Equity and Social Justice | Precision Medicine

Equity and Social Justice  | Precision Medicine


– Good morning everybody. Good morning everyone. – [Audience] Good morning. – I know everyone’s a
little short on energy. I think a few of us stayed up a little past our typical
bed times last night. I don’t know. Maybe it’s just me. My name is Alden Landry, and I’m the Faculty Assistant Director for the Office for Diversity, Inclusion, and Community Partnership, and I’ve had the pleasure of coordinating these equity and social
justice lecture series for the past three or so years. Just to give you a
little bit of background about our equity and social
justice lecture series, these are dialogues which target our Harvard and Longwood communities, as well as greater Boston, with the goal of bringing the historical current and future state of health equity and
social justice issues. We try and focus on four key areas. History and context,
culture and environment, health disparities, and
leadership and skills development. This is an exciting topic, because this is sort of
cutting edge information and we’re having an opportunity to talk about a health equity issue really in the forefront of the emerging stages of new technology, and something that’s gonna
impact our patient’s care and also our communities. We’ve assembled a great keynote and list of panelists, and I think we’re gonna have a really rich discussion
over the next few hours and I just want to say thank you all for getting up this morning, and coming to join us. Unfortunately, Dean Reed
is not able to join us but she sends her greetings, and with that, I would like to
introduce our keynote speaker who is going to be Vince Bonham. He’s the Senior Advisor to the Director on Genomics and Health Disparities at the National Human Genome
Research Institute, NIH. Vince is a graduate of
Michigan State University and earned a law degree from
the Ohio State University. Since 2003, Mr. Bonham has served as Associate Investigator for the National Human Genome
Research Institute, in the Division of Intramural Research, Social and Behavioral Research Branch. He leads Health Disparities Genomics Unit which conducts research that evaluates and approaches to integrate
new genomic knowledge and precision medicine
into clinical settings without exacerbating inequities
in healthcare delivery. He also serves as Senior
Advisor to the NHGRI Director and his research focuses primarily on social influences of
new genomic knowledge particularly in communities of color. With that, I want to say
welcome to Mr. Vince Bonham. (audience applause) – Good morning. I am pleased to be here, and look forward to this conversation that we’re gonna have this morning, and I’m pleased to be
with such a great panel and have an opportunity
to talk with each of you. What I want to do today,
is really set a context, and talk about a few issues, that I think are important
in this conversation as we think about precision medicine and where we are today in 2019, and the hopes for the future, but let me just start, this is my voice. It’s not the voice of the Department of Health
and Human Services or NIH or the Genome Institute. It’s my voice, as an
intramural researcher, and my perspective and my lens. I’m not saying that
everything that I would say is what NIH would say, or
the Department would say. Let me just start. When I think about precision medicine, I really think about a variety of ways to think about how do you provide, much more individualized care to an individual patient,
that can provide benefit? With this slide, just
really thinking about diagnostics, risk
assessment, pharmacogenomics, new drugs that are directly unique for an individual or
population of individuals and then genetic therapies, I think all fit in the scope of what I would describe
as precision medicine. This slide is a slide
that I took with my iPhone that I show often times when I give talks, and I think it’s pretty relevant for this audience here, because actually this is in
the state of Massachusetts. My family visits Martha’s
Vineyard almost yearly now and this is a slide that I took in Chappaquiddick a couple years ago and I was walking down
this path and I saw this, and I said I need to
take a picture of this, because I think this is a good metaphor for where we are with
regards to genomic medicine, precision medicine, and the future. If you look at this path, you see the path is going down, but you see a divide in the path, and I argue, that really
that’s where we are with precision medicine. The potential of this divide in the path where some will actually
be able to benefit, and others will not. I argue from the
perspective of my research and the work that I’m doing
at the Genome Institute, how can we limit that divide in the path? I used this really to help
us think about this question of where we are today in 2019, and where will we be in 2025, 2030, with regards to the actual integration of precision medicine in clinical care for all your patients, and how do make sure that those patients that are typically under resourced get the benefits of precision medicine that’s developing innovation and excitement that’s occurring today and I’m one that believes we truly are in a revolutionary period of time with regards to biomedical research and here I am at this great institution that’s leading a lot of that work, but the question is,
actually who will benefit, from the work that you’re doing, and the work that’s being
conducted at this institution and institutions across the world. What I want to do this morning, is talk about four challenges. Four challenges with
regards to making sure that precision medicine can benefit all. My first challenge is
the lack of diversity in genomics research, and I argue this is the
number one challenge. The lack of diversity in genomic and precision medicine research, and I am really framing it around genomic and genetic diversity,
genetic understanding, with regards to
understanding of difference related to health and treatment, and this is an interesting conversation and I have this conversation all the time about this lack of diversity and the importance of
the lack of diversity, and our institute had a
meeting, two weeks ago now. Eric Lander was there. Variety of people from Harvard and Broads and MIT were there, and it was a conversation about not the social justice reason why we must have diversity. The scientific imperative
to have diversity, and it’s an interesting
conversation that’s going on I think within the
field of genomics today, with a recognition that diversity is a requirement from a
scientific perspective, but I argue we must also at the same time have this conversation
about the need for diversity related to access and equity
and a social justice lens of thinking about precision medicine. When we think about and talk
about this issue of diversity, this is a huge issue, and there’s been some
really important work that’s come out over the last few years, and I just want to highlight this study. Actually, I’m highlighting two studies here in this article. This was published in Nature in 2016, by Alice Popejoy who at that time was a graduate student
at UW out in Seattle with Malia Fullerton, where they replicated a study that was done by Carlos Bustamante and David Goldstein in 2009, and so they replicated the study in 2016, and they show that with
regards to where we are with regards to the diversity
in the databases at that time that over that period of 2009 to 2016, during the past seven years, there continue to be a major number of our samples are focused
on European populations, but there had been some increase, and the increase was specifically
with Asian populations. Individuals from South Asia,
Southeast Asia, and East Asia where there had been an
increase between 2009 and 2016, but with regards to those
populations in the United States that are commonly identified
as those populations that are underrepresented underserved, there actually had not been an increase. Between 2009 and 2016, we really still have less
than 4% of the population in the genomics research studies are from African American,
Latino populations, American Indian populations. This challenge with
regards to understanding ancestral diversity across populations that are often disparity populations continues to be a major issue, but then I had an opportunity to work with Latrice here, with Dr. Landry on a study that we conducted, that was published in Health Affairs, and I know she may talk about this in the panel a little bit, but this study really
looked at specific diseases and looked at studies that looked both at genome association studies, and sequencing studies
that focused on diseases, to see do we see similar
or different findings than what Fullerton and Popejoy identify? We clearly found the same types of gaps with regards to diverse populations, so that the majority of the studies in the public genomic database, is dbGaP and GWAS catalog are based on populations
of European ancestry. This continues to be an issue, with regards to disease specific,
cancer specific studies, and significantly fewer studies exist of African, Latin American, and
Asian ancestral populations. When you look generally, with regards to the data in the databases, there’s this gap, and when you look specifically at the studies of diseases, there is a gap, and that this gap continues, and this gap will continue the divide and I argue, with regards
to who will benefit from precision medicine? When we think about this broadly, there is a study that just came out on genome wide association studies, where they really looked at a variety of different issues. You see this article from VOX. This recognition that this is a problem. We have a problem in science, with the lack of diversity, of populations, ancestral populations, in the research, that will actually
create harm for everyone, but particularly for those populations that are missing. Lack of diversity in genomics research. The potential of precision medicine to improve health for benefit patients from all backgrounds will depend on the ability to correctly
interpret genomic variants, and without having those
populations in the study it will continue to be a major issue. We have seen a number of examples, with regards to the
problems that can occur with regards to the ability to assess the risk for individual patients. Challenge two. Communicating human genetic variation. Communicating human genetic variation. One of the areas of work
that I’ve been involved in really almost the whole 15 years since I’ve been at the Genome Institute, is how we think about difference and talk about difference with regards to genomics, and I argue that this is
also gonna be important for the success of precision medicine. Is how do we communicate difference to both patients, the general
public, the providers, and how do we use this
information in a way to help in providing quality healthcare to individual patients? I’m just gonna show you a couple slides from a couple studies, just to put your focus on how the populations in the
studies are described. This study here, the
researchers are basically using the OMB categories of race, and how they describe the
populations in their study, and this study, these two studies, they used ancestral population descriptors using continental geographic descriptors. What does this mean when you talk about an individual patient
and how do we interpret that? Then this last one just came out in New England Journal of Medicine just before the end of the year, that was focused on issues with regards to kidney disease, and APL one, you see they used specific geographic locations. Haiti, Antigua, Trinidad, Panama. As how they described their
populations in their study. What’s gonna help us in communicating to patient populations? How do we approach this, and why do I talk about this, when we’re talking about
precision medicine? Well I think this issue of
how we think about difference and the issue of race is a conversation within the field of genomics, that we must continue to have and explore, how do we communicate difference? How do we talk about difference? What is the role of race? What is race, and what do we do with regards to actually providing individualized care to patients? This exploring, this question, this science commentary from 2016, by Sarah Tishkoff and her colleagues, argues that the field
of genetics and genomics must move away from using
race in research studies and exploring this question of is there a better way
to communicate variation than how researchers do today? I argue that we must
think about this question and we must think about it in the context of precision medicine, and where we are and where we’re going, and so one of the interesting areas is to talk about how we
use race and ethnicity in talking about treatment
and drug response and differences, and we
recognize that people from different ancestral backgrounds may actually metabolize drugs differently, may benefit from drugs differently and we must recognize and use that in a way to provide the best care for the individual patient, but how we talk about the populations? What do we do in a way that will help us in communicating to a patient population? The question of race and medicine, I think is part of this conversation related to precision medicine. A few years ago I conducted a study of practicing internal medicine physicians where we surveyed their
knowledge of genetic variation, their use of race in clinical practice, and we asked a number of questions, and we asked two questions. What does race mean to you, and what does ethnicity mean to you? These are the findings from this study, and you see that the vast majority of the physicians in our study, identified race as a genetic
or a biological group. A genetic or biological group, but you’ll see that the majority of the physicians identified ethnicity as a cultural or a social group, and this is interesting when I read a lot of literature and you see race slash ethnicity, when describing the
populations in the study and how we think about these concepts and use these concepts, within medicine, within a social context, within our society, and how do we communicate both the recognition that ancestral backgrounds may have genetic
variation that’s different but also understanding that race and ethnicity are
clearly social constructs that influence our lives. We ask the questions, biological difference
between racial groups affect health outcome differences. Almost all the physicians
agreed with this statement. Either somewhat agreed or strongly agreed, and then we ask whether
race is the best proxy clinicians have to
identify genetic effects, and you see a much different kind of slope with regards to responses. Now this study was conducted in 2012. I’m curious if I do this study today, will I have any different responses? Maybe this is gonna be something that’s on my research
