|
|
|
Twenty-Seventh MeetingMonday, June 20, 2005The Presidential Advisory Council meeting was held in Room 800, Hubert Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C., Louis Sullivan, M.D., and Anita Smith, Co-Chairpersons, presiding. Present:
PACHA Staff Present: Joseph Grogan, esq. Contents
Proceedings (8:42 a.m.) CO-CHAIRPERSON SULLIVAN: Good morning. PARTICIPANTS: Good morning. CO-CHAIRPERSON SULLIVAN: Let me thank all of you for coming and we very much appreciate your input. We have quit a full agenda for today and tomorrow, but I'm sure it will be a very productive day. As we begin, let me first of all thank Dana Ceasar and Delta Saint-Vil for their work in arranging the logistics for today's meeting and tomorrow, and Wanda Chestnutt from NIH also has been helpful. So we want to thank her as well. We also have a very productive council. Members who have published books recently that we'd like to recognize and thank and congratulate: Ted Green. Where's Ted? I saw him. Yes, right. Ted, congratulations on your book, Rethinking AIDS Prevention. That has gotten a lot of attention. And also Hank McKinnell has published a book, A Call to Action, about our health care system and health care reform. So, Hank, thank you very much for that. And that also includes a chapter on HIV/AIDS, which all of you, if you haven't read it, I certainly invite you to do so. Then Monica Sweeney has published the book Condom Sense. So those are three publications from our members. I think we should all congratulate them for their productivity. (Applause.) CO-CHAIRPERSON SULLIVAN: Now, let me be sure. Is there anyone else that we may have overlooked since this is a very prolific group? Well, thank you very much. Our public comment is scheduled for 9:35 on tomorrow, and Carol Thompson and Joe O'Neill will speak after the public comment. And members of the public who wish to speak can register to speak on tomorrow. And Joe Grogan, our Executive Director, also has a couple of comments pertaining to Carol Thompson and Joe O'Neill's visit. So Joe. MR. GROGAN: I know there was a lot of people who were looking forward to Carol and Joe's presentation, and they will be here tomorrow. The original expectation was that they were going to be able to unveil the administration's Ryan White proposal, but that looks like it's not going to be possible. They will be here. There are a couple of elements that came out in the final approval of the Ryan White proposal that need to be more thoroughly vetted, and it's not going to be possible with the number of people traveling on the Medicare Modernization Act rollout. So I apologize that they're not going to be able to unveil the Ryan White proposal, but they are going to be here, and they will touch briefly about some of the larger principals around Ryan White, and then engage in a round table discussion with the members and solicit some of your views on prevention and the nest steps beyond Ryan White reauthorization and what we need to do in the federal government to advance our HIV prevention and treatment efforts. CO-CHAIRPERSON SULLIVAN: Let me also mention that lunch for members of the council is available, but must be eaten here in the room. So we certainly would invite you to participate in that. Adjournment is scheduled for five o'clock, and depending upon how efficient we are in getting through our agenda, we'll see if we are successful with that or whether we might finish even earlier. Also, unfortunately I have a conflict. I will not be here tomorrow, but you'll be in the hands of our very able Co-Chair, Anita Smith, who will be chairing the session tomorrow. And then finally, a bus is scheduled to leave at 5:30 for the hotel at the end of the day. Are there any other questions or comments from members of the Council before we proceed? If not, then we will proceed with the agenda, and our first discussion will be from the Treatment and Care Committee that our chair of that committee, Dave Reznik, will guide us through that. So David. DR. REZNIK: Thank you, Dr. Sullivan, and good morning, everyone. We have quite an incredible set of speakers that are going to be joining us today covering some very important topics. I don't normally read parts of people's biographical sketch, but when I was reviewing them yesterday they were so impressive I think that the people in the audience who might not have access and everyone should actually know we have two speakers. Our first speaker -- I want to be sure I get this right -- is James Goedert. Did I get that properly? Names are not my specialty -- who received his B.A. in psychology from Yale University, his M.D. from Loyola University. He completed a residency in internal medicine and fellowship in medical oncology at Georgetown University Hospital. In 1980, he joined the National Cancer Institute, NIH, as a research fellow in epidemiology. Timing seems to be very important for many of our careers and why we're at where we are today. He recognized an unusual case of Kaposi's sarcoma in a young homosexual man in early 1981 and contributed to the original report of the disease now known as AIDS KS. From 1981 through 1999, he led prospective cohort studies of homosexual men, persons with hemophilia and pregnant women and their offspring. His study identified the major modes of HIV transmission, initial epidemiological evidence that HIV-1 causes AIDS, AIDS specific AIDS hazard rates used by others to estimate HIV-1 infection incidence and prevalence throughout the U.S., and the predictive value of CD4 lymphocyte counts, HIV viral load, and other markers for AIDS; the role of variations in human genes on HIV-1 susceptibility and progress and the effect of HIV/AIDS on infection of human papilloma viruses, which is the bane of oral health people and dermatologists in HIV right now and certainly a cause for cervical cancer and Hepatitis B and C; and numerous awards, over 288 publications, truly a remarkable individual that we have with us. We also have Dr. Yarchoan -- how did I do? I'm two for two starting off in the morning -- who is Chief of the HIV and AIDS malignancy branch in the Center for Cancer Research, National Cancer Institute. Along with two fellow doctors in the staff of Burroughs Wellcome Company, he co-developed AZT as the first effective AIDS drug and played a lead role in the first clinical trial of this drug. Also with the fellow doctors, he co-invented DDI and DDC as the next two effective AIDS drugs, as he led the first clinical trials of these agents. I think that is absolutely remarkable. He was Section Chief of the Medicine Branch of the National Cancer Institute from 1991 to '96, and was named Chief of the newly formed HIV/AIDS Malignancy Branch in '96. Since that time he has focused most of his research on AIDS related malignancies. Again, over 200 scientific articles and chapters and is co-inventer on ten issued U.S. patents. He has been awarded the Assistant Secretary for Health Award and several metals as a commissioned officer in the United States Public Health Service, including the Outstanding Service Medal in 2002. I hope one day before I retire that a quarter of my bio sounds as good as these two short bios. It's really truly remarkable. We're going to start our presentations with cancer and HIV in the population with Dr. Goedert today. So we please welcome you. DR. GOEDERT: Good morning, Mr. Chairman, ladies and gentlemen. Thank you for that very nice introduction. I'm going to be a little back in the corner here. If people can hear me I'll just speak up because it's going to be hard for me to see a little bit from there. REPORTER: Doctor, we need to report you for a transcript. You do need that microphone. DR. GOEDERT: I'm not going to be able to see the screen from here. Okay. So I appreciate the opportunity to discuss the magnitude of and changes in the problem in malignancy among people living with HIV/AIDS. Even as persons with HIV/AIDS are living longer and better, from the oncology perspective the problems are continuing and increasing in complexity. My colleague Dr. Yarchoan and I will discuss briefly these issues and summarize some of the points and leave some opportunity for discussion. If I can have the next slide, please. Thank you. Focusing initially on the U.S., I will touch on Kaposi's sarcoma, KS, the sentinel AIDS associated malignant disease; point out that the epidemic has changed with an increasing and aging population; describe our MET registry for surveillance of cancer among persons with HIV/AIDS; summarize the knowns and unknowns regarding cancer in highly antiretroviral treatment era; and finally, offer my impressions of the future implications. Next. Twenty-four years ago, in 1981, my colleagues and I reported the outbreak of KS among homosexual men in New York City, San Francisco, and Los Angeles. Next. Particularly among white men in San Francisco, shown in pink, the incidence rate of KS increased like a rocket in the population based cancer registries know as SEER. Next. This continued through the discovery of HIV by Dr. Yarchoan, et al. Next. It peaked in the dual therapy era. Next. And then plummeted a bit before the HAART era. In the early 1889s, we recognized -- I'm sorry. The AIDS epidemic shown in triangles followed a similar pattern. Of note, there continued to be twice as many AIDS cases, about 40,000, as deaths, about 20,000, resulting in the steadily increasing prevalence of people living with AIDS. There are now a million living with HIV in the U.S., half of whom meet the CDC surveillance definition of AIDS. Next. In the early 1990s, the recognized the need for population based surveillance of cancer among people with AIDS. To better characterize cancer risk in the affected population and to uncover clues to cancer etiology, more broadly we launched the computerized linkage project we call the AIDS-Cancer Match Registry. Next. For this project we developed and shared with the world new methods for computerized matching individual AIDS records to individual cancer records. We also developed new methods to assess cancer risk during the years before AIDS was diagnosed and during the progressive immune deficiency typical of the individual's AIDS relative time scale. Next. The risk of SK and non-Hodgkin's lymphoma, NHL, is increased hundreds to thousands-fold compared to the general population, although AIDS defining cervix cancer risk is increased only about fivefold, perhaps due entirely to sexually acquired papilloma virus infection. Anal cancer is related also to papilloma virus infection. Several other cancers have been elevated among people with AIDS. The relative importance of immunosuppression, life style and other factors are under investigation. Next. Currently we have linked the records of 465,000 persons with AIDS to the population based cancer registries of six metropolitan areas and seven entire states. We're available; we match but have not yet analyzed the records of persons with HIV infection. This is the AIDS population in these areas. The majority, male; 39 percent white and black; 21 percent Hispanic; 43 percent men who have sex with men; 27 percent injection drug users; and 11 percent heterosexual. Thirty-nine percent of the AIDS cases occurred after 1995. Next. Typical of AIDS, most of the cases are age 30 to 49. Next. However, on a log scale, the same data can show that we can assess cancer risk among more than 5,000 children and more than 2,000 elderly persons with AIDS. Next. We need to characterize the changes occurring in the HAART era. How is the spectrum changing? How large are the persistent excess of KS and lymphoma? What new malignancies are emerging and why? Are there extraordinary risks in certain subpopulations, especially among long-term survivors? What is the impact of HAART on survival for persons who have had both cancer and AIDS? Next. Analyzing the data to these questions is challenging, in part, because each person with AIDS travels through both calendar time and through his or her own individual time scale. Changes in cancer risk must consider both the calendar and individual time scales. Next. We have previously noted that women with AIDS had a reduced risk of breast cancer. This slide shows the individual time scale from four years before to five years after AIDS onset at time zero. Relative risk of one is that for the general population. Essentially all of these points are below one, and risk decreases nonsignificantly from early to late in each woman's HIV course. Next slide. By calendar time a different picture is seen. The points are still below one, but there is a highly significant increase such that the risk appears to be reaching that of the general population. We are working to explain this increase. Next. Four broad points about cancer in the HAART era. KS and non-Hodgkin's lymphoma risk have fallen, but lymphoma has fallen less than KS. Moreover, even now the risk of KS and NHL is still markedly higher for people with AIDS than for the general population. Several studies have noted an increasing risk of Hodgkin's disease of Hodgkin's lymphoma. There are persistent, substantial excesses of cancer that have known causes. Lung cancer with smoking, liver cancer with hepatitis infection, and cervix and anal cancers with papilloma virus infection. We are still at the beginning of the HAART era. Thus, follow-up is short and the impact on cancer is anything but certain. One certainty is that cancer is an increasing cause of death for persons with AIDS. The hospitals in France noted that cancer accounted for ten percent of deaths among AIDS patients before 1996 compared to 28 percent during year 2000. NHL was particularly lethal with lung and liver cancers and Hodgkin's lymphoma contributing substantially. Next. If sufficient funds are available, we intend to rematch the population based registries every three to four years to monitor and further study cancer among person with HIV/AIDS. I have not yet mentioned the developing world, but there is a raging epidemic of AIDS associated cancer in sub-Saharan Africa. KS has become the most common of all malignancies in Uganda and South Africa. To get a better handle on AIDS associated cancer in Africa, we modified the efforts that we developed for the United States and recently completed an AIDS cancer match in Kampala, Uganda. Next. Aging of the population in the HAART era inevitably will result in increases of cancer, including common types, such as colon, lung, breast, prostate, et cetera. Superimposed on aging, the immune perturbation that persists in people on HAART sets up the possibility for a vicious interaction. This