John Wilbanks, Chief Commons Officer, Sage Bionetworks

John Wilbanks – Sage BioNetworks
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Mark Masselli: This is Conversations on Healthcare, I am Mark Masselli.
Margaret Flinter: And I am Margaret Flinter.
Mark Masselli: Well Margaret, I see the Department of Health and Human Services is
taking an active interest in the world of medical research to create a clear path forward
on ways to keep human subjects safe in the world of biomedical research.
Margaret Flinter: Well, this is rapidly expanding world mark in this era of big data
computing and large scale partic ipation through platforms like Apple Research Kit and
patients like me and more motivated patients are becoming linked with researchers
through these online portals.
Mark Masselli: Researchers are now able to tap into a much larger group of
randomized tr ials, but there are ethical considerations that need to be reevaluated and
redefined. HHS wants to ensure that those participants who are selected for clinical
trials are given access to their data.
Margaret Flinter: And this is something that our guest today is very passionate about.
Mark Masselli: John Wilbanks has been an ardent advocate for opening up scientific
research.
Margaret Flinter: I think this is a very important topic, Mark.
Mark Masselli: Really is and Lori Robertson, Managing Edit or of FactCheck.org looks at
misstatements spoken about health policy in the public domain, but no matter what the
topic, you can hear all of our shows by going to chcradio.com.
Margaret Flinter: And as always if you have comments, please email us at
[email protected] or find us on Facebook or Twitter; because we’d love hearing from
you. Now, we will get to our interview with John Wilbanks in just a moment.
Mark Masselli: But first, here is our producer Marianne O'Hare with this week's headline
news.
(Music)
Marianne O'Hare: I am Marianne O'Hare with these healthcare headlines. The
Commonwealth Fund has released a comprehensive report on the costs of employer

John Wilbanks – Sage BioNetworks

health coverage, which not surprisingly varies wid ely across the country. The report
ranked States based on the average amount of the employee premium, the amount
defrayed by the employer. Employees’ contributions to their health insurance premiums
rose more slowly between 2010 and 2015 in 30 States in Washington D.C. Still many
families are spending on an average a bigger share of their income on healthcare than
they were prior to 2010, that’s because of median incomes despite their recent surge
have not kept pace with healthcare costs. Southern areas are more likely to die from
smoking related illness than in any other geographic region in the U.S. A report issued
by the American Cancer Society revealed about 40% of cancer deaths in the South
were smoking related compared to about 8% in other parts o f the country, where
smoking prevalence has declined in recent years. Smoking rates are noticeably higher
in States that don’t enact basic public policy interventions like higher excise tax on
cigarette purchases, banning smoking in public places, and red ucing nicotine cigarettes
to non - addictive levels. The study estimates at least 28.6% of U.S. cancer deaths in
2014 were linked to smoking that translates to 167 thousand lives that could have been
saved. The Veteran’s administration may have stumbled on a scalable solution in their
quest to reduce long wait times for patients. Vets regularly get next day and even same
day appointments for primary care now. No longer waiting a month or more to see a
doctor as many once did. Clinical pharmacists have sp ecial training that permits them
to prescribe drugs, other lab tests, make referrals to specialists and are handling the
chronic care needs of more and more patients. This frees physicians to concentrate on
new patients and others with more complex needs. The VA underwent a major
overhaul after a whistleblower revealed a couple of years ago, a culture of extremely
long wait times that led to untimely deaths and many poor outcomes. The VA has made
a pledge to Veterans seeking care. They shouldn’t have to wait longer than 30 days for
an appointment. I am Marianne O'Hare with these healthcare headlines.

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Mark Masselli: We are speaking today with John Wilbanks, Chief Commons Officer at
Sage Bionetworks, dedicated to redefining how openly shared da ta will transform
biomedical research. Mr. Wilbanks launched Consent to Research in 2011, a platform
for people to donate their health data for scientific and medical research. He served at
the Science Commons and created Commons, an open science effort aimed at freely
shared scientific and medical data. He won numerous distinctions and was named a
global game changer by the Utne Reader. He earned his undergraduate degree in
philosophy at Tulane. Mr. Wilbanks, welcome to Conversations on Healthcare.

J ohn Wilbanks: Thanks for having me.

