NHMA – NATIONAL HISPANIC
MEDICAL ASSOCIATION
NHMA – 15th Annual Conference – Health Care
Transformation to Expand Prevention and Health
Promotion for Hispanic Communities
Washington, DC
March 18, 2011
Contents
A.4. COMMUNITY-BASED PARTICIPATORY RESEARCH AND HISPANI C
HEALTH .................................................................................................................... 1
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A.4. Community-based Participatory Research and
Hispanic Health
[START RECORDING]
MALE VOICE: Good afternoon everyone. We’re going to get going.
Just so for some logistics if people require CME units
please come see me at the end of the workshop. There is a
signup sheet for that. My name is - -. I’m a sixth year
MD/PhD student from the National - - Latino Medical Student
Association. I’m also an NHMA executive board member. Our
first speaker up is actually Dr. Vivianne Aponte Rivera.
She is the lead psychiatrist and Director of the Hispanic
Latino Research Team and Clinic for Depression Study.
She completed her medical school and general psychiatric
residency at the University of Puerto Rico and her Child
and Adolescent Psychiatry Fellowship at Emory University.
She’s an Assistant Professor in the Department of
Psychiatry and Behavioral Sciences at Emory University
School of Medicine in Atlanta, Georgia. Dr. Aponte Rivera
is in the board certified child and adolescent
psychiatrists, and she is interested in the mental health
aspects of immigration and acculturation of the affected
children and their families. She is also interested in the
impact of cultural differences on the manifestation of
psychiatric illness.
DR. VIVIANNE APONTE RIVERA: Good afternoon. I’m Vivianne
Aponte Rivera, as previously said. I guess I need to click
on something here. Is this supposed to be it? Yes. Got
it. Basically, I’m going to be talking about how to
increase participation of Hispanics within clinical trials
and kind of link that a little bit to the topic of
community-based participatory research.
The objectives of my brief talk would be talk a little bit
about the demographics of our clinic. It is a dedicated
Spanish speaking clinic for the treatment of Hispanics, and
it’s for a depression research clinical trial that we’re
conducted at Emory. Besides talking about our patients and
our demographics, kind of understand how clinical research
studies can help us decrease health disparities, which is
one of our main concerns with Hispanic population and
minorities overall.
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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I’ll tell you a little bit about our study. It’s called
the Emory PReDICT Study. We like acronyms a lot, so it
stands for predicting response and depressions to
individual and combined treatment. I’ll tell you a little
bit about the study. It’s an NIH funded study. It’s two
grants, and it’s a study for major depressive disorder.
Our goal is to recruit 600 patients. We already have over
200 patients randomized, but our main goal will be to
recruit 600 patients. The purpose of the study is to
identify predictors of response to treatment in people who
have never been treated before, right?
We know we have a lot of treatments in psychiatry and
especially for depression that we know they work. We know
they’re good. The problem is it’s really hard to figure
out what is the best treatment for each patient. Over
time, the morbidity and the longer somebody is with
depression it has a significant impact in that person’s
life. You really want to get them better as quick as
possible and avoid those multiple trials of medications
until we get the right one. It’s more kind of like this
personalized medicine concept.
Basically, the first part of the study is a 12 week study.
It’s random assignments, so patients are randomized to
either medication or therapy. The medications are
escitalopram or duloxetine, FDA approved medica tions for
depression. We know they work. Cognitive behavioral
therapy, which is a type of therapy that is most widely
studied. It’s manual-based, manualized so you can do a lot
of reliability ratings and adherence, basically, ratings
for that.
Then, we have an extension study where we can treat people
for up to two years after the date of randomization because
we do know that depression can be a relapsing illness.
Unfortunately, what usually happens is people continue to
have episodes over time and the more episodes you have the
higher probability of future episodes. That’s one of the
parts that I really like about this study, the fact that
we’re looking at people two years down the road. It’s very
easy to say something was very effective for 12 weeks.
What happens two years down the road with that person?
That’s sort of like where we’re at.
I talked about factors that predict response to treatment.
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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What are we looking at? What factors are we looking into?
I can’t go into a lot of detail about them. I’ll just
briefly mention them, but basically we’re looking at a lot
of demographic and clinical factors. We gather a lot of
information about those patients. We do a lot of self
reports and clinician rated evaluations also, very
structured rigorous evaluations. We look at brain
functioning before, throughout the treatment, and at the
end as a factor of prediction of response. We do that
through FMRIs.
We look at genetics, so we draw their blood and process
their blood. We also look at the HPA axis because a lot of
work has been done, and the hyperactivity of the HPA axis
is part of the etiology for a lot of depression and anxiety
symptoms in patients. We also look at immune and
inflammatory markers. That is kind of like a new area that
has been explored in the last couple of years...well, a
little bit more than a couple of years but it has been
explored recently about how all these interleukin
cytokines, all these substances are related to depression.
We look at personality because we do know there are certain
personality traits that do predispose for depression. We
also look at early life trauma being an important predictor
of depression and possibly response to treatment. In our
patient population in Georgia it’s mostly recent
immigrants, first generation, so there is a lot of trauma
history in our patients throughout their immigration
process and in their countries of origin.
The primary site for this study is located within Emory
University in a research clinic that specializes in mood
and anxiety studies. It is solely for English speaking
patients, so we decided to create Clinica Latina - -.
Basically, it’s a satellite research clinic for the Emory
study. That’s what I was hired to do to develop this
clinic and to run this clinic. We are located within the
international medical center at Grady Memorial Hospital,
and I’ll tell you a little bit about the center because I
think it’s part of the importance of this. It’s very
important in the success of our study.
Basically, Grady is one of the largest public health
hospitals. It’s huge. It’s a tertiary care inner city
hospital. It has a lot of components, different satellite
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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clinics. It has been around for a very long time in
Georgia. Actually, it was a segregated hospital. I’ll say
that story. It’s in the shape of an H. It was the white
section and the black section, and the corridors were for
the nurses and the staff. It has a lot of history to it in
terms of talking about health disparities, right? We’re
within the international medical center. It’s a health
clinic for limited English proficient patients located
within Grady, but being Spanish speaking patients, our
largest minority group at this time point....
We have African-Americans, but in terms of different other
limited English proficient, Spanish speaking would be our
main group. All of the staff actually is Spanish speaking
and bilingual. Most of the patients seen at that clinic
are Spanish speaking. Our clinic is fully bilingual and
fully bicultural, and I make a point of that because it has
made a difference especially with mental health, the idea
that you understand me because we come from a similar place
for a lot of our patients.
This clinic was fully established 18 months ago. I do have
to say it’s a part-time effort. Emory doesn’t do a lot of
work with Hispanics, so we’re trying to integrate this type
of study to their ongoing research studies. It’s a parttime clinic, so we are only - - two days a week. So far,
we’ve had 1295 Hispanic patients call expressing interest
in the study. That is a lot of people, especially when
you’re doing a depression study. If you were doing
diabetes, high blood pressure, or breast cancer you’ll get
a lot of people, but depression is kind of one of those
things you don’t really talk about within Hispanic culture.
We definitely see that there is a need. People want to
know about it. People are asking about it.
Part of our evaluation...we provide a lot of
psychoeducation when they call. We get a lot of calls like
well somebody told me I might be depressed. What is that?
What is depression? I just feel sad and tired, but it must
be because I work a lot. Our screens involve a lot of
psychoeducation. In other settings, you have somebody who
calls for a study and says I went online and did a ten
question screen. I have major depressive disorder. I
think I qualify for one of your two FDA approved
antidepressants. It’s a very different culture. The
people need a lot of psychoeducation during their screening
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NHMA – 15 t h Annual Conference
March 18, 2011
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process so they can actually make an informed decision
about whether they want to participate in the study or not.
We’ve tried really hard to network and develop
relationships with the limited services we have in Georgia
for Spanish speaking patients. In terms o f having a
referral, what happens when patients don’t qualify because
we do know that for clinical trials a lot of people many
times just don’t qualify. We have a lot of requirements
and standards. We’ve had so far, and this data is up to
February, 146 screens. People have actually showed to our
clinic. Once again, it’s two days a week, so that accounts
for the number.
