of disorders of consciousness.
And again, to give you some background statistics,
traumatic brain injuries, when they're not
causing spinal cord injuries, they are causing other sort
of neurologic conditions like disorders of consciousness.
There are almost two million of these kinds
of new injuries each year in this country alone.
Many people experience permanent disability.
And today, largely, clinical diagnosis
is based on behavioral assessment.
And so, if we just kind of look at this umbrella
of disorders of consciousness,
there's the minimally conscious state,
where individuals in this state can actually
follow simple commands on and off.
They might gesture, they might be able
to have eye movements that are responsive to instructions,
by contrast to a persistent vegetative state where there are
some sleep wake cycles but really no purposeful movements.
And then, there's of course coma,
in which an individual is completely unresponsive.
So MCS, PVS, and coma.
So we won't speak at all about coma,
but we will focus on these two states right here,
because as many of you know, I'm sure,
we are able to obtain signals from the brain now
around consciousness that really is unprecedented.
Whether it's using magnetic resonance imaging
in its functional form where we get levels,
measures of blood oxygenation, or high-density EEG.
And in fact, I'm trained as a neuroscientist,
and all of these were my domain before
I started doing ethics about 15 years ago.
And so, again, I'm sure many of you are familiar
with these classic studies by Miko, Schiff in New York
or Adrian Owen who is now in Canada,
where participants with disorders of consciousness
measured against controls provide,
in response to certain stimuli, some levels of activation,
regional activation in the brain, that look similar.
So, for example, a patient, two patients
here in an disordered state of consciousness
compared to listening to stimuli of loved ones versus noise,
and all of you know these are subtraction experiments.
And they do sort of look alike.
Similarly here, in this classic experiment,
of patients who are asked to imagine
that they are playing tennis,
or navigating through their homes, compared to controls.
And you can see these activations
in supplementary motor cortex, pre-motor cortex,
and so forth, look similar to these controls,
suggesting that there is some form
of at least information processing, if not consciousness,
going on in the brains of these individuals.
These kinds of signals are measured in about one
out of every 17 to 20 individuals who are diagnosed
as persistent vegetative state.
So some of you might say, well that's a really small number,
what are we doing?
And some of you might say, that's a really big number,
what are we doing?
With a 40 percent misdiagnosis rate from clinical exam.
And so these patients who, from whom we're
able to obtain these activation signals,
are really in some state of consciousness,
that is, may or may not be, absent of cortical activity,
and we really don't understand how to deal with them
in our society either ethically or legally or medically.
So we embarked on the latter question,
how do we deal with them, in our Canadian
healthcare system in particular.
And we asked the question about clinical actionability,
again though three phases of work,
a bit mapping onto the work I showed you earlier,
and I'd like to call out here my colleagues Adrian Byram,
he's my graduate student, and Grace Lee,
who worked hard on these projects.
And so we embarked on three steps.
We went to map the landscape in the literature,
develop a conceptual framework in which we
would actually test the question of clinical actionability,
and then establish evidence for translation priorities.
So step number one was to map the landscape,
and with Alex Bennett, who is also my graduate student,
we did this giant bibliometric study
of who's talking to whom in the public literature.
And so you see here, here are the big guns
in the neuroscience community,
Mike probably knows all of them,
talking to each other, citing each other.
And what we found is that there are actually very few
networks of people talking about very few networks of works.
So there are isolated pockets of this
kind of work going around the world.
But I'm just going to point you up to here,
which is the little bit of the literature at the time we did
this study, in the area of bioethics and the brain.
So these are the ethicists talking about
the big fMRI studies.
So a lot of opportunity here for more work to be done.
But aside from that little commercial about opportunity,
we took all this literature,
and we put it into a conceptual framework
which will be very difficult for you to see,
I apologize for that, but there's no way to reduce it down.
But the bottom line is we asked, given the literature,
is this research clinically actionable,
and if the answer is yes, what kind of impact would it have.
And I'm just not going to talk all the way
through the slides, but basically we ask questions
about people, and institutions where people
are the patients and the families as well
as the medical care team, and the institutions
or the healthcare systems, health research,
policy law, scientific knowledge.
