var sync_data_records = new Array(
{ timecode: 0, handler: 'blob', id: 1, data: {text: 'REPRESENTATIVE JOE ARMSTRONG: Our first panelist is a follow-up dialogue on biologics. Our first panelist is Dr. James Powell who is a graduate of Virginia Union University and received his Doctorate '}},
{ timecode: 17, handler: 'blob', id: 2, data: {text: 'of Medicine degree from Cornell Medical College where he also trained in chemical pharmacology. Dr. Powell is a member of the Board of Trustees for the Center for Closing Health Gaps in the greater '}},
{ timecode: 33, handler: 'blob', id: 3, data: {text: 'Cincinnati area. He is also the principal investigator of the National Medical Association Project I.M.P.A.C.T. which is increased minority participation and awareness of clinical trials. Dr. Powell '}},
{ timecode: 49, handler: 'blob', id: 4, data: {text: 'is a Certified Physician Investigator through Strategic Medical Associations LLC. He also provides independent research and consulting that focus on improving effectiveness, efficiency, and population '}},
{ timecode: 67, handler: 'blob', id: 5, data: {text: 'balance for clinical research process. Our next presenter is Dr. Gary Puckrein, is the President and Chief Executive Officer of the National Minority Quality Forum. The Forum is dedicated to improving '}},
{ timecode: 85, handler: 'blob', id: 6, data: {text: 'the quality of health care through evidence-based, data-driven initiatives and policies. Dr. Puckrein is considered a preeminent authority on health information products and also the publisher of '}},
{ timecode: 104, handler: 'blob', id: 7, data: {text: 'American Visions in Minority Health Today. He serves on the National Advisory Board of Health Disparities for Health Research and Educational Trust for the American Hospital Association and also is a '}},
{ timecode: 120, handler: 'blob', id: 8, data: {text: 'Pharmacy Education Advisory Council of the American Association of College Pharmacists. Ladies and gentlemen presenting Dr. James Powell and also Dr. Gary Puckrein. DR. JAMES Powell: Thank you Mr. '}},
{ timecode: 145, handler: 'blob', id: 9, data: {text: 'Armstrong. Hello, good morning. My name is James Powell as you heard and I am the Principle Investigator for Project I.M.P.A.C.T. and very pleased to be here, very pleased the organizers allowed me to '}},
{ timecode: 158, handler: 'blob', id: 10, data: {text: 'come here and talk to you about this issue of diversity in clinical trials. Our program Project I.M.P.A.C.T. is sponsored by AstraZeneca at this time, but I am also very pleased that Lilly is your '}},
{ timecode: 170, handler: 'blob', id: 11, data: {text: 'sponsor because they have also been working with us and engaging with us and our program to help increase minority participation in clinical trials. What you didn’t hear is that I am a retired '}},
{ timecode: 184, handler: 'blob', id: 12, data: {text: 'industry executive. I spent nearly 30 years working on clinical trials. I have managed clinical trials from the initial introduction into humans all the way to post marketing into looking at '}},
{ timecode: 196, handler: 'blob', id: 13, data: {text: 'over-the-counter products. In addition I have worked on products that include small molecules as well as some biotechnology products or biological products. Now I want to apologize to some of you who '}},
{ timecode: 214, handler: 'blob', id: 14, data: {text: 'may know a lot of this stuff already but I want to ask one question and that is how many of you have ever participated in a clinical trial? Okay I got one or two, three people. Now how many of you '}},
{ timecode: 229, handler: 'blob', id: 15, data: {text: 'have ever taken a prescription drug? Well then you’ve all to some extent participated in some kind of a clinical trial, testing or not, whether or not that drug is safe and effective for you. '}},
{ timecode: 239, handler: 'blob', id: 16, data: {text: 'That’s essentially what we are gonna talk about. I want to make sure we all on the same page. Clinical trial is a medical research study in human beings that systematically evaluates factors '}},
{ timecode: 250, handler: 'blob', id: 17, data: {text: 'that influence our health. Some examples of such factors include drugs and biologics, environment, nutrition, lifestyle, and as was said before attitudes towards health. Trials are conducted to '}},
{ timecode: 268, handler: 'blob', id: 18, data: {text: 'understand prevention, diagnosis, treatment, quality of life, economic impact, and something you have heard about and are gonna hear a lot more about is comparative effectiveness. Those are also '}},
{ timecode: 279, handler: 'blob', id: 19, data: {text: 'evaluated in clinical trials. A fundamental point that I need to make clear to you is that the results of clinical trials best apply to the people that have similar characteristics of those '}},
{ timecode: 292, handler: 'blob', id: 20, data: {text: 'individuals that are in the trial. So when you interpret a trial you have to understand who was in the trial to know whether or not it relates to a specific population. Now the pharmaceutical and '}},
{ timecode: 304, handler: 'blob', id: 21, data: {text: 'biotechnology industries have developed and marketed products that have reduced hospitalizations and reduced the need for surgery and many illnesses, prevented disease and disability, and indeed '}},
{ timecode: 315, handler: 'blob', id: 22, data: {text: 'increased both the quality and duration of life for billions of people. Ultimately these achievements have led to reductions in the cost of illness. However Project I.M.P.A.C.T.\'s reason for being is '}},
{ timecode: 327, handler: 'blob', id: 23, data: {text: 'our desire to assure that the benefits of these achievements are enjoyed by all. Unfortunately this has not always been the case. Minority patients are often poorly represented in clinical trials, and '}},
{ timecode: 340, handler: 'blob', id: 24, data: {text: 'when we recognize that what we learn about benefits and risks of treatments we learn from clinical trials, then we should realize that poor representation in clinical trials does not maximize the '}},
{ timecode: 352, handler: 'blob', id: 25, data: {text: 'learning opportunity and has the potential to impact our health. Project I.M.P.A.C.T. seeks to improve the validity of clinical trials data, supporting medical interventions in African American and '}},
{ timecode: 365, handler: 'blob', id: 26, data: {text: 'other minorities. We do it by training patients and educating patients about clinical trials and also trying to develop more minority researchers and to try to increase their patients\' participation '}},
{ timecode: 381, handler: 'blob', id: 27, data: {text: 'in trials. At any given time in America, there are thousands of clinical trials being conducted. Recent data indicated that nearly 2/3 of clinical trials in patients in America are in studies '}},
{ timecode: 393, handler: 'blob', id: 28, data: {text: 'sponsored by private industry for the development of new medicines with the remainder being sponsored by government, nonprofit organizations, or medical device companies. Given this data, it is '}},
{ timecode: 408, handler: 'blob', id: 29, data: {text: 'important to consider the regulatory basis for racial and ethnic inclusion in clinical trial sponsored by each of these types of organizations. Since the 1993 NIH Revitalization Act, researchers who '}},
{ timecode: 423, handler: 'blob', id: 30, data: {text: 'have conducted clinical trials under sponsorship of NIH have been required to declare and research plan their intent to recruit a population with appropriate gender and minority representation. While '}},
{ timecode: 436, handler: 'blob', id: 31, data: {text: 'the FDA Modernization Act of 1997 requires inclusion of women and encourages inclusion and analysis of data from racial and ethnic minorities, it does not require minority representation or a stated '}},
{ timecode: 450, handler: 'blob', id: 32, data: {text: 'plan to achieve an appropriate level of minority representation consistent with the burden of disease or even proportional to the population. Although FDA guidance from 2005 encourages industry '}},