agenda as we go forward, but this question of
how healthcare providers think about these issues
is extremely important. I want to bring to your attention a paper that just came out
in December of last year. A content analysis of the
views of genetic professionals on race, ancestry, and genetics. Michael Bamshad is the Senior Author Along with Charmaine Royal, and it really does a nice job of an analysis that they did of a survey that they conducted with all of the genetic societies, the American Society of Human Genetics, the Medical College of Genetics, the Genetic Counselors, and exploring how these professionals think about race and ethnicity
and ancestry and use it. This quote from the
article, I just really like. “I have somehow managed to hold seemingly mutually exclusive views that race don’t exist and
are biologically meaningless and races have a genetic basis and biological influences on health.” This tension how we think about difference and communicate difference, I argue, is part of the context of the future of precision medicine, and that to really have the benefits of precision medicine, we’re going to have to tackle and struggle with these concepts, as we talk about care
for individual patients. My Director, Eric Green, and the Director of the National Institute Minority Health and Health Disparities, and I published a view
point in JAMA last November where we argued now is the time, to really grapple with
population descriptors and genomics and biomedical research. That we really need to push researchers, NIH, the community, in how we use these descriptors, and be more thoughtful and rigorous in the way we approach it. What we’ve done is we
have now pulled together I think about 16 to 17 different institutes and centers at NIH that are all interested in this topic, where we’re coming together to talk about what next steps NIH should take in really exploring this issue of how we’re using population
descriptors in our work. Precision care, not race based care. The potential of precision
medicine to improve health for patients from all
ancestral backgrounds will depend on the the use
of genomic information. All right, challenge three. Access to precision medicine, and the case study I’m gonna
use is Pharmacogenomics, but I want to start with this framework. My colleague at Johns
Hopkins is Lisa Cooper who some of you may know. Dr. Cooper is a general
intern as epidemiologist, and she developed this framework, and I asked her if I
could take her framework and modify it for a genomic context. What I did was I really thought about this from the perspective of
what are the barriers? What are the issues of services, and the mediators and outcomes, that are important with regards to both research and then ultimately care, for individuals related
to genomic medicine, and I highlight here a couple of things that I want to just
bring to your attention. One of the areas that I
see as extremely important is scientific knowledge. This is this issue about
understanding diversity. Understanding our ancestral diversity. Understanding what that means in perspective of
differences in gene variants related to disease and
health and treatment, and so without that
information we’re gonna fail. A barrier is making sure that we have that scientific knowledge, but this issue of costs,
insurance coverage reimbursement, is too and also a major barrier, that I would argue with regards to the ability to actually
integrate genomic medicine and precision medicine into clinical care. Thinking about it from that perspective, that is one of the key areas. What are the areas of mediators? I would highlight with
regards to mediators that actually could benefit or potentially be challenges, are related directly to the provider. The issues of the skills, the
knowledge of the provider, the biases of the provider, the stereotypes of the provider, are important in the ability to have positive outcomes, with regards to the integration of genomics and precision
medicine into clinical care and the ultimate goal
here are the outcomes, and how do we increase health, reduce mortality, improve the
benefits to all populations? Exploring these questions, and using this kind of a framework to think about those issues. I want to give one case example, that’s a pharmacogenomic case example. I want to talk about
Clopidogrel for a minute and I think Clopidogrel is a good example of something that is here today, with regards to genetic testing, that we’re not talking about the future. We’re not talking about a situation that’s very expensive, but can actually have an impact on the individual’s life. Clearly, this is a drug
that many patients are on. Maybe many patients you
prescribed are put on this drug. This drug is an important
part of the treatment of individual patients today, but not everyone can metabolize this drug, and so clearly there’s been
a lot of work and guidelines with regards to appropriate
use of Clopidogrel, and issues with regards
to genetic testing, and so I would argue from
a precision medicine today, and this issue of equity, this is an example that
we can all think about, not from a perspective of a very expensive type of testing or treatment, but from a pretty
reasonable appropriate way to make a judgment with regards to whether a drug is
correct for a person or not, and so I’ll tell you a little story, and this is an interesting story. It’s ongoing. The story has not ended
at this point in time. I don’t know what’s gonna
happen with this story, but I think it’s an important
story for us to think about in the context of my talk
today about who will benefit and the promise of precision medicine. Now about four years
ago, as everyone knows, I was trained originally as a lawyer. The Attorney General
of the state of Hawaii filed a lawsuit and the Attorney General filed a lawsuit against the
pharmaceutical companies that makes Clopidogrel, and
he argued in this lawsuit, that between 20% and 30% of
the population of his state cannot metabolize that drug well, and that the pharmaceutical
company knew this information and failed to communicate that to the healthcare providers
within their state. Because greater than 50% of
Native Hawaiian populations, Pacific Islander populations, have an allele that actually has an impact on the ability to metabolize the drug and so therefore individuals
should be tested, should have genetic tests. Whether this is appropriate
drug for them or not. This case is ongoing. I don’t know what’s gonna
happen with this case, but it raises an interesting question about do we now, right now today, have approaches to provide better care, more precise care for
individual patient populations that we’re not following, and are there ways that we can integrate precision medicine into
clinical care today? I argue that when we think
about precision medicine, we’re not always thinking about whole genome sequencing, or major very expensive
testing or treatments. We’re also thinking about
how do you integrate actual use of technology and
knowledge that we have today in a way that could benefit
individual patients? Coming back to the framework, this issue of scientific knowledge, issues of costs, issues
of thinking about this in the context of genomic medicine. The issues of provider
knowledge and biases is an important component
to ultimately look at this assessment of
whether precision medicine actually will improve outcomes. All right. But it’s not just from the framework of thinking about the delivery system of an individual patient and provider. We must also think about these questions from an organizational behavior, and organizational behavior perspective in thinking about these issues. Again, is also some of the work that Dr. Cooper has done, but I want to highlight here from the perspective of this conversation about precision medicine
and clinical care, and access to precision medicine. This issue of equitable care and the issue of diversity in workforce, organizational structure
that’s being taken on by institutions to
actually tackle the issues of integration of precision medicine. I mentioned to Dr. Landry
that I had an opportunity last summer at a National
Academies of Science meeting to interact with Dr. Armstrong,
Katrina Armstrong from here about some of the exciting
things that are happening here on better ways to integrate
precision medicine across all your patient populations, and how do you think about those issues in a way to address barriers? Organizational behavior
is an important component in whether precision medicine
actually will benefit or not and so I argue that when we study and think about these questions, we need to be thinking about the organization as well as the individual provider and patient. Access to precision care. The potential of precision medicine to improve health for patients from all ancestral backgrounds will depend on provider knowledge, decision making and costs. Challenge four. Challenge four is really
looking into the future, but I argue if you’re
gonna have a conversation about will everyone benefit or not, that we need to think about
what is on the horizon and some of the exciting
things that are happening on the horizon that I believe will be important component of precision medicine and I argue just a component, but will be a part of precision
medicine for the future, and so I want to highlight access to curative genomic therapies, and how we need to think
about that also today as we think about the integration
of precision medicine. I want to talk about some
research that I’m involved in that is also directly related to work that’s going on right here in Boston, and that’s the issue of
somatic gene editing, related to Sickle Cell disease. Somatic gene editing related
to Sickle Cell disease. I’m not talking about. I’m focused on somatic gene editing. The care of an individual patient, and so really focused on
it from that perspective and not the ethical questions about gene editing that are so important but the opportunities today, and that are on the horizon
for somatic gene editing and gene therapy to
actually benefit diseases that have impact significantly
on disparity populations, and the disease that I study
is Sickle Cell disease, and so there is some great work that’s happening here in Boston, around particularly BC 11A, a gene that’s involved with regard to fetal hemoglobin, the
ability to modify that gene in a way to enhance the fetal hemoglobin and reduce the severity of the disease. Stu Orkin and all his group here in Boston are really leading that work for the number of the biotech
companies here in this city, but there’s also work going on around the beta globin gene, of actually correcting the point mutation that causes Sickle Cell disease. These are two approaches that are now, one’s already in clinical trials. The other one’s moving to clinical trial that are gonna have the potential of actually curing the disease. I don’t know if anybody saw the New York Times article last Sunday about Sickle Cell disease. There’s a lot of work. Marti’s involved in
some work in this area, so this broader question about
curative genetic therapies and the potential benefit, but I argue this is
too an issue of equity, that we need to think about and explore, and to explore it from a
couple different perspectives. One is cost. When we think about these
curative genetic therapies and we think about the
cost of these therapies, this is gonna be question about who actually will get access to it. We’ll have the clinical trials. They will go forward, but as this gets integrated
into clinical care, who will actually be able
to get access to this? The expected cost right now is between half a million and $700,000. We don’t know exactly what it will be by the time it comes to the clinic, but clearly this is gonna be a major cost with regards to the ability to have access to these therapies. Who will get access? What are the issues around access? How will the decisions be made? What types of policy will be put in place to help to facilitate access? How do we question this from a perspective of limited resources and how
we explore limited resources. This is a question I think that we have to think about today, and not just in the future, and I think for this disease particularly, we need to think about this from a global context and not just a U.S. or European or high income countries. When you think about Sickle Cell disease the vast burden of this disease, is in sub-Saharan Africa, and India. The vast burden of this disease is in sub-Saharan Africa and India. Today still, the number of young children that die with Sickle Cell disease is vast and then thinking about
genetic curative therapies. How do we balance that, when we think about a disease? I think that as part of this conversation that we talk about who will
benefit and who will not we must think about this
question from a global context and not just a U.S. context. This slide is from the
National Academies of Science 2017 report on genome editing, where they identified
seven governance principles for human genome editing, and I highlight one of
those that they highlighted which is fairness, and I argue. I have the honor to go to the second human genome editing meeting in Hong Kong and I argue that it’s not fairness. It’s actually equity that
we need to be arguing, and that we need to be thinking about this from an equity context
and a justice context, and that when we think
about somatic gene editing that we really need to
put it into context. Both excitement and the innovation and the opportunity of these new therapies but actually who will
benefit and who will not, and how do we find this work in a way to increase the number of people who will benefit? Access to genetic curative therapies, the potential of genetic
curative therapies, to benefit disparity diseases in patients will depend on scientific innovation, industry priorities, provider
knowledge, and costs. I want to just walk
through some strategies that I think are some strategies to address this issue to making sure that genomic and precision medicine will benefit all, and I want to highlight a paper that my colleagues and I published in Nature Reviews Genetics, where it really lays out
our institute’s perspective on what we must do to
actually increase the benefit. It’s focused on diversity issues, and prioritizing diversity in human genomics research, but we lay out a number of our efforts and steps that we’ve taken, and that we plan to continue to take, to tackle some of these issues. I think there’s a recognition within the community, that there’s a lot to be done, and that we must take these steps today but we all have a place and a role, to play in this. I want to close with several
suggestions that I have of how do we make the promise of precision medicine a reality? First, I would argue we need to use electronic healthcare record as a tool for genomic medicine and equitable care. Both in the perspective