And we have three criteria about technical feasibility,
significance and change in outcome
and economic justification.
And if the answer were to be no, we wanted to know why not,
and if why not, what might we still do with the information.
Again, always having a very positive,
solution-oriented bend on our work.
And we conducted a study with, two phases of studies,
with experts across a wide range of expertise,
and there were 63 of them.
For those of you who do qualitative work,
interviews and focus groups with experts,
you know how hard it is to get people to respond
and participate, but we were very successful.
And we come back to conceptual framework,
and would anybody like to wager whether
our 63 experts landed on the side of yes,
clinically actionable, or no, not clinically actionable?
Can I have a show of hands for yes, clinically actionable?
Only one, really?
And the rest of you, raise your hand
if you think not clinically actionable.
So more of you, although some of you are clearly
abstaining from little survey here,
you are not going to be participants in my studies.
So actually, an overwhelming,
overwhelming response to the yes side.
Our experts suggestion was clinically actionable,
but with certain caveats, so let's talk about
what those caveats are.
The first one, whether the caveats or priorities,
is that we have to know more about really
the correlations of neuroimaging with behavior.
We have to have as a priority in going forward
and really moving towards clinical actionability
the incidence and prevalence
of these disorders of consciousness.
What are the probabilities of covert consciousness?
Clearly harmonize methods and paradigms
and stimuli for running these experiments.
Because if everyone, even if there's six
or eight or a dozen sites around the world
doing these kinds of experiments,
everybody's using different paradigms
and using different languages,
we're just not going to learn enough
about these disorders of consciousness,
which inherently, by their nature,
given the nature of injury, the nature
of individuals are messy enough.
And about quality of life.
They also told us about translational priorities
or caveats before moving forward,
and here they gave us some examples.
For example, major themes about guidelines
from the timing of neuroimaging tests.
When do we do it post-injury?
How often do we do it?
What's the cost?
What are the best practices?
What protocols do we have for communicating risks
and benefits to caregivers who have to decide whether
to involve their loved person in an experiment like this?
And again, harmonized terminology.
So harnessing the power of multiple groups
who are working in silos.
And on priorities for self, which is actually,
and for those of you in the area od public policy
in particular, understanding how this new kind of work
tells us about personhood and will and preferences.
Imagine, especially, if these kinds of patients
would be able to use such a tool,
certainly not fMRI in our hospital settings,
but maybe portable EEG system down the road,
could actually express their wills and preferences.
And also, therefore, if we can imagine rolling
this tool out more in the public domain,
we need laws for defining capacity and competence.
I'll come back to that in just a moment.
And so, this work has led to two directions, two very
important directions that I think are very exciting.
And one is, we ask the question,
and it really goes back to selfhood and wills
and preferences, and laws about capacity and competence.
So all of you, I'm sure, are aware of the new laws
that are being passed around physician-assisted suicide.
So imagine if we coupled this kind of technology,
and somehow enabled or empowered these patients
to make decisions by producing brain signals
in these proxy paradigms with a large amount
of statistical processing, and we said,
"Do you want to live, do you want to die?
Do you want to listen to Mozart,
do you want to listen Michael Jackson?"
Right, very different kinds of questions,
but very important, particularly the first one.
And no one has really thought about end of life
decision making in the context of neuroimaging
and disorders of consciousness.
And so with Manny Cabral, we embarked on analysis,
and this is really a totally theoretical analysis,
that was a little dicey as a topic.
And we are now very excited to have paper
at press in JAMA Neurology, where we looked
at this question, the question being:
Can we use functional MRI, that is the functional signals
from brain activations in the context
of end of life decision making?
Ought we use it?
And how do we ask that question and analyze it?
And we chose three frameworks from the ethics world,
although it's just three of the many many
we could have chosen: clinical ethics, feminist ethics,
which for those of you who don't know,
really relies on relationships,
it's really an ethics of relations, and disability ethics.