{ timecode: 463, handler: 'blob', id: 33, data: {text: 'sponsors to document race and ethnicity, it specifically states that it does not address the level of participation of racial and ethnic minorities in clinical trials. We believe diverse population '}},
{ timecode: 477, handler: 'blob', id: 34, data: {text: 'inclusion as required by the NIH Act originally is from the Fundamental Tenet of Distributive Justice as stated in the Belmont Report. For those of you who are unfamiliar, the Belmont Report is '}},
{ timecode: 491, handler: 'blob', id: 35, data: {text: 'basically a report issued in 1979 that is the ethical basis for the conduct of clinical research in this country. And essentially, it says that the burdens of clinical research should be equitably '}},
{ timecode: 503, handler: 'blob', id: 36, data: {text: 'distributed among those who will benefit from it. No one population should share unequally in the burden. That’s our bottom line since the rules for NIH that require diversity but there are no '}},
{ timecode: 519, handler: 'blob', id: 37, data: {text: 'rules for FDA related studies to require diversity. We feel it is inappropriate that the ethical requirements for clinical trial be a function of who pays for it. Well, why should you care? I know '}},
{ timecode: 537, handler: 'blob', id: 38, data: {text: 'from time to time I go into the communities and they say, “It’s okay with me if you test it all out on one part of the population. Bring it to me after you have proven that they '}},
{ timecode: 545, handler: 'blob', id: 39, data: {text: 'work.” But that doesn’t quite work for us because as we all recognize, human beings have the potential to respond differently to the same treatment. Both the nature of a disease as well as '}},
{ timecode: 555, handler: 'blob', id: 40, data: {text: 'the nature of the body’s interaction with a specific treatment may be driven by genetics, which are often shared by groups with common ancestry. The common ancestry combined with a similar '}},
{ timecode: 569, handler: 'blob', id: 41, data: {text: 'environment, diet, nutrition, habits, practices, attitudes, and lifestyle can combine to engender a drug response that varies in association with race and ethnicity. I want to make it clear that this '}},
{ timecode: 582, handler: 'blob', id: 42, data: {text: 'is no way, I mean no way saying, there is a biological basis for race, which we know does not exist. Now one of our major issues is that many industry sponsors and their regulators have not routinely '}},
{ timecode: 594, handler: 'blob', id: 43, data: {text: 'acted upon the potential for diverse response. Products are often developed, approved, labeled, and promoted as if one size fits all. When we do so, we put at risk our understanding the benefits, '}},
{ timecode: 606, handler: 'blob', id: 44, data: {text: 'risk, and the means to best use innovative technology for the fastest growing segments of the American population. These limitations in our knowledge have the potential to perpetuate the disparities '}},
{ timecode: 619, handler: 'blob', id: 45, data: {text: 'rather than reduce them. In an age of heightened consumer expectation of personalized medicine, it’s not just a question of whether a drug works, but we need to know who does it work for and how '}},
{ timecode: 632, handler: 'blob', id: 46, data: {text: 'can we make it safe and effective for the most people and who should be avoiding that medication altogether. Now the potential for diverse responses to biosimilars can occur as a result of differences '}},
{ timecode: 647, handler: 'blob', id: 47, data: {text: 'in the synthetic process. Now biologics are large, complex approximations of naturally occurring products and they are manufactured in living systems under very tightly controlled conditions and are '}},
{ timecode: 665, handler: 'blob', id: 48, data: {text: 'often difficult to produce consistently. Now differences in processes between respected manufactures may generate the same therapeutic activity but with slightly different structures and potential '}},
{ timecode: 679, handler: 'blob', id: 49, data: {text: 'impurities that could cause a variation in useful activity and individual immune response. Furthermore, a person, say someone living in the Far East environment, with an Asian diet and exposed to '}},
{ timecode: 694, handler: 'blob', id: 50, data: {text: 'different profile of environmental proteins and industrial byproducts might not respond the same as one who lives on a Western diet here in Indianapolis or anywhere else in the US. If we continue on '}},
{ timecode: 709, handler: 'blob', id: 51, data: {text: 'our current path of inadequate clinical trial diversity, the potential business impact to sponsors of the medical market misalignment with a portfolio of products and treatment regimens that are out '}},
{ timecode: 720, handler: 'blob', id: 52, data: {text: 'of touch with the evolving mainstream of American patients. A major concern for those who are pursuing greater diversity in clinical trials is that it would contribute to increase cost in time of '}},
{ timecode: 733, handler: 'blob', id: 53, data: {text: 'developing new medicines. This is highly likely to be a social debate for the development of biosimilars as well. However, we believe that by planning for diversity before the trial and effectively '}},
{ timecode: 744, handler: 'blob', id: 54, data: {text: 'and appropriately engaging an otherwise underutilized population of minority patients in clinic trials the cost in time and the impact is likely to be neutral or perhaps even improved. Now, I want to '}},
{ timecode: 758, handler: 'blob', id: 55, data: {text: 'make mention of some of the barriers that have led to reduce minority representation in clinical trials because you as legislators can have a role in addressing them. They include limited awareness of '}},
{ timecode: 771, handler: 'blob', id: 56, data: {text: 'clinical trials by patients and their physicians, limited access and interaction with the healthcare system on the part of minority patients, as well as limited referrals and requests to participate. '}},
{ timecode: 781, handler: 'blob', id: 57, data: {text: 'However, the most widely quoted reason for inadequate minority participation is mistrust. While mistrust does exist, we believe that based on the available data it is often exaggerated and sometimes '}},
{ timecode: 798, handler: 'blob', id: 58, data: {text: 'it appears to be utilized as an excuse for ineffective effort by researchers to engage the minority community. We as consumers, patients, and in fact tax payers, we eventually bear not only the '}},
{ timecode: 812, handler: 'blob', id: 59, data: {text: 'disease burden but the financial burden resulting from a clinical research enterprise that fails to maintain pace with the changing diversity of the population it needs to serve. This burden comes '}},
{ timecode: 824, handler: 'blob', id: 60, data: {text: 'from patients who receive medications with limited potential to benefit from them and who will continued to suffer from their disease or their illness as well as the potential adverse effects of '}},
{ timecode: 835, handler: 'blob', id: 61, data: {text: 'exposure to the medicine. And perhaps exposure to the suboptimal therapy. Ultimately, more than the patient will pay the cost of this problem which might otherwise be preventable. Now as you know, '}},
{ timecode: 853, handler: 'blob', id: 62, data: {text: 'most of the laws that govern how we do clinical trials in this country are federal laws. But given the complex nature of this environment, there is an important role that state legislators can play '}},
{ timecode: 864, handler: 'blob', id: 63, data: {text: 'and help to address several of these issues, and I want to identify just a few of them. First of all, as community leaders, it is important that you learn about clinical trials, their benefits, and '}},
{ timecode: 876, handler: 'blob', id: 64, data: {text: 'the rules and regulations that are in place to protect individuals in the communities you serve. Now, at the back desk - and for those of you looking over the webcast you can contact us at '}},