We’re usually pretty busy. Of those 146, 42 patients have
actually been randomized to treatment. We do - - extensive
evaluation, basic lab work, EKGs...so they do get some
benefit even if they don’t qualify. We might be the first
person to tell them I think you might have diabetes. You
really need to go to a doctor. These are all the valuable
things I see in this clinical trial. Just even if you’re
not randomized there is a benefit to it.
Our research staff works at the primary English site when
they’re not at our clinic. That is a good thing because
we’re able to maintain a lot of - - reliability. You have
the same people doing the same thing in two sites. Also,
it’s a great way to get employment for bachelor’s level by
Hispanics. All our staff is actually bicultural, so we’ve
been able to provide jobs for these students, too. We do
need to have a greater staff to patient ratio. That’s just
something you have to understand when you’re working with
Hispanics. They need a lot of help navigating the system,
understanding it. You want to know that when you’re
writing your grant and before you develop your study,
right?
We worked really hard to incorporate the concept of patient
navigators. That has been talked a lot about in a lot of
our meetings. Just that person that guides the patient
through the system. We can’t tell a patient show up at the
MRI building at 9:00 and somebody will do your scan. We
really have to tell the person I will meet you here at
9:00. I will walk with you. We’ve even done a contract
with a local cab company where they show up to the
hospital. We have one staff member who gets in the cab
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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with a patient and then they drive to the FMRI because it’s
just very complicated, very difficult for them to do.
Public transportation is not always great. Many times we
have to print out maps, MapQuest, get on bus number X. It
leaves at 9:30 and you will be there at 10:00. We have to
help them in order to be able to facilitate their
participation because they do want to participate.
The patients come in. They sign a consent to undergo an
initial evaluation, and if they’re eligible they sign our
extended consent. We are located within a general medical
clinic, which I think has also been very helpful. They
don’t go to this mysterious place to do my evaluation. I
don’t know. It’s this research study. They actually go to
a clinic. They go to a waiting room where there are
pregnant women, children, people speaking different
languages, and they’re there to get their healthcare. We
happen to be in one of those offices. It also adds a
little bit to the concept of this is an illness for
Hispanics and the fact that you’re not making this up. It
wasn’t that you couldn’t handle a situation. It is a real
illness.
We looked at the questions that came up during our informed
consent process with a goal of being able to identify
things that could be causing a lot of trouble for the
patient in terms of understanding some of the questions.
What was difficult for you? Because we really want to use
the data we gather from here to make all the changes that
we can during the study while adhering to protocol but at
the same time be able also to inform future studies about
what were the types of doubts and questions and how can we
make even better informed consent.
There were questions about documentation, legal aspects,
and confidentiality, which we sort of expected. There is a
lot of concern about what is going to happen. Where is my
data going to go? Who are you going to inform? I have a
Green Card. I’m working on getting citizenship. How is
this going to affect it? That type of concern, right? It
was very interesting that they tended to request a lot of
further clarification of the protocol and study procedures.
I’ve been giving that a lot of thought because people would
read something and then they would go okay. They would
grab the informed consent and ask you okay so the medicines
are X and Y, right? Yes. They are FDA approved, right?
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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It almost felt like they needed that personal contact.
Here in the US a lot of people are used to just signing
documents, and that is even more important - - what people
say. I have it written. I need that email so I can
certify that you did that.
For them, this personal contact was so important. We
talked about the fact that yes these are the medications.
Yes, these are the side effects. I found myself kind of
repeating a lot of the things that were written in the
consent. It was only after they heard it from us then they
would okay I’m signing. There are also the concerns am I
going to be a guinea pig and a lot of concerns about
medication side effects.
I’ll tell you a little bit about our demographics. What
does our clinic look like? In terms of gender, as we know,
depression is more prevalent in women. It is kind of like
within the expected realm. We have 111 women and 35 males.
We looked at the country of origin, too, and it is very
consistent with our Hispanic population within Georgia.
The majority of our Hispanic population comes from Mexico
and mostly Central America. Here we have Mexico, Colombia,
that’s the order.
We do have quite a bit of Colombia, but they’re the biggest
representation from South America. It’s usually Mexico,
Colombia, and Guatemala. They go in decreasing order, but
it’s a significant difference. Ninety-two of the patients
were from Mexico, and then the next category, which would
be Colombia, the next Hispanic country there were ten
patients. It’s predominantly Mexican, our population.
In terms of a little bit more demographic information,
their average age is 37, but we went through the whole
range. Our study recruits 18 to 65-year-olds. The 66year-old here is because the patient turned 66 during the
study. We had the whole range of ages. The average number
of years in the US, which I think is very important, too,
in terms of considering the population that we had in our
study, was 11 years. It was people who had recently came
here. Many of them were not born in the US, but it did
range from one to 40 years.
Their educational level, the majority of them did not
finish high school, but in our population we do have people
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March 18, 2011
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even with doctoral degrees, so we were able to capture a
more representative population. The marital status, a
great majority of them were married, and there were some
people cohabitating. We also know that a lot of times
couples are separated because one of them is working
somewhere else or in another state but they’re still
married. There is that stressor, especially for the women,
of staying alone with their kids.
The number of children because a lot of that is said in
terms of depression and the stressors and the number of
children you have to take care of...so most of them had
children. One...two children is the green one, which is
the most number of kids...three, four, but we had patients
that had up to nine children. That tends to complicate
their ability to have access to medical care. Who is going
to take care of the kids so I can come to the appointments?
How are we going to make ends meet with nine kids and all
of that?
I want to talk a little bit about show and retention rates
because that is a big concern in trials, right? We get
people to come, and once you get them to come how do we get
them to stay? We have a lot of baseline data. You don’t
have a lot of endpoint data. It’s hard to come to
conclusions. Our no show rates for now...it’s really hard
to compare the two because the population at the main
clinic they’ve been running for two years longer than us
and they’ve been running five days a week, so they have
been able to recruit more patients, obviously. When we
compare the percentages....
Anyway, basically 20% of our patients have not shown for a
screening visit versus 28% from the main side. We’ve
actually had quite a bit of people show up. People do show
up for the study. Our retention rates are a little bit
lower, 69. It’s not bad, but we would really want it to be
more than that. The main clinic is close to 75%. I mean,
we’re very close to them, but we would like our retention
rates to be even better.
Based on that, we looked at all the reasons for early
termination so far with the patients that we have. I do
have to say, and going back to the previous slide, in those
18 months basically 20% of the sample is Hispanic. We’ve
been able to incorporate a significant amount of Hispanic
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NHMA – 15 t h Annual Conference
March 18, 2011
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patients to the study versus before this clinic was
established it was minimal or next to nothing. Now, 20% of
the sample is Hispanic, and we hope to continue increasing
it over the next couple of years.
Basically, the reasons for early termination in our
patients, there was some scheduling conflict. Our patients
are the middle column. The main clinic is the column to
the right of our 42 randomized and their 163 randomized.
There was intolerance to medication. I want to mention
intolerance to medication and adverse event. It’s just
three patients total among those three, but a lot of times
it makes you wonder whether was this termination due to the
belief that Hispanics are more somatic and have more
significant reactions to illness, or is it that Hispanics
do metabolize medicines differently, have more serotonin
transporters, and ten milligrams of X medication in them
means 30 milligrams rather than blame it on culture or race
or things like that, ethnicity.
In terms of the study, that’s another important aspect, the
fact that we’re looking at genetics, that we’re looking at
other data that will help us clarify some of that and will
provide significant information about Hispanics that has
not been gathered before. My final remarks about this, and
you wonder okay so how does all of this fit into communitybased participatory research. I see it as a building
block. We don’t have to go around replicating every study.
Why can’t we be part of a study and modify it in a way
where we still adhere to protocol but we are doing more of
a community-based intervention and taking into
consideration your population?
We’ve proven that you can actually modify a research study
while adhering to protocol so that it suits our population.
It increases diversity in the study population. I told you
- - already mentioned this. We have jobs for Hispanics
wanting to go to med school. - - in these 18 months our
third...we have two students that are going off to med
school, and we have one that was accepted into a psychiatry
residency. At least the treatment recommendations that
take ethnicity into account not only from a culture and
social perspective but also biologically because we’re
measuring a lot of biological markers. It leads to more
specific and effective interventions. It’s a great way to
provide treatment for an underserved population.