creates opportunity to understand how cancer relates to other immune perturbations, particularly as occurs in the elderly general population. Areas for emphasis for the HIV/AIDS population that are likely to apply as well to the general population include attention to diagnosis and treatment, vigorous cancer prevention to reduce smoking, to vaccinate for Hepatitis B, and potentially papilloma virus, and to screen for cervical cancer, basic research of carcinogenesis and novel approaches to cancer treatment. The immediate keys to prevention of AIDS associated cancer are to prevent transmission of HIV and to diagnose and effectively treat those who are infected. Although much of the future is cloudy, this much is certain. The number of people with HIV/AIDS and cancer will continue to increase and to present complex challenges. I'll be happy to entertain questions or we can go directly to Dr. Yarchoan's talk. DR. REZNIK: Why don't we go directly to Dr. Yarchoan's talk and save questions at the end? Next we'll have Dr. Yarchoan, and then we'll take some general questions from members after both presentations. DR. YARCHOAN: Thank you. I'll be giving a presentation about malignancies in the HIV era from the perspective of treatment and pathogenesis. Again, following up on Jim's talk, we've traditionally viewed AIDS malignancies as the classic AIDS defining malignancies of Kaposi's sarcoma, lymphoma, and cervical cancer. But there's another spectrum of malignancies that are important in this population. One of those that are increased in patients with subtle immune dysfunction, diseases such as Hodgkin's lymphoma, seminoma, and such. There are also certain cancers, as Dr. Goedert alluded to in his talk, that are associated with exposure factors that are increased in people with HIV/AIDS. Again, this would include cancers such as lung cancer and anal carcinoma. And then finally, there are the panoply of other carcinomas that can occur in people with HIV that, one, pose problems in treatment because of the unique nature of the populations and, two, as we study the population of HIV infected people may be infected by the epidemiology. Next slide, please. So, again, from a clinician, and this is more of a ground's eye view, what sort of patients are presenting now with AIDS malignancies in the era of HAART. One are patients who are not being treated for HIV. Often these are people who are not aware of their HIV status, present with a tumor, and at that time discover that they're HIV infected. There are some patients who are poorly controlled on HIV drugs because of resistance, because of toxicity or because of compliance. There are patients who are otherwise well controlled on HAART, and in particular these patients can present with those tumors that occur at higher CD4 counts, such as Burkitt lymphoma, cervical cancer, or Hodgkin's disease. Next slide, please. And one of the themes that has emerged as we've studied AIDS associated malignancies over the years is that most of these cancers are associated with other oncogenic viruses. Shown here is a list of some of the important cancers that are associated with HIV infection. Those in the orange color are those that are in the group of AIDS defining malignancies. Those in white are those that are increased, but not necessarily AIDS defining. And as you can see, they're associated with a number of viruses, and the discovery in 1994 by Yvonne Chang and Patrick Moore of KSHV, Kaposi's sarcoma associated herpes virus, which was a new herpes virus found to be the cause of Kaposi's sarcoma, really nailed this point home. And as you can see, Epstein-Barr virus, Kaposi's sarcoma associated herpes virus, and human papilloma virus are the most important viruses right now in these AIDS associated malignancies. Next slide, please. So these virtual associated malignancies offer certain opportunities and certain challenges. One is that prevention and treatment of these can be affected by any retroviral therapy, and this is especially true for those viruses that occur with low CD4 cells. And some cases of Kaposi's sarcoma, in fact, can respond to effective treatment with highly active anti-retroviral therapy. There's also the possibility of prevention of these cancers in the future with an effective vaccine against the oncogenic virus. For example, researchers in the NCI and those in the private sector are now developing vaccines for human papilloma virus, and these have the potential of dramatically affecting the incidence of cervical and anal carcinoma in the future. There's also the possibility of vaccines against EBV or Kaposi's sarcoma associated herpes virus, and there are also the potential for viral targets for therapy that are unique targets that are different than those in the human cells. One can potentially find ways of using antiviral drugs, for example or immunologic approaches against antigens that are unique to the viruses. And also I should mention that this research will potentially benefit non-AIDS patients with similar viral induced tumors. Next slide, please. As an example, let me just talk for a second about primary effusion lymphoma as seen here. This was really recognized as a distinct form of lymphoma in 1994 when KSHV was discovered. It forms pleural effusions or effusions in other cavities. It's a B cell lymphoma, and it's an AIDS associated tumor. It's found in people who are KSHV positive. The tumor cells are infected with KSHV, and about 80 percent of them are also infected with EBV. It's often very poorly responsive to standard cytotoxic chemotherapy that we use for other lymphomas, and the median survival is measured in months right now. And interestingly enough, this tumor is associated with activation of some of the lytic genes of KSHV that can then be targets for therapy for antiviral drugs, and there are a number of groups that are studying this at this point. Next slide. There's also as I mentioned before tumors that develop in the context of sole immune dysfunction or inflammation, and these include, for example, Hodgkin's lymphoma or Burkitt's lymphoma. And as Dr. Goedert mentioned, the incidence of these tumors is likely to increase as HIV infected patients live longer. There's evidence of Hodgkin's lymphoma is also increasing. There's also the possibility of increased incidences of other cancers, and insights from this population and therapy that we develop for it again has the potential of benefitting people who don't have HIV infection. Next slide. So, again, this population of patients with HIV and cancer pose certain unique challenges in terms of developing therapies. One is that these patients have two life threatening diseases, each of which require at this point complex therapies. There are relatively few physicians in the United States who have expertise in both AIDS and cancer, and this is a problem both with the therapy of patients who present with these and also for conducting clinical research in these conditions. The optimal cancer treatment in these tumors may differ from those in non-AIDS patients. For example, these AIDS patients tend to be very fragile. They have compromised immune systems, and they're often more sensitive to various therapies. For example, they often get a lot of mucosal toxicity if giving radiation therapy in the mouse, and there's also cumulative drug toxicities as we combine the complex therapies for HIV with those for cancers, and the possibility for a lot of drug interactions that can affect these drugs in ways that are not totally anticipated. Next slide. There are also substantial challenges in entering these patients in clinical trials. One is that patients are often in minority groups or have poor access to health care, and the other thing is that patients with HIV infection who may present with other common tumors are at present usually excluded from clinical trials with these tumors, again, because of their HIV status makes them a unique population that may respond differently to therapy. And, again, research in this population may provide insights into the optimal therapy of cancer in other fragile patients, for example, the elderly or others with immune dysfunction. Next slide. In spite of this, some progress is being made. For example, in terms of Kaposi's sarcoma, the treatment is markedly improved now. Doxil, which is a liposomal form of an anti-cancer drug has been approved, and scientists in our group are starting the combination of Doxil and a cytokinem IL-12 in people with KS. This shows one patient on one of the trials. This has a dramatic improvement in spite of no real change in its underlying HIV status. Next slide. And, again, in terms of AIDS lymphoma, a regimen of dose adjusted EPOCH, which is a combination of five anti-cancer drugs has been tested. It has been found to overall have about a 79 percent response rate, and these results with a very long survival, and these results suggest that AIDS KS patients can in certain situations be curative and have a very long survival. And the AIDS Malignancy Consortium, which is a group of extramural scientists around the country who studied AIDS, lymphomas, and other tumors are studying this approach in a large, randomized trial at this point. Next slide. So, again, just to summarize, these malignancies offer certain opportunities and challenges. As I said, the viral induces tumors offer opportunities for prevention and therapy. On the other hand, there's an increase in certain tumors as we've seen now as patients live longer and patients are now the most frequent cause of death in AIDS patients. There's a change in distribution as we're seeing of tumors, and this will require research on prevention and therapy, and the optimal treatment for these patients is often different than the general population. So I think at this point I'll end and open the subject for questions, and, Jim, why don't you come up also? DR. REZNIK: We have time for a few questions. So Dr. McKinnell. DR. McKINNELL: Well, thank you for a very interesting presentation and some thought provoking data. And I guess my question is really based on the fact that those of us seeking additional public funding for early treatment I think have a very fundamental problem, which is to most of the public HIV/AIDS is one word. They just don't get the benefit of early treatment of those with HIV, but they do get cancer treatment. So my question is: is your data robust enough to support a statement along the following lines: for every 10,000 HIV positive individuals treated appropriately, you prevent X thousand cases of cancer? DR. GOEDERT: Yes, definitely. Coming up with the actual number would take a little work, but for sure, I mean, the markedly lower incidence rates of Kaposi's sarcoma and non-Hodgkin's lymphoma alone would justify the statement that you're trying to make and coming up with the number would take a little work. DR. McKINNELL: Yeah, I would encourage you to do that work and publish it and then those of us advocating for funding for early treatment would have a pretty powerful argument, I would think. DR. YARCHOAN: If I can add one point, it's that in terms of the epidemic, we don't -- because HAART has only been around for a little under a decade now, we can't project beyond ten years. We can certainly say that it delays certain tumors. We just don't know what it's going to be beyond ten or 20 years. So those could be tweaked in terms of delaying the onset of tumors, and it would be important. DR. GOEDERT: If I can add one more thing, I guess there's one difference between cancer therapy and HIV/AIDS therapy is that the ladder for HIV as far as we know how is for life, whereas cancer therapy we usually think of as trying to induce remission after, you know, a period of some months to years. DR. REZNIK: Okay. The next question is for Reverend Sanders. REV. SANDERS: No your slide that addresses associated malignancies caused by viruses, you draw the relationship between HPV and cervical cancer. Is there any evidence of the degree to which clinicians, caregivers are addressing the relationship directly and regularly with patients? There's a lot of discussion now as to whether or not some of the same strategies that we have used to deal with issues of prevention around HIV might not be well applied in this regard, but my sense is that it's not routine. It's not necessarily the case that clinicians are making that connection and making it a part of strategies for treatment with people that they're seeing. DR. YARCHOAN: You're accurate in that. The issue with papilloma virus is that it's much more common in the population. There are multiple types of papilloma virus, and there is a sense that cervical cancer is in part related to the degree of exposure. Right now we also have PAP smears as a way of preventing cervical cancer, and that has been the main target for prevention of this, but certainly some of the strategies that would be used against HIV would be effective with cervical cancer. We just have better options in cervical cancer that are easy to apply. And there is also a vaccine that is now in very large scale clinical testing against the main malignant subtypes of cervical cancer that is likely to be very effective around the world. DR. REZNIK: The next question is from Dr. Judson. DR. JUDSON: I just want to follow up on Dr. McKinnell's question on early treatment and not leave the committee here with the impression that the is a simple diagnosis of early disease and that, as we discuss that and recommendations for earlier treatment, you get into all the complexities of CD4 viral load, months, years of duration and clinical symptoms so that if we're referring to treating people very, very early in infection, I think that's controversial as it relates to the tradeoffs between cost, treatment, toxicities and improved survival. Did you want to comment on that? DR. GOEDERT: As Bob mentioned, many people these days are not diagnosed at all with HIV infection until they present with a life threatening disease, either a malignancy or an opportunistic infection. I think that's the distinction, is getting them before they get to that point. I think the discussion you're raising is whether to try and treat people very early in the immune deficiency process. If you're lucky enough, effective enough to make the diagnosis at that stage, I agree. I think there's discussion as to when to initiate therapy. But I think everyone would agree that you want to initiate therapy at some point before the onset of clinical disease, malignant or otherwise. DR. JUDSON: The second question is: is there any evidence that any of