{ timecode: 890, handler: 'blob', id: 65, data: {text: 'impact.nmanet.org to get more information on this - but we have a brochure here that’s entitled “You’ve Got the Power.” It was developed for consumers to tell people what they '}},
{ timecode: 905, handler: 'blob', id: 66, data: {text: 'need to know about clinical trials and their protection in the process. Now, by you as legislators understanding the clinical trials, you can be a leader in reducing mistrust and misinformation that '}},
{ timecode: 917, handler: 'blob', id: 67, data: {text: 'is pervasive in our communities. You can also better protect the interests of those you serve with respect to legislation relevant to this issue. Now the second point is that many states have laws '}},
{ timecode: 928, handler: 'blob', id: 68, data: {text: 'requiring Medicare and some private insurers to pay for routine care as a part of clinical trials. Unfortunately, in many cases, there are no laws requiring the disclosure of these programs. So '}},
{ timecode: 941, handler: 'blob', id: 69, data: {text: 'patients may avoid clinical trials because they\'re fearful of losing their insurance when in fact that might not be the case, since there may be requirements they be paid for. Now most of these '}},
{ timecode: 954, handler: 'blob', id: 70, data: {text: 'programs look at cancer but should be expanded as a part of any comprehensive program that addresses mental health, obesity, diabetes, or other chronic illnesses. If your state does- has laws that '}},
{ timecode: 967, handler: 'blob', id: 71, data: {text: 'require coverage, and I believe that legislation should be enacted to require disclosure to patients. If your state laws do not require coverage, it should be in the interest of your community to '}},
{ timecode: 978, handler: 'blob', id: 72, data: {text: 'enact such legislation. The third point that we’ve talked about is part of Project I.M.P.A.C.T. is that most often drug labels do not provide much information regarding the clinical trial '}},
{ timecode: 990, handler: 'blob', id: 73, data: {text: 'populations used to evaluate the safety and effectiveness of the medications. Legislation that requires the disclosure of data on the diversity of the populations used and the clinical trial, I think '}},
{ timecode: 1001, handler: 'blob', id: 74, data: {text: 'especially relate to biosimilars, can be of value to physicians in deciding which product is right for their patients of diverse backgrounds. You might imagine that since biosimilars are likely '}},
{ timecode: 1015, handler: 'blob', id: 75, data: {text: 'developed as the low cost alternative to the original medications that our communities and some of the communities you represent are likely to be the first to see them. I want to be clear that I '}},
{ timecode: 1029, handler: 'blob', id: 76, data: {text: 'believe that clinical researchers and their sponsors in general have a desire to achieve diversity in clinical trials but have yet to define the means to achieve this efficiently. The solution is more '}},
{ timecode: 1041, handler: 'blob', id: 77, data: {text: 'than simply managing the current clinical researchers to enroll more minority patients in the trials. We believe and we are engaged in efforts to train competent physicians and researchers and educate '}},
{ timecode: 1053, handler: 'blob', id: 78, data: {text: 'consumers and the people they trust to help develop the research infrastructure of the minority community. We think that is an important contributor to the goal of personalizing medicine. We need your '}},
{ timecode: 1067, handler: 'blob', id: 79, data: {text: 'help to use the clinical trials instrument equitably, effectively, and efficiently to grow our knowledge of diverse responses and act upon this knowledge to eliminate the disparities in health in our '}},
{ timecode: 1079, handler: 'blob', id: 80, data: {text: 'society. Indeed, the future demands a new paradigm of partnering with our fast growing minority communities for conduct of research to the benefit of all. I want to thank you for your attention. DR. '}},
{ timecode: 1089, handler: 'blob', id: 81, data: {text: 'GARY PUCKREIN: Morning. I want to thank Representative Armstrong and the others for giving me the opportunity to present this morning and I also want to thank Lilly. We’ve done a lot of work '}},
{ timecode: 1113, handler: 'blob', id: 82, data: {text: 'with Lilly. For those of you who know us, you know that we have done a Diabetes Atlas and you are able to go online and look at your district and see the prevalence of diabetes and we have done lots '}},
{ timecode: 1126, handler: 'blob', id: 83, data: {text: 'and lots of other diseases. If you go to z-atlas.com, you will be able to go to your district and look at diabetes, cardiovascular disease, etc. I want to talk this morning about follow-on biologics '}},
{ timecode: 1138, handler: 'blob', id: 84, data: {text: 'but I want to give you some context for this conversation. We are in the middle of the most profound social revolution in American history. If you look at what’s happening in terms of the ethnic '}},
{ timecode: 1152, handler: 'blob', id: 85, data: {text: 'mix of the American population, it is absolutely profound. In the year 2000, 70% of the American population classified itself as white. By the year 2020, talking about 11 or 12 years from now, 40% of '}},
{ timecode: 1176, handler: 'blob', id: 86, data: {text: 'the US population will be minority, and 60% will be white. By 2050, there is no more majority population. America has been governed by a majority population. That majority population gets expressed in '}},
{ timecode: 1194, handler: 'blob', id: 87, data: {text: 'our healthcare system. One of the profound changes that we see in our system is that I’m going to declare to you today that no president of the United States can be elected without minority '}},
{ timecode: 1211, handler: 'blob', id: 88, data: {text: 'participation. That’s over. What it means is we stop talking about ourselves as minorities and start talking about ourselves as emerging populations. What I am going to talk to you about this '}},
{ timecode: 1226, handler: 'blob', id: 89, data: {text: 'morning is emerging populations in the American healthcare system. One of the privileges that we\'ve have had at the forum is that back in 1998 we began collecting data at the zip code level for the '}},
{ timecode: 1242, handler: 'blob', id: 90, data: {text: 'whole US population. It’s given us a very unique view. Right now, we have about 700 million patient records. We have the Medicare database. We have the Medicaid database. And we see how '}},
{ timecode: 1260, handler: 'blob', id: 91, data: {text: 'resources, and speaking about medical resources, are spent in this country. Let me give you a few numbers. Right now, the white population is about 67% of the US population. 80% of every dollar spent '}},
{ timecode: 1281, handler: 'blob', id: 92, data: {text: 'on direct medical services in the United States is spent on whites, even though they are 67% of the population. 80% of every dollar, all right? Per capita, we spend about $4,200.00 a year on whites, '}},
{ timecode: 1298, handler: 'blob', id: 93, data: {text: 'about $3,200.00 a year on African Americans, and about $2,000.00 a year on Hispanics. Even in Medicaid where minority populations are over-represented, even in Medicaid, in your state, you spend more '}},
{ timecode: 1316, handler: 'blob', id: 94, data: {text: 'money on whites than you spend on minority populations. Those variations in what we would call consumption patterns, minority populations consume health care very differently. So when we listen to the '}},
{ timecode: 1334, handler: 'blob', id: 95, data: {text: 'health care reform and bending the health care curve, we scratch our head a little bit and say what does that have to do with us? We have been under-consuming health care for years and it is expressed '}},