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March 18, 2011
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Also, what I’ve noticed throughout our study is that we’ve
been able really to increase awareness about mental health
and depression because we go around promoting our study
trying to advertise it. When we go to the radio and we do
community shows and the TV we also talk about depression.
We demystify this whole depression and mental health thing
and try to explain why it is an illness and that there is
treatment and there is treatment available for them at no
cost through the study and a way to decrease stigma.
I know my time is up, but we do have questions at the end I
believe, right? Thank you.
MALE VOICE: Thank you, Dr. Aponte Rivera. So we’re going to
have about a 15 minute question session at the end once we
have gotten all the speakers taken care of. Hold onto
those questions. Write them. Our next speaker is Dr.
Paula Goodwin. She is in the health sciences administrator
for the National Institute of Minority Health and Health
Disparities at NIMHD. She is primarily responsible for
directing the community-based participatory research
program, which supports partnerships between academic - research institutes and communities to improve the health
of health disparity communities.
She completed her doctorate in human development and family
studies in 2001 at the University of North Carolina at
Greensboro and completed her post-doc fellowship at the
University of California LA and the University of North
Carolina Chapel Hill. Prior to joining the NIMHD, Dr.
Goodwin was a professor in child development and family
studies at Purdue University in Indiana. She also worked
as a statistician in the Center for Disease Prevention and
Control.
DR. PAULA GOODWIN: Hi. I’m Paula Goodwin, and I’m from the
National Institute on Minority Health and Health
Disparities because our acronym is NIMHD. We recently
became an institute, so I’m getting used to saying that
acronym also. Today, I’m here to talk to you about our
initiative in work with communities and how we have a
program of community-based participatory research that
actually our academic research partners with communities to
implement interventions. Also, to talk a little bit about
how we specifically with Hispanic Latino populations...some
of our CBPR projects that target that specific population.
NHMA – NATIONAL HISPANIC MEDICAL ASSOCIATION
NHMA – 15 t h Annual Conference
March 18, 2011
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We were established as a center in 2000 with public law
106525. Part of that law also gave a definition of what
health disparity populations were. That defined a health
disparity population as a population where there’s a
significant disparity in the overall rate of disease
incidence, prevalence, morbidity, mortality, or survival
rates in the population as compared to the health status of
the general population.
With that definition, racial and ethnic minority groups
including Hispanic and Latino populations were considered
health disparities populations. With the passage of the
Affordable Care Act in 2010 ten years later we were
elevated to an institute, so we’re now the National
Institute on minority health and health disparities. With
that, we were charged with coordinating health disparities
research across the national institutes of health and also
supporting research and programs with the goal of reducing
health disparities and ultimately eliminating health
disparities in the US population.
With that in mind, we established programs that had that
goal in mind with reducing and eliminating health
disparities. We know sort of the traditional research; the
traditional approach to research may not be as effective
with some of our health disparities communities. That’s
why we focused on creating a CBPR, a community-based
participatory research program. When we did that, we
called upon experts in the field like Dr. Barbara Israel
and Dr. Eugene - - and some others as advisors to help us
to develop a CBPR program that had the goal...we wanted it
to support intervention research. Our CBPR programs, all
of our grantees are implementing or are planning to
implement interventions to address a disease condition that
is of interest to the community.
They use the CBPR approach and the principles and methods
of CBPR. Again, the goal is to reduce and eliminate health
disparities. What’s unique about our program is that, one,
we require a partnership, an equal partnership that
communities are equal partners in this research grant. We
require that there be some partnership that has been
developed. Often times, we see where community groups are
co-PIs or community groups are key personnel on the
research grants. We also require community involvement so
that each of our CBPR grants has to have a community
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March 18, 2011
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advisory board. The goal for this, again, is that we want
science to be translated and want it to be done in a way
that is of meaning to the community and is relevant to the
community and also that this is sustained...after the
research funding ends that some capacity has been created
in the community so that the good that has come from the
intervention can be sustained after sort of the academic
researchers leave or the funding dries up.
With that in mind, our CBPR program is a three phase
program. Our first phase is what we call our planning
phase. With that phase, it’s three years of support where,
again, equal partnership in all phases in all aspects of
the research but communities and researchers partner. You
have three years to sort of form and really work out the
development of those partnerships.
There is a community needs assessment done. With input
from the community, you identify the disease or condition.
The academic researchers are not the ones who say okay
we’re going to focus on this particular disease or this
particular.... They have to in collaboration with a
community partner decide what is the disease or the
condition. I can give you an example right now. We have a
set of some planning grantees. They start out in writing
the grant. They have an idea of what they think the
disease or condition may be that they want to focus on, but
within these three years and as they develop I get phone
calls about the community really took it in a different
direction. That’s good to hear because that lets us know
that the community is involved and has some say in what’s
going to be done and how it’s going to benefit their
community.
During this three year phase it’s also a time where you
really work with your community and plan the methodology
for the intervention and also do a pilot intervention. Our
next phase is phase II, and that’s what we call our
intervention phase. That’s five years of support. Here is
where you further define or develop the logic model, the
conceptual framework, the research design, and the
methodology. You develop evaluation plans. This is the
time when you actually...having that planning and
solidifying that partnership that you actually have five
years to implement the intervention. You do an evaluation
study, and then there are plans for dissemination. Again,
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March 18, 2011
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I say this with each phase, at each phase there has to be
involvement with the community and you have to have a
community partner in these grants.
The third phase is a three year phase, and we call this the
dissemination phase. These are provided to grantees who
have demonstrated effective interventions. This is an
opportunity, again, in collaboration with the community
disseminate research findings in an effort to improve the
health status of underserved populations and eliminate
health disparities. Again, in working with the community
it’s not always from the academic perspectives about
writing research or empirical papers, but the community has
an input in what’s the best way that we can disseminate the
findings from this research to our communities, to
communities like ours. What’s the most effective
culturally appropriate way to do that?
As you can see, with those three phases...and each one of
those phases is a separate competing phase. Just because
you received a planning grant, you don’t automatically go
to the intervention or the dissemination, but if you’re
funded for all three phases that’s 11 years of support in a
community working with a community. Again, back to what I
said when we decided to sort of develop this program and
brought in the experts, we wanted to ensure or to make sure
that we had sustainability. That it’s not sort of a drop
in for three years in the community and you leave out so
that you could actually get funded for 11 years to work
collaboratively with communities to implement these
interventions.
Currently, I can tell you a little bit about our history.
Our first planning grant - - started in 2005. We had our
second wave of the intervention that started in 2008.
Currently, we have 40 intervention grantees that are
implementing CBPR products across the country. We were
fortunate enough to start a planning phase with ARRA funds,
the American Recovery Reinvestment Act funds. Currently,
we have six planning grantees. We haven’t yet gone through
a full cycle through the dissemination, but our
dissemination phase will start in 2013. Afterwards, we
will have a full cycle and be able to report on, again, did
we reach our goal of eliminating and really building
capacity and sustainability in those communities.
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March 18, 2011
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NIMHD CBPR grant portfolio. Like I said, Hispanic Latino
populations are certainly considered a health disparities
population, and our grant portfolio reflects that. Like I
said, we have 40 intervention grantees. We have six
planning grantees, and of those about a third either
exclusively target Hispanic Latino populations or they
target Hispanic populations because of the area that they
work in that is primarily Hispanic or have a large Hispanic
population.
We realize and our grants reflect diversity within Hispanic
Latino populations, so our grants do reflect that. We have
a diversity of target populations when we talk about
Hispanic Latino CBPR projects, and just some of the
indigenous Mexican farm workers we have a CBPR grant in
Oregon that actually works with indigenous Mexican farm
workers at nurseries to implement an occupational safety
intervention where they’re actually testing for markers of
oxidative stress. They actually have an intervention where
they have a culturally appropriate...in the indigenous
language where they actually do docudramas and also videos
and DVDs as opposed to sort of the standard way among
nurseries or pesticide workers that you receive a
written...something in English that tells about the
occupation safety. We have - - grant in Oregon that is
actually working with these farm workers to implement a
culturally appropriate occupational safety intervention.