of providing better care to individual patients, but a way to monitor what’s going on, and monitor differences in treatment, that we really can use data that we have as a learning health system, as an approach, as a way of monitoring and making sure we highlight the gaps, and disparities that we see in treatment, but also to help us with regards to providing better care
to individual patients. I think the second is we need to support and this is really from
a research context, support the development of resources that adjust for diversity during analysis and interpretation. We need better tools, to understand difference and variation and how we think about small
population differences. That we need to create those tools in a way that can actually be beneficial. Really putting the efforts and energy on technology development that are gonna help us with that process, I think is an important
step that we must take. We need funded targeted
research initiatives. I am pleased that the National Human Genome Research Institute is leading the way in
this area of recognizing that we need to require researchers to recruit specific populations
where we are under involved in participating and if they can’t do it, they can’t get the funding. This ability to start to really build those bridges, in a way to actually work
with those communities that are now not at the
level that they should be within our databases. Engage with those communities. Our institute has targeted a number of our initiatives for under resourced populations. For minority racial ethnic populations, for rural populations, for populations that are often left out of the research. Sustained community engagement, education and partnership. We must continue to have dialogue and engagement with communities. We can’t just go ask
for their DNA and leave. We must understand and
recognize their priorities and what they want and how to actually make sure that the research
that we’re conducting, the work that we’re doing is actually something that
is of community interest and of community benefit. With that I just want to close to let you know that our institute is in the process of developing a strategic plan for
2020 for our institute. The National Human
Genome Research Institute from its very beginning, has had these strategic
plans as milestones. Leading the Human Genome Project for the United States, we had five year strategic plans on what was to be done by certain dates and our institute has continued to do this type of an approach to help guide and direct our research program, and so we are now in the
midst of this process. I invite you to go to our website, to send in notes, your feedback. What you think needs to happen. What you think shouldn’t happen. Of how do we move forward in a way that can actually benefit everyone? With that, thank you, and I’ll take any questions. (audience applause) – We do have time for a few
questions for Mr. Bonham. For those in the room, there’s a microphone in front of you. Please hold down the button while you’re asking your question so everybody in the audience
can hear your question. – Good morning. Can you hear me? Thank you for your talk. I have a question, a followup. You mentioned how we’re trying to separate the science from
the representation itself or the social component, but one of the issues that we have is that the populations that we’re lacking in all these databases, are
heavily underrepresented in science through not doing the research, so it’s really hard to decouple that, especially if you’re going to talk to these populations who have experienced so many injustices. Can you elaborate on
what’s currently being done or how you’re thinking
about how to work those? – I totally agree with you. I was going back and forth. Should I have five challenges
or four challenges. How much time do I have? They only gave me 35 minutes. My next challenge was
really this workforce issue which is a huge issue, and it continues to be a major issue around genomics research, around biomedical research more broadly and around healthcare, and without having
members of the community, people who are engaged
from those communities, the perspective of the work is different. The perspective with regard to how they engage and work with
the communities is different and I think that it continues
to be a major problem and actually I’m on Thursday giving a talk at the American Society of Human Genetics where that is the whole conversation about what can we do now? Our institute is doing a
couple things right now. One is there’s a recognition
that this is a problem, and we are seeking in a variety of ways to work with our grantees, particularly our large grantees, like this place, that how can you bring in more people from under represented communities actually doing the science? Can we provide you additional funds to help you do that in a way that helps develop that? We have taken on an approach where we provide additional resources to grantees in helping to do hat. We also are developing
different training programs at different types of
institutions across the country, to reach out to different
kinds of institutions to actually how can we increase our workforce in that way? But I think the biggest issue is to put a spotlight on it. To put a spotlight on what
the numbers look like. To what the challenges are,
and help to develop plans on how do we build people to be able, and I think one of the
challenges is the pipeline issue. That’s the problem, but I argue that we also have this loss that happens right from
graduate students to post doc to those initial academic positions that we really need to put a highlight on. There’s a number of
different programs at NIH that are taking on this issue. This continues to be a major issue, and I think it is a challenge related to ultimately
precision medicine also. – Thanks so much for the talk. I’m a genetic counselor, and I’m on the Diversity
and Inclusion Task Force of the National Society
of Genetic Counselors which is just starting. It’s only a year long task force, and what I’m thinking about many things, but one is that NSGC is
such a small organization in comparison to some
of these other genetics, national organizations, and how we might be able to dialogue with some of the other organizations that have already endeavored on even just diversity statements. What kind of platform there could be for cross organizational conversations about the same issues? – Two things. You’re gonna give me a
card before you leave here. I’m gonna take it to
Mona at ASHG on Thursday when I give this talk. I actually think that was a great thing connecting Kathy Wickland and some of the other folks I know, within the genetic counseling, and actually I think genetic counseling is really one of the real problems, from a clinical perspective, it really is an outlier. I’m happy to help be a bridge, of bringing organizations together to talk about these issues, and how working together. I think genetic counseling is, I don’t know how many. Everybody knows it’s a unique profession and one that is a very small profession and it’s becoming so important with regards to clinical care and then when you look
at the diversity of it there is none. I think I can count almost all of the African
American genetic counselors in the country. It’s a huge issue. I am happy to help in any way I can in helping bring the work that I do at the National Human
Genome Research Institute to try to build some of
those bridges to help and I know it’s been a major problem. I know it’s been brought up at various times over the last 10 years, but I think now’s the
time to bring it up again in a different kind of
way maybe, so let’s talk. – I guess with the rise
of voluntary participation or excitement in the public
with things like 23 and Me, where people are just getting more excited about learning about their own genes, but there’s a lack of clarity
on how that information is stored or shared, and
possibly skewed towards those who are in more
affluent populations, that are actually able to participate in things like that. Could you just talk about how you think that is pertinent to this discussion on equity and genomics? – I think it’s an important question and there have been
people who have been doing research in this area, and it’s kind of interesting. I don’t know how much it’s
perceived as a problem or how much it is the problem, and most recently in
the work that I’ve read is that’s not the
primary issue of concern. It’s much more about I have limited time. I gotta take the children to school. It’s a get the healthcare
to do those kinds of things to use it are barriers and challenges versus these issues of
concern with privacy, but I do think it’s a continuing issue we need to raise and study, but actually the most recent studies are showing that’s not
the highest priority. Why people are not participating. I know Dr. Landry and she may talk about some of the work that
she’s done with 23 and Me and some of the other kinds. We have all of us can talk about the perceptions and
experiences they’re having. I think there’s a variety of issues, and I think that there’s an obligation, both for those companies,
as well as the government, to do everything to protect information but I also think that
there are other issues that are going on that may be barriers. I know we don’t have much time. Last question. – [Woman] Thank you. Do you think there is an impact of fear about identifying genetic differences related to the historic
sector of eugenics? – Marti might go into
that a little bit also. I think we, how would I describe it? I think people recognize difference and intuitively understand difference. I think that the challenge is that difference does not fit
into our social categories, and that is what creates this problem. When we use our concept of race, and talk about difference, we know that that is
not necessarily valid. I would argue that we need
to tease these things apart and this is why I see this as a challenge. The ability to communicate variation and that we too often in my opinion, talk about difference in a construct that does not necessarily
fit scientific variation. That we’ll put a person in a group. You are black. This is what you are, but they understand from
an ancestral background that they have a significant amount of European or American Indian blood and background and ancestral, so what does that mean? How we use these concepts, is where I think all have to work together in better ways to talk about and to
communicate difference. Thank you. – Thank you. (audience applause) We’re gonna transition
now to our panelists. They’re gonna come up individually, but I’m gonna introduce our moderator who will introduce all our panelists. I should know this bio by heart, given the individual who I’m introducing, but I wanted to bring
up Dr. Latrice Landry. When we were tasked with this, developing this equity and
social justice lecture series, I was fortunate to have
a personal relationship with an expert in the field, and she helped pull together, not only our keynote
speaker but our panelists, so Dr. Latrice Landry is a
Clinical Genomics Fellow, at Brigham and Women’s Hospital and Dana Farber Cancer Institute, and also at the Harvard
School of Public Health where she focuses on precision medicine and health disparities. She received her undergraduate training and graduate training at Tufts University, and she’s focused her research, on a number of large patient populations including the Boston
Puerto Rican health study, the Jackson Heart study,
so on and so forth. She is going to introduce our panelists, and our panelists will
come to the microphone, give their presentations, and then afterwards,
we’re gonna hold questions for the individual panelists, until all of their presentations, then we’ll have them here in the front where they can interact
with the entire audience and answer questions. With that, Dr. Landry. (audience applause) – Please excuse me. I’ve never had the opportunity to do this, but thank you Dr. Landry
for that introduction. Welcome. I think this is going to be an exciting, an engaging panel discussion and we have a very diverse group of panelists to speak with us today. I’d like to also thank Mr. Bonham for his presentation, and leading us through some frameworks in which we can think about this. Thinking about different
types of precision medicine in terms of diagnostics, therapeutics, targeted therapies, and also thinking about some of the challenges we have before us. Each of our panelists was selected based off of their expertise in this area. As Dr. Landry mentioned,
each one will come up, and give you a short presentation to sort of introduce you to their, where they live in this
precision medicine space, and then we’ll open it up
for all of us and Mr. Bonham to sit on a panel discussion to have a more free flowing dialogue around these issues. Our first speaker will
be Dr. Marti Gilbert. Marti is the Director of Programs for the Personal Genetics
Education Project here at Harvard Medical School and the Department of Genetics. The goal of the Personalized
Genetics Education Project is to engage the public
in awareness and dialogue about the benefits as well as the ethical, legal,
and social implications of genetic technologies. Dr. Gilbert’s most recent initiatives have focused on organizing
congressional briefings as well as advising writers, producers of television and film, and working with communities of faith, around workshops, around
personalized genetics, and also leading and educating teachers in both primary and secondary education around these issues. She leads an NIH science education partnership award program, a five year award, from NIH, on engaging multiple communities and those in Massachusetts as well as South Dakota around topics around genetics, and the idea is to bring and integrate discussion in genetics, in both the classrooms,
and in those communities. Marti is a very gifted
speaker in this topic, and she will help to address some of those historical issues that were mentioned before. Marti, we look forward to your discussion. Thank you. (audience applause) – Thank you Latrice, for that kind introduction, and it’s really a pleasure to be here with you all this morning, speaking with Mr. Bonham, and the panel of speakers here. As Latrice said, I’m based in the Department of Genetics here
at Harvard Medical School where we are really my colleagues and I are so excited about the potential of the technologies that are coming out of genetic labs here at Harvard and around the world,
to improve healthcare knowing that there’s a
lot of important work that needs to be done, to make those technologies
available to all and to make sure that these technologies are not widening the gap between the haves and have nots, and really appreciate Vince, your comments this
morning about strategies for how we can do better. I’m also speaking from the Personal Genetics Education Project, where our lens on social justice is really thinking about equity across all communities, and access to information
