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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 related data collection activities. In fact, we really think it's very important for those providers to have access because of the high risk of the consumers who come to their services have for HIV/AIDS protection. We also know with certainty that HIV/AIDS disproportionately impacts minority communities. According to the latest statistics, minority populations account for almost 60 percent of the reported AIDS cases and injection drug use continues to play a major role with HIV transmission. In fact, the CDC reported that injection drug use among African Americans and Hispanics counts for over one-third of all AIDS cases. Even substance use that does not require the sharing or reuse of syringes or other blood contaminated equipment still puts an individual at risk. The loss of judgment, reduced inhibitions, poor communications associated with the use of other substances of abuse, such as alcohol, prescription drugs, elevate the risk of HIV/AIDS and hepatitis infection as well. Frustratingly, the CDC also estimates that one quarter of the U.S. residents infected with HIV are unaware of their HIV status. In fact, an overwhelming number of individuals who have made the effort to get tested at public funded sites never return for the results. Understanding this data, SAMHSA's rapid testing initiative goes far beyond simply making public funding available to test for HIV/AIDS. The rapid testing initiative is being implemented as a strategic intervention that will both facilitate the early diagnosis of HIV among at risk minority populations and will increase referrals to counseling, treatment and other supportive care services. And it's also going to provide counseling to those who tested negative to further decrease the risk of becoming infected. We are evaluating the initiative to capture the number of test administers as well as to determine if we improved in the early identification of infection. In other words, we need to find out if it's going to accomplish what we hope it's going to accomplish, and so we're studying it very carefully. Along with the test kits, SAMHSA launched a new program initiative in January this year called substance abuse HIV and hepatitis prevention for minority populations and minority reentry populations in communities of color. Fortunately the goal is shorter than the title. (Laughter.) MR. CURIE: The goal is to make sure that community level, public and private and nonprofit entities strengthen prevention services specifically for minority populations and minority reentry populations. A total of $20.6 million is available to fund up to a possible 82 awards in this fiscal year and an average annual award ranging from 250 to $350,000 per year in total cost, both direct and indirect for up to five years. SAMHSA is also piloting a new program to expand sustained HIV and substance abuse prevention education on the campuses of historically black colleges and universities, Hispanic serving institutions, and tribal colleges and universities. I want to mention that these prevention initiatives are operating in addition to the prevention and HIV/AIDS early intervention set-aside in the substance abuse prevention and treatment block grant, and in addition to our currently funded and ongoing targeted capacity expansion grants. With regard to the block grant, approximately 40 percent of the funds expended annually by states for substance abuse prevention and treatment come from the block grant. At $1.8 billion, the federal block grant combined with state funding is really the backbone of the substance abuse prevention and treatment system in this country because that's clearly where most of the dollars come from in terms of the public arena for substance abuse treatment and prevention. There are specific provisions and funding set-asides within the block grant, such as a 20 percent prevention set-aside and an HIV/AIDS early intervention set-aside. Regarding that HIV/AIDS set-aside, states with an AIDS case rate of ten or more per 100,000 of the population are required to obligate and expend a portion of their block grant for early intervention services for HIV. And in FY '05, that total is just about $60 million. The block grant, with its set-asides, has created the foundation and the infrastructure that makes initiatives like rapid testing kits possible. Sustaining that infrastructure is critical in order to carry out our treatment and prevention initiatives. The block grant required states to submit detailed annual plans and explain how and why they will spend their funds. Through this process, states and communities get focused on prevention, early intervention and treatment which moves us all forward together from planning to provide services, to achieving recovery based outcomes for all people the block grant money reaches. Along with the block grant, the targeted capacity expansion grants also play an important role. For example, the HIV prevention services and planning grants I mentioned earlier provide multiple year funding to community based and faith based organizations. This grant program was designed to enhance and expand substance abuse treatment and outreach services, pretreatment and prevention services in conjunction with HIV/AIDS services in the community. The grantees under this program are establishing networks among substance abuse treatment centers, medical personnel, mental health personnel, and public health professionals to prevent further spread of the disease and to provide high quality care to infected individuals. As our presence made clear, another way to prevent the spread of HIV and hepatitis is to fight drug addiction through treatment. President Bush made a commitment to help more Americans get the treatment they need. He made good on that promise with Access to Recovery or ATR. ATR was designed to expand treatment capacity by increasing the number and types of providers, including faith based providers who deliver clinical treatment and/or recovery support services. ATR is a voucher program that's based on consumer choice. It allows consumers in need of treatment to use their voucher to find and purchase the best services for them. This way recovery can be pursued through many different and