We have a project in Boston at Tufts University working
with Caribbean Latinos. That was one that when I mentioned
about the planning, this is a planning grant where
originally when the grantees submit it they had some ideas
about what issues or diseases they wanted to focus on.
When they got there, it wasn’t what they expected. The
community said, particularly the young people in the
community said, we’re interested in mental health and self
esteem and well-being. This particular project, the
grantee has youth from middle school and high school that
are actually working as researchers on a team...and help
developing the intervention. They have a seat at the
table, and they’re having a say in the intervention that’s
being developed to target their particular population.
We have - - populations. We also...a lot of times with
CBPR in recruiting, you know, a lot of our grantees have
difficulty recruiting males into sort of these behavioral
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interventions. We have a very unique one in North Carolina
that targets rural Latino males in HIV prevention and
sexual health. It’s unique in an initiative in that they
actually go to the soccer leagues, and they recruit men to
be sort of the lay health advisors. These males are then
the leaders who recruit other team members, and they
provide the intervention that way. We work with children.
We have a CBPR project in Texas where they actually partner
with the Girl Scouts that have a large Hispanic population.
They’re working with Girl Scouts and Girl Scouts leaders to
implement a physical activity program for overweight and
obese Latino adolescents and preadolescents. Again,
diversity in terms of the regions in the United States that
we focus on, so our projects do reflect the diversity that
is within the Hispanic population.
We have a number of diseases. Again, these diseases and
conditions are collaborative. The community has a say and
an input in what is addressed. We have a number...again,
from the plenary session and looking at sort of the top
diseases and conditions among Hispanics and how Hispanic
populations may be overly burdened by particular diseases.
Our CBPR projects in the Hispanic populations cover
obesity. There are a number that work with physical
activity about healthy eating where they have people...lay
workers or promoters who go into homes and sort of deliver
interventions. Diabetes is one that comes up often that we
have a number of programs working with diabetes. HIV and
sexual health. The one I mentioned about pesticide
exposures. Cardiovascular diseases and then the metabolic
syndrome in and of itself. These are just, again, some of
the diseases and conditions that are being targeted in
Hispanic Latino communities.
We have different strategies. Again, the goal and the
reason for involving communities is that researchers may
bring certain skills. Also, we realize that communities
have skills that they can contribute to the research. Part
of that is knowing the culture and knowing the people in
the community. We want interventions that are developed,
that are culturally appropriate, that are effective and
that will be adopted by the community. In doing that, a
lot of the strategies they’re culturally and linguistically
appropriate strategies. They involve community involvement
where we have community health workers that are trained,
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people in the community that are trained to educate and
carry out interventions and to educate the people that
they’re working with.
Also, a lot of our grants, like I said, about
sustainability and giving something to the community, a lot
of them focus on advocacy. We have communities that are
working with researchers to advocate for green space, to
advocate to their community leaders and politicians for
certain things. It’s not just about implementing just an
intervention about diabetes, but it’s about building
capacity and having sustainability. A lot of our grants do
focus on advocacy for community members and how they can
sort of get what they need in order to live and lead
healthier lives.
You can, and I think you’ll have this available to you, but
the NIH reporter is a public site. If you want to know
more about what are the CBPR programs, and if you want to
know who is the PI and how to contact them and what has
been published, you can go to NIH Reporter. That’s the
website address that will give you more. If you want to
know more about our specific programs or about the CBPR
program, you can visit our website. You can also contact
me. Like I said, I manage the CBPR portfolio at NIMHD, so
you’re welcome to contact me if you want to know more about
the program or just specifically about some of the programs
that we have. Thank you.
MALE VOICE: Our last speaker is Sara Tyloski [phonetic]. She
has two decades of experience in strategic planning,
management, and pharmaceuticals with pharmaceutical and
biotech industries. She previously worked both in small
and large companies including Intercell USA and
GlaxoSmithKline. She provided strategic project planning
to launch several new projects focusing on the Hispanic
Latino markets...working with advocacy groups for disease
awareness campaigns and recruitment. Her passion is
working on cross-cultural business goals with particular
expertise in helping to accelerate outcomes for product
development. She most recently actually organized to
spearhead the first ever Hispanic Heritage Conference
called - -. Actually, LMSA was invited to this as well as
NHMA, so we had about three representatives in that
particular conference. They’re going to actually follow up
on that.
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The conference itself was just focusing on how to reach the
Latino community for clinical trials and medical research.
Sarah has a BA and an MBA from Florida Atlantic University
in Boca Raton, Florida, and travels back and forth between
Florida and Mexico.
Ms. SARA TYLOSKI: Well, unfortunately, I don’t look like a
Latina because my last name is - - Tyloski, so I apologize,
per hablo Espanol; yo - - a Mexico. I’m just real curious.
I know we only have a few minutes. I think it’s very brave
that you guys are hanging in here until 5:00. I’m just
real curious. Out of this group here how many of you have
been involved in some way in a clinical trial, raise your
hand? Have currently or have in the past. So about three.
The only reason I was asking is that’s what this whole
subject is about. Of course, how do we get you guys more
involved? With that, I’ll just get started here.
I’m actually representing MMG. They are a full service
patient recruitment and retention company, and they
basically recruit and retain patients for clinical trial
research. Their clients would be people like Emory
University. They actually have patients that in NIH
studies, people like GlaxoSmithKline...so those that we
would be familiar with. That’s their job. Basically, our
objectives, it looks hairier than it is. It’s very simple,
but what do we know? I think we’ll zip through those
slides because I think everybody here knows the basic data
about Hispanics and Latinos and their involvement.
I would like to share a little bit of a story, a real story
about a lady that I met who is in clinical research as a
patient. Why are Hispanics and Latinos not involved and
how to get involved as a physician? In this group, who has
PhDs, MDs, or are on their track? Most everybody...okay so
good. I just want to make sure we’re hitting the right
target here. What do we know? I’m going to zip through
these slides. I think everybody in this group knows
this...but background. As you know, in fact, the data has
recently been updated. Pew Hispanic Research says that
there are now 51 million Hispanics and Latinos in the US,
so it’s even probably a little bumping closer to this at
16%. Hispanics and Latinos are the dominant force in the
US in terms of impact and influence.
I thought it was interesting that the youngest demographic
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group has a median age of 27.4, so it’s a younger
population that’s growing in the US. I think everybody
knows that here. It’s growing quickly. Probably the
biggest thing is that the Hispanics are growing quickly.
By 2050 that’s important for clinical research because it
takes time to get something to market. The average
medication to market is ten to 15 years, eight to ten
billion. We’re way behind already.
I think the other thing that’s important is that okay who
is Hispanic in this room? Raise your hand, if your origin,
that is. Everybody? I’m the only one that’s not and you
and Dr. Goodwin. I also think it’s interesting the second
generation dominates growth. You’re the representation
right here, right? That’s people who have been here
already for a bit. That’s the big growth group.
I know everybody knows this, but just to touch on the fact
that if you’re not in California and Texas in the clinical
research world you’ve missed the boat. Everybody knows
that, right? Interestingly enough, in fact, there was some
new data I was just reading the other day. There are some
states like Ohio and Idaho and Alabama...they’re really
coming up in those areas. I think Alabama had the largest
increase in Hispanic growth, so these are great
opportunities. I mean, there are 16 states with at least
half a million Hispanic Latino residents, so that’s pretty
significant.
Then, I think the other thing that’s important in terms of
clinical research, I think you touched on it a little bit,
is what is the economics of Hispanics and Latinos
participating in trials specifically? There are a lot of
challenges in the United States. This is, again, on census
data. You may or may not know this; you probably do, but
one in four US Hispanics live in poverty. That definitely
affects both the elderly and the younger folks. A lot of
Hispanics hold down more than one job, so that makes it
difficult for them to get to a trial, as you know. Then,
again, the vulnerability is the children and the elderly
and then, again, caring for it, as you alluded to in your
presentation. That’s a big challenge.