about genetic technology, so that our communities are aware about the choices that they’re facing, but are prepared to
make informed decisions. Whether they want to use genetic
technologies in their lives or whether they choose not to, and that the voices of
our communities are heard. The concerns are heard by researchers. I will just. Vince it was such a great introduction, I think I can just go through
these slides fairly quickly but just to ground these conversations in what the field of
genetics is making possible, so when the Human Genome
Project was completed that the first sequence
of the human genome took over 13 years, cost $3 billion. Today consumers can get access to their full genome
sequence, for under $1,000, and the exact price point depends on if you want that
information interpreted or just a long list of As, Cs, Gs, and Ts. It is very clear to our colleagues that this technology will
not be accessible to everyone unless the cost keeps coming down, and so there are many researchers, who are working to make the cost of genome sequencing free. Vince talked about pharmacogenetics that our bodies metabolize
medications differently and so here I give another example of how a person’s genetic information can inform healthcare decisions. Here talking about the drug codeine, a pain reliever, which our
bodies metabolize into morphine, and genetic variation, in CYP2D6, can influence how efficiently our bodies metabolize the drug. In this room, there’s probably a few of us if we take codeine for pain
after a dental procedure who have experienced
very little pain relief. There are people who metabolize, who CYP2D6 variants, predispose them to slowly
metabolizing the drug, whereas and so for them, they don’t experience much
therapeutic relief from codeine. Even more concerning is people who are rapid metabolizers
of codeine into morphine and if these individuals are given codeine they can experience very severe and even life threatening reactions and so an individual
who goes into the doctor when their doctors asks, if you have any family
history of allergy to codeine, it’s a very important question. Somebody mentioned 23 and Me. People are increasingly have access to their genetic information through tests that are available online that can give a range of information whether it’s risk for disease, carrier testing for the variants that they can pass on to their children. Learning about their genetic contributions to their family story, their ancestry, and other traits, and this
is as people think about whether to participate in those questions about privacy, questions about how when they submit their samples, who will have access to
their genetic information whether in the context of research, or since the forgetting the name, but how their information
might be available to law enforcement, and last week we heard
from Family Tree DNA that had made public a relationship that they have with the FBI, for processing samples from certain very violent crimes, and then the law enforcement would be able to compare the samples to other samples in their database. Genetic genome sequencing is also making advances in prenatal tests that are increasingly
becoming the standard of care particularly for patients
of advanced maternal age, and these technologies
are making it possible to learn about the
genetic makeup of a fetus, from a sample of blood from
the pregnant person’s arm. Doctor, or Mr. Bonham also talked about the prospects of genetic therapies and very early but
promising results last week about how gene therapies might one day be used as a treatment
for Sickle Cell disease and also I need some water. In addition to concerns about access, there are major concerns
about the history of mistrust and who will participate
in clinical trials and there’s I think Dr.
Jackson will talk about some of the historical abuses
in medical experimentation that have been experienced in a number of marginalized communities in the field of genetics, we’re particularly aware
of our history of eugenics where flawed genetic arguments were used to justify what was thought to be superiority of some groups over others, and starting in 1927, and
going through the 1970s at least 66,000 people
were forcibly sterilized, because they thought that that would be for the societal benefit and so as this new wave
of genetic technologies comes out into the world, we feel a commitment to do much better in making sure our
communities are informed. That keeps flickering. At the Personal Genetics
Education Project, our mission is to raise awareness, and increase dialogue about the benefits and the ethical implications ethical and societal implications of genetic technologies
across all communities so individuals are
confident to ask questions, and to make informed decisions about their genetic information. I work with a really amazing
group of people shown here. We’re based in the lab of Dr. Tim Wu who runs a genetic lab. Many of us work here at
Harvard Medical School. My colleague Dana is up in Maine and run programs our of field’s corner because it became apparent pretty quickly that to engage our communities, while we could pretty easily get a group of people together from
affluent communities, in and around Boston, and it was much harder for us to engage with the communities closest to us, and so we operate on the principle that we need to meet our
communities where they are and talk about the issues and concerns that are most relevant to them. What do we do? I’ll just say really briefly. We go to schools, to community groups, and we talk about genetics. Both the potential good that
genetics can do for people, but also the ethical,
the personal, familial, and social implications
of genetic information. We work with teachers. We’ve developed a number of lesson plans for people to think about how genetics is entering their world, and we talk about topics
that are relevant to people. How they may be seeing
genetics in the clinic. The consumer market, but also concerns about
the history of eugenics. How genetic information might
be used in law enforcement. We travel around the
country to train teachers so that teachers, whether
they’re from science or history, or English, health, can bring these conversations, about genetics into their classrooms. We work with writers and
producers of television and film. As Latrice said we do
congressional briefings so that we can inform policy makers. These genetic technologies are moving so much faster than
conversations in the communities and also at the level of how policy makers will regulate them, and my last slide is communities of faith. As I said before, it’s really clear, that the challenges that we have in engaging our communities, and sometimes just showing up in a community where
you don’t know anything about the circumstances of
their life is offensive, and we reached out a few years ago to leaders from some faith communities. We’ve worked with Christina,
Jewish, and Muslim communities asking for their help because they have the
trust of their communities, particularly in
disenfranchised communities and so we have been working with them, and here’s one of the groups we’ve worked The Minority Coalition
for Precision Medicine who are a group of pastors
that have come together around concerns about diseases that are particularly prevalent in their African American community. Particularly Sickle Cell disease, and to say the first time, Michael and Shakir invited us to Baltimore for a meeting, and when we got there, we were expecting 200 pastors, and there was less than
10 people in the room. They at first were polite about why but then they, as the
conversation got going, they said, people from
institutions like yours, they come, they take,
they get what they need, and then they leave. Well a lot of people
didn’t show up that day, but there’s something amazing about a small group of people and powerful conversations
that you can have and we decided to get together again, and we had a followup
meeting here in Boston the following Spring, and the rapport that we’re building with groups is fragile. It takes time, but we’re
continuing these conversations, so that their communities can have the information
that they’re looking for. With that, I will end, and
pass it back to Latrice. (audience applause) – Marti, thank you very much for that very insightful presentation. As mentioned, we will have
each of the panelists present and engage in dialogue and discussions at the end of the panel presentations. Next I would like to
introduce Jonathon Jackson. Dr. Jonathon Jackson, who is the Director of the Community Access, Recruitment, and
Engagement Care Research Center at Massachusetts General Hospital and Harvard Medical School. Care investigates the impact
of diversity and inclusion on the quality of human subjects research and leverages deep community
engagement and entrenchment to build trust and overcome barriers to clinical trial participation. His research focuses on mid life and late life health disparities in the clinical setting that affect underserved populations. Dr. Jackson also works as
a cognitive neuroscientist investigating the early detection of Alzheimer’s disease. Particularly in the absence
of overt memory problems. He has become a well known representative to under served communities, and dozens of affiliated organizations particularly regard participation
in clinical research. Dr. Jackson serves on the leadership team of several organizations
focused on community health and has written guidance for local, statewide, and national groups, on research, access,
engagement, and recruitment. Please a warm welcome
for Dr. Jonathon Jackson. (audience applause) – All right, good morning everyone. I don’t have slides today, because in a previous life I was on an expert on mind wandering, and so I know better than to have some kind of competing
distraction behind me especially presented times four. I’m just going to be talking at you for the next 10 minutes, and hopefully we can get into some juicy conversation and
debate as we move forward. That said, again, mind wandering research. I know there’s stuff going on here, but please just try to focus as much as you can on what I say. If you get about 40% of it, you’re right on track for most adults. Good luck in listening to me for the next approximately four out
of the next 10 minutes. What I want to talk to you today is trying to present the information that we’ve discussed
previously with Dr. Gilbert and with the Associate Director in context and so namely that context is one from a historical perspective, so we need to recognize that there are these key ethics examples that we need to inject
into this conversation so that we understand the magnitude of the work that we’re doing especially as it moves forward. A quick show of hands. Who has heard of Henrietta Lacks? All right good. Great start. Who here has heard about
the Tuskegee Syphilis study? All right again almost everyone. Wonderful. Who here has heard of the
Havasupai Native American population in the Grand Canyon? We’re losing some hands here. Who here has heard of Vertus Hardiman? A single individual from
Lyles station, Indiana. Almost no one. Who knows what Columbia
University did in 1997 With regards to genetic information? The point that I’m trying to draw here is that there a couple of examples that we like to cite as
being the canonical examples but we often mistake
them to be exhaustive. One of the things that I often do especially in the month of February, is I like to outline a number of medical abuses and atrocities that have happened particularly
to underserved populations in particular we’re referring to Native populations, Latinx populations, black American populations, and prisoner populations. Historically, when we conducted
human subjects research we did it on communities of convenience. Whoever was the easiest to come by and in those days those populations were the ones that didn’t
have the opportunity to speak up or speak out. They were the ones who were silenced, either by systems, or by the design of the research study. We like to think that
we’re beyond those days, but if I’d like to make
a bit of a bold argument. I would say that we still largely rely on samples of convenience for our human subjects research. It’s just that those samples look a little bit different
these days than they did back in the 1920s, the 1960s. Whoops, the 1990s. We need to think about
the ethical implications of large databases of information when we are leaving some
people out of the equation. We’ve repeatedly blurred the line between clinical research
and clinical care. For those of us who are
on the research side we have that bright line. This is clinical care. This is clinical research, and we don’t violate it except when we do which is pretty frequent. We need to recognize
that that blurred line has cost us tremendously in the past, and to simply say that we’re doing these advances in the name of public good is to erase silence and ignore a lot of the history
of what’s come before. We often assume that these same harms, the same things that happened in Tuskegee, the same things that happened
in Columbia University in 1997 the same things that
happened just a few years ago with the Havasupai, we assume that they can’t happen again, because there are ethics policies that have been put in place. We’ve got the Belmont Commission and its intended report
published in the 1970s. We have ethics regulations and guidance from the Atomic Energy Commissions that was put in place in the 1950s. Again, we have these policies in place and we assume that that serves as an effective substitute for thinking about the ethical implications of the work that we’re doing, but again I would like to posit the humble suggestion that that is not enough. We have to recognize and this is really hard in New England where we don’t like
talking about these things, it’s hard to recognize that
our intent is not enough. Our intent is insufficient
to solve these issues, and if you think about it from a scientific perspective, thank you, if we had really good intent, to have a robust statistical analysis, but we didn’t really do the work, would we expect full credit? Would we expect that the peer review, that granting agencies, that our fellow colleagues would assume that that work was enough? We probably wouldn’t. If we were working with
a pharmaceutical company, and we said, we really intended the study to be done on time and on budget, but it wasn’t. We still tried, right? What would the monitor say? What would that company say? We need to be careful
that we’re not making the same excuses and that we’re held to the same level of rigor for any other aspect of our protocols. In terms of gathering the data, storing the data, asking