John Wilbanks – Sage BioNetworks

Mark Masselli: You have been a strong advocate for the past two decades for people
interested in accessing and sharing their medical data and we’ve had a sort of a number
of European friends and colleagues on, all adv ocating for similar version of open access
to patient data and there is this growing course, people demanding that scientific
studies, especially those supported by the Government should be made readily
available for people to access.

John Wilbanks: Scie nce has been for a very long time, at least since the 1940s in the
United States, the way that we do biomedical research and biomedical science has
been one in which the Government gives money to academic institutions, studies that
take long times, those p apers get published, and the expectation is that the market will
find ways to translate the things that are published in the journals and get those back
out to the citizens. What it’s created is a system that is quite glacially slow to change
and there is bureaucratic inertia that runs through the system in the way that we review
grants and give money away. You see it when you look at the ethical review processes
that happen before clinical studies, where the often the forms that are being used are
forms that develop 10 to 15 to20 years ago and then we haven’t had a lot of systems
designed thinking about, well how would we redo this. In many cases, we tinker around
the edges, we try to change the way that we access the articles. We try to use mobile
phon es to do mobile clinical studies. We have to start designing systems that are as
self reinforcing and in many ways intersectional with themselves as the current system
or we won’t be able to replace with one that’s sort of more modern.

Margaret Flinter: Well, John, you have been tackling this problem from a number of
angles and your works at the Scientific Commons and Creative Commons and these
entities have been advocating for open sharing of data for a couple of decades now and
how would you characteri ze the progress that you have made so far, what do we say?

John Wilbanks: I was very fortunate to be around some of the ideas of that Larry Lessig
had and so I got exposed to a lot of the ideas of the Commons and while I was there, I
sort of became fasci nated with how these things attach to science. A lot of these
concepts of the way that we build knowledge products like software or encyclopedias
could be applied to the way that we build knowledge products in science, because that’s
really what science i s about, because when you get down onto the weeds, you run into
a very messy reality that science is not nearly as methodologically clean as it thinks it is,
working at Creative Commons, we are exploring how would you share data, given that
copyright doesn ’t attach today, you can’t use the same licensing methods that you use
in software or for Wikipedia, how do you share things like biological materials. About six
or seven years ago, I started to get obsessed with informed consent, because it looked
increa singly like one of those leverage points, where individual citizens actually had

John Wilbanks – Sage BioNetworks

some leverage that could un - stick some pieces of the system and if we could put that
into context, with people doing data collection, with people doing data analysis, we
might have a chance to start building a system that works a little better than the existing.

Mark Masselli: Well, let me pick up a concept of informed consent. Walk our listeners
through sort of the historical context of informed consent and how it’s evolved ?

John Wilbanks: Historically speaking, informed consent has been around for a while or
you can trace it back, you know, at least to the early 1900s to some of the Yellow fever
work done in Caribbean, but what we found and we did some of our research at Sage,
everyone we talked to, loved informed consent. They loved the idea, the loved the
ethics behind it, but a lot of people despaired for the way that it actually happened in
reality. No one had time to explain the documents to the people that were sig ning them.
The documents were written in a format that made them very hard to understand. They
were often written by attorneys. You know, they don’t write the cleanest English
necessarily for people who are in a stressful situation and they seemed like an
opportunity that if you took some of the concepts that were sort of initiated back at
Berkman and Creative Commons about human readable contract, there was an
opportunity to start creating lay person readable summaries of these very complex
documents an d that gave us an opportunity to translate some of those to the screen.
Unfortunately, when you do that, you also run into two extra issues, one is that we are
sort to used to clicking okay to get to things that we want and the other is even if we do
read it, the evidences available indicates that physiologically we don’t read the same
way on screens that we do on paper and so we built a series of essentially interface
tools that allow us to create visual summaries of consent documents and we put all that
in front of the signing of a document, because we don’t expect people to actually read
the long form, because the evidence just shows that they won’t and even if they do, they
probably won’t process it.

Margaret Flinter: Well, you’ve said that creating a massive open database of health and
genomic information doesn’t have to be particularly complex and in your TED talk, you
note that such open platforms require four simple elements, so I am going to ask you to
tell us what they are, tell us how does the e xplosion of personal health data mining
devices fit into your thoughts about how these open platforms for health information
sharing can function?

