Intercultural Cancer Council

M. D. Anderson Cancer Center
Date: 2/2/2008
Duration: 0 / 36:56

Dawn Elliot and Daniel Goldberg.

Dawn Elliot:

Okay! So, I'm Dawn Elliot. I'm with the Intercultural Cancer Council and I'm going to be talking about the ICC and the national network of the Intercultural Cancer Council. So, the ICC achieves his mission through focusing its efforts in four primary areas and the areas are: education, information, dissemination, advocacy, partnerships, collaborations of issues, identification, and development. Problem statement by the ICC, ratio and ethnic minorities and medically undeserved populations experience unequal suffering and unequal death from cancer compared to the population at home. These populations are very important to the health status of the nation as they continue to rapidly increase in size and as a whole move towards becoming the majority population. If we do not adequately address the health disparities of these populations the national healthy people 2010 objectives including the unequal burden of cancer will not be achieved. So, this is a little bit about having ICC became about. It was established in 1995 to address the unequal burdens of cancer in ethnic minority in medically undeserved populations. So, the council is an outgrowth of the biennial symposium series on minorities medically undeserved in cancer. So, here are ICC national networks speaking with one voice. The ICC is actually responding...it was a response to the surgeon generals call for immediate action to close the gap on health disparities and it was an educational forum and national campus that was convened February 28 through March 2 in 1999 to launch a national network dedicated to this purpose. So, here is some of there...this is where we have membership of the ICC so we're represented across the US and Puerto Rico, Virgin Islands so we have a really wide broad membership of the ICC. Here are some of the resources of the ICC: We have our brochure, we have some fact sheets that talk about different cultures and populations, we have a website, and we also have a pocket guide it says cultural competence in cancer care, pocket guide that's available. Here the ICC participated in this Blue Ribbon Panel where community advocates gather at a roundtable to discuss strategies to eliminate cancer disparities. Members of the ICC served these chairs of specific topics. For an example you'll hear for her shortly, Venus is the chair per cultural competence, training, and education. Here is where we work with partners to resource and everything and issue a line math and we have member engagement as well as problem solving. These are some of the members [laughs], people that we work with and we've had experience with partnering with. There are some others [pause] so, a lot of people that we partnered with and worked with. We also are a part of the Comprehensive Cancer Control National Partnership and these are members of the Comprehensive Cancer Control National Partners and you see the ICC is one of the partners of this partnership. Here's the partnership with a cause. Where we partner with a group called a Lion in the House who brought things to the community and we had a community engagement with this where we went around and showed this and this was primarily cancer in children and cancers of partnership but it was a way for us to partner and with the Lion in the House as they took this to different communities across the country. We also had a Voices of the Community where the ICC was able to fund a community based organizations across the country and we provided this community based organizations with funds so that they could put their programs on in their specific communities. Project Reconnect is also a project of the ICC. We all know of some of the catastrophic excess that happened in our nation with Katrina and some of the other things and so we developed a Project Reconnect to connect communities and the people who are affected with healthcare because a lot of these are lost when these communities have a catastrophe. Okay and here I want to do a plug about our biennial symposium that is coming up this April 3 to 6 in Washington DC and this year they're viewing our market place by this and at our market place you have a unique opportunity to bring community based organizations, cancer survivors, medical researchers, students, government agents, nonprofit and for-profit agencies, and representatives to come together to share there ideas and resources and information. In here, collaboration that enables interaction that promotes change, change that empowers communities, the ICC together speaking with one voice we can and we will make a difference in battling the health disparities of our nation. Thank you! [Clapping]. Now, I believe Daniel Goldberg, you've probably seen your agenda Armin Weinberg and Jay Silver but we decided to come out early on a Saturday morning. Oh! What happened Daniel? Oh! Sorry. Thank you.

Daniel Goldberg:

Is it okay, Neil Hermon? No? Yes? Higher up. Let's go [whispering].