{ timecode: 1345, handler: 'blob', id: 96, data: {text: 'in health disparity. I mean, one of the outcomes of health disparities is that we don’t really in this country spend on minority populations. Now what do I mean by spend? I think Dr. Powell was '}},
{ timecode: 1364, handler: 'blob', id: 97, data: {text: 'talking to you a little bit about clinical trials. I am going to leave the commercial clinical trials alone and just talk about government clinical trials at NIH. Disproportionate spending on whites. '}},
{ timecode: 1379, handler: 'blob', id: 98, data: {text: 'Our tax dollars: disproportionate spending on whites. Different researches. And the point is that the science, the fundamental science that we need to understand why African Americans have the highest '}},
{ timecode: 1397, handler: 'blob', id: 99, data: {text: 'hypertension in the world - we are not even studying it. We don’t even consider it. There is nothing out there. When we look at and start to have a conversation about bending the cost curve, and '}},
{ timecode: 1417, handler: 'blob', id: 100, data: {text: 'there are lots of things in place in Washington to accomplish that, you have to appreciate that we, minority, emerging populations, are going to get disadvantaged in that conversation because the '}},
{ timecode: 1433, handler: 'blob', id: 101, data: {text: 'system already under-serves us. Let’s talk a little bit about follow-on biologics in that context. And I would put generics in the same discussion. So when you look at the clinical trials that '}},
{ timecode: 1462, handler: 'blob', id: 102, data: {text: 'were done for the follow-on biologic project or even the prescription drugs, what you’re going to find is that if there were minorities in the clinical trials they were not enough so that you '}},
{ timecode: 1481, handler: 'blob', id: 103, data: {text: 'could draw any conclusion about the safety - safety first - and efficacy of the medication. They are not powered to do that and what we also see, the trend now, is to do clinical trials offshore. Do '}},
{ timecode: 1501, handler: 'blob', id: 104, data: {text: 'them in India because it’s cheaper. Do them in Scandinavia. Has nothing to do with the diverse American population and the increased diversity of the American population. So the fundamental '}},
{ timecode: 1524, handler: 'blob', id: 105, data: {text: 'product, the branded product, already there is an important gap and the way in which we fill that gap is in the clinical setting. I think Dr. Powell was saying to you that if you’re taking '}},
{ timecode: 1537, handler: 'blob', id: 106, data: {text: 'prescription drugs you are in a clinical trial because no one studied that medication before it was given to you to understand safety and efficacy. I will push the safety first because if you go to '}},
{ timecode: 1550, handler: 'blob', id: 107, data: {text: 'FDA, FDA has this whole system when reporting on adverse clinical trials. If a new drug comes out and it doesn’t work and the doctor rings up and says I gave it to the patient and he dropped '}},
{ timecode: 1561, handler: 'blob', id: 108, data: {text: 'dead, you cannot find if it was a minority or not. Don’t capture that data. It’s not captured. The way in which it is found out is the doctor keeps giving it to his minority patients and '}},
{ timecode: 1576, handler: 'blob', id: 109, data: {text: 'either they fall out, or it doesn’t work, or it works. That’s the system. There are lots of reasons you can sort of rationalize it because if you go back to 2000, you know, 70% of the '}},
{ timecode: 1593, handler: 'blob', id: 110, data: {text: 'population, 80% of the market, so let’s serve 80% of the market as opposed to worrying about that small piece out there. So you can kind of understand it. Maybe. But I’m talking about '}},
{ timecode: 1606, handler: 'blob', id: 111, data: {text: 'looking forward when America is now diverse. Diverse workforce. How are you going to make sure that the products and services that you are offering them have the capacity to provide quality care to '}},
{ timecode: 1626, handler: 'blob', id: 112, data: {text: 'them? So in this conversation about bending the cost curve, there is a whole conversation about follow-on biologics. Biologics are made from living organisms. Complex process. Very funny how they '}},
{ timecode: 1649, handler: 'blob', id: 113, data: {text: 'work. They can react differently in human beings because they are proteins and your body reacts differently to proteins. So, once again, in the clinical trials that came forward, minorities were not '}},
{ timecode: 1670, handler: 'blob', id: 114, data: {text: 'in those trials but nonetheless, in the clinical setting we find out whether it works or not. So, they are trying to reduce - to bend that cost curve - the conversation now is how do we allow a '}},
{ timecode: 1683, handler: 'blob', id: 115, data: {text: 'biosimilar, a cheaper version of that medication so that we can reduce costs. Now I quickly raise my hand and say you\'re already spending 80% of the dollars over there so why do I have to be part of '}},
{ timecode: 1702, handler: 'blob', id: 116, data: {text: 'that conversation but I’m like, I’m a good American. I’m belly up. Be part of the system. But I would raise my hand and ask the question, “How do you know that that product, '}},
{ timecode: 1718, handler: 'blob', id: 117, data: {text: 'that new, that biosimilar, is going to be safe in me and my family?” Because in creating the pathway for biosimilars the argument is in order to keep costs down we don’t want to do any '}},
{ timecode: 1737, handler: 'blob', id: 118, data: {text: 'testing. We don’t want to test the product. We don’t want to do a clinical trial because that will just raise the cost. Right? We’ll let FDA kind of take a look and if it looks like '}},
{ timecode: 1753, handler: 'blob', id: 119, data: {text: 'it’s going to be something similar then we can go forward with it. Our suggestion is, and certainly what the Europeans have done, is that we need to make sure on a case-by-case basis whether '}},
{ timecode: 1776, handler: 'blob', id: 120, data: {text: 'that medication will be appropriate in America’s diverse population. We have to draw the line in the sand somewhere in which we begin to recognize that our future is diversity and we need a '}},
{ timecode: 1794, handler: 'blob', id: 121, data: {text: 'healthcare system that has that capacity. Looking at biosimilars and what’s being offered seems like a great place to have that conversation. There are a couple of bills in Congress right now. '}},
{ timecode: 1811, handler: 'blob', id: 122, data: {text: 'It looks like the Eshoo bill which has stringent safety protocols including clinical trials will lead the day. The Waxman bill really pushes the envelope by wanting to not have those clinical trials '}},
{ timecode: 1836, handler: 'blob', id: 123, data: {text: 'so we would urge the conversation and support the Eshoo bill so that we can make sure that these biosimilars are safe in our community. There is another part of the biosimilar conversation '}},
{ timecode: 1850, handler: 'blob', id: 124, data: {text: 'that’s important and this is around property rights, around the rights of the pioneering company. Now you look at it and you say well, that does not sound like a minority issue. You know '}},
{ timecode: 1873, handler: 'blob', id: 125, data: {text: 'it’s sort of intellectual property rights. Let them duke it out. The answer is no and here is why the answer is no. Going forward, we need new medicines. Our community is the sickest in the '}},
{ timecode: 1893, handler: 'blob', id: 126, data: {text: 'United States by far and some of that might very well be a function of the fact that the therapies are not as effective in our populations. So, we need to encourage innovation. We have to be on the '}},
{ timecode: 1914, handler: 'blob', id: 127, data: {text: 'side of innovation. We have to be there because when you look at everything that’s behind us, it wasn’t built for us. Just wasn’t built for us and it doesn’t work or it half '}},
{ timecode: 1928, handler: 'blob', id: 128, data: {text: 'works and we need to manage the excess diabetes, hypertension, cancer, HIV. You got to have a list, right? And so the argument that we would make to you is you have to stand firm on innovation. '}},