Even though the Hispanics and Latinos as a group are a
large part of the US population obviously under-represented
in trials, there’s actually not even a lot of data out
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there if you go out and look for the data. This is just
some summary. In 1995 to 1999 we found only three percent
of Hispanics and Latinos were in trials as
participants/patients. Then, there is another data point,
3.1. There is some data that shows the National Cancer
Institute funded trials it was around 5.6. Even as of
2009, minorities participating in clinical trials have
remained lower. We all know that, but if you make that
comparison of three to five percent participation versus
16-ish of the population demographics we’ve got a long way
to go in a short period of time.
Then, this is just an example. Even in something like
COPD, which we don’t think about because of that second
generation growth. Yet, if you look at the...is it because
we haven’t had good diagnoses - - the COPD patient well.
Why are they not in trials? We don’t really know. There’s
just not that much data out there. I threw this in there
because a lot of COPD patients go to the emergency room.
They haven’t even probably thought about a trial. They’re
usually getting treatment first. Mexican Americans seem to
have similar severities of COPD, but we just don’t know
that much. That’s the bottom line. We just need to have
more people in trials.
What does this mean? What it means is that the industry is
behind. I think NIH is to be commended for these projects.
It’s very exciting what they’re doing at Emory University,
but industry, meaning the GlaxoSmithKlines of the world and
the Pfizers of the world need to step up. That’s what I’m
trying to do with companies like MMG. I’ve talked to
physicians. A lot of you are either to be or are
physicians. You haven’t seen data on Hispanics and
Latinos, right? It’s not out there. Are you
comfortable...anybody a practicing physician yet? Do you
feel comfortable prescribing....? Here’s a new drug out
there that has never been studied in the Latino market. It
makes you feel uncomfortable, right? There you go. Of
course, I think you know that the FDA is encouraging based
on - - data that we do, in fact, try and reach out to these
categories of ethnic and race. Therefore, we need more
options. Bottom line.
We all know this. This is nothing new, but I wanted to
share with - - had a chance to meet my friend Gabriella.
I’m just going to give you the summary. I met Gabriella at
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the Clinica del Pueblo right here in Washington DC. She’s
a 45-year-old Latina who developed HIV from her husband
from an extramarital relationship in 1994, and through her
husband she also got HIV and passed it on to her daughter.
Both her husband and her daughter died within two years of
full blown AIDS. It was very sad. In that time period,
Gabriella really suffered with anger, depression,
frustration, confusion, and of course her own health
suffered because she had HIV and was doing nothing about it
because her husband and her daughter were dying of AIDS.
She ended up having to give up her two sons for adoption,
so you can imagine her situation was pretty dire. The
thing is that’s not so uncommon. I’m sure all of you have
touched lives of people who have had something handed off
to them in some way and they didn’t know what to do about
it.
She went to Clinica del Pueblo, and through an advocacy
program that MMG has learned about the opportunity to be in
clinical trials. I guess I should say it was pretty
severe. We were all crying in that room that day. She
ended up in the ER due to complications of tuberculosis - herpes, mouth infections, and eventually had hepatitis C
and Parkinson’s, so she was in really bad shape. After
five years of psychological therapy - - I was mentioning,
she did find out about this program that MMG has. It’s in
cooperation with NIH to just basically say hey there’s an
opportunity to join a trial. What does that mean? What
does that mean to you? She was able to join a trial in
2000 and has been in these studies ever since.
Fifteen years later, Gabriella has now started her own
group that is basically an advocacy group for Latina woman.
I think it’s called Latinas Unida...I forgot what the other
one or two were. I wrote it down. I think nuevo. Anyway,
the idea was she got together a group of women. They meet
every month. It’s growing. There are about 20 women in a
group. She is based out of DC, and she said that really
her sickness was one of the best things that ever happened
to her because through this whole process she has been able
to reach out and mentor other younger women to get
diagnosed early, to get treatment, to learn about what
their health conditions are. The other thing that’s kind
of nice is one of her sons that was sent off to adoption is
now living with her, taking care of her, and she just hopes
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that we’re going to be able to reach out to more Hispanics
and Latinos from her perspective. I think we’ve already
moved beyond that with some of these trials that are
starting to take place, but we know that we need to do
something about it, right? That’s where we’re at.
So why are Hispanics and Latinos not involved in clinical
research? I think we’ve seen some of the answers.
Recently in February we just had a conference called Todos
Juntos por la Salud that I helped put together with MMG.
Alvaro came. Dr. Elena Rios came. A lot of people were
actually at this meeting as the leadership came. What we
wanted to find out is what is going on and what can we do
instead of just talking about it. What else? What other
kinds of initiatives can happen from this? Basically, it
was a very short half a day session just to bring leaders
together at this point. I think these are things that you
guys would all say yeah that’s true, but these are the key
issues that we came up with.
One of the big ones that we talked about is the lack of a
clear message. I know that you probably experience this.
People just don’t know what clinical trials are. What does
that mean? We’ve got the Tuskegee experience. We’ve got
the experience of Guatemala, so it has got a bad rap. It
has got a bad name. It certainly has a bad name in the
minority community. We have to figure out what is the
message. Why are we even having clinical research? We all
know why, because we’re in the medical field, but an
average patient doesn’t know.
Then, of course, there’s a big mistrust in general,
especially by Hispanics and Latinos based on their country
of origin. White people like me except I’m culturally
competent, but white people really don’t get it. They
don’t realize that they need more staff...that you need to
hug somebody when they come in the front door. Those
Latino things that we all know, that language and culture
is very important at all levels, and that relationship is
key. There is that mistrust.
Then, what is the awareness on the patient, physician,
community, access to research, access to funding, access to
care? A lot of times people end up in the ER because they
don’t know where to go. We know the whole lack of
insurance story. Then, part of that is lack of training.
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Even here at this level I’ve talked to Alvaro. We’re
working with the Latino Medical Student Association to
create a cultural competency training that could be
standard for all people in research. That’s what we need,
the nurses straight on from when you walk in the front door
right on through the PI right on out the door. I was
thinking of a quick story that one of our participants was
telling us about a nurse who was in clinical research, and
there was a Latino patient who had come in. The nurse said
hey you don’t want to be in this study. It’s too much
work. Had we trained this nurse about the benefits of
research that it’s going to benefit this patient and it’s
going to benefit future generations maybe that wouldn’t
have happened. Training, would you guys not agree, is a
big issue in terms of just overall....?
From this conference, actually you guys are the first
audience to see the preview of the findings we’ve put
together. Again, nothing we don’t know, but we do need to
define the story. We’ve created sort of a phase. Phase I
is what is the story about clinical research. What does
that mean? So talk about...I don’t know. Has anybody
heard of the organization called - -? It’s a non-profit,
so it’s kind of a small company. They put together
educational videos, and they walk you through in language,
culturally appropriate, very well done. They have music in
Spanish, and it - - a church because the spiritual world is
very important in this community. Anyway, it walks you
through phase I through IV.
What does that mean? A patient can relate to it. These
are some of the tools we’re talking about. Discuss
stigmas. Use real people. We’ve got lots of people out
there in the media who have had certain diseases. Let’s
use them. Create access tools like community-based
organization ambassadors and online media to disseminate.
I was just talking to Alvaro today about the fact that if
we can have people, residents for example, coming out of MD
program or PhD program you have access to those people.
Let’s educate the patient so they understand what those
opportunities are when you’re seeing them in that emergency
setting at Emory University. Okay, oh we have this asthma
study. It becomes our job to educate the patient first so
that we can increase participation on the other side.
There are the tools. Then, share the benefits of being in
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research, which we talked about the support groups that are
out there.
That’s phase I. Then, of course, I think everybody knows - identify these groups. It’s eve rybody. It’s basically
everybody that’s involved in research in some way. It’s
the pharmas and the biotechs. I mean, I think they’re big
time guilty personally because I don’t represent any of
them so I can say that. Let’s face it; it’s very difficult
to get these pharmaceutical companies and biotech companies
to recognize the need. I think the census data has really
opened up the eyes in the industry.