Okay. So, thanks to all for having me. My name is Daniel Goldberg and I am an Intercultural Cancer Council Policy Fellow at the Chronic Disease Center at Baylor College Medicine and I'm gonna talk to you guys a little bit about the EDICT Project which is one of the primary projects I'm involved in at the Chronic Disease Center and you can see our icon up there on the top left corner and what we're working on is Disparities in Clinical Trials and what happens is when you issue the words disparities and care, disparities in clinical trials are not exactly the same thing but they're pretty important I think, we think has already gone and explained a little bit why the EDICT Project is a 4-year project that's been funded by an unrestricted educational grant from Genentech and we are currently in year three and at the ICC Biennial Symposium we will be rolling out a set of policy recommendations for public consumption and we're currently embedding those and revising them and editing them and so the idea here is that they are sort of small but critical parts of the puzzle that are coming together. The first is that health disparities are no longer being denies or ignored. The demand for shortening the time from discovery to delivery is increasing in importance that's why we have analogies, priorities on translation and research. I think Dr. Weinberg often likes to quote the statistics which is one of the reasons she got involved in EDICT to begin with which is something like it takes 14 years for 17 percent of the discoveries to actually make there way into clinical practice and so that is seen what is obviously a push in that from the focus on translational medicine that are safeguards on our foods and drugs. They'll have probably been following some of the reports on this regarding FDA, the need for new incentives for investment in the new products, and public engagement on issues that concern them. In the model of that, we are currently using or calling at the policy contacts model in the EDICT project and it is the series of concentric circles and you can't really show this very well in two-dimensions but they're constantly turning all at once. Basically it's how it works and so here is the science in social justice criterion. There is mounting evidence and I'll talk about what that evidence is in a moment. Growing populations were starting to care about both disparities in general and translational medicine and the political imperative as well. So, the problem as you can see as the title of this Baltimore Sun Article from November 18, 2007 is that in medical trials the lack of diversity can actually kill and why do we say this? What's the real problem with this? The message is starting to get out. You can see that was a heading from November 18, November 19, 2007 the Casa Network run a heading that said that coverage access and quality early clinical trials include few minorities, women, children, and older patients and so it's interesting because I only joined the EDICT Project in June and even when I joined in June it was very difficult to find a lot of media reports and discussions about disparities in clinical trials. Understandably disparities in care tend to dominate the health policy agenda but this has started to pick up steam and I can't claim any responsibility for that whatsoever but you'll just start to see some articles on that and the problem of course is that minorities in medically undeserved populations bare disproportion of burdens of many diseases and so its unquestionable that this members of these populations are dramatically under represented in clinical trials. The vast majority of people who are in clinical trials are Middle East Caucasian men and this is true for cancer. This is generally true for most disease profile except obviously something like Alzheimer's disease where you're not gonna be having these people on this trial. So that the problem is that there are differences across populations as what we're starting to find and I want to be clear here that this differences and that we're finding in the effective different biologics or interventions they're not just based on pharmacogenomics reasons. Okay, we though know that there are some pharmacogenetic linkages that cluster, we'll talk more about that in a little bit across populations but we also know there are very, very different social and economic differences across different subgroups and populations. And Lyn [phonetic] was talking about the difference in health literacy across certain populations and that's a really important one. For example, some of the work I do is in diabetic policy and if you're looking at some of the regimens that people have to use to self-managed there own diabetes care can be extremely complicated, am I right? And if you are evaluating the efficacy of a new intervention, if it's they require a level of high-health literacy and your targeted population has low-health literacy and your subject population are all a certain class of people who tend to have high-health literacy you think its gonna be efficacious. Hey! This works. Right? But when yo try to translate it to the actual patient population it doesn't work very well because the regimen is too complicated. The population has low-health literacy and so this is in addition to differences in drug absorption and other kinds of genetic differences that may cluster across different populations and this heading refers to the Abigail Alliance which I'm sure you're all probably aware of the Abigail Alliance Case I won't get too much in detail on that although if you're interested I just worked on that case as well. But that case is about whether or not terminally ill or seriously ill patients should have access to phase 1 biologics and investigation of new drugs and of course whether they have a constitutional right to it and then if they have found that but they didn't and the Supreme Court