research questions, interrogating the data, and finally returning results to the people who provided the data to us in the first place. Our intent is insufficient, and so this actually goes back to the Associate Director’s one of the points that you
made Mr. Bonham, which is, how do we balance the difference between thinking about diversity as an avenue towards social justice, versus making it an integral part of our scientific workflow. There’s value to both of those things but we need to keep in mind that one is not the
substitute for the other, and that to make a meaningful difference we have to advance both
agendas simultaneously. All right, so moving ahead, we’ve talked a little bit about some of the highlights
in the news recently, so I won’t go over there. Retread some of those things, but what I want to think about is why certain groups
are being excluded now and what we can do about it. We often talk about trying to engage with specific communities. We often talk about trying to sustain the work that we do. We talk about trying to improve the diversity of our workforce. However we haven’t thought about, moving outside of the existing workflows. Moving outside of the
existing workforce entirely. For example, if we’re talking about, the harvesting of large
amounts of genetic information there needs to be a
public education campaign. We need to make sure that we have a diverse and inclusive workforce interrogating the data for us, but we haven’t thought about other avenues of research
to engage populations. For example, what if we
allowed these communities to own the data that they’re providing? How might that change
the research enterprise If it was in the hands of communities? It would require us to create more sustainable reciprocal partnerships, because we did not have the data. We would need to seek permission. We would need to make sure there was a clear return of value. We would need to integrate
these individuals deeply into our research protocols. Into secondary analyses, but if that feels uncomfortable, we need to understand why
that feels uncomfortable. Does it seem reasonable to allow communities
individuals, neighborhoods, to own the data that we’re using to develop our scientific questions? Does it seem reasonable to allow these communities to devise the scientific questions? To put our resources into these areas, so that they can become, individual research entities. The radical idea of the
democratization of research is one that needs to be at the heart of the work that we’re
talking about today, because without it, we’re likely to rely on trust, which is a equivalent to, having these communities have faith in us, and given the history of genetic medicine. Given the history of what we have done, in numerous communities, in the United States, as well as outside of it, I’m not sure we’re at the point, where we need to be talking about trust, as much as we should be
talking about empowerment and in order to empower these communities, these communities that are often silenced, we need to recognize that we
have to give up our own power. We might think that our intent is enough. We might think that sustained community engagement is enough, but ultimately we need
to redirect resources, power, agency, into under served communities and populations. It’s the only way we’re
going to make this work. Otherwise we’re going to keep making the same mistakes, and one thing that I would
ask all of you to do, is to remember some of those
examples that I mentioned at the beginning of this talk. The ones that you hadn’t heard of. Go back and research Vertus Hardiman. Think about what Columbia
University did in 1997. It’s actually quite relevant to the discussions we’re having today. Think about the greater context of the Tuskegee Syphilis study, of the Havasupai population
down at the Grand Canyon. To think about much of what happened to Henrietta Lacks is still permissible within our research enterprise today, and only in understanding
all of these things, we can really understand
the best way forward and to make sure that the research that we’re doing moving ahead, is as inclusive as possible. I believe that’s my time. I’m happy to get into a
few more of these details during the Q and A section, but thanks for about
40% of your attention. (audience applause) – Thank you Jonathon
for that presentation. Next we will have Dr.
Jordan Smoller, who will. Sorry, next we’ll have Dr. Paul Underwood. Sorry. Who is representing or coming
to us from Boston Scientific. Dr. Underwood received his
medical degree from Mayo Clinic and followed it by his
cardiology fellowship at the Cleveland Clinic. His intervention cardiology training was completed at the Iowa
Heart Center in Des Moines, and he is practiced
interventional cardiology and clinical research in
Phoenix for over 18 years. Dr. Underwood has been actively involved in community based efforts, focused on promoting
cardiovascular health. He is the President of the Association of Black Cardiologists, and founding member of the Center for African American Health in Arizona. He’s served the American
Heart Association’s Desert Mountain Affiliate as well as nationally on the Women in
Minority Leadership Committee. The power to end stroke advisory committee and the Science Advisory and Coordinating committee
at Boston Scientific, Dr. Underwood recently received the interventional
cardiology business unit diversity award for his work with platinum diversity trial and the first interventional
cardiology study to focus solely on women and minorities. In 2015, he also received
the Chairperson’s Award from the National Forum for Heart Disease and Stroke Prevention. He is currently the medical director for the interventional cardiology structural heart franchise, and member of Close the Gap. Boston Scientific’s health, equity, and education initiative. We welcome Dr. Underwood. Thank you. (audience applause) – Thank you very much Dr. Landry for that wonderful introduction and certain it’s an honor
to be here before you today. I feel like a fish out of water, as a person from industry
coming to speak with you. I think we share many things in common. First and foremost I was
a practicing physician for about 25 years, so I have
a lot of clinical experience particularly in clinical research, and then about nine years ago or so, I joined Boston Scientific, largely through the clinical research to help with product development, and in terms of maintaining the products, making sure they stay on the market. Diversity in clinical trials has been a concern of
mine as an investigator as well as now from
the sponsor standpoint. What I want to do is share with you some of the things that we’ve
done with Boston Scientific to try to come about improving diversity in our clinical trials. Let me see how this works. What we did was develop
an app that we could use to open up the conversation
with hospitals, and I’ll just go through
this very quickly with you. What it can do is look at the hospitals. Say pretty much our accounts, and catchment in area around them, and also do a heat map that lets us know coronary artery disease prevalence in those particular zip codes. The data that we use comes from the National Minority Equality Forum, and then also from Med Par data, which is like Medicare Medicaid type data, and also is backed up with census data. We’ll have the, within a population, which happens to be the zip codes, we’ll know the demographics, whether they’re white,
non white men or women and then we also have estimated prevalence of coronary artery disease. Then we can look at
that particular hospital and in this particular case, where the little hearts are indicate where the coronary disease, or indicate the catchment area, for this particular hospital. This happens to be in Tallahassee. Then what we did is index to white males in terms of looking at treatment rates that we had from Medicare data to understand who in that
hospital’s been treated for coronary disease,
and particular stents. Boston Scientific is a
manufacturer of stents. We’re very concerned with people having access to percutaneous
coronary intervention. Looking at the data we can say that this is the rate, that this particular
hospital treated white males, that came to their hospital
with coronary problems and then what would happen if you compared it to other people within their catchment area? This is the rate looking at white women and then non white males and females here. Then based on the prevalence rates, we can see if there are
any gaps that exist, and in this particular case we can see that there are these gaps that come out in yellow, of what would be expected
in terms of treatment, versus what actually took place, and with this in mind we can then talk to the hospitals
about what they can do to try to help to improve their ability to access to have everyone access healthcare at that institution. Often times it would be going into diverse populations, and then understanding
based on the catchment area and the risk map, will
find certain zip codes, that may be more important
for them to look at. Other times it’s looking at gender issues certainly now in February, which is the heart month, and the Go Red for Women campaign, issues of gender disparity and cardiovascular
disease are very important so we can initiate programs to go into either the community to educate people about
what they need to do to come in to seek care
for cardiovascular disease or actually go to the
practitioners themselves to make sure that they understand some of the nuances that occur in people who have cardiovascular disease. With this we can say that for them there’s an opportunity
to access more people, if they’re able to actually access more of the communities, and we work with the different hospitals to see what they came up with, their plans to access the community. Last week I was in Los Angeles, at Memorial Hospital, and that’s in East Los Angeles, which is a very Latino population. They have certain approaches, they’re very concerned
with childhood obesity. Language is a problem as well. They’ve developed programs
within that hospital to try to be bilingual certainly and to start trying to address people particularly in their middle age about what they can do about
obesity in their children. Getting back to Boston Scientific this is just a screenshot of one of our clinical trial management systems. We use this to manage clinical trials. I think we have around 125 clinical trials that are ongoing pretty much all the time and with this you can see
the sites that we have, the trials here, to the far left, and then what we’ll do is look at say the number of patients enrolled. The average query age and then protocol deviations for patients. These are typical performance metrics that we look at when we engage our sites. If you happen to be one of our sites, you’ll know that our project members are always on. You do try to reduce
the protocol deviations to try to hasten your query response and we certainly want to enroll on time, but what we also did was
Matt, the demographics pages, to this database as well, so that we can see again, white non white and then a
gender enrollment per site and with this we’ll know, if we’re getting a diverse representation of their patient population. What we’re doing moving forward, is looking at the data
that I presented first in terms of what the
community demographics are. What the treatment demographics
at that hospital are and what is actually being
enrolled in our clinical trials and with that we’re able
to go to a site and say we really want clinical trial enrollment that’s representative of
the patients that you treat. We’d want to make sure
that there’s some match between what is actually there, and what’s expected to occur, in terms of enrollment, and then we also want the
hospital to be concerned with what’s going on
in their neighborhoods. Making sure that they’re able to go out, and collect those patients
that are potentially there that are not quite in the system, and that our goal is that of course, we get to have patients come in, and then once they’re in, to actually get them enrolled. With that I’ll leave it open for questions and I’ll see you after the panel. Thank you very much. (audience applause) – Thank you Dr. Underwood. We specifically designed this panel to include those from industry,
academia, and government, so we look forward to all
of these perspectives. Next I will introduce Dr. Jordan Smoller who is a psychiatrist and epidemiologist and geneticist here at Harvard, whose research focuses on, one, understanding genetic and environmental determinants on psychiatric disorders
across the life span. Two, integrating genomics and neuroscience to unravel how genes affect
brain structure and function, and three, using big data, including electronic
health records and genomics to advance precision medicine. Dr. Smoller is the
Massachusetts General Hospital trustee Endowed Chair in
Psychiatric Neuroscience, Professor of Psychiatry
at Harvard Medical School and Professor in the
Department of Epidemiology at the Harvard THT School of
Public Health here in Boston. He is an Associate Chief for research at Massachusetts Geneal Hospital in the Department of Psychiatry, and a Director of both the psychiatric and neurodevelopmental genetic unit and the precision medicine research unit at Mass General Hospital
Center for Genomic Medicine. Dr. Smoller is a family
MDH research scholar and also serves as Director
of the Genomics unit at MDH and the co director of
Partners Healthcare Biobank here as a part of Partners hHealthcare. He is an Associate member
of the Broad Institute and Vice President of International Society of Psychiatric Genetics. He’s a PI for the electronic medical records and genomics emerge study. Network and contact PI for the New England Precision Medicine Consortium, and part of the NIH Precision
Medicine Initiatives All of Us research program. He’s an author of more than
300 scientific publications and is also the author of
The Other Side Of Normal. Welcome Dr. Smoller. (audience applause) – Thank you Latrice, and thanks for including me today. This is an extraordinarily
important discussion and I think we’ve heard some
really important perspectives so I expect our panel discussion will be very engaging. What I want to do is talk with you a little bit about the
All of Us research program which many of you. How many people here have heard of The All of Us Research Program? Many, but not all. Okay, good. We heard from Mr. Bonham, I think, a beautiful overview of some of the issues that we are confronting if we’re gonna advance precision medicine and improve inclusion
and diversity in research and we heard in the presentations
that followed, thank you. Terrific. Some of the challenges that we face, and from Dr. Jackson some of