the current treatments actually promote cancer as an adverse outcome? DR. GOEDERT: No, but it needs to be monitored particularly because you're talking about lifelong therapy for very long periods of time. CO-CHAIRPERSON SULLIVAN: Why don't we give Dr. McKinnell a chance for rebuttal? And I do want to say please limit our questions because we're already behind schedule, and Dr. Sweeney, I will get to you afterwards, but, Dr. Sweeney, this is going to be the last question. I apologize. We are running late today. DR. McKINNELL: Well, it's not so much a rebuttal as a suggestion for further research, which is what scientists do. I think for the HIV to AIDS part of your question, Mike Sagg's data is pretty compelling, that you treat before 250 on CD4. To me that question has been answered. I think the question that need to be answered is where would you treat to present the X thousand cases of cancer I'm trying to prevent. I don't think that work has been done, and it may be a worthwhile avenue for you to follow CO-CHAIRPERSON SULLIVAN: And Dr. Sweeney. And this will be our last question on this section. DR. SWEENEY: So I'm only going to ask, one, because of time, and thank you for recognizing me, one is whether or not there has been any work on preventive screening in HIV patients, males in particular, using the same kind of testing as the papinickuli, for example, or doing screenings, for example, for rectal cancer in men who has sex with men to detect it early. Because eventually that will recognize some savings in treatment if we can start to get them early, and I don't think people are putting the connection to cancer and HIV and AIDS early enough so that by the time many people are diagnosed, it's far along the line. So just screening. DR. YARCHOAN: That's actually a very important point, and members of the AIDS Malignancy Consortium have been looking at the techniques which require special training and trying to do studies to look at the effectiveness of this in prevention of disease early. So this is an important point that's being studied right now. DR. REZNIK: And as the prevention and treatment and care committee will be working together, one of our keys is getting people tested early because at the graded health system infectious disease program, we're seeing a lot of young African American males presenting with relatively advanced Kaposi's sarcoma and plasmobastic lymphoma, having a couple of those cases. So we really do need to get treatment started. I thank both of you for your time and we greatly appreciate it. (Applause.) DR. REZNIK: As we all know, yesterday was Father's Day, and I think there's a very, very proud father in the room today, Dr. Beny Primm, because we have the honor of listening to his daughter, a very accomplished provider in her own right. Dr. Primm is an M.D.-Ph.D. and the Director of Minority and National Affairs for the American Psychiatric Association. She's also an Associate Professor of Psychiatry at Johns Hopkins School of Medicine. Dr. Primm is a graduate of Harvard Radcliffe College and Howard University College of Medicine. She completed her residency in psychiatry, fellowship in social and community psychiatry, and Master's of Public Health degree at Johns Hopkins. She is a nationally recognized expert on cultural issues in psychiatry and co-occurring psychiatric illness and substance abuse and has written and lectured widely on these topics. It's with great honor that I get to introduce the daughter and accomplished Dr. Primm's daughter, Dr. Annelle Primm. (Applause.) DR. ANNELLE PRIM: Thank you, Dr. Reznik, and good morning, everyone. It is, indeed, my pleasure to be here to speak with you today. Dr. Sullivan, thank you, distinguished member of the council, and to Daddy, Dr. Beny Primm, I want to thank you for your tremendous leadership in the area of HIV/AIDS and substance abuse and to thank you for your advocacy in bringing mental health to the table in this forum. I would also like to thank Diane Pennessi and Carol Svoboda of the American Psychiatric Association Office of HIV/AIDS Psychiatry, who provides considerable information on training, resources, technical assistance and policy guidance at the APA, and I hope that you'll take some time to look at your packet of materials which gives an example of the sorts of resource that the APA offers in this area. It is my pleasure to talk about this very important topic of mental health and HIV disease. Next slide, please. I will be covering the following points of what is mental health and mental illness. Some of the links that exist between mental health and HIV/AIDS, the relationship between substance abuse, which is a mental disorder, by the way, and HIV/AIDS, and also to put this in the context of health and mental health disparities as they exist in underserved ethnic and racial groups and the vicious cycle which includes HIV/AIDS, and to leave you with a vision of the future. Next slide, please. What is mental health anyway? We throw around this term rather loosely, and it really describes the successful performance of mental function throughout the life cycle, resulting in productive activity, fulfilling relationships, and the ability to adapt to change and to cope with stress. I think we often talk our mental health for granted, but indeed, it is the foundation for thinking and intellectual functioning, for communication skills, for learning, emotional growth, resilience, and also self-esteem. Next slide, please. Mental illness, which is not really the polar opposite of mental health really describes health conditions that are characterized by changes in thinking, intellectual functioning, and mood, and in behavior or some combination or some permutation of these three. The most important point is that mental illness is associated with distress and/or impaired functioning. Next slide, please. I'd like to call your attention to the Surgeon General's report on mental health. Former Surgeon General Dr. David Satcher really shed some light on mental health, and despite a 20 percent prevalence, at least at that time and some recent reports indicate even higher prevalence at any given point in time, about 30 percent of mental illnesses, they are significantly under treated in this country, and we continue to struggle against the stigma that is associated with having a mental illness and seeking care for it, and this stigma is a major barrier to people receiving mental health care. Associated with this stigma is the discrimination that continues to exist in insurance coverage and reimbursement for the treatment of mental health problems. Even people who are very well insured have to pay a copay. It's handled differently than other sorts of medical problems, and this, too, is a significant barrier. We in this country are experiencing significant under treatment of mental health problems in a number of special populations. They vary by age, ethnicity and race. Certainly children and youth are significant underserved. This is a huge problem. Our older adult population is underserved, and the four major ethnic and racial groups, African Americans, Native Americans, Asian Americans, and Pacific Islanders and Hispanics are significantly underserved. And this really portends a very important role for primary care physicians and other health providers in addressing the mental health needs because of that stigma, if people get any mental health care at all it's most likely to occur in the primary care setting. Well, let's link this with HIV/AIDS now. Next slide, please. Certainly we know that the epidemic is not over, and it continues to exact a huge toll not only on our country with the 1.1 million Americans who were affected as of December 2003, but also globally. Forty million people are infected with HIV and including five million individuals who were newly diagnosed in 2003. Certainly you all are very familiar with these statistics, but they certainly don't reflect some of the human suffering that's associated and often comes out in the form of mental health problems. And perhaps we need to be more cognizant of the ways in which the mental health problems associated with HIV/AIDS exact their toll, and certainly we must labor hard to do something about this. Next slide, please. HIV and mental health issues, certainly HIV can cause significant emotional distress and crisis. And we also know that HIV directly affects the brain, and this can lead to a number of organic mental health disorders, neurocognitive impairment, and what this means is that if we miss a diagnosis of mental illness, it can lead to irreversible impairment, and it also lets us know that if we can intervene, we can help to improve our HIV/AIDS treatment outcomes. Next slide, please. Certainly complex drug regimens can result in mental health problems. Some of the medications that we use in the treatment of HIV are attendant with side effects that may be manifest in psychiatric symptoms. Certainly substance abuse, which is often concomitant with HIV, certainly is a risk factor and even coexistent with it can mask some of the underlying psychiatric symptoms and problems that can surface in the context of HIV infection. And most importantly, for people whose mental health is compromised this can certainly interfere with their adherence to treatment, and we know how critically important it is for people with HIV infection to adhere to their treatment plan in order to maximize their outcomes. Next slide, please. If we look at HIV and mental health as co-occurring disorders, we know that all populations are at risk. However, members of underserved racial and ethnic groups are disproportionately affected, and if we do not treat these problems, they can result in serious disabling consequences and, again, can have an impact on treatment adherence, and this is really a toll that our society cannot afford. It has a tremendous impact on overall health, productivity, and quality of life. Next slide, please. So what about some of the specifics of how mental health has an impact on HIV and vice versa? Certainly the psychological impact is key. We know that HIV infected people experience a great deal of psychological distress and psychiatric disorders, and just receiving the diagnosis of HIV is very stressful. We often see these individuals experiencing a great deal of bereavement as a result of numerous losses, a break-up of relationships, financial worries and work problems, very deep unhappiness associated with the emotional distress that comes along with having this diagnosis. And certainly some of the societal reactions to people who have HIV/AIDS can lead them to feel rejected and discriminated against, which only compounds their psychological distress and causing them to be more depressed, more demoralized, and this can contribute to a rapid progression of disease. We know that there are links between mental health and immune function which certainly can have an impact on HIV/AIDS, and all of this can make it very difficult for individuals to lead a normal life. And here's another dimension. What about those children who will lose their parents to HIV/AIDS? This is certainly traumatic, and the concern is that after the loss of their parents, these children may not be integrated into new families, and certainly in and of itself this is quite traumatic, losing one's parents, but not having support after that can yield devastating consequences to the mental health of these children in terms of their development, and certainly as they become adults. Next slide, please. HIV has a direct impact on the brain, and it can almost be thought of as an assault. It can create central nervous system impairment and a wide range of neuropsychiatric disorders. And, unfortunately, the current antiretroviral treatments that are available show rather poor penetration into the brain, and so it makes certain neuropsychiatric disorders more likely and difficult to treat. And certainly for those individuals who have had a mental illness prior to contracting HIV infection, as well as those who have a significant substance abuse, we need to be very mindful of assessing their cognitive status and neuropsychiatric status which may be compromised by the mental illness and by the substance abuse. So this can be a double or triple whammy in many cases. Next slide, please. The spectrum of HIV related disorders can range from neurocognitive impairments, psychiatric syndromes and somatic syndromes, and I'd like to talk about each of these. In terms of the neurocognitive impairment, there are three dimension of this. In its most severe form really these are referred to as AIDS dementia complex, or ADC. Some of the aspects of the impairment include impairment to cognitive function. For example, people having difficulty with their memory; in terms of behavior, having difficulty with agitation or psychosis, another word for losing touch with reality. Motor functioning can also be compromised and can be borne out in gait disturbance or even incontinence, and certainly we need to take into account that while these neurocognitive deteriorations can progress gradually, we can see some early signs and symptoms, including short term memory loss as manifested by forgetting appointments, misplacing things, forgetting to take medications, which we know is quite concerning, loss of fine coordination, not being able to perform handwriting as usual, difficulty putting objects together; cognitive slowing, not being able to follow a conversation, taking longer to speak or to understand, being slow in interviews; and certainly mood changes, having low motivation and apathy, depression and hyperactivity; and certainly being unresponsive, being agitated, having hallucinations, paranoia, and even having loss of bowel and bladder control, as well as inability to walk. All of these things are controlled by the brain and the impact of HIV infection can have this sort of direct impact. Next slide, please. Other aspects of neurocognitive impairment include two conditions, HIV associated dementia or HAD, and minor cognitive motor disorder, MCMD. These are complications in which there may be direct or indirect impact of HIV on brain tissue, and certainly even at autopsy we see that at 90 percent of AIDS patients have some evidence of central nervous system disease, and 80 percent of those who are hospitalized show some type of organic mental disorder, such as these during their hospitalization. This, by the way, is really a spectrum with the minor cognitive motor disorder being on the lower end of the spectrum in terms of severity, with HIV associated dementia