just decided that they're not gonna hear it but if they found it would have dramatically changed the entire way we structure health care and research in this country because it would mean that people for the first time have a constitutional right to some form of health care. So, these kinds of things are starting to really come up in the news more and more clinical trials. Clinical researches are starting to be seen in the old idea that there is really no difference, no substantial clinical difference across populations is starting to be questioned quite seriously as well. It should be because it's not really borne out by the evidence and I would get to that evidence, okay, right here. Okay, so there's a lot of evidence for this and if you're interested in this I encourage you to check out the EDICT website or the ICC website both of which have a lot of information and evidence space for a lot of these things. But if you're really interested I think some of the best, one of the best articles I've seen literally came out this week in the Archives of Internal Medicine and you can see the citation there. There's one on the left which I think is extremely important. There was a med analysis that was done on and it was comparing Medicare beneficiaries like the population of demographic characteristics of Medicare beneficiaries with the demographic characteristics of the subject populations of the studies with which the RUC which is the subcommittee at CMS that determines Medicare coverage. You will see how closely are these related and the results of the study I found to be perfectly stunning. Basically, that they were not similar at all. As a cardio they really look only at cardiovascular disease. So, you have to go back and try to explain how important this is. We basically have the largest public insured in the United States. You have a substantial population of healthcare and health cost and health expenditures being covered through Medicare so its really important to determine what's gonna be covered by Medicare and what isn't, right? And it turns out that RUC, the subcommittee that is most directly responsible for making a lot of these coverage determinations are basing there decisions on studies with subgroups, with populations who look nothing like the population of Medicare beneficiaries, okay. So, this is a pretty serious problem in the sense that it doesn't mean we just throw out all the evidence we have, of course not. But it seriously affects the quality of the evidence we're using and if we wanna have both evidence-based medicine as well as evidence-based public health policy this is a problem, okay. And that these disparities are increasingly intolerable and so the author also concluded that data is frequently unavailable on subgroup populations. That's exactly what the EDICT Project is really addressing is that it really, you can't make a scientific case let alone an ethical case and we'll talk about that in a moment, right? But it's very difficult to make a scientific case that testing this particular clinical study which because they're global, it's often done all over the world on you know, a population for example in the middle of Sub-Saharan Africa is going to tell us how the intervention is going to work on a population of for example Korean Americans in California that the scientific basis for that is increasingly and correctly in our view coming under some fire. It doesn't work very well at least as well as we think and ought to and of course you can also this with children which becomes a problem. I don't know how many of you caught this but there was an episode of front line a couple may be a month ago. You can actually view it on-line and it talked a little bit about that we're now using very sort of powerful psychoactive medications on very young children because it turns out that children who were used to think 20 years ago couldn't be depressed at age four and five probably can, okay. You can have all sorts of other very serious psychiatric conditions but the problem is for a lot of reasons we obviously are not enrolling three, four, and five year olds in the clinical trials to test this, okay. And so basically psychiatrists are acknowledging and they are acknowledge in the front line episode that is basically one giant experiment. We don't know what Depakote is gonna do to a 3-year-old. We just don't know and I'm not suggesting that we can do something about that disparity. Okay, that's a problem because we're just not enrolling three year olds in the trials for bipolar and I understand that but that same analogy doesn't hold with regards to other subgroup populations. We can enroll elderly persons in clinical trials. We can enroll people from rural populations in clinical trials. You can enroll African-Americans and Hispanics and Asians in clinical trials. And we have in our view, sort of a moral obligation to do so because these populations are medically unreserved to begin with. They bear disproportion that burns up disease and have substantially worst outcomes. In here, I'm referring to general health care disparities and I also do some work in the history of medicine in public health. It is important to remember that unfortunately and sadly many members of these populations were also populations that have been the victims of unethical research in the past. When you're talking about African-Americans in Tuskegee, whether you're talking bout mentally disabled children in Willowbrook, the elderly in the Jewish Chronic Disease Hospital. The examples are pretty legion so it's almost like there is a doubled disservice from the disparities in clinical trials. Not only are we failing to have the best evidence and the best evidence based policy that we could but we're sort of perpetrating another injustice on populations who have already been victims of injustice and research. And so there was a commentary in these archives