It’s what I’ve seen. PIs, principle investigators,
community doctors...those doctors that are out there in the
community we need a referring way to get these patients
into trials that’s trustworthy. Is that not true? - lots of yes’s there. Even people like Wal-Mart. I have a
friend that’s in research at SMU, and she works actually
with Walgreens in a very informal way. They do health
fairs, and they go out into the community and they just
educate what’s going on. Those kinds of low key things - possible grant, I think. Then, so we have to do the
education as we’ve talked about this already.
Then, I think the other big one is cultural competency
training, which we talked about. What does that mean? Put
it in simple language. It can’t be in some college level
language for a patient. A lot of these patients, as you
mentioned, they don’t have a high school education. They
need it in simple. I like the docudrama idea. Keep it in
a very simple format that a patient who is going to benefit
from a trial is going to understand. Then, bring that all
together, the phase IV.
What does that mean from out Todos Juntos projects? What
are the relationships that we have been able to create?
Then, what are the tangible things that are going to be out
in the marketplace? What projects that are clinical
research are going to help bring those new medications to
market so that the Hispanic Latino community can benefit
and doctors feel comfortable prescribing those medicines
that can really make a difference. There are a lot of new
diabetic drugs coming out there. I don’t see a whole lot
of Hispanics necessarily being studied consciously as part
of that.
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So this is something you guys know, but this is just an
example of cultural competency. A grandmother from Puerto
Rico in New York versus a single man living in rural Texas
versus a second generation Cuban student living in Miami is
completely different. The white folks don’t understand
that necessarily, but I think it’s coming, poco a poco.
Then, of course, it’s beyond Spanish. It’s not always the
language. It’s also the culture.
In fact, most second generation Hispanic Latinos English is
their first language. I think everybody knows this. It’s
more let’s tell the other people about it. That is let’s
connect through food, traditions, and then there was an
interesting campaign. I think it was the Susan B. - campaign. They had a Facebook project where they...but
they had bras on Facebook and they got people to sign up
quick. They appealed culturally to the various groups.
Give us something to do, right?
Then, I’ve got a little video. Create a message with maybe
a little bit of Spanish in there, but it’s really eye
catching that makes sense. It’s culturally appropriate.
I’m going to show you quick. This is a Spanish language on
a VW ad that was viewed about a year ago. So did that
resonate with some of you? Yes. Come on, liven up. It’s
the end of the day. The point is it doesn’t have to be
obvious. It could be just a couple words and there you go.
Where was I? I’m almost done guys. What does that mean
for you all that are in the research world or PhD or
practicing doctors? How can you get involved in research?
As PhDs or MDs is anybody involved in research in the room?
You are, okay. Would anybody like to be involved in
clinical research? Good deal. We got a couple there.
You probably know all this. I mean, you probably do know
all this, but this is just some basic overviews. I think
probably Dr. Vivian Aponte...talk to her. She obviously
knows everything about that, but I think this is a really
key part. How do you become a principal investigator or
subPI for that matter? These are just the basic steps.
Obviously, you’ve got to know the regulations and have your
site inspected. I like what Emory University is doing
where they have a subsite to the university. You’ve got to
get your IRB approval, sign a contract, and prepare a
visit. I know this is very simple. I know. I’m giving
you the very basics. You definitely...I hope you will
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comment on this and build your network. Probably number
six is where you have to start, like who is your network
first, right? Where are you going and - - relationships?
Anyway, I don’t know if you’ve seen this or not. We really
weren’t sure what the audience was, but you have to know
the regulations. Obviously, who has done GCP here in this
group, anybody? So there you go. Well, good clinical
practices are just basically international quality and
standards for being in clinical research. It goes through
a whole compliance...many of the resources are available
online. I’ve gone through it. It’s not difficult, but
it’s based on providing public assurance that the rights
and the safety of the patients are being looked after. It
came out of Helsinki. That was a really one second
version.
Then also, there are a whole set of codes that go along
with that, which as you know are quite complicated. That’s
basically about how to provide the information to the
sponsor of the drug or the university in that process.
There are a whole set of regulations that go with that.
Part of it is you have to have a site. For community-based
physicians, more likely you’ll be referring to a site
that’s existing.
As Dr. Vivian Aponte...I think this idea of having a
subgroup out of a university I bet you could probably get a
grant through the NIH and do that. Here we got the nice
partnering going on, but you do need to have that site and
then, of course, have it inspected. It’s a big long
process, but if you have a sponsor who is interested and
you have access to Hispanic patients, you probably have a
good shot at getting that process going.
The IRB is just basically a review board that overviews all
your information as far as recruitment, retention, all the
information you’re going to provide the patient they have
to approve that. The IRB board can be a combination of
lots of people, usually academic people, government people,
sponsor people...it’s a large group of people, and there
are companies that do that. I’m giving the very short
version, right? You guys can answer those questions
better. Then, you have to sign a contract, which is very
important to get proper...because - - talk about your
responsibility as a physician, a sponsor’s responsibility,
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when the data is going to be provided, what does it look
like, statement of work, what does the followup model look
like, how are you being paid per patient per visit per all
that? It’s quite complicated, so you probably need a
lawyer for that.
Then, in the perfect world, all sites have a visit to
inspect that you have all the various qualifications that
are needed, which are fairly complicated in the study
world. The purpose is just to make sure that everything is
according to the plan that you’ve put out for the sponsor
in order for you to enroll patients and follow the right
procedures. For example, you may have to have a
refrigerator, and it depends on the study, at a certain
temperature. You may have to have a drug room that’s
separate from your other drug room. It’s quite
complicated. Again, I think for community-based physicians
referring to or grouping together as a group in a subarea
like with a university...I know Alvaro is involved at the
University of California Irvine. I think that’s where
there are opportunities that I see that would work for the
community-based physicians.
Then, I think this is probably the first place to start.
Who are your contacts? Who are your people that you want
to do a study with? There is a great website that you
probably do or do not know about, clinicaltrials.gov.
Right now there are about 20 trials that either have
happened, are happening, or are going to happen
specifically for Hispanics and Latinos. I think Emory...I
think your trial is listed there, as a matter of fact, with
Emory University, yes? I think it is. GlaxoSmithKline has
trials. There is this huge diabetic awareness trial going
on, so this might be an opportunity for you to say okay you
can go find out what company, who is the contact person,
and as a community-based physician or person in research
build those relationships.
That’s it. The summary is we know Hispanics and Latinos
are a very important population. They have a lot of unmet
needs. There are unique barriers. We need appropriate
outreach and, of course, we hope to help. We’ll save all
the comments and questions for the end. Thank you for your
time. Gracias por - - tiempo.
MALE VOICE:
So now I guess we’ll take any questions.
Is the
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microphone set up over there? If anyone has a question,
just go up to the mic please so that way everybody can hear
you. Then, I’ll ask the same of the speakers, whoever the
question is referred to.
FEMALE VOICE: My question is so we get Latinos into a study, we
find a drug. It’s a great drug. It works. Then, they
charge five billion dollars for it and they can’t afford it
any longer. Now we’ve helped them for like two years,
three years, maybe five years. What about the next ten to
15 years when they can’t afford the drug anyways or neither
can any of their counterparts, so what’s the use?
FEMALE VOICE: I mean that’s a good question. That’s a
situation I struggle with. I struggle with my research
with even more basic questions. During the screen visit I
had a very high blood sugar. The patient doesn’t have
insurance. What do I do? I get this lab work and say you
have to go to a primary care that they don’t have or they
don’t have the money to see. That’s where you have to team
up with a lot of agencies in the community. There are
physicians. That’s where you also have to become an
advocate.
There are patient assistance programs where you can try to
get them enrolled. You don’t always need a brand
medication. A lot of studies are done with medications
that don’t have generics available, but there are still
some old medicines that do work, too. It depends on your
study. It depends if you’re doing a pharma...it’s a
clinical drug trial, sometimes they’ll work with a patient
to try to figure out what’s the best way to continue the
patient on the medication if that’s the only medication
that worked. It is very relative, and it’s a concerning
topic.