being at the severe end. And certainly these are important to take into account. Many people assume that when these sorts of symptoms, mood swings, depression, et cetera, occur, it is assumed that this may be some sort of only psychological sign and symptom which has no relationship to the HIV, but we know that, indeed, this is a result of the direct effect of the virus on the brain. And what might be some of the manifestations? Imagine an individual, an attorney 35 years old who had prided himself on being able to speak very well, be quick on his feet, and suddenly speaking slower, having difficulty following the thread of a conversation, staring off into space, very uncharacteristic for an individual, and this would be an example of the ways in which HIV infection can have an impact on the brain. Next slide, please. Among the most common disorders, mood disorders such as anxiety and depression, commonly seen in co-occurring with HIV infection, certainly substance abuse, personality disorders, individuals who have certain characteristics, perhaps a lot of apathy or negative thinking maybe only more pronounced in the context of HIV/AIDS, and certainly these conditions tend to be seen more in the later stages of HIV infection -- excuse me -- psychotic symptoms, for example, though not very prevalent, can be quite disabling, but at the same time treatable. And certainly, substance abuse frequently coexists with psychiatric disorders, which makes it very difficult to diagnose and treat. Certainly, suicide risk is a huge issue among people with HIV infection and all the more reason why we need to recognize and treat the conditions early so that we can prevent suicide. Next slide. There are numerous somatic syndromes or syndromes which affect the body that are associated with HIV/AIDS and certainly with mental health problems. Pain, in particular, is common in HIV infection really throughout the course of the disease, and we know that pain disorders can be associated with numerous psychological symptoms. In about 30 to 80 percent of patients with HIV experience pain, and we know that there are significant disparities among certain ethnic and racial groups, and the extent to which they receive treatment for there and really, in general, individuals with HIV infection may easily be overlooked as needing treatment for pain. Endocrine problems, such as low testosterone on estrogen levels, can produce wasting, fatigue, mood disturbances, difficulty with cognitive functioning and irritability, and regarding the wasting that's associated with these endocrine problems, this adds to the stigmata of the HIV infection which can add to lower self-esteem and that feeling of outside stigma that the infection brings. And in terms of medication side effects, this, too, is a challenge. There's several HIV medications that have mild to severe side effects, which may resemble some of the psychiatric complaints that I've talked about earlier, but it's important to recognize these so that medications can be changed and there can be some alternatives used to address these concerns. Next slide, please. In terms of substance use, very important to recognize that about 34 percent of individuals experience injection drug use, and that direct transmission of HIV may occur through the substance use pathway. With sharing of needles, indirect transmission certainly can occur, through sexual contact with HIV positive injection drug users, and even noninjected drugs, when they are used. For example, alcohol or cocaine, this too increases risk for HIV because of the effect on judgment. People who are intoxicated do not exercise the same level of judgment that they would normally exercise, and this affects their decision making and may involve increased sexual risk taking. This is important for us to consider when we think about teenagers and young adults who may be abusing substances, and this is a direct pathway to HIV infection risk. Next slide, please. When we think about substance abuse, certainly there are a number of symptoms that may be confused with aspects of HIV infection, some of the malaise, fatigue, weight loss, fever, et cetera, that can accompany substance abuse withdrawal. That can be confusing. Some of the medical complications of chronic substance use may also have an extra impact on HIV infection. For example, pneumonia, sepsis, endocarditis, tuberculosis and Hepatitis C are all very common among individuals with substance abuse, and certainly people with HIV infection are particularly vulnerable to these, and neurological symptoms that accompany substance abuse problems of particularly alcohol, severe alcoholism, chronic alcoholism can lead to dementia, and this can be superimposed on some of the neurocognitive problems that I discussed earlier associated with HIV/AIDS. Next slide, please. Substance abuse can, again interfere with rational decision making, and it can interfere with treatment adherence, too, which for those who have both substance abuse and a serious mental illness, this, too, can be a double whammy interfering with the maximization of outcome in the treatment of HIV infection. Next slide, please. And certainly HIV/AIDS sufferers often turn to alcohol or drugs to manage their disease. This only make the problem worse, and again, we need to be cognizant of teenagers who often experiment with drugs and alcohol which can be a significant pathway. Next slide, please. What about populations at risk? Well, the point is really everyone is at risk, but particularly individuals who are in the 13 to 24 year old age group, men who have sex with men, IV drug users, prison inmates, and even seniors. We're seeing more HIV infection among older adults, and certainly among underserved ethnic and racial groups. Next slide, please. Dr. David Satcher and his report as Surgeon General on some of the culture, race, and ethnicity aspects of disparities in mental health, he pointed out that while mental illness affects all, there are striking disparities in mental health care for the four major ethnic and racial groups, and this is manifested in less utilization of mental health services, poorer quality of care, and under representation in mental health research. And all of these taken together impose a significant disability burden on members of these populations. Next slide, please. And there are many factor which affect the utilization of mental health services among these populations, namely, African Americans, Native Americans, Asian Americans and Pacific Islanders, and Hispanics. Certainly racism is something that regardless of socioeconomic status has an impact on all of these populations. Discrimination in so many realms, employment, housing, education, et cetera, often tied to economic impoverishment, certainly mistrust of the health care system that's associated with some of the health disparities that these groups experience, as well as fear. And certainly, we must take into account some of the cultural and social influences in terms of illness behavior, in terms of explanatory models of illness, in terms of idioms of distress. These are all ways that may mediate the presentation of mental illness among different groups. And, of course, we always need to consider biological, psychological, and some of the social and environmental factors in which these mental illness or mental disorders arise. Next slide, please. And in terms of the high need populations, certainly ethnic and racial minority groups experience more than their fair share of these conditions: homelessness, being in the correctional system, and as some of you may know, that the majority of individuals in the correctional system at this time are people of color, with African Americans constituting over 50 percent of those in the correctional system. And, by the way, the correctional system is currently the place where the most people with mental illnesses are now housed. It used to be the state psychiatric hospital system, but that's where people with mental health problems and substance abuse are located. Certainly alcohol and drug abuse refugees and those immigrants from other countries are among the high need populations. People of color are over represented among victims of trauma who are quite vulnerable from a mental health standpoint. Certainly homicide, particularly in the African American community, among young African American males, extremely high, but you also have to think about not only the direct victims of homicide, but also the survivors and the witnesses of the violence that occurs in these communities make people vulnerable to mental health problems. And certainly, children in the foster care system, quite high, and many of these young people have unmet mental health needs. Next slide, please. The Institute of Medicine report, "Unequal Treatment," released in 2002, focused on the fact that racial and ethnic disparities exist regardless of socioeconomic status, and this is borne out in the higher morbidity and mortality from some of the leading causes of death, including HIV/AIDS, and a poorer quality of care that has been found across the board in a number of different disease states, with the result being worse outcomes among these populations. And I call this the "death gap." Next slide, please. And the death gap, just some examples to highlight African Americans with excess deaths to heart disease, stroke, cancer, et cetera, and HIV/AIDS, and among Hispanics, also HIV/AIDS among some of the leading causes of death for which they die sooner and more of, and important to put this death gap in the context of mental health because often these diseases co-occur with mental health problems, and because of that it makes it very difficult to recognize and to treat these conditions optimally and to forestall poor outcomes and the ultimate poor outcome being death. Next slide, please. Important to understand some of the barriers and mediators to equitable health and mental health care for racial and ethnic groups. There are many barriers which span from the personal and family barriers to the structural ones. How available mental health services are, for instance, or some of the financial ones in terms of insurance coverage and reimbursement levels which may be barriers to getting health and mental health care; certainly the types of services that are used, whether it's primary care and specialty care, which we know that ethnic and racial minorities tend not to get, and they are more likely to get emergency services, which is not a good place to treat one's HIV nor one's mental health problems. Very little preventive services received by these populations. And let's look at the mediators. How could we intervene here where certainly the quality of providers in terms of their ability to understand the cultural context of individuals, to be able to communicate across cultures, to be knowledgeable about the conditions for which some of these populations are vulnerable, and also to undo some of the bias and stereotyping which may be unintentional, but nevertheless has a significant impact on the quality of care that people receive. And ultimately what we want to reach is improved outcomes, avoiding mortality and maximizing well-being and functioning and good, effective partnerships between patients and providers. Next slide, please. Ultimately what we want to prevent is this vicious cycle, and I propose to you that by identifying and treating mental illness early, it's really a way for us to prevent HIV infection. Imagine if we could identify mental illness early. We might prevent people from self-medicating, which we so often see, people with unmet mental health needs reaching for alcohol and drugs to self-medicate, and unfortunately this is a particular problem in under served ethnic and racial communities which may be low income, and we certainly see in these communities great availability of alcohol, with liquor stores on every other corner, open often 24 hours a day seven days a week. Talk about access. And, again, with open air drug markets, this makes it very accessible to get alcohol and drugs, which as I mentioned before reduces one's ability to exercise the kind of judgment to protect oneself and to keep oneself out of harm's way of exposure to sexually transmitted infections like HIV/AIDS, hepatitis and so forth. And this vicious cycle can go in any of these directions. Think about how the substance abuse can lead to violence and certain incarceration. Certainly among minorities we know that there's very aggressive policing in their communities, and God forbid if such an individual residing here has an untreated mental illness and a substance abuse problem. Rather than getting the mental health needs met, they end up in the correctional system, which unfortunately is not the best place to receive care for these conditions. And certainly as we go around the cycle, the cycle continues of poverty and homelessness and broken families and so forth. So we really need to think about mental illness as a way of interrupting this vicious cycle. Next slide, please. Just to give you some examples, if we think about major depression, an illness that is characterized by change in mood, a change in a sense of well-being, and change in self-esteem, as well as often associated with thoughts of suicide and death, these are the diagnostic criteria for major depression, and someone would need to experience five or more of these in a two-week period in order to reach the diagnosis. Next slide, please. And we know that depression is an equal opportunity illness, and if you look at the ethnic distribution shown here, there is a slightly significantly higher rate among the white population in the lifetime prevalence category, but for the most part these rates of depression are quite similar. Next slide, please. But what is different is the difference between the prevalence of depression -- and these are actually depressive symptoms in this case, not depressive illness or major depression -- and if we compare the prevalence of depression to the actual diagnosis of it, we see a huge gap which is more pronounced among African Americans and Hispanics than their Caucasian counterparts. But I might add that as you can see, we're not doing well across the board in diagnosing the depression that's out there in the community, but this just underscores the level of disparities that we see not only in major depression, but even in some of the subsyndromal types of depression, which can also exact a toll on someone's mental health. The next slide, please. Certainly one of the challenges is being able to recognize