if you're on mostly referencing of the first article I discussed here that talks about the concerns over the generalized ability of clinical trials and they note the importance of having appropriate subgroup representation. And that term "appropriate" is in quotations for a reason because the doubles and the details in determining what is appropriate representation will vary wildly from case to case? It depends on who's the targeted population. It depends on whether or not for example what phase of the trial were, right? I mean nobody is gonna suggest that you will need to have appropriate subgroup representation in the phase 1 trial. They have 15 to 20 people with this one child. Well, that's not necessarily appropriate. It may be or it may not. But in the phase 3 trial where you have 10,000 subjects the ability to effectively power your subgroups becomes both more plausible and more appropriate, okay. And so anyway, I encourage you to go take a look at this and any of the other literature on the EDICT website or the ICC website. It really has a lot of evidence for a lot of these ideas and so of course a lot of this implicates complicated issues of race and signs and this is an important issue. It's one which we at the Chronic Disease Central are really going to tackle head on after we go through some of our, what we call the dissemination phase of our policy recommendations which culminates in April when we release the policy recommendations at the Biennial, the ICC Biennial. But the problem is that and I think there are some scholars who have really sort of explained this very well, one is a law professor at Northwestern in Dorothy Roberts and she' talked about this and the problem is that you wanna be very, very careful in my opinion about how we're going to use racial categories and think about racial categories in both clinical practice and in clinical research and what do I mean by that? Well, you know the idea that race is a biologically based category, first of all it doesn't hold up to scientific evidence, okay. We know and the scientific principle is that in-group variation exceeds between group variations. And what that means is that you're more likely to have greater genetic variation between two members of the same community or race than you have between say an African-American and an Asian-American. Okay, so you cannot construct race on genetic lines, right? And so that's why I cautioned against thinking about differences among races and communities only in terms of genetic characteristics because that does not really hold scientific water, okay. It also of course doesn't hold ethical or historical water because reducing race to biological characteristics has proved extremely dangerous in the past hundred of years. Many people believe and I do some work again in the history of research ethics and the genetics. Many people believe that genetics is primarily a German phenomenon in the early 20th century and that there were some Americans who are doubling in it as well but if you look at the historical scholarship on this so that's exactly backwards, okay. The Germans were really impressed with what the Americans were doing with the genetics in the early 20th century and our efforts to reduce racial differences to purely biological characteristics. In fact, most people don't know this but one of Hitler's most important dreams while he was in prison was the Dearborn Observer which was the notorious races weekly that was put up by Henry Ford in Detroit. Okay, and so the idea is there is a tradition and a sad tradition but one we nevertheless need to be aware of attempts to reduce racial and clinical differences to biological characteristics. And so we have to be really careful in our view and this something we have struggled with and tried to educate as well. When you're using racial categories or its urban hopefully benign ends I need to reduce disparities in clinical trials that you're not at the same time refine, ethically, scientifically, and historically discredited biological conceptions of race. And the easy way to do that is to just think of race as a social and category and that's what races are even if we can't find biological and genetic basis that distinguish between races, right? There are differences between races. There's differences between communities as Lynn pointed out very well. And so, the point of this is not to suggest that race isn't a real category. Of course, it's real, it's a social reality and the evidence of disparities is proof positive. That's our differences between how people reacts and evaluate and treat and respond to communicate to members of different races. But if those differences are not rooted in purely biological and genetic characteristics and so that's something that we have either has tried to be very carefully because our whole project would basically be thrown off its feet. It's the very populations we are trying to benefit where if by doing so if we promulgated the view of races based on biological characteristics we might as well just stop now 'coz we're not doing any good frankly. In fact we're doing wrong. Okay, and so that's something else to be concerned about when you start thinking about this very thought in general and disparities in clinical trials. And something that we, at the Chronic Disease Center hope to take forward beyond the EDICT Project 'coz we think it has importance well beyond that. So, other projects that EDICT is involved in, this refers to the class standards and how many all know what a class standards are just out of curiosity, okay? Not many. It's interesting. There's a presentation that our group, David Sukra [phonetic]in which you think would know about the class standards. But it doesn't look like there's a lot of publicity about the class standards. So we are working to change that. The class standards were promulgated by the Office of Minority Health and you