And we took the four variables on the y-axis of this table,
it's not really a figure: communication,
health decision making, end of life decision making,
and relief from pain and suffering,
and sort of plugged those together.
And so, what might these ethics frameworks
tell us about these four variables?
And I think for each of them that we come down
largely on the side of autonomy,
empowerment potentially, informed consent,
if in fact we could trust these signals to tell us
that somebody's able and has the capacity
to provide consent.
And so, we were pretty optimistic about
this until we started looking at things
like the signal clarity, in terms of reliability
and reproducibility, and this is with no disrespect
to the functional MRI community, I was part of it.
But we are still working out the kinks
in the meaningfulness of this signals, unequivocally.
There's a sliding scale of competence,
and there's an allocation of limited resources.
And from each of the points of view of ethics,
clinical ethics, feminist ethics, and disability ethics,
we come down on the side of not ready yet.
Not never ready, but just not ready yet.
And in fact, the catch 22 that we've fallen on,
at least in the Canadian healthcare system,
we don't know what your healthcare system
is going to look like in the coming time,
but the bottom line is that we might have a tool that,
with its limitations and its power,
might be useful for empowering patients
within a disordered state of consciousness,
to make some decisions about the quality of life.
Maybe about music, certainly about pain,
but not reliable enough about end of life decision making.
So we have an expensive tool that we might use
for quality of life issues, but not yet good enough
for real questions of justice and end of life.
And so that's our catch 22 right now
that we're trying to now, in the next phase
of this work try to sort out with our colleagues
both in the legal and health sciences community,
medical community, and our neuroscience
colleagues of course.
And finally, and this is, I alluded to this study,
it's just coming out now in Nature Biotechnology,
and I was tempting Mike and Linda last night over dinner.
We asked the question, well we're starting to see,
especially those of us who review papers and grants,
a lot of patents around brain devices and brain methods,
and we started to see things like brain regions
being invoked in these patents,
and this was making us very nervous.
And so we embarked, with Dillon Edris-Roskums,
who is a law student in Canada, on a patent analysis,
we did a patent landscape analysis on patents
from 1976 to actually 2005, it's cut off on this graph.
And you can see there's an increasing number
of patents that invoke brain writ large.
And so imagine a patent that somehow invoked the colostrum,
which from the work of Chris Koch,
might actually underlie consciousness.
So we looked at these patents through three ethics lenses:
practical, principle, and ideological,
and we learned the following things.
One is that we did not find any patent, per say,
that has yet attempted to patent a brain region,
not the anterior cingulate, not the subthalamic nucleus
for DBS, not the colostrum.
However, the language of some of these patents,
particularly those in the more recent years,
is so broad and so vague, that it does
actually protect brain regions.
And from a neurosurgical point of view
or a research point of view, those of us
who are doing interventions on certain brain regions
could be challenged in a patent case,
given how vague and broad some of the language is.
And sometimes, how the intervention
is described in the patents actually
go beyond just the target disease condition.
So we found patents that, in effect,
talk about Parkinson's disease,
a target for Parkinson's disease,
for which that target has never been
associated with Parkinson's disease before.
So there's a lot of work to be done in patent arena,
both for disorders of consciousness, and more broadly,
and for people in the area of neuroscience
and public policy, this is a rich space
that is going to require a lot more work.
Because I would submit to you, that like genes,
and for those of you who are familiar with the Myriac case,
where there was a patent around the BRCA gene,
sorry, brain regions ought not be patented or protected.
You just can't own biomaterial, not a gene,
and not a brain region.
If I haven't exhausted you yet,
I want to show you a third case in my neuroethics space,
which is departure from the other two, and deliberately so.
I'd like to talk a little bit about Alzheimer's disease,
and about neuroethics in the wild.
All of you know that the population is aging,
Alzheimer's disease and vascular dementias
are probably carrying a huge burden
of neurologic disease in our society.
And we might be able to predict many
of these diseases at this time, but we cannot cure them.
There are lots of challenges around prediction.
Besides not being able to cure them, there's a lot
of uncertainty about sensitivity and specificity.