John Wilbanks: What I tend to be biased towards the system is that are, what I say are
simple, weak, open, and together and so weak doesn’t mean weakness, simple doesn’t
mean simplistic, and open doesn’t mean, you know, unpaid necessarily. A weak
system for example would like HTML, as a language for formatting and displaying
content, HTML is a relatively weak one and that means that you don’t break future

John Wilbanks – Sage BioNetworks

things that might add power to it, so because it was weak, it was extensible and so the
idea is that if you are going to build, you know, a system like this, we should build it in a
way that it can be extended by other people. One of the rules inside the web
consortium is what’s called the Rule of Least Power, which is when in doubt, use the
least powerful tool that solves the job and I think that that’s a concept that we can really
bring forward from the web design world into the legal design world and then the idea
that things need to be open, you know, it doesn’t mean that they are free or unpaid, it
means that they are nondiscriminatory. The rules are clear and can be taken forward.
Open might be somethin g like open source software, but in many ways something like
water or like electricity are things that are utility functions. Those things that were
available to anyone that was a participant in the system and then the together part is
more to indicate th at if we are going to do this without consuming a massive amount of
resources and then charging a lot of rent, we have to build it ourselves. If we wait for
the Encyclopedia Britannica, it’s going to be quite expensive and they are going to sell it
back t o us, whereas if we build it together, it will be more like Wikipedia, it will be
something that we own together, something that we can change together, something
that we can use together.

Mark Masselli: We are speaking today with John Wilbanks, Chief Co mmons Officer at
Sage Bionetworks, a collaborative of network partners dedicated to redefining how
openly shared data will transform biomedical research. John, you know, we’ve got
stage 2 of meaningful use that allows an individual to get access to their data, to
download it, to transmit data, you’ve got Sync for Science working hard. You all, at your
company are also working on the same, walk the consumer through all of these
changes that are coming on, grab my information, and do everything I want to do with it.

John Wilbanks: You know, in many ways, all of these things that you’ve mentioned
come together to the context of empowering the individual to get a copy of what’s
known about them, whether it’s our medical records, whether it’s our ability to o rder our
genomes, it’s the capacity to profile in ways that haven’t been possible and then the
right to get a copy of it and no one really knows what it’s going to be like when all of
these things really gel. They are, I don’t think, they have quite gelle d yet, you know, I
can’t sort of just log on, put in my provider ID and get my EHR yet. I have to send an
email to my provider. They send it back as a PDF, right, and you what it means is that,
you know, first of all we are going to have more power that’ s the point of empowerment,
but we are also going to have a lot more obligations and a lot more opportunities to
make mistakes. You know, I am more savvy than most folks in this area and I don’t
know what do with my genome, you know. I wouldn’t know what to do with my EHR
and so as the system gels and lets us get access to this and send this data around, we
are going to need to have a marketplace, an ecosystem that merge of interpretation
tools that help us understand what these things mean for our daily life, what choice
should I make while I get insurance next time, but also, you know, who is the trustable
recipient. Who should I actually send my EHR to through Sync for Science and you
know, what I would like to see is, is some kind of member owned coll ective or coop or
credit union style organizational structure emerge or even something like alliance trust,

John Wilbanks – Sage BioNetworks

where you know, if you and I share common goals, may be we both have the same
disease, we can pool our data with a bunch of like minded people and m anage it
together, because in the end I do not keep my money in my mattress. I keep it in a
bank and my expectation is that that’s where we are going to wind up as consumers
and so I just, I tend to think that there’s going to be an ecosystem that spring s up to
meet the function, when the function is there and my hope is that we can shape that
ecosystem in a way that it’s not venture back companies who want to make ten X
returns or hundred X returns that some of this is about member ownership and
governan ce mechanisms that are appropriate to you and me because we share the
same goals.

Margaret Flinter: So, John, I would like to ask you about a project that we are all
hearing a lot about and engaged within that is the National Institute of Health Precisio n
Medicine Initiative spearheaded by Dr. Francis Collins, the man who oversaw the
Human Genome Project. Dr. Collins has called for a million citizen scientists to
participate in this very bold venture to accelerate the pace of research and to make sure
th at it is inclusive of everybody, we’d love to hear your comments on the kind of
infrastructure that’s going to be required to pull this off. How can efforts like Blue Button
help us move towards the goals of precision medicine and what do you think is goi ng to
be done to build a more robust infrastructure that allows for this kind of data sharing?