depression and other mental illnesses as they arise in different cultural clothes, if you will. Among Latinos the complaint, presenting complaint for depression might be nerves and headaches. Among Asians, weakness or imbalance. Among American Indians, being heartbroken. And among African Americans, the experience of anger or evil may be the presenting complaint. And even though all of these groups may also experience somatic complaints in the context of depression, which also can make it very difficult for the unsuspecting clinician to identify it. So here is an example of how individuals of various groups may go under the radar screen in terms of their mental health, and if they have HIV infection, we risk not being able to maximize the benefits of treatment because of the impact of depression on treatment adherence, et cetera. Next slide, please. Certainly in certain age groups, for instance, adolescents, this may sort of color the way in which an individual presents and may lead to depression not being recognized, the sense of hopelessness, declining academic performance, acting out, loss of interest in activities, and substance abuse, again, often a clue that a young person is having a mood disorder. And in our seniors, where it is also quite difficult to recognize and treat depression, physical complaints, anxiety, loss of ability to feel pleasure, lack of interest in personal care. Next slide. And, again, mentioning the fact that depression occurs with a number of other diseases, HIV/AIDS, heart disease and stroke, and even cancer, which we heard about a moment ago, making all of these conditions quite difficult to treat. Next slide, please. In terms of mental illness and substance abuse, we know that there's a very high risk of substance use disorders in people with anxiety disorders, mood disorders, and schizophrenia, and it can go in either direction, that people with substance abuse have high risk of mental illness, and people with mental illness have high risk of having co-occurring substance abuse. And all of this increases risk for a whole plethora of negative outcomes. Next slide. Now, we also know that there's a drug treatment gap, that 3.9 million people in our country need drug treatment for whom no services are available. So these populations are very much at play. Race is a main factor in admission to treatment outside of the criminal justice system, meaning that populations of color are very vulnerable in this regard. And we know that admissions are linked to insurance status, which means that 62 percent of those who are receiving care are white, 24 percent African American, and less than 13 percent Latino. Next slide, please. I've spoken about this before, about the risks of incarceration in populations where mental illness and substance abuse have not been recognized. Certainly these conditions predispose to incarceration for the minor offenses, and certainly the high arrest rates that we see in association with the War on Drugs also fuels this. But the problem is that once people end u in the correctional system, they find themselves in a hotbed of HIV/AIDS transmission, only fueling the epidemic more, and when people are released, you know what happens in the community. Next slide. We know that these trends are increasing and that more and more it is people of color who will be populating the correctional institutions. Next slide. Certainly our government has taken some leadership in these areas. SAMHSA has expressed a vision of life in the community for everyone and the need to build resilience and facility recovery. They've developed programs and issues to focus on that include co-occurring substance abuse and mental illness programs, looking at substance abuse treatment and homelessness, targeting some of these high need populations, those with HIV/AIDS and hepatitis, and the criminal justice system, and always crosscutting with these is the need to pay attention to cultural issues and the need to eliminate disparities. Next slide, please. And certainly the President's new Freedom Commission on Mental Health in 2003 talked about achieving the promise, transforming mental health care in America, and improving access to quality care that's culturally competent, and certainly imploring states to address ethnic and racial disparities and increase diversity in the mental health work force which really relates to Dr. Sullivan's leadership and his report on missing persons, and this is quite an issue for us in the mental health sectors as well. Next slide, please. To summarize, mental illness is a risk factor for and consequence of HIV/AIDS. Certainly co-occurring mental illness and substance abuse is a common pathway to HIV/AIDS exposure, and addressing these issues is one way to reduce HIV/AIDS risk. Certainly integrated treatment of co-occurring disorders can improve HIV/AIDS adherence and outcome, and we certainly need to take into account the ways in which ethnic and racial disparities in HIV/AIDS. We know that communities of color are particularly hard hit with HIV/AIDS, and that means that we must identify and treat mental health needs and substance abuse whenever we can because without that, it's a lethal combination. Next slide. I'd like to leave you with a vision for the future, that we must improve public awareness of mental health problems in people with HIV/AIDS, awareness of effective treatment that exists for these conditions, and promote prevention, early detection and access to integrated care, in particular, where people in one location can get HIV care, substance abuse care, and mental health care, sort of the idea of a one-stop shop, which improves adherence and receipt of treatment, certainly increased funding for treatment and research. And next slide, please. We must insure the supply of mental health services and providers. We must increase the work force and educate them about these co-occurring disorders, HIV/AIDS, substance abuse, and mental illness. Certainly, parity in the way that we provide services, community based approaches and culturally competent clinicians so that we can be better able to tailor treatment to age, gender, race, ethnicity, and culture. Next slide, please. I want to thank you so much for your attention and just provide you with some hope that in working together that we can tackle these very significant problems in our society. I hope that the American Psychiatric Association, my Office of Minority and National Affairs, as well as the Office of HIV/AIDS Psychiatry can be helpful to this council and individually to each of you with your constituencies. Thank you very much. (Applause.) DR. REZNIK: Thank you, Dr. Primm. That was an exceptional presentation, and each of us is charged with writing a paper this year, and we will be calling upon you. I actually told Joe Grogan. I said we should just get the transcript and that could be our mental health section of the treatment and care part of the program. It was very well done. We have a few minutes for questions. We are running late, but let me get a pen and who? Okay. Dr. Yogev. DR. YOGEV: Thank you very much for your talk. I would like to urge you to separate the pediatric adolescent into those who have got the infection through pregnancy, who already had the brain affected to such a way that they are already handicapped by the cognitive, to start with, and then they're coming into adolescence in a different set-up, already being in a minority, single mother, poor, and cognitively handicapped. DR. ANNELLE PRIM: Yes. DR. YOGEV: And discrimination is part of it, but disclosure is a majority, that they don't know about the disease suddenly to discover. And it's a different population that needs help, and as you mentioned, the pediatric is really way behind on psychiatric approach, and I don't see the government putting them in a special category to work versus the adolescent who just received the infection, which have a different perspective. So I would appreciate if your office will really put stress because we find major difficulties in getting psychiatric, psychological/psychiatric help to this type of population that are small in number, but each one of them is very important. DR. ANNELLE PRIM: Yes, thank you for pointing that out. I had not focused on that population, but I think your point is well taken. They're extremely vulnerable and need mental health services probably right from the start. So thank you for that. DR. REZNIK: Our next question is from Jackie Clements. MS. CLEMENTS: Thank you. As you did say and we all know that HIV does affect the brain and sometimes the onset of mental illness can be very, very subtle, and if you'll allow me the experience of my husband, you know, from beginning to forget keys, where he put them, to what you think, "Oh, that's age," to the point of forgetting numbers, which was probably his quick, you know, best thing. He was like a phone book and then all of a sudden to the point of forgetting how to get home. So how often and when? Because we do think, you know, as we age, oh, it's okay to forget those things. It's natural to forget some things, but how often and when do you begin to assess a person's mental illness possibly so that it doesn't get to the point of dementia and forgetting your way home before you realize that they're becoming affected mentally by this disease with dementia? DR. ANNELLE PRIM: HIV infection can affect the brain directly from the very sort of inception of infection, if you will, and I think what it really suggests is that psychiatrists need to be an important part of the treatment for anyone with HIV/AIDS so that they are evaluated and you establish very early on in the illness a baseline against which you can compare people over time what they look like in cross-section so that you'll know, you know, what is occurring and be able to pick up on, you know, symptoms and signs like what you just described. So I think that really just makes a case for the involvement of psychiatric evaluation very early on, you know, once the infection is detected. Very difficult to know that if there's no baseline and it's just sort of coming out of the blue, but a very, very important point. I think my first case of AIDS that I ever saw, I had just finished my residency and a family member brought in a young woman who just suddenly seemed just out of it and sort of looking off into space. And you know, over time we figured out what was going on. It was in the early '80s when this occurred, and no one had seen her behave that way before. It was very uncharacteristic. So you're very right. These are quite subtle. So we need to have a high index of suspicion for someone who has the infection to be able to identify those as dementia. DR. REZNIK: Dr. Primm -- a committee chair choice here -- we heard from the oncologists early today how they're tracking incidents of cancers. People are living longer and longer on antiretroviral therapy. Is there a similar tracking that's going on on mental health status for people who have been on therapy for several years? DR. ANNELLE PRIM: Diane, if you're in the audience, maybe you know this better than I, if there is some sort of registry or tracking process that's going on. MS. PENNESSI: No. DR. ANNELLE PRIM: Okay. I guess someplace for us to get to, something for us to work on, but thank you for raising that. DR. REZNIK: Dr. Green? DR. GREEN: Yes. Thanks for a very interesting presentation, Dr. Primm. DR. ANNELLE PRIM: Thank you. DR. GREEN: I was looking at your slide, the vicious cycle, substance abuse, mental illness, violence, incarceration, and so forth, and that's not even adding the possibility of being HIV infected and having neurocognitive disorder. Your plea is for early detection and treatment of mental illness, and this certainly sounds reasonable, but you know, what realistically would the options be for treatment? Who would do the treatment and how much treatment is needed? Just thinking about substance abuse, arguably self-help groups like Alcoholics Anonymous have done as much or more than professional treatment of just that one problem here in the vicious cycle. If we're talking especially about somebody poor, from a minority group with these multiple problems, you know, realistically what would the treatment or the care options be? DR. ANNELLE PRIM: Well, certainly there are community mental health services that are available. I do have to agree with you that it's difficult to get people to treatment because of the stigma that exists, and I've been fortunate to be involved in some community based activities, to actually organize community leaders, church members, et cetera, to conduct health fares where individuals receive depression screening and other sorts of mental health screening, and then are equipped with the resources to provide individuals about where to get help. Of course, these are supervised. These health fares are supervised and backed up by mental health professionals, such as psychiatrists, nurses and social workers, but this has been a very effective way of penetrating some of the barrier and some of the stigma that people may associate with coming to an institution to get help. Other ways are to locate mental health services in the same place where people get other sorts of services, like social services, for instance. There has been a very successful program like that in the State of Illinois where mental health services have been locate and screening has been located where people come to receive their welfare to work sorts of resources. There are other examples. I have had a very wonderful experience being the first psychiatrist to ever set foot in the Johns Hopkins substance abuse treatment program, where I worked alongside the primary care physician treating the individuals there who were receiving substance abuse care, treating them for mental illness and often working in concert with the HIV/AIDS physicians, as well. And so, again, that one-stop shop approach where you don't always have to wait on someone coming to the mental health provider, which is unlikely, particularly in these populations, given the stigma, you really need to be strategic about where those mental health services are offered so as to increase the likelihood that people will receive them and benefit from them. Another approach is to educate primary care physicians and others how to identify and treat mental illness. We know that particularly in the minority community if individuals are going to get care at all, it's most likely to come from a primary care physicians. So equipping and empowering primary care physicians to be