As we learn more about genes,
we learn more about disease and clinical sub-types.
There are issues around distributive justice
of healthcare access, pleiotropies and the effects
on third parties, and whom to test and when.
And the challenges of prediction are no more great
than when you go out of our comfortable urban settings,
where there are plenty of challenges,
and you go out into the rural areas, maybe of Wisconsin,
or in my case in the rural areas,
real remote areas of British Columbia.
And we started a line of work that we called
cross-cultural neuroethics, specifically seeking
different world views about advances in brain sciences,
and some of the ethical social issues and policy issues,
that are important to people who don't live
in the world that we live in, particularly
those of us in neuroethics who have
largely been of European background.
And this is Dr. Lynn Beattie and myself,
up about 2,000 kilometers, so 1,500 miles
north of British Columbia, so above the Alaska border,
really really far in the north,
a place to which we had to particularly charter airplanes
to do our work with the Tauhtan family
to whom we are incredibly grateful for their generosity.
And the question is, this family has been
identified to have the PS1 gene.
They are at high risk for early-onset
familial Alzheimer's disease, which affects
anyone in whom the gene exists.
It's a novel autosomal dominant gene,
and is very different from late onset
sporadic Alzheimer's disease.
It affects people around the age of 50,
and there are many many socio-cultural issues
around caring for them, including where they live,
which is so far and remote, and issues
around understanding genes,
understanding genetic testing, understanding prediction.
And you can imagine that the closest
university facility for testing
is the University of British Columbia, 2,000 miles away,
and the closest care facility for those
with the advanced phases of the disease
from the reserve where this family is primarily located,
is about 1,000 miles away in
traditionally warring territory.
So you ask the question, why aren't they flocking
to the university setting for predictive testing?
Right, we're all waiting for them to show up,
and they're just not coming.
And our clinicians said, "Why aren't they coming?"
And I said, "Well, did you like, ask them?
Did you ask them whether they understand
what a genetic test is, or a gene,
or what we can do in the university setting
to make this valuable to them?"
And so this is kind of, this is what
keeps us in business, right?
All of us in this room, this is what keeps us in business.
And so we embarked on a very long community
based participatory research project.
I think it took us about six or seven years to do this work.
We would go up to the north, as well as some
of our local communities, but most
of our families were up north, and we used
both our western as well as our indigenous methods,
including sharing circles, to engage in focus groups
with these individuals, both the elders, the adults,
and the younger members of the community,
and we conducted not a few individual interviews
with them to understand, to develop the research
questions together, and understand
with them what it means to have Alzheimer's disease,
what it means to have a genetic test,
and whether we are intervening positively or intruding,
like my former slide suggested, into their lives.
And in fact, we learned from them,
and I think it was through the good work
that we did together, that medicalization
with good education really can go hand in hand
with traditional views, and this led us
really to understand with them that medical diseases,
that we consider medical diseases,
can be viewed through what's called a two-eyed seeing,
the alignment of traditional views
of a disease and understandings of causes
of a disease, and the biomedical ones.
We learned that knowledge sharing is vital,
particularly when the knowledge is good knowledge.
Testing looks like will remain irrelevant,
we just haven't demonstrated meaningfulness,
and it seems to remain irrelevant.
And there are really complexities
when we talk about cross-cultural work,
particularly in these highly sensitive areas.
But I want to share with you, well,
I'll share with you a deliverable.
So this was very interesting, again,
for those of you in public policy,
and particularly with the students,
we were talking earlier about what kind
of deliverables can you have.
So we've published a dozen or so book chapters
and academic papers and all the usual stuff, I'll call it.
But with this community we also published
a book for the adults, called Wellness
in Early Onset Alzheimer's Disease,
which uses the narratives and the photographs
of people in the nation themselves to describe,
with them and for them, what this early
onset form of Alzheimer's disease was.
And through our work with them, we also learned
that their youth really didn't have an understanding
of this disease, and with them,
through an indigenous illustrator
and an elder from the community, we produced a comic book,
of sorts, called The Mind Thief,
so it's not very comical, I have to say.