{ timecode: 1945, handler: 'blob', id: 129, data: {text: 'I’m not saying excess. Because business people get excessive. It’s not something I’m talking about. I’m talking about encouraging the marketplace. I’m going to end with '}},
{ timecode: 1960, handler: 'blob', id: 130, data: {text: 'this little story. We were wandering up the halls of Capitol Hill and we went into a legislator’s office and we were talking a little bit. It wasn\'t – it was a social conversation about '}},
{ timecode: 1973, handler: 'blob', id: 131, data: {text: 'follow-on biologics and the member said to us, this is a member of the Caucus, “I’m going to sit this one out because I don’t see the importance.” We are part of the governing '}},
{ timecode: 1994, handler: 'blob', id: 132, data: {text: 'majority of this country now. Even those little things that don’t seem like they are really important are extraordinarily important for our community particularly in the area of health care. '}},
{ timecode: 2007, handler: 'blob', id: 133, data: {text: 'Because the system has to be changed and we have to pay minute attention to how it evolves. So I leave you hopeful that you understand, and maybe you already understood and I’m preaching to the '}},
{ timecode: 2027, handler: 'blob', id: 134, data: {text: 'choir, that’s okay, that on the issue of follow-on biologics, we have to have a position. Thank you. REPRESENTATIVE JOE ARMSTRONG: Thank you Dr. Prowell, Dr. Puckrein. We have always had at '}},
{ timecode: 2049, handler: 'blob', id: 135, data: {text: 'NBCSL a strong relationship with the National Medical Association and each year we get together for our annual colloquium to exchange ideals from us as policy makers to those that are practitioners '}},
{ timecode: 2064, handler: 'blob', id: 136, data: {text: 'and we continue each year to keep developing and this relationship is evolving and I think of this as kind of an outcropping of that relationship that was started some years ago. As we prepare for '}},
{ timecode: 2078, handler: 'blob', id: 137, data: {text: 'questions, and of course, we always have supported those of Surgeon General, we recently sent a letter from this committee and from the NBCSL to Dr. Regina Benjamin congratulating her on her '}},
{ timecode: 2097, handler: 'blob', id: 138, data: {text: 'nomination as U.S. Surgeon General, as we have in the past with Dr. Satchel and even with Dr. Jocelyn Elders. So we continue that practice. But we’re going to open up with a couple of questions, '}},
{ timecode: 2111, handler: 'blob', id: 139, data: {text: 'we’re going to have two questions from this group, then we’re going to move to Columbia and then onto Jackson, so we ask that you come to the mic, if you could state your name for the '}},
{ timecode: 2122, handler: 'blob', id: 140, data: {text: 'record and so we’ll start. REPRESENTATIVE HOWARD MOSBY: Good morning, I am a state representative, Howard Mosby out of Georgia. Two quick I would like to get your comments on two quick things. '}},
{ timecode: 2137, handler: 'blob', id: 141, data: {text: 'One, African Americans’ representations on IRBs, I guarantee you that we’re not sitting there to be able to answer those questions. And then with the black medical schools, as you know '}},
{ timecode: 2151, handler: 'blob', id: 142, data: {text: 'first time studies in man, those Phase I studies look like the Tuskegee experiment, how do we overcome that and then if you do come up with a study that looks good in our community, how do you get '}},
{ timecode: 2167, handler: 'blob', id: 143, data: {text: 'somebody to come behind you and fund that study? So, just those two comments please. DR. JAMES POWELL: Hopefully everyone recognizes that IRB is the Institutional Review Board, this is a committee '}},
{ timecode: 2182, handler: 'blob', id: 144, data: {text: 'that sits and reviews human research that is conducted under protocol around the country. One of the things that we’ve advocated for is the adequate representation into all levels of the '}},
{ timecode: 2196, handler: 'blob', id: 145, data: {text: 'biomedical research process. IRBs, investigators, patients, and also we have gone to the FDA and said “You need a little diversity in your ranks as well.” Now, probably most IRBs do not '}},
{ timecode: 2212, handler: 'blob', id: 146, data: {text: 'actually reflect the population in the country and that’s something that a lot of organizations are trying to do, and in fact I am working with some to try to recruit people, and if you are '}},
{ timecode: 2224, handler: 'blob', id: 147, data: {text: 'interested, let me know if any of you are interested. The thing about a lot of the first in human studies is that those are extremely intensive studies that are conducted under very, very controlled '}},
{ timecode: 2240, handler: 'blob', id: 148, data: {text: 'circumstances and people tend to go them because the volunteers who have no disease, they get money from them. They get paid for doing them. And guess what? Guess who volunteers for studies that you '}},
{ timecode: 2256, handler: 'blob', id: 149, data: {text: 'get paid for? You get a lot of Latino and you get a lot of African Americans in those types of studies. And so, that’s just been the way it has been. Those are the people who have volunteered '}},
{ timecode: 2270, handler: 'blob', id: 150, data: {text: 'for those kinds of studies. Now the rest of your question regarding how do you get additional information, I’m sorry, I’m sorry, black medical schools. REPRESENTATIVE HOWARD MOSBY: Black '}},
{ timecode: 2287, handler: 'blob', id: 151, data: {text: 'medical schools to be interested in clinical trials. The academic mission usually they don’t go after the Phase IV, Phase III studies because it doesn’t look from an academic standpoint, '}},
{ timecode: 2297, handler: 'blob', id: 152, data: {text: 'like something they want to do. DR. JAMES POWELL: Well I think we’ve been also instrumental and active in trying to get people involved in clinical trials, both Phase III, Phase IV, trained '}},
{ timecode: 2309, handler: 'blob', id: 153, data: {text: 'positions, to be a part of the research process. One of the big issues has been that most medical schools don’t train people to be clinical researchers. They don’t train them or give them '}},
{ timecode: 2320, handler: 'blob', id: 154, data: {text: 'any information about clinical research, so one of the things that I know that is happening in the Association of American Medical Colleges is trying to create new programs to get more of this, not '}},
{ timecode: 2330, handler: 'blob', id: 155, data: {text: 'just minority medical school, but all medical schools to teach clinical research as part of the curriculum, first of all. But I know that we’ve interacted with the black medical schools to try '}},
{ timecode: 2342, handler: 'blob', id: 156, data: {text: 'to get them involved in studies, but one of the big issues has always been “What do the academicians get from it when they participate in the clinical trials?” They will participate in '}},
{ timecode: 2354, handler: 'blob', id: 157, data: {text: 'trials so they can get a Phase II where there’s new information being generated or phase for some of those trials. And then those are things that they can get academic credit for. But sometimes '}},
{ timecode: 2365, handler: 'blob', id: 158, data: {text: 'their trials, they’re not likely to give them credit, so spending your time to do that, that’s asking a lot for some of them when they have a lot of patients to take care of. And '}},
{ timecode: 2376, handler: 'blob', id: 159, data: {text: 'that’s one of the big issues that we continue to address and try to get more of our physicians and more of our community researchers to participate in the process. REPRESENTATIVE CALVIN SMYRE: I '}},
{ timecode: 2387, handler: 'blob', id: 160, data: {text: 'listened to both of you all and as it relates to, you know, we are an advocacy group and the biggest source of resources for us as state legislators is our policy and Mr. Chairman I’d like for '}},