At least for us, the two medicines we use in our trial
neither has a generic. They’re quite expensive out of
pocket, and when people leave the trial or they can’t come
to visit us anymore we do work to try to get them.... We
usually see them up to three months after the trial. I can
continue to treat them. We don’t charge them for doing
that. We make sure that they transition to another mental
health place within Atlanta where we’re located. I
sometimes write prescriptions for them for something as
similar as possible. I don’t want to get into all the
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details, but in the study if we’re using escitalopram I can
write a prescription for escitalopram. It’s generic. It’s
four dollars at the local pharmacy. At least we do some of
that. I think it’s a little harder when you’re doing
investigational drug studies and new drug studies and
that’s the only medicine the patient responded to.
We have to abide by all the ethical principles, and we
can’t leave a patient unattended because they stop
participating in the trial. They need to have services.
They need to be transitioned out. At least in our study
design, we do take care of that.
[inaudible]
FEMALE VOICE: He just asked like six months - - how many people
- - drug. Actually, we’ve been very surprised. A lot of
people said it wasn’t going to work. A lot of people told
me that Hispanics are not going to come and that it’s not
going to work. It’s working. They’re coming. We just had
our first group of patients complete their 18 month visit.
Many of them are still on the medicine. Some of them don’t
want to stop taking the medicine because they’re feeling so
much better, and we’re negotiating about that.
Our study is more kind of like naturalistic in nature, so
it’s not like you get a medicine for six months and then
you stop it. We talk to the patient after a year of
treatment and say most studies recommend at least a year of
treatment. What would you want to do? Provide education,
and if they say I want to continue on the med they do. If
they don’t, they don’t. We still follow them because we
really want to know what happens down the line with a
patient. We’re trying to recreate what would happen in a
clinical scenario, so we actually have real live data about
relapse and sustained remission and all of these things.
Most of the patients are still taking the medicine after a
year. It’s an antidepressant. A lot of Hispanics
initially were uncomfortable with it, but they find it very
helpful. Then, they want to refer other family members.
Are there any other...?
FEMALE VOICE: I just wanted to make one point. That’s why with
our CBPR and with a lot of our grantees - - I talked about
advocacy and policy and bridging that. Beyond just the
science part but also empowering communities to be
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advocates so that what your question is...after you’re in
the science and the science is completed, what next? But
leaving something behind in the community so they can
advocate and they can help shape policies to get some of
those things on the table. Really bridging those two
things.
FEMALE VOICE: I just want to add a comment that I think those
of you that are going in or in Hispanic Latino research or
you’re MDs in practice. I don’t think you realize...well
maybe you do, but you’re very valuable to research. I
think one of the points that I would say if I was a doctor
in research today in Hispanic and I had a relationship with
a sponsor, I would say what’s going to happen at the end of
this study. Can you make drug available through your
patient assistance program to my patients? I would demand
it. I think that’s something that’s in the planning stages
of the protocol that’s missing that pharmas and biotechs
are not thinking about. It’s not that they don’t care.
They’re not thinking about it.
Let’s also recognize that it does take ten to 15 years to
bring a drug to trial and ten million dollars and all those
things. Obviously, when they bring a drug to market
they’ve got to make their money back. At the same time, I
know in Brazil they’re doing a program now where it’s a
five year extension for those patients...I forget. It was
some complicated disease. The point is you have the power
as a Hispanic Latino physician to demand that if you’re
going to be in a trial because, believe me, you guys are
the market. There are pharma companies and biotechs that
are dying to get Hispanic doctors into trials. That’s a
reality. You need to demand what your plan is, what you
see is important, because you’re the one that has a
relationship with the patient. Thank you.
MR. OLLIE THOMAS: Thank you very much. Ollie Thomas
[phonetic]. I’m an internist based in Seattle, and I’m
doing a one year fellowship - - at Harvard. I had a
question for Dr. Aponte Rivera about the implication of
your study. I’m concerned because I really quite
appreciate the way you set it up and the qualitative
outcomes, but I’m concerned about some of the quantitative
implications in terms of what does it mean when you have
these differences in treatment dosages if you look at
Latino versus majority patients. Just to back up a step,
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I’m an internist. One of the big controversies when I was
finishing medical school in 2002 was about the treatment of
African-American hypertensive patients.
I think there is actually a significant misinterpretation
of the literature for treating African-Americans, which has
actually increased disparities because it has caused many
people to underuse ACE inhibitors for African-Americans who
actually have indications. This is the core of what I’m
actually going to drive at. I think a very central
challenge for research is that we still tend to read
biology into race and ethnicity when race and ethnicity
aren’t biological.
I was really influenced by a talk at Harvard by Dr. - Batista, who founded the UCLA Center for Latino - -. He
raises this question because there just aren’t discrete
genetic bundles that correlate with phenotype. He pointed
out...he looked at the first 41 families that founded Los
Angeles. How would you characterize them biologically?
You can’t because most of them were interracial couples.
If we start to see these outcomes by race and ethnicity, my
fear is that we have as Americans always interpreted that
as biological as opposed to social and cultural. I’m
seeing that we still continue to do this - - the NIH. I
think that there’s still the potential for NIH funded
research to do that not because of the research being not
well done or executed but simply because of how we’re
interpreting the findings of the research.
DR. APONTE RIVERA: That’s an excellent question that has been
brought up many times and is one of the struggles that we
do have sometimes. I am a Latina. All the other
investigators are Caucasian American, mostly males. It has
even been a challenge for a lot of people to understand
that Hispanics come from...what you call Hispanic it’s 23
different countries in various continents. I find a lot of
value in what we’re doing because we’re going to look at
genetics.
Maybe that’s what’s going to happen. Our outcomes are
going to be...you know what, all these people are Hispanics
and they have nothing in common. I think a lot of people
confuse and there is...a lot of people use interchangeably
ethnicity and race. Those are two very different concepts,
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and we’re piling people from 23 different countries and
saying these are the medicines that work for them.
We’re on our way. I see this as a step to get there, and
we’re going to gather data to say just saying everybody who
speaks Spanish comes to the study and you’re one population
is not accurate. I think it’s displayed in one of the
previous slides where it was how does this Hispanic in this
place versus this other Hispanic and these other Hispanics
identify. With us, it has been very interesting...where we
do our intake packets we ask people about what is their
race. We use the ones that have been identified by NIH and
NIMH, and they don’t know what to answer. The write other,
and then they write Hispanic again because...I don’t know.
I think this is going to be very good data for biological
scientists to see that we cannot pile groups together.
What I was talking about transporters would be we’d be more
specific. What if certain groups of people...? It doesn’t
necessarily have to be Hispanics, and maybe it sounded like
that. If we measure the amount of serotonin transporters
and 15 years down the road we can do, well, a very basic
blood test and say you’re the person that needs a very low
dose of the medication versus you’re the type of person
that needs a much higher dose of a medication. I think
that’s where it’s going in terms of the personalized
medicine.
MALE VOICE: I’ll ask a quick followup. Are you also doing any
qualitative followups of the very interesting finding that
patients needed to have information repeated multiple times
because I think that’s an interesting cultural—
DR. APONTE RIVERA:
sorry.
They needed to have what repeated?
I’m
MALE VOICE: They wanted to have information repeated. Like
they wanted to get information from you as opposed to from
the piece of paper...because I sometimes sense that in my
African-American patients. I just wonder if there is going
to be some qualitative study that might follow that up.
DR. APONTE RIVERA: Well, we initially started...what we’ve been
doing with our trial, actually, I see a little bit of this
link with a community-based participatory research is every
consent form that is signed has a cover sheet that we’ve
developed where every single question that the patient has
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is written and the answer that we’ve given to them. That’s
where I got those common themes about the question. It
wasn’t like what were my thoughts about what people asked.
I actually sat down with hundreds of questions and tried to
find themes. I was hoping to find more themes than those
because the ones were kind of like the expected ones. We
were hoping to see other things.
The fact that a lot of people are asking for the
verbal...it’s kind of like a verbal consent means more for
them than the written consent has been my clinical
experience - - talk to the doctor. You’re the doctor, oh
and you’re Hispanic, okay so I’m trusting you to make
this.... For me sometimes I’ve had patients come up and
they say no, no, no.