the historical challenges. What I want to talk a little bit about is what are some of the opportunities from the future and in particular, how does the All of Us Program potentially contribute to that? Let’s see if I can work this. The All of Us Program is part of the NIH Precision Medicine Initiative, which really kind of got its start in President Obama’s 2015
State of the Union Address. He said my hope is that this becomes the foundation of the architecture, whereby in 10 years from
now we can look back and say that we have revolutionized medicine. A very ambitious goal and as
a result of that initiative the All of Us Research Program, was ultimately launched with the goal of accelerating health research and medical breakthroughs enabling individualized prevention, treatment, and care for all of us, and it is the cornerstone of this precision medicine initiative. It’s been allocated funds from the 21st Century Cures Act. That will extend over a decade, and the ambitious goal, in maybe the best sense of the word, is to enroll a million or more Americans reflecting the broad
diversity of our country. They’re gonna be opportunities for volunteers to provide
data on an ongoing basis, and the idea is that
this will be a platform for precision medicine research, in all kinds of areas,
for decades to come. I want to tell you a little bit about what’s involved and also what we’re doing here locally in Boston. One of the central core values, and in fact, an essential
in some ways reason for being for this study, is to make sure that we are representing the diversity of the country. In many ways specifically
because of the issue that Mr. Bonham highlighted, there has been a fairly dramatic under representation of many communities, and the risk that with the advances that we’re seeing in precision medicine, folks will be left behind,
in terms of advances, or knowing whether certain things are going to help or contribute to health. The All of Us Research Program has this real emphasis on diversity. Not just by ancestry, but also things like geography. Spreading across the country. Urban versus rural. A diversity of data types. A diversity of health status and so on. The program is ambitious in terms of the kinds of data
that are being collected. It’s begun with participant surveys. Electronic health records. Physical measurements, which to date are relatively limited. Mostly anthropometric measurements. Biosamples that include
blood urine samples. Mobile, wearable technologies. Geospatial environmental data, and the notion is that this may actually expand as the years go on. The core values which are, and I can tell you as somebody who has participated
deeply in the program, these are the things that we are constantly talking about. Participation is open to
interested individuals. What that means is that
anybody can join the program. What I’ll show you is that
some of the enrollment in this program is through
health provider organizations but a big part of the enrollment is also as direct volunteers. Folks who are not necessarily connected to a health provider organization or in regions where there
isn’t an organization participating in the
program can also sign up. The program is gonna reflect
the diversity of America. Participants will be
partners in the program. I’ll say a little bit more about that. Trust through robust engagement
and full transparency. Access to information in a way
that has really not been done in most research studies. Return of information. If we have it essentially you can have it. Data from the program
will be broadly accessible to empower research not just by certain academic institutions, but citizen science as well. Privacy and trust
principles in data security which is always an issue
that we’re talking about and catalyzing innovative
programs and policies. The value of participating in the program, which is something that
we try to articulate to people who are
interested in the program, is potentially several fold. One is that you may learn more about your own health status or indicators, because there is return of information. Obviously the important
mission of fighting disease and improving health
for future generations and then ensuring that your community is included in studies. This is sort of the social justice and equity aspect of this which is crucially important and being part of the movement. Being part of something that is potentially going to change the game. Those are some of the core things that we hope people will see as valuable about participating. I mentioned that participants are really partners, not subjects, and to instantiate this, participants are represented on all of the communities, and panels and designing
aspects of the study. We have our own community advisory panels here in Boston that are guiding the work that we are doing here as well. I won’t go through this in detail, but the notion is that if you have a resource, a data platform and resource, that is of this scale and scope, the potential for scientific
discovery is large, and not simply in genomics,
or pharmacogenomics, but in many other aspects as well, in terms of community engagement. Mobile health technologies, development of biomarkers and so on. The hope is that this will be a platform that continues to pay dividends in terms of discovery for a long time. Data sharing is a core
principle of the program and is a priority. The notion is that data
will be broadly shared, with obviously consent of all participants who are participating, and there are extensive privacy and safety security
standards that are in place. We could talk about that
further in the panel discussion if folks are interested. This is kind of the
inaugural national network of participating partners involved in the enrollment and
engagement in this program. You can see spread out around the country, I’ll note that the New England
Precision Medicine Consortium is up there and that’s
the work that we’re doing here locally and that’s a
collaboration of partners healthcare system, which of course has many
hospitals in this area. Mass General, Brigham, Wellesley,
community health centers and Boston Medical Center,
and its HealthNet Network, and Community Health Centers as well. We are aiming to enroll and engage nearly 100,000 individuals
in the Boston area and this is just a representation of some of our enrollment
sites around the area and you can see that we are in many places and working with many communities. The program actually
launched in May of 2018. There are more than 100,000 folks who have really completed the initial components of the program. There are, I focused on the promise. There are certainly challenges, and I think that’s a focus of what we’re talking about today. One of them that we confront
in a study like this in particular is the digital divide, because much of the, in fact, essentially all of the enrollment process involves some kind of connection with digital technology
or digital communication, and as one might expect, different communities are
differently connected digitally, and this is something that’s a challenge that I think we are
still trying to confront. How do we overcome the fact that there are disparities in
digital communication, and in our ability to engage? Building trust and overcoming fear is one I think that highlights the work that Jonathon talked about. We’ve been fortunate to
have Jonathon on the team informing our efforts as well, but this is a real concern
that we build meaningful trust, meaningful engagement, not a
simple one way interaction. Articulating the value proposition. What are the things that communicate that participation is valuable sustaining engagement. Again, not simply
engaging with a community and then a couple years later, informing folks of what’s gone on, but really building a
reciprocal relationship that is sustained, and
that is also something that is challenging in part
because of some of the mistrust and concern that folks have
with understandable reason because of past experience, and then retention. Engaging people is important up front, but for example, we’re setting
up email addresses for folks in some cases who don’t have them. What’s the likelihood that people will connect that way in the future if they haven’t been previously? I actually welcome suggestions
and input from this group to help us think about these challenges, because this really is one of
those opportunities I think that doesn’t come around all that often for us to do something differently and I think there’s a
tremendous desire to do that, so I’ll just end by letting you know if you want to participate
in the study itself or just want to learn more about it, you can go to the website. There’s a lot of this material. You can also call us here locally. We’re also very interested
in expanding our workforce here locally and making sure
that we are representative of a community as well, so if folks want to get involved in the program itself, in terms of how we do it here in Boston, or be part of the effort, I would also welcome your
following up with me. I’m gonna leave it there, and look forward to the discussion later. (audience applause) – Thank you Dr. Smoller. Now I’m gonna as our
panelists to turn their chairs to the other side of the table, so we can face the audience. We’re gonna get started on
our panel discussion shortly. I like to set a few ground rules. We like to embrace Harvard etiquette, Southern charm and Minnesota
niceness, in this dialogue, so remember your manners, and then also we want to remember and highlight the scope of
what we’re talking about here. We have experts here who are talking about who are experts in precision medicine, genomic medicine, personalized medicine. I’ll talk about that in one second. And Education, science, and practice. We’re talking about the full scope of precision medicine here. I also just want to state that for the purpose of our panel discussion and I got permission from all
of our panelists about this, the terms precision medicine,
personalized medicine, and genomic medicine will
be used interchangeably. If you don’t like that, feel free to ask a question about it. All right with that, we’ll get started. Again, just to remind you of how your microphones work. At each of your desks,
there’s a microphone. If you hold down the button in front it will turn green. You need to hold the button down throughout your question for the audience to be able to hear you. – Hi, thank you so much
for this panel discussion. My first question is for Dr. Gilbert. Dr. Gilbert thank you
so much for including the faith based communities. That’s really unique. They are stakeholders that
often forgotten in science so I appreciate that, but my question is in regards
to personalized medicine. For example. It costs about $400,000. How would you scale it, and how would you make sure a marginalized population
have access to that? Thank you. – Thank you for bringing
up that point of access. It’s a huge point. I’m actually, I’m not
sure if I have the answers for how you scale that. I think could be other people on the panel have better except to say that I think the cost if it goes down and the goal is for the cost to go down, is then for people to have information about where the barriers of fear are not keeping people away
from those technologies but I think you’re right that the cost is a huge barrier right now. I don’t know if, Vince you have
anything to add about that? – One comment I would make is I think there’s a responsibility right now for us from a policy perspective to also think about how do we assess who gets access. Thinking about Medicaid, Medicare. Thinking about different
types of delivery systems, approaches to make sure that
there’s equitable access about who really needs
it, who can benefit, and how we make decisions, and then there’s a larger issue that our country is
struggling with about costs, or generally with regards to healthcare, that I think we’re gonna
have to continue to have to help with regards to these
new innovations in treatment. – Hi, to piggy back on Aber’s comment, is there any advocacy for biosimilars in order to tackle the gap? If you don’t have access
to the drug itself, I think there’s a push for biosimilars in order to find something that’s more of a generic type drug, that can also accomplish the same thing. Is there anything being done on that? – Certainly there is
some work in biosimilars. Typically when drugs are developed, then that company has put quite a bit into developing that and there are certain limitations on how it’s
going to be shared, but now there is quite a bit of work looking at biosimilar
and biosimilar research. Typically the compounds may
not be exactly the same. They may be very very small differences and those differences could be important so understanding how they’re
made, how they’re produced, and then how they’re
going to be distributed is very important, but I think it’s key
that more people use this that they’re aware of this, and that there’s a demand, because that demand will
also drive competition and that will eventually
lead to some reduction in cost as well. – Hi my name is Shawna Anderson and I’m actually from Sanofi. I am not on the pricing side of things. I actually design clinical trials, but I will say that when it comes to the pricing and when it comes to, I completely agree that there is quite a bit that goes into getting these drugs to market, and so unfortunately I don’t
know if that will change. I think you’re right, demand and policy will have to play a role in whether or not how the patent lives are determined. The length of those times, and how the decisions are made in terms of how patents are extended, because I think currently
that’s where barriers lie in terms of whether or not biosimilars and or generics can
actually come to the market and when they can come to the market, but I will caution that, unless the price of getting these drugs to market in the first place, somehow is also tempered, that people will not, companies will not invest, to get some of these drugs to market, and that’s particularly important to me because I work in rare disease, so there really is no financial benefit to companies whatsoever for what I do. This is purely in many cases, it is a humanitarian cause that comes in addition to everything else that the companies do. A lot of the other drugs, the cardiovascular drugs, that funds in many ways, what I can do. However, because there are so few people who benefit from it, the price tag tends to get quite high, for when those drugs come to market. I think it’s a very complex issue, but policy demand and then also what is the time and the cost related to getting these drugs out there? Those are all things
that have to play a role. – Sorry I just wanted to
offer one last comment. In my home area of expertise, which is less about talking
about disparities and access and more in terms of neurology, we know that the promise
and the advent of A.I. Is potentially one solution to some of these tricky thorny issues, so at the latest conference
that we have every July, we talked about A.I.