John Wilbanks: Yeah, we at Sage were very fortunate, we are a subawardee in the
Precision Medicine Initiative, PMI, and so I have been fortunate to be particip ant in a lot
of the last several month’s worth of work on it and it’s both the recruitment cohort of a
million or more residents of the United States of America, but it is also the technology
infrastructure to do the measuring and the dissemination of that data back off to
science, so it is really interesting to watch how these pieces are coming together and
things like Blue Button and Sync for Science really piece into this, because the concept
of this study is kind of unique, it’s not simply that we are g oing to measure people
through their phones, which is great and I’ve done a bunch of those through Sage. It’s
not simply that we are going to do a physical exam and get a sample, which is you know
what the UK Biobank has done and we are not simply going t o call through EHRs like
many studies have done. The idea is we are going to bring all those things together, so
that we have the ability to track the interactions of the medical system through health
record synchronization and we have the ability to do s ome longitudinal monitoring out in
the environment with people’s phones or variables; the real promise is that the tech
platform that supports all of this will be re - purposable in many ways to use for lots of
follow on and knock on studies. It will have a large enough cohort that’s diverse and
inclusive enough to actually let us look at rare disease under study populations and then
we will be able to run these sub - studies, you know, relatively cheaply and relatively
profusely because the technical infrastr ucture is there and I don’t really know what’s
going to come out of it, that’s probably the most exciting thing. You know, what bores
me about traditional clinical studies a lot of time is that we know what’s going to happen
and what I find fascinating ab out the Internet, the Web, mobile devices as platforms is
that the vast majority of the really valuable things that happen on them are things that
nobody predicted and so by building this sort of generic massive detailed resource and

John Wilbanks – Sage BioNetworks

not predicting exactly what’s going to come out of it, we have a chance to bring some of
that same, you know, Jonathan Zittrain calls it generativity, we can finally start having
that in clinical studying.

Mark Masselli: You know, Margaret did mention that we were fortunate t o be selected
as one of the 10 health organizations that is part of that NIH initiative and I want to really
give a shout out to Dr. Collins, who really thinking about it from our vantage point for
people who live in poverty, who is the sort of main cohort of the folks that we care for
and obviously racial and ethnic diversity amongst the population and I was fascinated
when you started talking about interpreting tools, because I think that’s really going to
be something that’s going to be important for all the different groups, who are going to
receive information back, because you also, at Sage, are out on a million lives’ quest.
Talk to us a little bit about the work that Sage is doing.

John Wilbanks: Sure, so it’s a nice clean round number that I woul d get to help rally
support, but it’s also probably close enough to start doing some really interesting work.
You know, I discovered pretty quickly that it was very hard to make informed consent
portable so that you just carry it around with you and so th at the PMI is a good example
of study that’s going to go right at that million number frontally. What we’ve been doing
at Sage is a little bit different, which is, you know, we’ve over the last couple of years
started running our own clinical studies. We started hosting clinical studies for others
and use Apple’s Research Kit Framework 10 roll through iPhones. We’ve just gotten
into Android in the past month or two with research stack as our first foray there and will
be adding more there as well and we are in all phases of clinical study; at this point, we
are working with academics and disease foundations and we are also working with the
pharmaceutical industry and the biotech industry and what we do is we say within any
given study, we want to make sur e that individuals have the right to donate a copy of
their data to science and so it’s more that we want to offer people the choice to do a
donation inside a study that they are motivated by, so something like our Parkinson’s
mPower Study. We’ve even rol led more than 20 thousand people in 18 months. We
ask them, would you like to have the data stay with us at Sage or would you like to force
us to share it with qualified researchers world wide and what we are seeing is, you
know, generally somewhere betwe en 70% and 75% of participants across all of the
studies that we are involved in, so I think that for us, that’s where that million person
number is going to come from, is from that percentage of people, who decide to prevent
whoever is running a study fro m siloing it off and keeping it as a trade secret. We are a
42% nonprofit and that’s only four more employees than total awardees in the PMI, so
that’s why it is so much fun to be a part of it is that we can take what we learn at Sage
and feed it over to PMI and we can take the learning from PMI and feed it over to Sage,
that’s a pretty nice way to work.

Margaret Flinter: We’ve been speaking today with John Wilbanks, Chief Commons
Officer at Sage Bionetworks. You can learn more about their work by going to
Sage.base.org or follow him on Twitter@wilbanks or sagebio. John, thank you so much
for joining us on Conversations on Healthcare today and for the fascinating
contributions you are making to knowledge.