able to better treat those conditions using effective screening and quick screening, for instance, for depression tools like the PHQ-9, for instance, this is another mechanism for quickly identifying depression and being able to treat it and track it over time. There are a lot of things that we're employing, and some of my work in developing educational video tapes on depression, one called "Black and Blue, Depression in the African American Community," the other "Gray and Blue, Depression in Older Adults," which is a multi-cultural video, shows individuals of these ethnic and age groups who have experienced depression themselves, talk about it, and it really helps for individuals who might have depression to relate to that person and to see that it is good to get help, professional help, or to get treatment. So those are just some of the examples to try and reverse that trend that you speak of. DR. REZNIK: Dr. Primm, would you be able to stay through our lunch break today? DR. ANNELLE PRIM: Yes. DR. REZNIK: Because there are other questions, and I've turned down Dr. McIlhaney twice now, and it's not appropriate because in the military -- I'm sorry -- but the last question is going to go to Dr. Sullivan, but you will be at the top of our list after our next mental health update from SAMHSA. CO-CHAIRPERSON SULLIVAN: Well, thank you very much, Mr. Chairman, for this special privilege you've granted me. (Laughter.) DR. REZNIK: I think it's on target. CO-CHAIRPERSON SULLIVAN: The question I have, I was struck by your statement. I want to be sure that I heard it correctly, and that is there are more HIV/AIDS individuals in corrections institutions than in the health system. DR. ANNELLE PRIM: No. I mean there were more people with mental health problems in the correctional system. That's the place, the correctional system is the place where the most, the largest number of people with mental illness are now housed. It used to be the state psychiatric system, but I think my point was that in being in the correctional system, those individuals who are vulnerable because of their mental health needs and their substance abuse issues are vulnerable yet again, being in a setting that is currently a hotbed of HIV/AIDS. I did say that because of the sorts of things that go on in the correctional system. That was my point. CO-CHAIRPERSON SULLIVAN: Well, if I might follow with a related question, do you know what percentage of those patients with mental illness, with HIV in the correction system have access to mental health services? DR. ANNELLE PRIM: I don't know the percentage of those with mental illness and HIV/AIDS, and I don't have a percentage for you of how many have access to mental health services. There are mental health services in some correctional settings, but they tend not to be of high quality, and there are some places where there is minimal to no care. So this is a challenge for the nation because, as you know, once people are released, they are not welcomed with open arms in our communities, and even some of the community based mental health providers are not excited to receive these individual and treat them. So that's a big gap there. Thank you very much. DR. BENY PRIMM: I would like to recommend some biased applause for my daughter. (Laughter and applause.) DR. REZNIK: We're going to take a short break. We had originally scheduled a ten-minute break, but our next presenter needs to be at another meeting at 11. So if you could please keep it to five minutes and hurry back, I appreciate it. Thanks very much. (Whereupon, a short recess was taken.) DR. REZNIK: Our next presenter is Abby Block, who is the Senior Administrator to the CMS Administrator or became Senior Advisor to the CMS Administrator in October of 2004. She has played a leading role in implementing the Title I and Title II provisions of the Medicare Modernization Act. She's worked extensively with health plans and beneficiary advocacy groups to insure an effective transition to the new Medicare Advantage and prescription drug program in 2006. We had the pleasure of hearing Abby Block at the Treatment and Care Committee meeting earlier this year, and I'm very proud and happy that she's here once again to fill us in on the Medicare prescription drug benefit and how it's going to impact people living with HIV and AIDS in the United States. MS. BLOCK: Well, thank you very much, and of course, Dr. McClellan sends you all his very best wishes. He's on a bus somewhere in New Jersey, and as many of you may have heard because the news coverage was very good, the President formally kicked off our outreach campaign right here in this building on Thursday and then went to Minnesota with the Secretary for some follow-up, and today is Florida Day. and so Dr. McClellan and the Secretary are, as I said, on a bus somewhere in Florida reaching out to seniors and to their families as we begin the formal enrollment effort for this new, very exciting 2006 Medicare prescription drug benefit. So just a quick overview for those of you who aren't already familiar with it. I'm sure most of you are. As you know, the Medicare Prescription Drug Improvement and Modernization Act of 2003 was passed in December of 2003, and beginning in 2004, we initiated the prescription drug card or the discount card and also saw a significant enhancement of Medicare Advantage plans in the program. In 2005, preventive benefits were initiated for the first time in the Medicare program, and those preventive benefits have a very strong link, of course, to the prescription drug benefit since prescription drugs can play such a huge role in preventing more serious events really at all levels in the cycle of care for patients with all kinds of problems, including severe chronic illnesses. In January of 2006, the prescription drug benefit formally goes into effect, beginning January 1. Right now, in June, CMS is engaged in a huge effort with the Social Security Administration, getting people who are eligible for a low income subsidy information and forms to help them sign up for that benefit. It's a huge benefit for low income subsidy eligibles, and that effort is going on right now. Enrollment in the new program begins November 15th of 2005, and not only will Part D plans or prescription drug plans be available, but many, many additional Medicare Advantage plans, both regional PPOs and local plans all over the country. Some of the key dates that we're looking at at this point in the process. The final bids were due to CMS on June 6th. We received many, many, many bids both on the MA side and the MAPD side and the stand alone PDP side, and the response, to say the least, has been robust. We're not giving out exact numbers at this point because the bids need to be analyzed and negotiated, the benefit packages reviewed, and until the actual contracts are signed, we don't really have accepted participants. The date for signing those contracts will be some time in mid-September. So everyone at CMS is working very hard at this moment in time reviewing those bids and seeing what they look like. In October plan marketing starts. The Medicare and You handbook becomes available. It will be in the home of every Medicare eligible in October, and dual eligibles, that is, the Medicare/Medicaid dual eligibles, in October will be auto-assigned to a PDP plan. They will be notified in October of what plan they've been auto assigned to, and in that notification they will also be told that they have the option of changing to any other plan of their choice, and they will, of course, be able to do that during the regular enrollment period. But we wanted to make absolutely sure that nobody would have a gap in coverage, that is, none of the Medicaid eligibles who will be losing their Medicaid coverage on January 1. They will absolutely be enrolled in a Medicare prescription drug plan before January 1 so that they have continuity of coverage. The formal open enrollment period begins on November 15th and ends on May 15th of 2006, and that May 15th date is just for the first year of the program. In subsequent years, the open enrollment period will be from mid-November to December 31st. As you probably know, there is in the statute a standard Medicare prescription drug benefit, and I want to stress that this is just the standard benefit because plans have all kinds of opportunity to modify that benefit so long as it's actuarily equivalent to the standard benefit. That is, it can't be less than the standard benefit. And so what we're looking at is considerable variation on the part of plans, and in addition to that, there is in place a payment demo which gives the plans even more latitude in terms of how they can design their benefit packages. So this is the standard, but there will be considerable variation from this standard, and before I give you this, I need to remind you that none of this applies to dual eligibles; that dual eligibles pay nothing other the $1/$3 prescription drug copayment, and dual eligibles who are institutionalized pay nothing at all. So this applies to others than the dual eligibles. The standard benefit is the $250 deductible up front, after which Medicare pays 75 percent of drug costs up to $2,250. The beneficiary pays 25 percent of those costs. After that the beneficiary will pay 100 percent of drug costs between that $2,250 and $5,100 amount. At that point the beneficiary's total out-of-pocket cost will be $3,600, and then the catastrophic coverage kicks in. And after that Medicare will pay about 95 percent of the costs. In terms of others than the full dual eligibles, just as an example, for beneficiaries with income up to 135 percent of the federal poverty level, there are no gaps for beneficiaries with incomes at that level. Only the area in red must be paid by the individual, and the total out of pocket is the sum of the two to $5 copays for up to $5,1000 worth of prescriptions. So there's a lot of help there in terms of subsidy eligibles and low income eligibles. There's a lot of help for people in those categories. In terms of where we are, I'd like to tell you a little bit about the road to implementation, the progress that we've made so far, where we are, and what's ahead. As you probably know by now, the MMA directed the Secretary to establish prescription drug plan regions, and that process was separate from the final regulation. On December 6th, 2004, CMS announced the establishment of 26 MA regions and 34 PDP regions, and there's what the map looks like. This is a map of the PDP regions, and each of the territories, in addition, is it's own region. I'm happy to say that at this point we have maple bids. We have no expectation that there will be fall-back plans anywhere in the country. We expect to have full coverage everywhere, including the territories as of this point in time. And in addition to the very robust response on the PDP side, on the MA side participation has increased significantly. We are anticipating that in 2006, actually by the end of 2005, where plan contracts are already approved, we know already that at least 80 percent of eligible beneficiaries will have access to an MA or MAPD plan beginning in 2006. So coverage had been extended significantly, including coverage in rural areas. CMS has released a lot of guidance in addition to the final rule. Subsequent to the final rule, we released very specific guidance on long-term care coverage, on the transition process that will be required, on fiscal solvency standards for the plans, on prescription drug event data which is basically claims data that we'll be monitoring very carefully to have an understanding of what and how prescription drugs are being used. On employer waiver guidance that's for those retirees who are covered by a plan provided by their former employer. We also -- and this is of special interest, I know, to this group -- when we issued our formulary guidance, we specified that there were six drug classes of special interest. Those were the anticonvulsants, the antipsychotics, the antidepressants, chemotherapy drugs, HIV/AIDS drugs, and immunosuppressants. And we have required that all or substantially all of the drugs in those categories will be covered, and we've just release additional guidance that clarifies that, and I can assure you once again that in the HIV/AIDS category every drug will be on the formulary. And just as a special note with special provision for the HIV category drugs, the plans will not be able to use preauthorization for anybody stabilized on these drugs of, in fact, for any new prescriptions for these drugs. The only drug for which preauthorization will be permitted is Fuseon, and the reason for that is to insure from a patient safety perspective that it is being prescribed at the appropriate time in the treatment cycle, and there was, you know, considerable news on that issue. So you may already be aware of that. In Part D, our goals were as follows. We have a primary goal regarding access, and that is to insure that plans are available nationwide, both prescription drug plans and Medicare Advantage plans, and we've been really successful in achieving that first goal, I'm happy to say. In terms of operations, our goal is to insure that plans provide high quality service to beneficiaries and are able to operate effectively. That will be part of the review process as we look at the bids and the proposals, and we'll be working very closely with the plans to be sure that they can, in fact, deliver the services that they're promising. In terms of education outreach and enrollment, our goal is to insure that the 42 million Medicare beneficiaries can make confident decisions on their prescription drug coverage, and that means a huge, huge education and outreach campaign, which as I indicated was officially kicked off by the President here on Thursday, but which began really well before that, back into April when we really started our outreach seriously. Forty-two million medicare beneficiaries need to be educated so they can make confident choices on their prescription drug coverage. That's a lot of people, and the target populations include seniors in general and people with disabilities who are Medicare eligible. It includes the low incomes population, of course, with special emphasis not only on the dual eligibles who are working on with the states, but also the low income subsidy eligibles who, as I mentioned, were at this very moment working with SSA closely to get them all the information they need to apply for the subsidy. Retirees, those are the people who are covered by a former employer's plan, and the