{ timecode: 2404, handler: 'blob', id: 161, data: {text: 'you to look at the bills that you mentioned, in fact last night, Bart and Nate Miles mentioned a bill that was pending in Congress and they were talking about an issue as it relates to a bill that '}},
{ timecode: 2419, handler: 'blob', id: 162, data: {text: 'they were interested in. So I’d like to see if we could get the bill that was talked about last night and the bill that you just mentioned and see what kind of resolution we could get supporting '}},
{ timecode: 2429, handler: 'blob', id: 163, data: {text: 'those positions at our conference in December in Fort Lauderdale, because that’s the heart of our, and I forgot which bill it was, but we need, if you would Mr. Chairman, get your committee to '}},
{ timecode: 2446, handler: 'blob', id: 164, data: {text: 'look at it and research it and see if there’s any way for us, as you know, through the process, if there’s any way for us to have you introduce it, because I think we’ve passed the '}},
{ timecode: 2458, handler: 'blob', id: 165, data: {text: 'deadline for membership. But you as chair, the committee, we could look at both the bills that was mentioned last night and the one that he mentioned today and if you all could have some further '}},
{ timecode: 2470, handler: 'blob', id: 166, data: {text: 'discussion on it, I think that would be a great idea. REPRESENTATIVE JOE ARMSTRONG: Okay, Mr. President, of course this committee has had 15 resolutions already introduced and Vice Chair Usie Richard '}},
{ timecode: 2484, handler: 'blob', id: 167, data: {text: 'and myself received about 5 additional. One of those were on bio-assembly so we do have the caption to incorporate within that the ideals and perspectives… REPRESENTATIVE CALVIN SMYRE: Are we '}},
{ timecode: 2499, handler: 'blob', id: 168, data: {text: 'still within the timeframe? REPRESENTATIVE JOE ARMSTRONG: It met the September 30th deadline. REPRESENTATIVE CALVIN SMYRE: Okay. REPRESENTATIVE JOE ARMSTRONG: Yeah, so we are of course we have the '}},
{ timecode: 2507, handler: 'blob', id: 169, data: {text: 'chair of the resolution committee here looking at me. REPRESENTATIVE CALVIN SMYRE: Well, I, I, well, as president I think, I’d like for you all to consider that heavily if you hear me. But we '}},
{ timecode: 2523, handler: 'blob', id: 170, data: {text: 'don’t want to violate any deadlines, but if you have a caption, you have a caption there? Okay. REPRESENTATIVE JOE ARMSTRONG: We have a vehicle. But now, let us move on to South Carolina with '}},
{ timecode: 2543, handler: 'blob', id: 171, data: {text: 'representative Leon Howard. REPRESENTATIVE LEON HOWARD: We\'ll now have five minutes o take questions, Ms. Ava Brumfield, our assistant here, have some questions that individuals in the audience have '}},
{ timecode: 2558, handler: 'blob', id: 172, data: {text: 'put forth for answers. AVA BRUMFIELD: Yes, the first question, “Many of our African American youths are labeled as ADHD and are often prescribed a stimulant to aid in managing their impulsivity '}},
{ timecode: 2574, handler: 'blob', id: 173, data: {text: 'and ability to focus. Biologically, what chemical imbalances, if any, are factored in to support this diagnosis and treatment with a stimulus?” DR. JAMES POWELL: Unfortunately, that is not my '}},
{ timecode: 2590, handler: 'blob', id: 174, data: {text: 'area of expertise, and so I can’t answer it.1 That is not are of expertise and so I can’t address it directly, but what I would say is that one of the issues that we’ve dealt with is '}},
{ timecode: 2605, handler: 'blob', id: 175, data: {text: 'the need to do certain types of clinical trials in our community regarding the proper diagnosis of the illnesses in the people in our community. If you’re not a part of those trials that look at '}},
{ timecode: 2616, handler: 'blob', id: 176, data: {text: 'the diagnostic criteria, then of course, sometimes, people in our community get labeled inappropriately with certain types of conditions. AVA BRUMFIELD: A second question: how many biologic trials '}},
{ timecode: 2630, handler: 'blob', id: 177, data: {text: 'have been done on mental health medications? And is this a preemptive measure? DR. GARY PUCKREIN: You know, again, I’ll plead ignorant on that. Unless James, I don’t know the number. But '}},
{ timecode: 2648, handler: 'blob', id: 178, data: {text: 'will dare speculate on though for minority populations that whatever the trials were, we certainly were underrepresented in them. DR. JAMES POWELL: But one comment I want to make is in looking '}},
{ timecode: 2662, handler: 'blob', id: 179, data: {text: 'forward, the expectation is that 50% of the medications that are going to be in the marketplace within the next few years are going to be biologics. And so, we’re making a big transition from '}},
{ timecode: 2677, handler: 'blob', id: 180, data: {text: 'the small molecule to biologics, so we need to be vigilant with respect to the representation in those trials and supporting those products. REPRESENTATIVE JOE ARMSTRONG: Okay, we’ll move to '}},
{ timecode: 2690, handler: 'blob', id: 181, data: {text: 'Jackson, Mississippi with Representative Broomfield. REPRESENTATIVE BROOMFIELD: Thank you very much, the question that we have is what natural advocacy organizations are being worked with to assist in '}},
{ timecode: 2705, handler: 'blob', id: 182, data: {text: 'educating the community at large about these issues and this question is asked by Ms. Wendy White who is with the National Alliance on Mental Illness in Mississippi. DR. GARY PUCKREIN: There are lots '}},
{ timecode: 2724, handler: 'blob', id: 183, data: {text: 'of minority organizations that are attempting to look at these questions. I know that National Medical Association and others. But one of things I would point out to you, that I think is really '}},
{ timecode: 2741, handler: 'blob', id: 184, data: {text: 'important is that they\'re under-resourced, and so when you look at how - the example I can only give is how advocacy is done in Washington D.C. - frequently minority organizations are approached to '}},
{ timecode: 2760, handler: 'blob', id: 185, data: {text: 'sign a letter in support of something, but what they’re not provided is the capacity to study the issue on their own. That’s really important. It’s a really important difference. And '}},
{ timecode: 2774, handler: 'blob', id: 186, data: {text: 'one of the things that you can do is to make sure that those who come to you are appropriately resourced. Let me give, just a Washington example, a group came in to meet one of the representatives '}},
{ timecode: 2788, handler: 'blob', id: 187, data: {text: 'whooping and hollering about a piece of legislation they didn’t really know much about. They had a letter that they had signed and the member looked at them and said “The bill was passed '}},
{ timecode: 2797, handler: 'blob', id: 188, data: {text: 'two weeks ago.” But that is more the norm, right? And so part of that infrastructure-building is that, I love the American Cancer Society, I love the American Heart Association, I love the '}},
{ timecode: 2813, handler: 'blob', id: 189, data: {text: 'American Diabetes Association, they gobble up a lot of resources and our communities are not getting the resources to think through the issues to help you with informed conversation about its impact '}},
{ timecode: 2831, handler: 'blob', id: 190, data: {text: 'on minority populations. I think that’s, so we’ve got a lot of groups out there, but they’re not, they don’t have the power to do the kind of work that needs to be done. '}},
{ timecode: 2845, handler: 'blob', id: 191, data: {text: 'REPRESENTATIVE JOE ARMSTRONG: When you come to the mic, state your name. REPRESENTATIVE JOE GIBBONS: Joe Gibbons, state of Florida. Question: what I heard you say was that there are really no '}},
{ timecode: 2856, handler: 'blob', id: 192, data: {text: 'statutory legal requirement in the area of clinical trials as to where companies have to or are mandated to look at our communities. So as a group of advocates as President Smyre said, what we look to '}},