personal pathways. If you have 200 people in a room in recovery from substance abuse and they tell their story, you'll have 200 different stories of recovery, some common elements, but recovery is clearly an individualized process. So the challenge for government, especially governmental bureaucracy which likes things in nice, neat protocols, to operationalize recovery can be a rather messy thing to do, can be a rather challenging thing to do. So Access to Recovery gives individuals choice about options available to them to pursue what pathway is best for them. The great news is interest in Access to Recovery has been overwhelming. There's a solid chance this coming fiscal year, I hope, if the field rallies that we can receive a 50 percent increase in funding from 100 million to 150 million. I will say it doesn't look as promising at this moment when the House mark came in with level funding for 100 million and not the 50 million we would like to see added because without any additional dollars, there's no way we can expand it beyond the 14 states and one tribal organization that we're funding currently. So we're hoping that when the Senate comes out with their mark and as the process continues, that 50 million that the President is asking for will be realized because, again, we have quite a gap in terms of the need for substance abuse treatment and substance abuse treatment and access to care in this country, and we can't let a year go by when we're asking for 50 million new dollars not for that to be realized. So hopefully the field will rally and will press and we'll see that $50 million that we need. These new dollars will help thousands of people seeking help find the help they need for their substance abuse problem. In turn, this will help many people in their addiction and will help to further prevent the spread of HIV or AIDS or help people gain access to HIV services. For those with mental health disorders who are at risk or who have already contracted HIV/AIDS, SAMHSA is working to make sure a life in the community is possible for them as well. In fiscal year 2001, SAMHSA initiated a grant program to address the unmet mental health treatment needs of individuals who are living with HIV/AIDS, who have a diagnosed mental disorder, and who are also from minority communities. Twenty community based organizations received five-year cooperative agreements to expand current service capacity through this program. Additionally, SAMHSA has made it possible for approximately 200,000 mental health care providers to receive training through the mental health care provider education program. This training helps providers increase their understanding of how to better address the mental health needs of people living with or affected by HIV/AIDS. I hope I've been able to shed some light on the many ways in which SAMHSA's helping to stop HIV/AIDS and hepatitis from devastating more lives. If we continue to build on these initiatives, maximize the power of the public health approach to prevention, expand substance abuse treatment capacity, recovery support services and continue to improve mental health services, we'll be better serving those with or at risk of HIV/AIDS and other diseases at the same time. Ultimately, we'll be better serving all Americans, including those in the criminal and juvenile justice systems, our homeless, our adults and our children and families. And I do firmly believe as a compassionate nation we can do no less. I'd be happy to answer any questions you might have. Thank you very much. (Applause.) DR. REZNIK: Dr. McIlhaney. I looked straight over there first. DR. McILHANEY: Dr. Curie, thank you. That was an excellent presentation. There's some data that would suggest that unless you try to help people not get involved in any risky behavior, you're not going to be very successful in helping them avoid the risky behavior you're focused on, such as substance abuse. Are you aware of or do you have any involvement in any pilot programs in which they're trying to help people not get involved in any risk behavior? In other words, programs to help to prevent people from getting involved in drugs, alcohol, cigarettes, sexual activity, as compared to programs just trying to focus on substance abuse involvement? MR. CURIE: Absolutely, and that's an excellent question. In fact, strategic prevention framework is really doing just that. We are clear that the risk factors that exist in communities as well as the behaviors that promoted substance abuse also promote a range of other activities, and that they're very much the same type of risk factors. So we're very engaged with the youth development efforts that are at play and the range of faith based efforts, and we're looking for each community under the strategic prevention framework to bring all of the efforts that you've just described. I mean, the vision that we have, and we've seen communities do this, there were about 127 communities, I know, in Pennsylvania where I just came from -- well, it's been a few years now. It feels like I was just there. Time goes fast -- that implemented a communities that care approach, which basically while substance abuse was a primary factor, all risky behaviors are looked at. And, again, that's the scope we're looking for for strategic prevention framework, and when you're going to hear from Wade Horn later to day, I mean, we think the partnerships we have with HRSA, with ACF, with CDC addressing the realm of risky behaviors has to be part of this. You can't just separate them out. DR. McILHANEY: Do you have any data comparing programs that are focused primarily on just one risk behavior, such as substance abuse as compared to -- MR. CURIE: We probably could get some. We could follow up with you and give you some data in terms of the evaluation of programs to see, you know, what type of clarity. Many times, as you know, when a program has been evaluated, it has been evaluated kind of along the silo way in terms of these interventions. We do have a national registry of effective programs that initially started out to be primarily focused on substance abuse prevention. We're now looking for it to include mental health promotion and also the treatment realm, and we can send you that registry and the criteria used, and that can give you this type of data. Thank