population that's already enrolled in Medicare Advantage plans. The beneficiary target support list, this is how it breaks down. Percentage-wise, about 5, point -- I'm sorry. It's not percentage. It's numerical. The 5.7 million who are in Medicare Advantage plans now, the 11.8 million who are covered by a former employer's plan, 6.3 million people with Medicaid, 7.7 million other people with limited means -- those are the low income subsidy eligibles -- and 11.0 million who are the remaining general population, and that's the group that's either covered by Medigap or has no prescription drug coverage at all at this point in time. We understand that we need to increase the percentages in the following categories. We need to make beneficiaries aware of the Medicare prescription drug benefit. There are some surveys out there that say a huge percentage of beneficiaries are totally unaware of the program, and that includes the Medicaid beneficiaries. The survey or surveys were really taken well before our outreach campaign began, and I can assure you that beginning now there will be nobody left in the country who will not be aware that this benefit is available. Beneficiaries need to believe that the Medicare benefit has a positive impact on their lives, which means an understanding that there is a substantial federal subsidy in this program, and that it is to everybody's advantage to sign up. Beneficiaries need to understand that they have to make a decision regarding enrollment. Unlike Part B, it is not an opt out program. It's an opt in program. So except for the dual eligibles who will be auto enrolled, in order for people to receive the benefit, they must sign up. And they have to take action regarding their drug coverage, and they have to actually enroll. As I mentioned earlier, President Bush kicked off the awareness campaign on Thursday, June 16th, here at HHS, and that began the nationwide awareness drive. The President urged everyone on Medicare to sign up. To quote him, he said the message to seniors was when they have a form, when in doubt, fill it out. The President and Secretary Leavitt visited Minnesota on Friday, June 17th, to continue the focus, and Dr. McClellan and the Secretary are in Florida today, again continuing the outreach campaign. The general campaign message is that every Medicare beneficiary will be eligible for drug coverage that will help pay for the prescription drugs you need. The coverage will pay for both brand name and generic drugs. You've have a choice of at least two plans, and there will be additional assistance for those in need. That's our campaign message, and we're carrying that forward through every possible medium. There will be targeted messages to Medicare Advantage enrollees. What we're telling them is you will get more drug coverage through your health plan because of the prescription drug subsidy to retirees with good coverage through their employer plan. We're telling them your drug coverage will now get new support from Medicare because employers can receive a 28 percent subsidy for continuing their current coverage and also have some other mechanisms for continuing coverage if they choose to go a different route than the subsidy route. To people with Medicaid, we're telling them they will get comprehensive coverage with Medicare, and that comprehensive coverage is, as I said, full coverage, no coverage gap, no deductible. The only cost to people with Medicaid will be the $1/$3 per prescription copay, which is written into the statute. For other people with limited means, you need to apply for the low income subsidy, for comprehensive coverage, and that application process is going on right now. To the remaining general population, our key message is this is an insurance program. You need to enroll for help with current drug costs and for future peace of mind, and you save by enrolling on time, that is, if you enroll before May 15th, then you don't incur the one percent per month penalty that kicks in after that date. In terms of our time line, June to September 2005, we focus on awareness and limited income enrollment. We're building awareness including national grassroots education campaign, and we hope you all will be helping us with that. The low income subsidy applications are available. Community events on the low income subsidy and on the drug benefit will be taking place, and retirees will be enrolled and will be informed of the opportunity through their employers. October 2005 is support for the prescription drug enrollment. "Medicare and You" handbook will be mailed to all beneficiaries. Specific plan information will be available, and the plans will be starting their marketing campaigns. People with Medicaid will be notified about their Medicare plan enrollment, and we'll be supporting enrollment through grassroots education and counseling. November 15th, as I've said, is the open enrollment period beginning date. January 1st, 2006, the prescription drug coverage starts. May 15th, 2006, the open enrollment period ends, and after that there's a penalty just like for any other insurance where you enroll late. We've had a lot of ongoing training and assistance for plan sponsors. There were major training programs in Baltimore, quite a few of them. Weekly calls that says through June -- actually the weekly call schedule has been extended at least through the end of August. So we'll be in touch with the plans on an ongoing basis. There will be some training on how to submit claims data for Part D in July and August. Payment and enrollment conferences in Baltimore in August and September, and a retiree drug subsidy national conference July 12th and 13th in Dallas, Texas. And I might also add we're starting regular meetings with the states. We'll be meeting with states on a regular and ongoing basis. Some of that has already begun because it's really critical for us to work closely with the states, particularly in terms of the dual eligibles and also where the states have SNAP programs which cover additional people with limited income. So that's another ongoing effort.a Our field operations include a national strategy with a local execution, and when I say "local execution," I can tell you that that means literally down to the county level. This has been broken down county by county throughout the country so that there will be literally outreach activities in everyplace in the country. There will be a huge community network working through the CMS regions that are part of this huge outreach effort, and there will be a layered, coordinated outreach starting, you know, with the national partners and getting down to the local level. Partners will be targeted with application materials. National partners are drilling down to their local affiliates, and we have a time line, as I keep saying, for the low income subsidies that's carefully coordinated with the Social Security Administration. Partnerships, of course, are critical to the success of the drug benefit program. They allow CMS to work with organizations that are trusted by beneficiaries. They help CMS to focus information to specific audiences. CMS and its many partners share the common goal of helping people with Medicare get answers and make better informed health care decisions. We have started our collaboration, as you know, with the HIV/AIDS community. We've coordinated national level CMS regional offices, SSA local offices, and states. Some of the activities that we plan will be train the trainer activities. We're going to facilitate information dissemination through the state AIDS Directors, through HIV/AIDS specific medical providers, through pharmacies, and we have indicated -- I did it the last time I was here, and I again extend our willingness to participate in any national conferences that you all may have scheduled where we could help in this outreach effort. In conclusion, we've made great strides to implement the drug benefit. We're encouraging flexibility. We're willing to work with partners as we move forward. We've established a variety of mechanisms to answer questions, including training events, Web materials, user group calls, and a Q&A database. And if any of you are not aware of it, there is an extensive Q&A database up on our Website where questions can be sent in. They're reviewed. They're studied. Answers are prepared, and then the answer or answers are then posted on the Website so that they're available to everyone. With that, thank you very much. (Applause.) DR. REZNIK: Do you have any time for questions? MS. BLOCK: Yeah, I have maybe five minutes. DR. REZNIK: Okay. Questions? Dr. McKinnell. DR. McKINNELL: Thank you for your presentation and your work on implementation of Medicare Modernization Act, the success of which is important to all of us. You're recognized the importance of partnerships, which I think is absolutely critical. Our research shows that people don't know very much about this benefit. The more than they, the more they like them. And in your partnerships, I would encourage you to include private sector that knows something about marketing and communication and what's the help available. And where I think it will impact the program is in two variables: messaging and charted audiences. The better message seems to be not so much CMS pays because CMS, in fact, doesn't pay. They reimburse. They reimburse private plans, and I think your private plans will come up with a much better formula than Congress did, and that hasn't yet played out. So I think that message is very important. The other is the target audience. What our research shows, the benefit has enormous importance to the children of beneficiaries. So I wouldn't leave them out of the equation. MS. BLOCK: Well, thank you. As a matter of fact, you're right on target with where exactly we are. We're not only targeting the children of beneficiaries; we're targeting the grandchildren of beneficiaries. We're going into the colleges and recruiting the grandkids who are so computer savvy to work with their grandparents because tons of information and very good decision tools will be available on the Web, and it will be enormously helpful to have computer users help with that effort. We're particularly targeting, by the way, the Boomer women who we think will play a key role in working with their parents on this effort. So we're exactly there. We're also working with the industry. The industry has its plans, you know, for its own outreach campaign. We're working very closely with them, and I assure you since I sense some doubt about the communications skills of the federal government, we have excellent private sector professional consultants working with us on this outreach effort. It's a very professional effort with enormous private sector input. DR. REZNIK: Dr. Judson. DR. JUDSON: One comment and a couple of questions. This really is a huge new layer of complexity which is going to be baffling to an awful lot of people. The question is are the necessary information systems in place yet to allow the enormous new quantity of tracking to take place. MS. BLOCK: I'm happy to say yes. The information systems are, in fact, in place. They've already been through extensive testing, and as best we can tell at this point in time, everything is up and running and will be ready to go. DR. JUDSON: The other part of that, and you addressed part of our group earlier, is that in the tradeoff or the rationalizing between prior Ryan White, Medicare and Medicaid programs for funding of HIV care, how does this sort out again now? The new benefit is taking over for what prior parts of funding for HIV? MS. BLOCK: Well, it's actually available to everyone, including people with HIV, if they're Medicaid eligible. If they fall into that dual eligible category, then they really have virtually first dollar coverage. The only thing that they pay out of pocket is that $1/$3 copay. For people with slightly higher incomes, the subsidies range, but none of them have a coverage gap. They pay that two to $5 per prescription copay. In terms of contribution toward any of the drugs that are not covered for people who would fall outside of those categories, I think the issue that you're asking about was whether funds that were used to pay for the not covered parts of the Medicare benefit could count toward the true out-of-pocket, or TROOP, and that was a policy discussion that was had very early on, and the conclusion was that no federal funding could count toward true out-of-pocket, or TROOP. Other funding can. Any charitable contributions, contributions from foundations, those kinds of things can count toward the true out-of-pocket, but not federal dollars. DR. JUDSON: I just another way of asking the question is: of the estimated $29 billion of new taxpayer funding for this benefit for year 2006, is any of that being double accounted through current Medicaid, Medicare and Ryan White? MS. BLOCK: No. So far as I know, none of it is being double accounted. DR. REZNIK: Abby, thank you. One final question. Will patient assistance programs through the pharmaceutical industry count as true out-of-pocket expense? MS. BLOCK: That's a really interesting question, and it's one that we're still looking at. We don't really have an answer to it yet because it will depend on how those programs are structured. The issue there really is if the assistance is such that it's tied specifically to a particular drug that is made by a particular manufacturer, there is some problem with that. If it's a general contribution or a generalized program where it could legitimately, you know, be deemed a charitable contribution, then we're fine with it, but we have some issues and concerns with programs that are specifically linked, that is, where a particular drug manufacturer is offering some special discount or program associated with the drug that they manufacture. So, you know, that's the issue that we're looking at there. DR. REZNIK: Abby, thank you for that, and I know you have to leave. (Applause.) MS. BLOCK: Thank you very much. DR. REZNIK: Okay. We'll be hearing more from CMS on this because there still are many issues out there. I was actually at the HRSA IAS clinical conference before I came here, and the physicians are still very confused as to what is covered and what is not covered. So we're beginning the outreach process. Our next presenter, we're going back to mental health issues because we saw that there was such incredible interest from our first presentation by Dr. Primm. this is from Charles Curie. I think I've got that name right, the Administrator of Substance Abuse and Mental Health Service