{ timecode: 2869, handler: 'blob', id: 193, data: {text: 'do is advocate for something. Now, I’ve heard mention of a couple of bills. Last night we heard Bart Peterson tell us about one bill that dealt with intellectual property where it was a 14 years '}},
{ timecode: 2881, handler: 'blob', id: 194, data: {text: 'versus 12 years, well to me that’s not really relevant to what we’re here to advocate for. We need more information. What can we do as state legislators in our different states, because '}},
{ timecode: 2890, handler: 'blob', id: 195, data: {text: 'from what I’m hearing there are no real statutory or legal requirements for these companies, be they dealing with Medicaid, Medicare, or anything to force them to have to include us in some of '}},
{ timecode: 2900, handler: 'blob', id: 196, data: {text: 'these medical trials. DR. JAMES POWELL: I really appreciate that question, because it is one that I struggle with quite a bit, because in the past we’ve advocated for a requirement and in fact, '}},
{ timecode: 2912, handler: 'blob', id: 197, data: {text: 'harmonization of the regulations for NIH and for the industry-sponsored studies. But having been in the industry for 30 years, I walk cautiously in that area. The reason I say that is because I know '}},
{ timecode: 2927, handler: 'blob', id: 198, data: {text: 'that, as a manager of clinical research, if they told me I had to have a certain percentage of African Americans, I’m going to get it. Period. Now, what I’m always concerned about is '}},
{ timecode: 2937, handler: 'blob', id: 199, data: {text: 'making sure that the community is educated to that same level so they\'ll be prepared to respond to my inquiries. I don\'t want to recreate a problem that we’ve had in the past that people are '}},
{ timecode: 2947, handler: 'blob', id: 200, data: {text: 'concerned about: inappropriate involvement in clinical trials. So we have to be, my point is that we have to be careful. I think that regulations with regards to supporting conduct of clinical trials '}},
{ timecode: 2957, handler: 'blob', id: 201, data: {text: 'as I mentioned earlier, regulations that say you disclose the population and - that was used in the clinical trials and that still, I still want to encourage, continue to, efforts to strongly '}},
{ timecode: 2972, handler: 'blob', id: 202, data: {text: 'encourage participation, but I’m a little concerned about quotas for representation. Yeah, yeah, mandatory represent-- yes. Something, some regulation to ensure that we have adequate inclusion. '}},
{ timecode: 2989, handler: 'blob', id: 203, data: {text: 'I think if we can come with the right language, where it does not put our community at a disadvantage, I’d be all for it and I would direct our project to support that as well. DR. GARY '}},
{ timecode: 3001, handler: 'blob', id: 204, data: {text: 'PUCKREIN: I just want to... several years ago the federal government had a similar issue with the pediatric population. Companies didn’t want to put children into trials, because, you know, '}},
{ timecode: 3018, handler: 'blob', id: 205, data: {text: 'adverse reaction, bad publicity, etc., and they came up with a provisions called the Pediatric Exclusivity Provision, and what that does, it’s Phase IV, it\'s post marketing study and the company '}},
{ timecode: 3031, handler: 'blob', id: 206, data: {text: 'gets an extension on its intellectual property rights for doing a clinical trial on a pediatric population and, you know, there’s some language about the Secretary of Health asking them to do '}},
{ timecode: 3044, handler: 'blob', id: 207, data: {text: 'it, etc., etc. We think that a minority exclusivity provision will begin to get at that issue. Now, it doesn’t deal with Phase III trials in which, you know, the initial trial, but it is a post '}},
{ timecode: 3059, handler: 'blob', id: 208, data: {text: 'marketing study. It will give us good science and it will begin to get an intellectual base so that we get the fundamentals down about where we’re getting population differences. So, we’ve '}},
{ timecode: 3079, handler: 'blob', id: 209, data: {text: 'been encouraging a minority exclusivity provision. We think it’s extraordinarily important that we cannot go into the year 2020 doing investigative research the way we’re currently doing '}},
{ timecode: 3095, handler: 'blob', id: 210, data: {text: 'it, so we think that’s sort of the step in the right direction. DR. JAMES POWELL: I want to follow up on that because I can tell you that our project is also advocated for similar exclusivity '}},
{ timecode: 3109, handler: 'blob', id: 211, data: {text: 'provision but what we’ve said is that the amount of exclusivity should diminish the longer it takes you to get that data, and the reason we say that is because when the product goes to '}},
{ timecode: 3121, handler: 'blob', id: 212, data: {text: 'marketplace it is available to everyone and sometimes we don’t really understand it as well as we should, as well as we could, from our clinical trials so we think it’s important to get '}},
{ timecode: 3136, handler: 'blob', id: 213, data: {text: 'that information in the clinical trials that are used to get the product marketed, and the longer you take it the less additional - exclusivity you get. So, you need to know it as soon as possible '}},
{ timecode: 3149, handler: 'blob', id: 214, data: {text: 'from when the product is available. REPRESENTATIVE JOE GIBBONS: We know recently as legislators there has been a proliferation of biotech companies, as a matter of fact, I think just about every '}},
{ timecode: 3161, handler: 'blob', id: 215, data: {text: 'state’s economic development agency is trying to recruit these biotech firms to their state. I know we established a corridor, I think at the research triangle, they established one in I know in '}},
{ timecode: 3175, handler: 'blob', id: 216, data: {text: 'Florida and in north Georgia, north of Atlanta. All of us are looking at the economic development aspect of these biotech companies, but no one has brought up about these small companies and not '}},
{ timecode: 3190, handler: 'blob', id: 217, data: {text: 'having a broad base being able to reach out to a population. You know if a biotech company is located in Silicon Valley then their outreach might not go past Silicon Valley or in Tennessee where '}},
{ timecode: 3205, handler: 'blob', id: 218, data: {text: 'it’s located next to the University of Tennessee Medical Units, that it might not reach out. Is there some concern, or are there some solutions to some of these small biotech companies '}},
{ timecode: 3217, handler: 'blob', id: 219, data: {text: 'that’s coming up and their ability to access minority populations? DR. JAMES Powell: Well, for the most part in these clinical trials of new biologics these are very large and complex clinical '}},
{ timecode: 3231, handler: 'blob', id: 220, data: {text: 'programs so a lot of the small companies have a lot of difficulty with them and so they tend to partner with larger companies. So, for the most part they seek larger partners to partner with them to '}},
{ timecode: 3250, handler: 'blob', id: 221, data: {text: 'conduct these clinical trials and then that expands the outreach. I think that a lot of these companies also use contract research organizations who will have the national outreach - the small '}},
{ timecode: 3264, handler: 'blob', id: 222, data: {text: 'companies can’t do it themselves. They have to use other companies that can help them with their ability to access patients across the country. That’s generally the way it’s worked. '}},
{ timecode: 3273, handler: 'blob', id: 223, data: {text: 'Either with a partner or with a contract research organization, if they have sufficient funding. What they have to do is to provide the right expectations to those contractors to make sure that they '}},
{ timecode: 3285, handler: 'blob', id: 224, data: {text: 'know that the company expects of them to seek diversity in the clinical trials that they’re sponsoring. DR. GARY PUCKREIN: I would add that, you know, developing a drug is like - a biologic - is '}},