you. DR. REZNIK: Our next question is from Dr. Primm. DR. BENY PRIMM: A great presentation. Let me ask a couple of questions that are dear to my heart, and that is what's going on with the block grant, for example. How does SAMHSA monitor what has been deemed as set-asides in the block grant that states doing what they're supposed to do with those dollars and whether they are distributing them in terms of substance abuse treatment? When there's a ten percent set-aside for HIV, for example, are they also applying those dollars to different modalities of treatment, particularly in states like Louisiana? My second question is about the prison system. I note that the Center for Substance Abuse Prevention has HIV/AIDS and HCV, and in the prison system there are multiple problems concerning HIV and Hepatitis C. What is the Center for Substance Abuse Prevention doing in that area and what is the Center for Substance Abuse Treatment doing in that area? And what about the expansion of treatment in those areas where those people are coming back to the communities now and in North Carolina where prisoners have been discharged to certain counties, the incidence and prevalence of HIV goes up and follow-up on those particular incarcerees and people who are ex-incarcerees? MR. CURIE: Thank you. In terms of the block grant monitoring, the way that is monitored, each state has an assigned project officer and each state is to submit their annual plan and then annual evaluation in terms of how the plan was carried out, and that's monitored, again, yearly by staff within CSAT and CSAP team primarily, and evaluating whether they're attaining their goals, whether they actually have set the goals, if they meet the criteria, for example, for the set aside that they have several benchmarks they need to reach. However, and your question is a very good one because block grant monitoring is very challenging, and states view block grants primarily as more flexible dollars as much as possible because, as I stated earlier, when it comes to substance abuse treatment, the block grant, the state match, what we do at targeted capacity expansion, and then anything else that a state may do on their own really makes up the substance abuse treatment delivery system in this country. Medicaid is becoming somewhat of an increasing partner in that area and arena, but it hasn't been as substantial as, let's say, it has been in mental health. So substance abuse really has been relying on these funds. What we're looking to do now is to strengthen the accountability around the block grant by holding them accountable to national outcome measures, which we've developed ten domains, and we can make sure that we share those domains with the councils so that we can see what's emerging around that which would measure outcomes in people's lives, whether these dollars are really working toward helping people not use, abstinence being a major part of it, as well as people gaining employment. Do they have stable housing? Are they staying out of trouble with the criminal justice system? If they have HIV/AIDS, are they receiving the medical support they need ongoing and are they getting the treatment they need? And really being able to paint this picture for the first time around these domains we're going to have a state picture painted on an annual basis, which will really bring the accountability to light and, I think, strengthen our hand in that arena. So that's something that we've made as a priority. So while there has been ongoing monitoring, we feel the need to strengthen it based on those outcomes. In terms of the prison system, we have several initiatives that are in place especially through CSAT. CSAP has been involved to some extent in these, but CSAT has been the lead on our reentry programs with Justice. Also we have worked very closely with Justice around both drug courts as well as mental health courts, and it gives us a forum to address the high risk illnesses and diseases that go along with addiction, such as HIV/AIDS. I could circle back with you to let you know what we're looking to plan around more of the prevention area and arena, but those are the forms that we primarily use. For example, when someone is reentering into the community, if they're under one of our grant programs, we're working with Justice, and they have HIV/AIDS. That's very much an issue that's address then in terms of how they will receive ongoing care and how prevention initiatives can continue in that area and arena. So we can circle back also with what we're looking at with CSAT. DR. REZNIK: Just so you know, I have on my list Jackie followed by Karen, Dr. Judson, and the Reverend Sanders. So Jackie. MS. CLEMENTS: Thank you, Dr. Curie. You did say that SAMHSA procured a federal contract for tests at no cost. MR. CURIE: Right. MS. CLEMENTS: Eligible service providers, what makes them eligible? MR. CURIE: Well, what we have done, and we actually have a question and answer sheet on the whole HIV rapid testing arena that we're going to make available to you that hopefully will address a lot of these questions. But our work primarily has been with providers of treatment that they can use it as part of their assessment when someone comes in and they've been referred. So up front you can determine if the individual has been infected, especially if they were an intravenous user. So there really has been no criteria used financially except that they're in our system and that they're beginning to receive treatment. Also, we're working with the State Departments of Health. In May we have what we called our May initiative to make sure that any State's Departments of Health in the states that wanted access to this to make sure it was available through their public health centers would have that available as well. So anyone who would be a client of the public health system in a state or would become a client in our substance abuse treatment delivery system would be eligible. DR. REZNIK: Okay. Next, Karen. MS. IVANTIC-DOUCETTE: Thank you for your presentation. As I listened to the things that SAMHSA is doing, you know, I still consider it kind of a top down model where you're trying to get the biggest bang for the dollars, and that some of the grantees are really those that are interested in a very stigmatized field. One