John Wilbanks – Sage BioNetworks

John Wilbanks: My pleasure.

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Mark Mas selli: At Conversations on Healthcare, we want our audience to be truly in the
know when it comes to the facts about healthcare reform and policy. Lori Robertson is
an award - winning journalist and managing editor of FactCheck.org, a nonpartisan,
nonprofi t consumer advocate for voters that aim to reduce the level of deception in US
politics. Lori what have you got for us this week?

Lori Robertson: In the final Presidential debate, each candidate misrepresented the
others position on abortion. Let’s start with Donald Trump. He claimed that based on
what Hilary Clinton was saying, “you can take the baby and rip the baby out of the
womb in the ninth month on the final day.” First, late term abortions are rare, just 1.2%
of all the abortions in the Uni ted States occur after 20 weeks gestation. Second,
medical experts say there’s no such thing as an abortion on the final day or the due
date as Trump describes. Daniel Grossman, a Professor of Obstetrics and Gynecology
at the University of California, Sa n Francisco, told our fact checking colleague that as a
matter of fact that if the mother’s life was in danger, the treatment would be delivery.
The New York Times similarly quoted the chairman of obstetrics and gynecology at
Oregon Health and Science Uni versity as saying the scenario Trump described “is not
happening in the United States. As for Clinton’s position, she has been a staunch
defender of abortion rights, but she has said, she is open to restrictions on late term
abortions provided exceptions would be given when the health and life of the mother are
an issue, but Clinton also misrepresented Trump’s current position. She claims that
Trump said, “there should be some form of punishment for women who obtain abortion.”
He did say that, but he als o walked back that statement only hours later. On March
th
30 , Trump pulled MSNBCs Chris Matthews that women who get abortion should
receive “some form of punishment” if the procedure is banned in the United States. He
also added that the man who impregnates the women should not be responsible under
the law for the abortion, but on the same day, he put out a statement recanting the
punishment claim. He said that if abortion were outlawed, the doctor or any person
performing this illegal act upon a woman would be held legally responsible and that’s
my fact check for this week. I am Lori Robertson, managing editor of FactCheck.org,

Margaret Flinter: FactCheck.org is committed to factual accuracy from the country's
major political players and is a project of the Annenberg Public Policy Center at the
University of Pennsylvania. If you have a fact, that you would like checked, email us at
www.chcradio.com . We will have FactCheck.org's Lori Robertson check it o ut for you
here on Conversations on Healthcare.

John Wilbanks – Sage BioNetworks

(Music)

Mark Masselli : Each week Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. No parent wants to hear their
young child’s chronic health issues requiring complex and risky surgery, but that was
exactly the case for 3 - year - old Mia Gonzalez; plagued for years with severe life -
threatening respiratory issues, her doctors discovered the cause was a severe aortic
abnormality that would eventually kill her without intervention. Dr. Redmond Burke,
Head of the Pediatric Cardiovascular Surgery at Nicklaus Children’s Hospital in Miami
would once have deemed her condition inoperable. So we chose a new tactic, created
3D printed model of her actual hea rt to offer surgeons a chance to map out an approach
to the complex surgery.

Dr. Redmond Burke : This was printed out because she was thought to be inoperable
and by having this type of model, we were able to conceive of an operation that hadn’t
been done before.

Mark Masselli: Dr. Burke said he carried the heart around with him for weeks analyzing
the problem from every conceivable angle, the surgery ended up being a resounding
success.

Dr. Redmond Burke: Her operation was extremely successful and she is recovering
very well. Now, her life instead of being measured in terms of days and weeks is going
to be measured in terms of years and decades.

Mark Masselli: This method of deploying 3D technology could help surgeons
everywhere create workable solu tions to complex surgical problems. A 3D printed
model of a patient’s organ offering surgeons a visual tool to help tackle complex surgical
dilemmas, leading to better surgical outcomes. Now, that’s a bright idea.

(Music)

Margaret Flinter: This is Con versations on Healthcare, I am Margaret Flinter.

Mark Masselli: And I am Mark Masselli, peace and health.

Conversations on Healthcare, broadcast from the campus of WESU at Wesleyan
University, streaming live at www. wesufm.org and brought to you by the Community
Health Center.

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