can find them on the website and there's 14 of them and a few of them were actually mandated and there are the mandates are current federal requirements for all recipients of federal funds. And actually currently the failure to really to satisfy this mandates has lead to where were in contact with some of the people at the Offices of the Rights and I think this is not to make you guys nervous but they are currently looking into whether or not the failure to comply with this mandates constitutes to civil rights violation and this is actually acceptable in the law itself. So, next one to make you guys nervous I'll just stress that there are some important things going on here. There are some things that are already law and most people and most people don't even know about the class standards. Class guidelines are activities recommended by OMH for adoption as mandates by Federal, State, and National crediting agencies. And some of the class standards are recommendations that are suggested by OMH voluntary adoption by healthcare organizations and we are currently one of the projects that EDICT teams are actually working on is a funded project through Office of Minority Health and the Office of Women's Health is going to try and take this class standards and apply them to clinical trials actually. So, how would that work? What would it look like? What do we need to be? What are our best practices? Are there any examples that you can get? And so that's called the class act standards basically not something that again we hope to unveil in April at the Biennial Symposium. And so, the Color of Health Care Diagnosing Bias In Doctors so, this was an article in the New York Times and they reported that a new study by researchers Nash General and other institutions at affiliated with Harvard provides empirical evidence for the first time that when it comes to heart disease bias is the essential problem. And I think that there's probably a tendency when we look at the literature on disparities to understandably trying to find any reasons for disparities that don't reduce to naked bias so that's understandable. Because of course disparities are a complex social phenomena then your probably not merely reducible to biases but I think it's also important to understand that unfortunately we all have biases, we all have prejudices and they probably do affect and a list of frequency if not the quality of healthcare disparities. There's a study that Dr. Weinberg likes to site which found that white referees in he National Basketball Association were calling fowls at a higher rate on black athletes than on white athletes which is actually pretty interesting. And of course we all know, I don't have to tell this audience that when you look at the evidence based for disparities in clinical care you can control for every variable, everything, insurance stuff, education, income, employment. You can control for everything and the disparities are still there okay. And so, at some point there's surely probably some unknown variable and some compounders that we don't know off but at some point probably got to conclude that bias and unconscious bias unfortunately is probably a factor, okay. Studies have found racial disparities and how black and white applicants of almost of equal education virtually equal qualifications, equal resume, equal background, have they got calls for job interviews? There's a disparities in survival and health among people belonging to different racial groups. Black babies have higher death rates than white babies significantly higher. Black women are more than twice as likely as white women dies of cervical cancer. In 2000, a death rate from heart disease was 29 percent higher among African-Americans than among white adults. The date rate of stroke was 40 percent higher and on and on and on and this just go on and they're right there. And most different kinds of chronic disease diabetes, cardiovascular disease, MIs, it virtually runs across the board, infant mortality. So, what is the real problem as we keep going? Well, the problem is that we actually have a law. Most people don't really know this unless you really sort in to the clinical research enterprise. We have a law that mandates appropriate inclusion unless you have some very good nondiscrimatory reason. This law was passed in 1993 and the best evidence that EDICT team has been able to collect is that we have still have very, very, very serious problems with disparities in clinical trials. So, for whatever reason, in 14 years, the revitalization that has not accomplished. I'm sure that most of us proponents had hoped it would accomplish. So, why not? Well, there are a lot of reasons for that. One of the biggest reasons is that between 60 to 80 percent of all clinical trials are privately funded and that proportion is increasing. Richard Reddick said in 2000, which is 8 years ago at this point, that the note clinical research is no longer firmly encouraged in the public sector and this trend is this very low evidence in this day and age especially with NH its budget is increasingly shrinking but that is going to reverse any time soon. These private sponsors of clinical trials are simply not bound by the mandates of the revitalization that they don't have to fine appropriate inclusion. Conflicting attitudes also hinder participation in clinical trials. The study comes from the Journal of Healthcare for the Poor and the Undeserved and three teams are merged from an analysis of focused group discussion as to why for example do African-American women why would they be unwilling to participate in clinical trials? And these three major teams that emerged from these discussions: Fear, distrust, and health and of course distrust is a very serious one and a major one. I'm pretty sure that there was another article that just documented mistrust among African-Americans for both healthcare and the research