But it is one that we've not distributed hundreds
of copies to members of the nation,
and we've also produced a YouTube video
explaining the disease, and a Facebook page
for support for this community, in particular,
and also for other aboriginal communities
and indigenous people affected by these kinds of disorders.
So a very different range of products
than you would expect from an academic setting,
and I really encourage all of you to think
out of the box when you're thinking about public policy
and reaching your legislators, your citizens,
your community out there.
There are all kinds of different ways
to communicate that they feel sometimes odd
for us in the academic community,
and sometimes they're not really valued
by our colleagues or by administrators,
but they do need to be, and we need
to work hard to have them recognized.
And so going back to continued neuroethics directions,
so where did this see two-eyed seeing lead us to?
Well, one of the things we learned from our family up north,
is that with our collaborative work they started
to understand the medical underpinnings
of this early onset Alzheimer's disease.
They still retained some belief about the causation
that was grounded to the environment
and the land and the water.
And as this beautiful quote says by one
of the Tauhtan elders, "I am part of any environment
and if my environment suffers, I suffer as well".
And this is a community around which many
mining operations have opened over time,
for which they've struggled, for economic advantage
on the one hand and threats to the environment on the other.
And so we started to take this as an untapped source
of inquiry, and have gone down this path to something
we're calling environmental neuroethics.
And sort of using their understandings
and their beliefs about the environment,
we started to look into the literature around the mining,
and fracking in particular, and asked the question:
how much has brain and mental health,
how much was brain and mental health actually
referenced in the mining and fracking literature?
And sure enough, we found very little of it.
We found a lot about respiratory disease,
asthma, we found a lot about cancer,
we found a lot about skin cancer,
but we found virtually nothing about brain
and mental health in the mining literature,
either environmental ethics, environmental health.
Really we combed the literature,
and you see we see a lot of like maybe brain
and mental health is discussed,
but maybe it's discussed briefly,
and I think we found one paper, two papers,
and one of them was ours, in which brain
and mental health was invoked as an important issue
for us to be thinking about as we
go forward in contaminating our lands.
In the ethics discussion, I'll just show you,
there was mention of safety and no harm,
but otherwise very little about other ethics concerns,
such as trust, vulnerability, justice, empowerment,
and a little bit about the precautionary principle.
Right now, I'm waiting to hear on a large grant
that I've submitted to a Canadian foundation
to see if we can actually put brain and mental health
on the national policy agenda for the environment.
And these competitions are tough,
but I'm really hopeful that I'll be successful,
because I think this is a huge area of inquiry
that we need to embark on now, not later.
So this is the framework we're working on
for environmental neuroethics.
It draws very much on the framework from neuroethics,
per say, where we think about the brain sciences,
relationships, cross-cultural factors, social policy,
and the ever importance of public discourse,
all associated with the environment,
and the brain of course.
And so, let me just summarize.
I've given you three case studies, I've given you a primer,
sort of a framing for neuroethics.
I tried to give you three examples,
I hope I was successful in grounding your ethics inquiry
in selves, in systems, in communities
as it relates to autonomy and self and communities.
And I hope that through the narratives
of these case studies, I showed you a little bit
about how we're able to prioritize
and discover important issues in the neuroethics,
and ethics and the brain, address them empirically,
embark on open and transparent discussions
to bring us closer to good guidance
and good policies where policy is appropriate.
And I just conclude, then, that I think it's essential
to integrate human values into all aspects
of the neurotechnology development that we do,
and our neuroscience discovery, and I urge you
to leave no stone unturned as new opportunities
for neuroethics arise.
And I invite you to engage with me today, and as we
go on either through my website, through my email.
And we've been talking a little bit about
the International Neuroethics Society
for the past day and a half.
Please, get involved and join us,
we are really endeavoring to be the authoritative body
for all this neuroethics, neuroscience, and public policy.
We're a group of about 400 individuals now, and growing
in a very robust way, and we would welcome you warmly.
So thank you very much for your attention,
and I'm happy to answer your questions.
(applause)