simulating some elements and starting to automate some parts of the drug discovery process, and to try to simulate
the underlying etiology of various diseases to
look for common factors which is a way forward in the
rare disease space obviously. If you clump a bunch of diseases together, by underlying etiology, then it becomes a little bit easier to justify the cost of investing, but it also potentially may make it a little bit more accessible or appealing, because if you can find
that underlying etiology, than you can simulate or replicate a number of biosimilars, and then you have to talk about maybe the transfer of patent to, instead of a particular mechanism, to the underlying A.I. technology and whether that can
be potentially licensed to kind of mine this underlying etiology for additional biosimilar therapies. I think that is going to be
one of the waves of the future to try to understand this. Now it depends on how this
mechanism is ultimately deployed or weaponized by different companies or academics, whether we can come up with a fair and equitable licensing scheme
for something like this, but that may be the way forward. – Who has a question here? – Dr. Jackson. You had mentioned a couple of cases where everybody was raising their hands if they had heard about
the bad clinical practices. I guess with regards to genetics, and there were two cases at the end that pretty much no one
raised their hands for, I was wondering if you could quickly just tell us a little
bit more about those. – Sure, very quickly. I think there were three that I mentioned that people hadn’t really talked about. The one that I saw a couple
of hands was the Havasupai. This is an indigenous tribe that lives pretty much at the base
of the Grand Canyon. They’re one of the most remote Native American populations
that we know of. In the early 2000s, around 2002, to 2003, they worked with the
University of Arizona, I think or was it Arizona state. Arizona State University, where they worked with a
small number of investigators, to try to understand the
huge health disparities in that group related to diabetes II, so they just had this absolutely insane rate of diabetes II, and their population almost
wiped out a generation back in the 60s and 70s. That consent form contained broad language that was translated to vaguely consent for additional research and what happened was researchers at Arizona State also went on to look for evidence
of the group’s ancestry which violated their cultural beliefs. They also went on to look
for evidence of inbreeding. They looked for evidence
of mental illness. Now there was not individual consent given to each of these areas. There was this broad consent that was not well understand
by the leadership of the tribe so what happened was it severely damaged the relationship between most scientists and Native populations. The second one that I wanted
to very quickly talk about was Columbia University in 1997. They had a basically
very clear consent form where they unsealed the
juvenile court records of individuals who were
convicted of various crimes and then contacted their siblings, their siblings who were usually nine or 10 or 11 to see if there was any
predisposition to future crime. White people were specifically excluded from this study, and all of this was
approved by the local IRB. This was just over 20 years ago. These things are still happening. The last thing I want to talk to you about was Vertus Hardiman who was part of a small cohort of children actually this was done
to thousands of children all over the United States. Their heads were irradiated, to look at the effects of radiation on skull bones and skull fractures. His family was told that the
doctors were treating ringworm, which was obviously not true, and if you look up
pictures of Vertus Hardiman there’s actually a documentary of him that was published about 10 years ago called A Hole In the Head. Because for the remaining
70 yeas of his life, his skull bones slowly dissolved, exposing brain tissue
every day of his life. This is a handful of some of the examples where we thought we had ethical guidelines to cover some of this stuff, and we still kind of clever researchers still managed to find a way around it. We need to realize that the
systems that we have designed are not sufficient to address some of these more complicated issues. – I wanted to ask the panel if each of you whoever
could speak a little more about what the U.S. government could do on the federal level to protect citizens privacy. Something like the
European GDPR for example. – I think it’s important for us to watch what’s happening in Europe, with regards to those regulations and how they’re getting integrated, and can we learn from that, in a way that can actually
improve protection within the United States? I think that’s one step. I think we also need to continue to develop the technology, of approaches of how
we protect information and then transparency with regards to when there’s breaches, and in a way to make sure
that the public understands the limitations that we all have with regards to our privacy. – Yeah, so I would add that, one is that, our genetic information right now in the United
States is protected by use in health insurance and employers, so health insurance to dictate coverage or how much to charge for coverage for employers basis of
hiring and firing decisions. So that there is some
level of protection now. I think there’s some consideration of whether those protections, should be expanded for other areas. Life insurance and so forth, and to think about, and I think what Vince said, with the focus on the informing part, I think when I listen
to some of the examples that you give Dr. Jackson, that there are scenarios of bad actors, but there’s also scenarios where we think society has consensus
says that we’ve done well but that we how will it
look in 50 years from now? That the gold standard
of informed consent, will that still hold up? Just challenge ourselves to really think about as transparent as
we think the language is, as accessible as it is, that if that really that information is understood in the
way that we think it is and that communities will they feel that every effort has been made, for them to be informed
to make these decisions? – I think you wanted to
hear from all the panelists. We’ll try to quickly go. I’ve got some strong opinions on this, and I think Jordan’s heard
a number of them already. I think the only solution is to codify some return of the actual data to non academic sources. We have to give the data to communities and allow them to develop oversight and partnerships so that they can be, they can be in better charge of how that information works. In the case of Henrietta
Lacks and Havasupai we see that these are limited examples of how that data can be
protected and overseen. We need to copy those
examples and expand them along with the laws that
Dr. Gilbert talked about like specifically GINA, the Genetics Information
Non Discrimination Act, which talks about how employers and certain insurance,
but not all insurance cannot discriminate against you on the basis of this information but we also need to
think very long and hard about what happens not if
but when data gets leaked. Especially if that data
becomes identifiable because we’re digitizing this to make it a little bit easier for us
to come into collection to but we have to recognize
that we’re gonna fail, and we need to understand what
fail safes we have in place or additional measure we’re
gonna be putting in place when we inevitably screw this up. – In the interest of time, we want to hold Dr.
Underwood and Dr. Smoller to short responses to this question. – Certainly. From an industry standpoint, data regulation such as GDPR
are very important to us and certainly being
compliant with regulations is extremely important to us. We have to think long and hard on how we draw the consents, and how we use the data that we receive from patients, from people, understanding that for product approval we do need patient level data, particularly here in the United States, and we want to keep data safe, and only for the use, for the benefit of people or individuals and capture but not
necessarily share with all but we do agree that
data should be collected amongst all and we should try to develop a culture of research so that everyone is very willingly participate
in clinical trials that will make it a little bit easier for them to understand how they would want their data used in the future. – I won’t add much except to say I assume that by the government
protecting our privacy you don’t mean globally. You mean with respect
to genetic information or research or something. I mean I think I would
underscore what others have said which is that transparency, so that people understand
where their data might go and who might have
access, and in what form, because there are ways
to use the minimally, the most removed from
identifiability you can, but sometimes you do need
those kinds of things and so there I think
transparency and consent are very important. I also think we don’t want to go too far in the other direction, that we really cripple research, because of the bad actors, and so having consequences in place. Having the most feasible
but restrictive use of data, and I think the All of Us program has done a good job with this but these are going to be a moving target as technologies advance. – Yes. – We already know that we
don’t implement what we know in medicine equitable, so we can talk about collecting data until we’re blue in the face, but if we don’t have a plan to use it to take care of
under served communities, I’m not interested personally. Now in terms of business, we know that under served communities, will make up more than
50% of the population. Not too long distant future. It behooves the private sector to start thinking about this being a very important market, because as Dr. Anderson says, if you have a rare disease, or if precision medicine means that there’s a small number
of people with benefit, nobody’s going to invest
but at some point, there are gonna be a large
number of these people. I think that’s really important, and I would like to also say that there has to be political activity, in relation to this. To what extent, people
who work in this field, are also working in Washington, to help prepare the ground for being able to implement these advances, among the people we want to serve. – I’ll ask Dr. Gilbert and
Mr. Bonham to respond to that. – Yeah, we started doing
congressional briefings a few years ago, because we heard from friends, I don’t know if you’d agree, Vince, that genetics was almost a
dirty word in Washington D.C.. It wasn’t a word that lawmakers wanted to talk about, and we go, I think it’s always the challenge, is getting people in the room to want to have information. D.C. is no exception, and what we did was we went not to advocate or to
lobby or to ask for money, but to share information
about what technology, or what technology was making possible and then to provide more connections to researchers who had
answers to their questions and then that was one that even in D.C. The silos that exists between the researchers who are doing the analyses and the policy makers that are setting, and decreasing those barriers, something we’re continuing to work on. – With that we will bring our panel. No you want to have? Sorry, I’m getting flashed for time. With that we’ll bring our
panel discussion to a close. If we could have our panelists bring their chairs around, and we’ll open it up for closing remarks from our next speaker. (audience applause) Thank you all for being here for this equity and social justice meeting on precision medicine. I think it’s important to note that each of our panelists has presented the idea that
precision medicine is here. Started as a goal of
distant future medicine but these issues are here. They’re happening now in real time. With that, I’ll bring up
our closing remarks speaker, Dr. Shawna Anderson. Dr. Anderson earned her MD
PHD form Tufts University School of Medicine, where
she graduated in 2013. She has devoted her career
to biopharmaceutical research with a a specialization in
autoimmune and rare disease, having polished her skills
at pharmaceutical companies including Biogen,
Aegerion, and now Sanofi. She is a complex problem solver who brings energy, integrity, and strong work ethic to
translational medicine. Shawna is currently director
of clinical research in rare blood disorders at Sanofi and has served as a student advisor at the 2016 and 2018 Boston Science Careers Student Conference so she’s a friend of the Office of Diversity and Community
Partnership here at Harvard. Thank you Shawna. (audience applause) – I wanted to thank you
Latrice for inviting me. This has been incredibly interesting and I’ve learned quite a bit actually by listening to the speakers
that have come before and by listening to the kinds of questions that people have, and the conversations
that it allows to happen and I sincerely hope
that these conversations do not end here, because that will basically reinforce the fact that we will bring it up. We think we’ve done our good job. Pat ourselves on the back. We need to continue these conversations in every aspect of where we work. We bring it back to our legislator. We bring it back to our
divisions where we work and we try to encourage and to expand these conversations,
because that’s the only way that we’re actually going
to get anything done. I don’t know your name sir, but to your point, we need a plan, and so I wanted to summarize by saying that I’ve heard quite a bit, but one of the things