Administration. He was nominated by President George W. Bush and confirmed by the U.S. Senate October of 2001. As SAMHSA's Administrator, Mr. Curie reports to Secretary Leavitt and leads a $3.4 billion agency responsible for improving the accountability, capacity and effectiveness of the nation's substance abuse prevention, addictions treatment, and mental health services. I think it's also important to note that Mr. Curie holds a Master's degree from -- the Administrator of Social Services Administration is also certified by the Academy of Certified Social Work. Thank you. MR. CURIE: Thank you very much, David, and good morning, everybody. I want to thank you for that kind introduction and the opportunity to be here today. I'm pleased to join you this morning to discuss mental health, substance abuse, and HIV/AIDS. And I think that we all agree that the research fundings that came out of CDC last week bring an even greater sense of urgency to our work. With over a million Americans now living with HIV< our service systems must rise to an even greater challenge, and our efforts to prevent new infections must continue to improve. At SAMHSA, we're hard at work trying to find new ways to improve the quality and the availability of prevention and treatment services. The consumers of SAMHSA supported services are many of the same individuals who are at high risk of becoming infected or living with HIV. These issues, what we do at SAMHSA, what you're focused on here today are so interrelated that I believe substance abuse prevention and treatment are HIV prevention and treatment. And mental health services are a critical element to the spectrum of HIV/AIDS services delivered. So, in essence, what's going on at SAMHSA is what's going on in HIV/AIDS prevention and treatment, and if we're doing our job, striving to attain our vision and accomplish our mission, it's part and parcel of us accomplishing the mission around HIV/AIDS prevention and treatment. The outcomes and benefits are the end goal of SAMHSA. Especially those I'll cover this morning are many of the same outcomes and benefits that all of us in this room are looking for in terms of preventing and treating HIV/AIDS. SAMHSA is the core box in the nesting box. Addiction and mental illness have so many other illnesses that stack right up around them. If we're doing our job right, if we're doing substance abuse prevention right, if we're doing substance abuse treatment right, if we're doing mental health services right, then we are reducing the spread of HIV/AIDS and improving the lives of people living with HIV. This year alone, SAMHSA is investing just over $100 million in efforts to further develop local capacity to provide mental health and substance abuse treatment and prevention services for individuals living with or at risk of contracting HIV/AIDS. These funds are assisting states and local communities with conducting outreach and training, addressing the special needs of racial and ethnic minorities, and with studying the cost associated with delivering integrated care. Just as Secretary Leavitt has continued to make HIV/AIDS a priority for all of us and all operating division within HHS, it is clearly a SAMHSA priority. At SAMHSA we've aligned our budget, policies and programs around a core set of priorities. And I think you all should have received a copy of our SAMHSA matrix, which gives you a visual of SAMHSA priorities. If you don't have a copy, we'll have some for sale in the lobby afterwards during the break. But this matrix clearly begins to outline how we begin to approach our work. I call the blue axis, which is the horizontal axis, the leadership axis. These are set priorities, to make sure we're doing the right things, and that's what leadership is, is doing the right things. I call the red axis, the vertical axis, our management axis. That makes sure we're doing things right. That's management, doing things right, in the right way. So this matrix tries to represent SAMHSA's priorities and focus in doing the right things and doing those right things in the right way. And if you might notice in terms of these priorities, one of the reasons we developed this tool and one of the reasons after I came aboard SAMHSA we worked hard to focus on a few priorities is that we knew that it was critical, and I know that it's critical, especially in the mental health and substance abuse arena with so many needs out there. If you don't have a framework for your focus, it's very easy to fall into the trap of trying to let 1,000 flowers bloom, fund a lot of different types of initiatives trying to do a lot of good things, but if it's not done in the context of a framework in terms of trying to institutionalize what I call some solid redwoods, because, after all, I recognize that I'm a temporary steward in this position and I'll be here only for a few years, and when I leave we need to make sure there are some things that are solid. And you might notice that one of those major priorities specifically mentioned is HIV/AIDS and Hepatitis C because it is so critical in the substance abuse and mental health arena to be addressing that. It's clear that these illnesses, with many of our nation's most pressing public health, public safety, and human services needs, have a direct link to mental health and substance abuse disorders. The obvious link is why HHS has put a strong focus on prevention efforts and also building treatment capacity. Over the past four years we've worked hard at SAMHSA to align our resources. Right in the middle of the matrix is our vision statement: a life in the community for everyone. And to realize that vision of a life in the community, we need to accomplish a mission which we've redefined as building resilience and facilitating recovery. Again, the traditional mission of SAMHSA is to assure access to quality prevention, treatment, and assessment services, and that's still a major part of our mission. I want to let people know we've not wavered from that. But we felt that the mission should articulate the end game, that until people realize recovery in their lives, until people are really working toward and we're helping them build resilience in their lives, they're not going to attain that life in the community. And that's what we need to be doing in everything that we fund, in everything that we do, in policies that we develop, in how we frame things. We need to be leading in a way to help build resilience and facilitate recovery. Stopping drug use before it starts is foundational to that success, and it's also foundational to the success in the prevention of HIV/AIDS as well. In partnership with other federal agencies, states, local communities and faith-based organizations, consumers, families and providers, we are working to insure that every American has the opportunity to live, work, learn, and enjoy a healthy, productive, drug-free life. Under the leadership of President Bush, we've embarked on a strategy that's working. The most recent data confirms that we are steadily accomplishing the President's goal of reducing teen drug use by 25 percent in five years. Now at the three-year mark we've seen a 17 percent reduction. There are now 600,000 fewer teens using drugs than in 2001. This is an indication that our partnerships and the work of prevention professionals, the work going on in our school systems, with parents, with teachers, with law enforcement, with religions leaders and local community anti-coalitions is paying off. We know when we push against the drug problem it recedes. And fortunately today, we know more about what works in prevention, in education, in treatment than ever before. But we also know our work is far from over. To provide a science based, structured approach to substance abuse prevention, SAMHSA has launched the strategic prevention framework, and you'll notice that's another specifically stated priority on the blue axis. The framework allows states to bring together multiple funding streams for multiple sources to create and sustain a community based approach to prevention. We now have a framework that can cut across existing programs. I've seen it time and time again first hand. I've had the privilege to visit many cutting edge prevention programs in many communities around this country, and I've been tremendously impressed. But I also have been extremely frustrated when I leave because I see those prevention programs scrambling for limited dollars, for multiple federal, state, local, and public and private sector funding streams all have specific and sometimes competing requirements. All have different time frames in terms of how long the grants or the dollars will last, and in fact, my frustration also becomes even greater when I sense prevention programs and spending more time applying for grants than they're able to provide prevention services to the community. So in the Department of Health and Human Services alone there's the Health Resources and Services Administration, our good friends at HRSA. There are our good friends at CDC. There's our good friends at ACF. You'll be hearing from Wade Horn later today on youth development. There's the National Institutes of Health, and then there's the Departments of Education and Justice, as well as SAMHSA, that provide money for a range of prevention programs in the local community. These don't even include state, local and private funding streams. The problem is with them being so siloed going down to communities, many times communities don't even know all of the dollars they have to even develop a plan to leverage those dollars. And, secondly, each one becomes almost a trickling stream down to a specific program and ends up having a minimal impact in communities. With strategic prevention framework, we're looking to bring those trickling streams into providing an ocean of change in a community, to leverage those dollars together, and I firmly believe by focusing our nation's attention, energy, and resources, we can continue to make even more progress in reducing drug use and, concurrently, of course, HIV/AIDS. Whether we speak about abstinence or rejecting drugs, including methamphetamines, tobacco and alcohol, whether we're promoting exercise and a healthy diet, preventing violence, preventing HIV/AIDS or promoting mental health, we are really working towards the same objective: reducing risk factors and promoting protective factors. SAMHSA has awarded strategic prevention framework grants to 19 states and two territories. The grantees are working systematically to implement a risk and protective factor approach to prevention at the community level. Under these new grants participating communities will implement a five-step public health process known to promote youth development, reduce risk taking behaviors, and build assets and resilience and prevent problem behaviors. This approach also provides states and communities with the flexibility to target their dollars in areas of greatest need. This strengthens our ongoing efforts to use prevention dollars in ways that are meaningful and relevant to at risk and disproportionately affected populations right at home and in the communities in which they live. The success of the framework rests in large part on the tremendous work that comes from the grassroots community anti-drug coalitions. That's why we're so pleased to be working with the Office of National Drug Control Policy to administer the Drug-Free Communities Program. This program supports approximately 775 community coalitions across the country. Again, under the context of strategic prevention framework, we're looking for each community to be able to first come together, determine all that's being funded around prevention in that community from the different sources, and now that we're administering drug-free communities, we'll make sure they're at the table locally along with everything else we fund. And the other operating divisions within HHS have indicated that they will do everything they can to make sure what they fund in local communities come to that table as well. Education and Justice have expressed great enthusiasm about this approach and working with us. And once we have those folks together at a community level and that community then embarks on a process of identifying their risk factors that contribute to substance abuse, that contribute to seriously emotional disturbance, that contribute to the juvenile justice problem, that contribute to HIV/AIDS being a problem in the community; once those risk factors are identified and then protective factors are identified, they can embark upon a strategy to invest those dollars in programs that have an evidence base, that reduce substance abuse, that reduce problems in those other areas that we're discussing, and reduce the impact and have a baseline to be able to judge the effectiveness in the future and truly have a strategic prevention plan in their community. Along with launching this framework and finding new and innovative ways to partner with community based providers and faith based providers, SAMHSA has taken a lead role in the Secretary's Minority AIDS Initiative, or MAI. Through SAMHSA's Center for Substance Abuse Treatment, our MAI programs have provided funding for numerous community-based organizations. In FY '05, a total of 143 grantees received over $61 million in MAI funding and tens of thousands have been served. Through SAMHSA's Center for Substance Abuse Prevention, our MAI efforts are helping community based organizations to expand their capacity to provide substance abuse and HIV/AIDS prevention services. Through this program, SAMHSA has awarded 130 infrastructure and planning grants in amounts ranging from 100,000 to 125,000 over 200 multiple year service grants in amounts from 250,000 to 350,000. Our HIV/AIDS prevention activities also include SAMHSA's rapid HIV testing initiative. SAMHSA has several strong partners, including the National Institute on Drug Abuse, NIDA; the Centers for Disease Control; and again, HRSA, to name only a few who have helped us design and launch the rapid HIV testing initiative. SAMHSA has secured a federal contract with OraSure Technologies to supply rapid HIV test kits at no cost to eligible service providers. We began the implementation of the rapid HIV testing initiative during fiscal year 2005, and to date over 200,000 rapid HIV test kits have been distributed. And training on rapid testing is ongoing. For example, 87 SAMHSA funded grantees and 16 opioid treatment program providers have received training on rapid HIV testing, prevention, counseling as well as rel |