It’s cultural. You are the doctor. If you say I should be
in this study then I’ll be in this study. I’m like no, no,
no. I want you to understand what this study is about, and
then you tell me if you want to be in this study. God put
you here for a reason. I’m like well thank you for
trusting me, but I need you to understand what the study is
about. I won’t enroll you in the study until you do. That
is my responsibility rather than just trying to grab
patients and get them into a clinical trial.
MALE VOICE: A real quick question. - - third year medical
student at Drexel in Philadelphia. This question is
largely to Dr. Aponte. First of all, thank you to all the
presenters here. Dr. Aponte, it seems to me that you’re
really a pioneer in - - your own little part in it doing
this research in Latinos to a bigger study. I congratulate
you for that. My question is what barriers did you find or
what barriers did you yourself have to go over and
obstacles moved through in order to do this study as part
of a larger study professionally in the institution. Can
you speak to something that...?
DR. APONTE RIVERA: I’m glad that we have medical students here,
and I do want to tell you that I was trained clinically.
It was clinical training, and as I got involved with other
things at Emory over time I realized that I just couldn’t
remain quiet. They’re doing all these clinical trials.
All this data is coming out. This is what works for this
patient. This is what we’re doing, and I’m like but you’re
not getting it. The whole thing like all of them are
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Hispanic. They came up with this idea to do the clinic,
and I agreed to do it. They hired me to do it, but I was
raising all these concerns. I couldn’t believe it. I was
at this big meeting. You asked about barriers. I am a
young woman, Hispanic; I fit like all the minority
categories in many ways. I wasn’t born here. I was raised
in a Spanish speaking country. I’ve only been here four
years. You don’t know anything about the US...things like
that.
But it was very interesting for me that they said why are
you so concerned about this - -. You go down there, do the
same thing you’re doing here in English, but we translate
the papers. I was told things like why are you so
concerned about getting fully bilingual and bicultural
staff members. Why don’t we just buy Rosetta Stone and we
train our research interviewers with Rosetta Stone and then
they’ll be able to do these interviews.
I mean, there has been a lot of...it’s just lack of
knowledge. I used to get offended by it, but they don’t
know and that is our role to advocate even within PI
meetings and research meetings. There have been a lot of
challenges, but I do want to encourage all the medical
students to do this. You have power. I mean, if in 18
months two days a week we’ve been able to recruit 20% of a
clinical sample population. I mean, there’s a lot that can
be done. They need you. You are the Hispanic expert, and
don’t let them tell you otherwise. You can do it. You can
develop a small clinic, and it’s a great way to get
involved in research. You’re protected by these people
that are the big researchers. You’re trying to develop
your career, and that’s kind of like a way to get going
within a major institution.
MALE VOICE: I just have a comment and a question. One, I guess
the question that was asked that was actually my question
for my poster downstairs, which was socioeconomic factors
playing a role in cardiovascular disease modified by race
and ethnicity because often times they are confused. You
can say you’re controlling for socioeconomic factors, and
then you say that being Latino puts you at a higher risk
for cardiovascular disease. Then, is it really the race or
ethnicity, or is it the fact there are environmental stress
factors living in a neighborhood with a lot of gangs and a
lot of violence. It’s very difficult to control for those
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factors, but my poster touches on some of those things.
could be interesting to some of you interested in that
topic.
It
My other question is there have been a lot of interesting
articles being published involving community participatory
research. A couple of years ago there was the Two Feathers
paper that came out speaking about promotores as an
intervention that was successful in treating diabetes.
Recently, about two months ago I think, in the Annals of
Internal Medicine there was a very interesting paper that
talked about the use of DVDs where patients watched a DVD
which was made by somebody in their neighborhood showing
them how to take blood pressure medications regularly and
in a certain way.
These people watched the DVD. That was the intervention,
and then their blood pressure was reduced an equal amount
as the blood pressure medicines themselves. It showed how
that intervention was done. This was done in a black
population in the South. I was actually interested in
reproducing it in a Latino population, which would
obviously be different due to culture and language. I
guess my question to you, just a basic question on what
type of funding is there available to somebody who would
want to do a project like that. This question goes out to
anybody.
[crosstalk]
DR. GOODWIN: Certainly, our institute with the CBPR program
that I talked about, that’s what we fund. We have a number
of grantees that actually take sort of established
interventions and actually work with communities to adopt
them to that specific population. There is funding. Like
I said, we have planning intervention and dissemination
funds. Currently, we don’t have any CBPR - - funding calls
at the moment, but certainly we have other funding
mechanisms within our institute that would fund research
because our goal is to reduce and ultimately eliminate
health disparities.
We target health disparities population and creating
research and interventions to address that. Our institute
is an institute...you should definitely visit the website
and give us a call and know what funding opportunities are
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available to support that type of research.
FEMALE VOICE: Because I’m representing MMG, they’re out here in
the exhibit hall area. They are taking names if you will
of Hispanic Latino doctors who are interested in being in a
database for those exact things because their clients are
the pharma and biotechs. If there is something down the
pipeline that makes sense to match up, then that’s
something that could come together in terms of communitybased as well as education as well as drug development kind
of thing, if that helps.
MALE VOICE: Now, we’re just going to take one more question and
then wrap it up.
MS. KIMBERLY NORIAN: Hi. I’m Kimberly Norian [phonetic]. I’m
also trained in internal medicine and am one of the health
policy fellows - -. Just saying in this vein looking at
the social determinants of health, this question is for Dr.
Goodwin. I’m wondering how much of the portfolio of your
grantees for the CBPR actually do address either
environmental or social factors as a means of promoting
health equity, or what other avenues are there to do that?
DR. GOODWIN: I specifically spoke about our CBPR program, but
you mentioned social determinants. This year, last year in
2010 we actually funded R01s, which are sort of the
traditional...that actually were focused on the social
determinants in health disparities. Our institute
certainly realizes the importance of social determinants of
health and what role that plays in health disparities. We
actually had a specific request for applications to
actually study the role of social determinants in health
disparities.
Many of our CBPR grants because they’re sort of based at
the community level do consider the environment and what
those influence and those structural influences and address
that, like I say, through advocacy and through capacity
building. We very much recognize that it’s not all
biological. I think that’s what makes our institute unique
at the National Institute of Health because we do recognize
the social aspect.
FEMALE VOICE: I also just want to let you know that there are a
lot of different funding opportunities. You just have to
go online. I feel like I work for NIH...NIMH now here. I
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mean, there is a big section of pharma that are separate
types of clinical trials you can work with. They’re very
structured. They’ll give you manuals. They’ll guide you
by the hand. I mean, they’re very structured. If you want
to go - - NIH...well, we do a lot of mental health - -, but
NIH route there are...you can go on the website. There is
like a kiosk. You can put like your information and - figure out what would be the best grant for you. You also
need to take into consideration that the Hispanic
population is increasing, so you can either go through the
health disparities route or you can actually go through
just the main NIH grants and just say that you want to
study a - - population of Hispanics.
There also are a lot of K awards. I don’t know how many of
you know about K awards, but that is an award that is
designed to get you involved in clinical trials and
actually it pays part of your salary. Mentorship is a big
portion of that award, so that could be a potential place
to start. A lot of just general NIH programs are
interested in information about Hispanics, so there are a
lot of ways to go around it. That doesn’t necessarily have
to be...if for some reason there is no funding right now
through - - health disparities you can go through another
route, but there are a lot of routes and ways to do this.
Or join a big study and kind of carve out your little piece
and move that way.
[crosstalk]
FEMALE VOICE: Maybe for the next conference you should have NIH
or funding, so that people know because, like you said, you
can actually sign up on NIH in the Office of Extramural
Research. If you email me, I’ll send you that where you
can get every Friday funding opportunities like what
funding opportunities. We have 27 institutes and centers
at NIH and 24 of them fund. I just represent one, but we
also have different institutes that have funding available
to address health disparities. Like I said, we coordinate
health disparities research at NIH so all our institutes
and centers address that.
FEMALE VOICE: What was your email address?
write it down.
MALE VOICE:
We’re just going to wrap.
We weren’t able to
Now, I just want to
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thank the speakers on behalf of NHMA. One more thing
before we go is if anyone needs to sign up for CME units
you have to come to the front to get the signature. Thank
you guys very much.
[END RECORDING]
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