enterprise in general I think this is in the last moth or so. So, counter the negative, the research is called for greater involvement of Academic Medical Centers with minority of low socio-economic status communities where they could become partners in research to address the health problems and concerns of the community and they noted unfortunately that this type of research partnership takes time to establish and maintain. And I think the way I often think about this is in context of the Americans with disabilities act in making buildings compliant with the ADA. How do you do that? Right? And so, you know, obviously going back in the retrofeeding a 50-year-old building making it compliant with the Americans Disability Act is pretty difficult. Often times it's impossible. But most people don't know that actually if your proactive, if you're setting out to design a building and you want to design it with what is called universal accessibility, it's actually not that expensive. It actually is pretty efficient and easy to design a new building so that it is accessible to everybody regardless of you know with goals of what kind or physical impairment that they have. Virtually anybody can get in and so the idea here is to include community participation in setting the priorities and in actually helping to evaluate and even on occasion may be contribute something on the way of designing particular protocols, right? And so this is the way of instead of performing research on the bodies of members of these under represented populations the idea is to include them in the research enterprise to make it what they noted and older by Paula Seagrams [phonetic] she has turned a spirit of joint adventureship in clinical research which is dealing what it should be instead of just something that's in the procedure of generalized knowledge that may or may not have anything to do with the communities who were providing the bodies on which experimentation is being conducted. And so CDOs and community participation is very important part of the EDICT Project which is partly why were still happy to be unveiling propulsive recommendations at the ICC Biennial because that's obviously a huge part of what the ICC does. And so, this actually could affect you believe it or not and it's important to know that when we talk about underrepresented populations in clinical trials we are certainly talking about racial and ethnic minorities but we are not just talking about racial and ethnic minorities right? Because elderly persons are substantially underrepresented in clinical trials and that's in large part because of the comorbidities that often sort of dim them on the exclusion criteria, right? And understandably we want to control for all these variables but what's the point of introducing a biological intervention to a population which has all those comorbidities right when you purposely excluded all those comorbidities from the very trial which you evaluated in the intervention. That doesn't make a lot of sense, okay. So younger people underrepresented in clinical trials, persons with disabilities for same reason as the elderly population. Comorbidities are generally excluded from clinical trials. Those of limited access like rural populations are generally excluded from clinical trials. Women are aside from reproductive health trials are dramatically underrepresented in clinical trials and pretty much goes down the board. Any, you can just, any marginalized or disadvantaged population you would care to identify and look at is probably underrepresented in clinical trials. And you know, to some extent its understandable because it's hard to get anybody into a clinical trial and we understand that but the scientific and the ethical cases for making greater efforts to include them is we feel compelling. So, we are trying to raise interest from different sectors and that's one of the things that EDICT Project is doing. We're not interested in issuing unfounded mandates and telling people what they have to do without telling them how they can do it, right? And so, we're trying to include representatives from the public sector. We've got a lot of people from the government working with us. From the private sector, we have industry collaboration and buy-in on a lot of what we are trying to do and of course we're hoping to generate even more. And of course, the nonprofit sector whether we're talking about foundations like Coman [phonetic] that fund research or whether we're talking about grassroots community based organizations who are interested in working with us. It's very important to include all of these in the project and that is something that we have been committed to. So, small but critical parts of the puzzle come together. There's public engagement on issues that concern them. Is there? Well, if you start to look at the media then the answer is starting to be yes. People are starting to pay more attention both to clinical research in general sometimes for unfortunate reasons, related conflicts of interest. But people are starting to pay more attention and they're starting to be more and more attention paid to the idea as we put it a little touch phrase in EDICT. Was this, how do I know this works for me? This is what the patient's gonna ask, okay. And well, if the answer is well we know it works for you because we've evaluated it and the next question is, well, were the people you evaluated on, did they look like me? Okay, and this is starting to we believe in EDICT, a leader is starting to pick up momentum as something that the public is getting increasingly interested and hopefully this will translate into actions. What they buy? Would they donate? Who and what will they bought for organs? And how they trust and continue to interact both with the clinical care system in general and with recruitment and retention into clinical trials. That's all. Thank you!

[Clapping