that really struck home was the fact that the
significant lack of diversity, that Dr. Bonham described
would actually create harm for the populations where data is lacking, and that is something that’s
really important to me. I am an MD PHD obviously, so therefore data is very important to me. I also design clinical trials and my entire job is designed around collecting enough data such that whatever drug it is that I am working on, to try to promote and get
out into the community which I hopefully believe will help and will actually improve
the lives of others, but I need to have enough data to convince heath authorities around the world and ethics committees around the world that one, this clinical
trial is worth doing and two, that the data
that we’re gonna collect is actually going to be meaningful, and is actually gonna tell us whether or not the drug
is going to help people. We have to have a plan, of not only taking this
information into play but what are we going to do with it? I think that there are
many important questions that were brought up. How do we define race,
ethnicity, places of origin? Because that makes a lot of difference. You don’t think about it, but our statistical friends, they do. When it comes down to
creating these algorithms for how we’re going to analyze our data, I actually just missed a
statistical meeting today but that was all about
what kind of information do we put into our
statistical analysis plan? How do we define populations? Then how do we summarize
these data to mean something? If we don’t know if we’re using OMB, geographic, or ancestral origin, then who are we talking about and what does that information mean? I think that understanding is there race and if it does exist, then what role should it play in our understanding of the data that we’re bringing in? Our data means nothing, if we can’t integrate that and dispel it and understand what it
means for all of us. I will also say that I also have somehow managed to hold two completely mutually exclusive understandings of whether or not race matters, and then what it means to
our understanding of disease. I have also advocated that
I need to look at race because I believe that
there may be discrepancies in how my drug might work, but at the same time I also don’t believe that we are so very different genetically that there should really be a
concept of race to begin with. I am incredibly encouraged by the fact that All of Us
campaign is currently ongoing, and I really am looking forward to having a million people enrolled into this clinical study. Completely diverse. A population where we can hopefully get a better understanding because I think that the
only way we can dispel or to in fact determine whether or not race truly exists, is by collecting the data
and doing the experiment. If we then compare all
the data that we have and all the genetics, we may simply find out, it doesn’t mean very much at all. That perhaps it’s just polymorphisms that we see in various genes, that may dictate whether or not you’re a fast or slow metabolizer of a particular type of drug and maybe that is where we need to focus the intent of our work, but we won’t know, until we can gather the trust, and to educate the population so that they are willing to work with us. I have been scribbling away, as I’ve been trying to gather, all that thoughts and
everything that has come up. I think that we are all horrified by the cases that we may
not have known about, that Dr. Jackson brought to light. Especially the more recent one in 1997. One would have thought and hoped that IRBs and ethics committees would
have put a stop to that. I know that it’s quite
challenging for myself to get through IRBs and
to ethics committees on various studies that I want and that they can be quite challenging and they should be quite challenging, That is their job. It is to protect people. We need to do a better job. We need to ensure that
those who sit on IRBs understand what it is
that they’re looking at and understand the impact
and the downstream effects of the studies that they
are allowing to go on, and from the perspective of a sponsor and somebody whose bringing
those studies there, we need to have very significant
introspection as well. What are we asking of these communities? We’re asking them to give us our data. What are we going to do with that data., and if we hope to do any
sort of exploratory research which many of us would want to do once we have these information, once we have those samples because it’s a treasure trove, right? It’s gonna be a way for
us to figure things out but we really need to have a very very and I think across the board conversation industry in term of in academia, as well as in politics, for what are we allowing to happen, and how frequently do we
have to go back to patients and say you know what, thank you so much for giving us your data. This is the result of that experiment that you actually allowed us to do. We have your sample, and this is the next experiment, if you so wish that we would like to do. Many times we do have to
go back and reconsent, because the intent that
they gave us the sample is no longer the intent in
which we have to use it, but we need to make sure
that we don’t allow ourselves to get fooled into thinking that just because we have a sample, it means we have the permission to do whatever we wish to it, and I think that that
needs to be something that’s very carefully looked at, because otherwise we will
never gain the trust, and therefore we will
never be able to enroll communities where we actually really need to study, to make sure that we are incorporating into our programs, because otherwise we once again, we risk the potential of significant harm because we simply don’t have the data and we might be giving
drugs to people for whom or treatments to people for whom, they will not benefit, and in fact, will actually
hurt them in the long run. We need to understand what
it is that we’re doing. I think that it’s very important from a diversity conversation, that it is not only those for whom we are interested in studying, but those who are doing
the studying itself. Those are creating the trials. Those who are analyzing the data. The statisticians, that are putting together the statistical analysis plan and those to whom we will give the task of actually explaining
what it is that we found because in many cases, and I know many of you will feel the same, the language that we speak to one another, this doctor-ease, is not something that’s easily consumable to the general public at large, and so there are many people in pharma and many perhaps in academia who are tasked with the job of explaining what it is that we found and something outside
of a peer review article that we published in JAMA or in New England Journal of Medicine, which for most people
have absolutely no access, nor will they be willing to find, or to read or to even understand, because I think that’s
where we build trust too. We need to understand what
it is that we’re saying, what we’re finding, and how can we convey that information to the communities who actually need it because that’s where they’re gonna be, the decisions that they’re making to take a drug or take a treatment, or whether or not to get into a trial, is going to depend on that level of trust. I think it’s a very
interesting conversation that you brought up, and
the idea of ownership. I think that’s something
that we need to talk about. Who owns it? I know that the IP lawyers
if they were to hear this particular conversation, would not agree with that at all, but we need to have that conversation, because perhaps that’s one way to lay a brick to build trust. I don’t know whether
it’s gonna go anywhere, but it’s worth having
a conversation to ask, and I think that as I said before, for me working in rare disease, the concept of costs, the clinical trials that I run because I work in rare disease there are only a few thousand people around the world often times that actually have the disease that I’m interested in , or that I’m working towards, so my clinical trials generally cost a whole lot less
than his clinical trials in cardiovascular disease because we’re talking about thousands. Nine, 10 thousand patients when it comes to some of the Phase III clinical trials that really get the data. My trials I’m lucky if we
get up into the hundreds. Cost often is quite low, but I still have the same, and I should have the same process. I have to do research. I have to do toxicology. I have to do Phase I, Phase II, Phase III, in order to really
understand what’s happening and that’s the route that all
these research have to take. Perhaps we can use some of
the emerging technologies to try to minimize some of these stages, but in the end we cannot
necessarily understand what’s gonna happen in a person, by what happens in an animal, or by what happens in a computer model. We have to do the study. We have to do the experiments and we have to analyze that data, but I think cost is quite important. I don’t want that the drugs that I work on is only going to be used to
for those who can afford it. Ultimately, I want the
drugs that I work on to be used for those who need it, but how can we make sure that those people actually
have access to it? I think we need to consider
Medicare, Medicaid. I think that those are conversations that are currently
happening around the world. Many other countries, they negotiate quite
hard, on a country basis, for price points for the
drugs that we bring in. They decide based on the benefit and the risk for their entire population which drugs might actually get in and sometimes that may seem unfair, but they have limited resources, and so they have to decide, what kinds of drugs can we bring in? They may not take the
newest flashiest drug that comes out with the higher price tag. They may go with a tried and true options which may not necessarily be the best for their patients, or may not necessarily
be the most efficacious, but they know in many cases it works, and that has to be the
best thing for them. How do we sort of balance these absolutes? The U.S. is definitely much
more on the freer side. It’s really dependent a lot
on the insurance companies, whereas in many other countries, it’s really dependent
on a government basis and I don’t know that either is right. I think we need to figure
out where that balance lies so that most people who need the drug have access to it, but at the same time as I say, the investment in making sure that these drugs are safe, that they’re efficacious,
that is quite high, and so unless we find a
way to minimize that cost, companies simply aren’t going to put the investment out there if they don’t see any sort
of return on that investment. We need to figure out a way to balance these aspects of things. I think ultimately one
of the major questions that we need to ask is, is it fairness or is it equity? Now fairness is a very
interesting concept. What’s fair to one person, may not at all be fair to another. It’s really quite subjective. Equity on the other hand, equity can be quantified
to a certain extent. You get a pair, you get a pair, so do you. Everyone gets a pair. That may be in many ways something that we want to go forth with. We want to make sure that
each person has what they need so maybe you don’t need a pair. Maybe you’re allergic to that pair. We have to figure out
what are we going to do and how are we going to get the medicines, the treatments, the information to the communities who need it, those who deserve it, and for those for whom it’s actually going to make the most impact. I’m gonna end here, but I really am so grateful, to have had all of you in one room to hear what you had to say, and I really hope that each of us, take this information,
take these discussions, and I know I definitely will, back to where we are, and incorporate these
discussions into what we do because that’s the only way
we’re gonna make a change, and I would ask that
when it comes to policy that we pull something together. We try to make a way for all of us who are sitting at the table, and those who are much higher than us, can sit down and actually have these important conversations, because I think that technology is always outstripping the policy, and we need to find some
way to make that comparable. Thank you. (audience applause) – Thank you Dr. Anderson
for your wonderful remarks in trying to summarize
such a varied topic. I want to say a couple
rounds of thank yous. Thank you to Jackie Wright, Teresa Ying, and the rest of the DICP staff, for helping to pull this together. Thank you to Dr. Landry
for all of your hard work pulling this together, and thank you to our keynote, Mr. Bonham, our panelists, and again
to you Dr. Anderson, for closing our remarks. I just want to draw everybody’s attention to the back of the brochure. There are a list of other equity and social justice activities
that we have going on including next Wednesday, we’re doing a conversation
on Asian American health in the intersectionalities that go along with those communities. There’s some other events
that will be discussed including we have a discussion, around maternal fetal health as well as the digital divide. Both of those happening in May, so look forward to those
email announcements. Again, thank you for your time. Thank you for participating, and again another round of applause for our keynote and our panelists. (audience applause) Enjoy your morning. Thank you.

Author: Kennedi Daugherty

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