{ timecode: 3300, handler: 'blob', id: 225, data: {text: 'like any business, and the extent to which you can incentivize as part of your attempt to attract - if you put incentives in there that encourage diversity. You know, you think of California and '}},
{ timecode: 3316, handler: 'blob', id: 226, data: {text: 'certainly Texas and New York, the majority or the people are minority. But, you’re doing trials on everybody but the people in your—it’s kind of nutty and a lot of states are '}},
{ timecode: 3327, handler: 'blob', id: 227, data: {text: 'flipping that way and so the point is in order to be a part of the conversation, and I think that’s what we’re urging, is that every step along the way you’ve got to put a little '}},
{ timecode: 3338, handler: 'blob', id: 228, data: {text: 'bread crumb in there to encourage the diversity, create the change. You know, business people respond to rewards. So, if you get them out there, I think they’ll respond. REPRESENTATIVE JOE '}},
{ timecode: 3346, handler: 'blob', id: 229, data: {text: 'GIBBONS: Okay. I think this is the last question. AUDIENCE MEMBER: Thank you, Mr. Chairman. In listening to your discourse this morning it is obvious that America is going through a demographic '}},
{ timecode: 3362, handler: 'blob', id: 230, data: {text: 'evolution. As that evolution happens and transpires we as policy makers have to make a determination as to how we’re going to spend our states’ money and you spoke about 65% of the '}},
{ timecode: 3379, handler: 'blob', id: 231, data: {text: 'population receiving 80% of the medical dollars and I suppose that’s a nationwide statistic. What I would like to know at this point, in the midst of this dialogue is what could we do as '}},
{ timecode: 3393, handler: 'blob', id: 232, data: {text: 'policymakers, and I know you made some suggestions, but you know we can consider several things that the majority of, 80% of our medical dollars are also spent on the last 90 days of life and so we '}},
{ timecode: 3407, handler: 'blob', id: 233, data: {text: 'know who that’s spent on. How do we change - there are so many ingrained, unwritten rules, the way the laws are written, the expectations, ethnocentrism and we can go forever talking about why '}},
{ timecode: 3426, handler: 'blob', id: 234, data: {text: 'these issues are like they are. What do we do to change these issues? DR. GARY PUCKREIN: You know, certainly the first place to look at is Medicaid, where you control the Medicaid budget and there are '}},
{ timecode: 3442, handler: 'blob', id: 235, data: {text: 'nationally speaking very good - some states - about 36% of the African Americans who have health insurance get it through Medicaid. When you go and look at Medicaid you see all kinds of barriers. In '}},
{ timecode: 3456, handler: 'blob', id: 236, data: {text: 'Medicaid, even to access to medications and the crazy part about it is, again, in Medicaid, we’re not spending the money on the minority population even though they are the majority in Medicaid '}},
{ timecode: 3474, handler: 'blob', id: 237, data: {text: 'and so then you add on it all of these restrictive formulas, etc. and then we go back and do the whole conversation about what is appropriate medicine, etc. So, our sense is what’s in your view '}},
{ timecode: 3488, handler: 'blob', id: 238, data: {text: 'right now is Medicaid and you ought to take a good close look at how Medicaid is structured to make sure that we’re getting the sort of quality care that those patients ought to be receiving. '}},
{ timecode: 3504, handler: 'blob', id: 239, data: {text: 'So, I think that would be the first place I would look. REPRESENTATIVE JOE GIBBS: Excuse me. Joe Gibbs again. Another comment about Medicaid, in order to help reduce medication costs in Medicaid what '}},
{ timecode: 3524, handler: 'blob', id: 240, data: {text: 'they’ve done is that, at least in Florida and two counties is that they’ve authorized a pilot program to where they’ve completely changed the way they administer medications in '}},
{ timecode: 3534, handler: 'blob', id: 241, data: {text: 'Medicaid. I’m on the board of a mental health clinic and what has happened is with this experiment to reduce costs, what they’ve done is patients that have taken years to find the right '}},
{ timecode: 3544, handler: 'blob', id: 242, data: {text: 'medication combination to have them stabilized so they can exist and work within our society. Some of those medications now, with this new Medicaid cost saving experiment, those medications are not '}},
{ timecode: 3555, handler: 'blob', id: 243, data: {text: 'included in that so therefore it has thrown them completely out of whack and sent us in the wrong direction. So, I think as we look at changing health care and Medicaid, especially from a federal '}},
{ timecode: 3566, handler: 'blob', id: 244, data: {text: 'government standpoint, we have to be very careful with our cost saving measures that we take because they have an unintended consequence of setting us back further than we want to be and what the '}},
{ timecode: 3577, handler: 'blob', id: 245, data: {text: 'program is designed to do really hurts us disproportionately to other portions of the population. DR. GARY PUCKREIN: I would absolutely concur. I think we’ve got a really good reason to be very, '}},
{ timecode: 3591, handler: 'blob', id: 246, data: {text: 'very careful, because what’s interesting about it, when you look at the data, so the majority of the physicians who have Medicaid practices, they have large Medicaid beneficiaries, a lot of '}},
{ timecode: 3606, handler: 'blob', id: 247, data: {text: 'African Americans who have commercial insurance go to them. As so the doctor doesn\'t sit there and say oh, this one’s a Medicaid and this one’s commercial. No, I’m giving everybody '}},
{ timecode: 3614, handler: 'blob', id: 248, data: {text: 'the same thing, so it seeps out into the commercial world as well so that even though you don’t have Medicaid you end up really being informed by the decisions that Medicaid is making. So, '}},
{ timecode: 3627, handler: 'blob', id: 249, data: {text: 'it’s a really important insurance system and we just need to be extraordinarily careful on how we manage it. And I realize, I’m not sitting at the table having to figure out how to slice '}},
{ timecode: 3639, handler: 'blob', id: 250, data: {text: 'the pie up to make it work, but what I can tell you the way the pie is getting sliced up right now, minorities are getting disadvantaged. REPRESENTATIVE JOE ARMSTRONG: Thank you Dr. Puckrein with the '}},
{ timecode: 3651, handler: 'blob', id: 251, data: {text: 'National Quality Minority Forum and also Dr. Powell with the National Medical Association.'}},
{ timecode: 0, handler: 'slide', id: 252, data: { width: 650, height: 488, slide_id: 4581, count: 1, alt: '07', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4581.jpg'}},
{ timecode: 1138, handler: 'slide', id: 253, data: { width: 650, height: 488, slide_id: 4513, count: 2, alt: '05', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4513.jpg'}},
{ timecode: 1176, handler: 'slide', id: 254, data: { width: 650, height: 488, slide_id: 4509, count: 3, alt: '01', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4509.jpg'}},
{ timecode: 1260, handler: 'slide', id: 255, data: { width: 650, height: 488, slide_id: 4510, count: 4, alt: '02', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4510.jpg'}},
{ timecode: 1290, handler: 'slide', id: 256, data: { width: 650, height: 488, slide_id: 4511, count: 5, alt: '03', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4511.jpg'}},
{ timecode: 1433, handler: 'slide', id: 257, data: { width: 650, height: 488, slide_id: 4512, count: 6, alt: '04', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4512.jpg'}},
{ timecode: 1493, handler: 'slide', id: 258, data: { width: 650, height: 488, slide_id: 4514, count: 7, alt: '06', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4514.jpg'}},
{ timecode: 2042, handler: 'slide', id: 259, data: { width: 650, height: 488, slide_id: 4582, count: 8, alt: '08', src: 'http://framewelder.com-cache.s3.amazonaws.com/presentations/236/slides/480/4582.jpg'}}
);