of the issues though is that each one of these people is a person, and one of the things that we also know is that a lot of the prevention and care and treatment and effect in mental health outcomes is done in the one-to-one, in the primary care provider with the relationship and a trusted kind of situation. And I'm just wondering what SAMHSA is going in this. You have these large programs. You're looking at large aggregate outcomes, including homelessness drop and things along those lines, but what's happening on that personal one-to-one kind of scale? And just to put it in a framework for you, I'm a primary provider, and I'm dealing with this on a day-to-day basis, and one of the things, you know, whether I'm dealing by bipolar, substance abuse, and HIV all in the same package, but I'm getting good outcomes, but my other providers don't get the productivity release that I might get to do that. So is there a provision to begin to move SAMHSA, these large aggregate programs more down to that field of support? MR. CURIE: That's a great question. I'm a firm believer that unless what you've just described is going on at the individual level, we're not going to realize the aggregate outcomes; that we need to make sure that we're doing it right and that it's done right at a local provider level. We try to offer supports to local providers through our various technical assistance centers, and I'm finding all the time that it tends to be that SAMHSA grantees know who are like our addiction transfer technology centers are. We have regional centers affiliated primarily with universities, as well as we have what we call the prevention technology centers, the CAPTS, which focus on prevention, and then we have mental health technical assistance centers, and through these we are providing a range of not only information available on Web sites, as well as information directly available through clearing houses, but also training and ongoing trainings that are available to work with providers to help give and equip staff with what they need in terms of effective interventions. And let me make that all available ot you to make sure you're all aware of how you can reach out to those resources. Because I think we do need to equip the field. I think one of the things that the federal government can do quite well is provide an economy of scale of information that a local provider, especially in rural areas or more remote areas may not have access to, and in this day and age of technology, if we can provide more training and information and really utilize our clearing houses and have them utilized to a greater extent, I think it can foster the type of things you're describing, and that's available free of charge. Well, you paid for it through your taxes, but it's available to the provider free of charge. DR. REZNIK: Dr. Judson. DR. JUDSON: I think that when you start off a new program or funding a new program that having funding goals may be appropriate, but I think very quickly as you understand the problem better, emphasis needs to shift to evidence based outcome goals. MR. CURIE: Absolutely. DR. JUDSON: The parallel area that I'm most familiar with in terms of substance abuse is tobacco addiction over the many, many years, and I thought it was useful to look at Steve Schroeder's perspective on this. He's former President of Robert Wood Johnson, which has spent a major part of its funding effort over the years in tobacco prevention. And when he looked at sort of the bottom line for what worked, he concluded that there were just two factors. One was in the economic arena, where the cost of tobacco was very definitely related to consumption, and the other was changing societal norms in terms of where it's comfortable to do it, where it's supported to do it, and that, in turn, led to Clean Indoor Air Acts or environmental tobacco smoke laws. His feeling was that probably most of the so-called educational or informational programs were in the end marginally or ineffective. So when you cite a 17 percent reduction in substance abuse during the last four or five years, I'm fairly old now. So I've watched political parties take credit for anything that's trending in the right direction whether it has any direct relationship to a funded, targeted program and to disavow or put backwards to some other political party when things go the wrong way. Is there anything that you're truly enthusiastic about as being a cost effective approach, applicable program to substance abuse that you think has some causal relationship to the 17 percent reduction? MR. CURIE: That's a great question. Here's my opinion based on what I've been with the data. I think you can directly relate it when you talk about changing the norms. I think a major message has been going out in the last three years, and especially when you see the battle with marijuana, for example, and that's where we've seen a lot of the decrease of teen use. When the data is out there in terms of the new information coming out from NIDA about the impact marijuana is having on the brain and that begins to work its way into school systems and beginning to equip parents, I know when I'm out now I hear a distinct difference, and some of this is my own anecdotal experience, but it's things that I know that we've been doing differently the last four years trying to press the message, a strong message, much along the tobacco lines because I think they were successful in changing those norms, that marijuana is already illicit. So are the other drugs we're talking about primarily. Even under age drinking, alcohol is illicit if you're under 21, if you want to look at it that way. So in terms of laws already on the books, trying to point out that not only these things are illicit, but they are truly harmful, and what we're seeing in our household survey from year to year, that the year before we're seeing the decline in drugs, we are seeing the previous year an increase in the perception that these drugs are dangerous among youth. And so, again, I would never say that's a causal relationship. It's a correlation that we're seeing at this point, but in my mind it goes back to when you push back against it and really make more of an aggressive effort to say marijuana is harmful, especially the young, developing brain, and it's something we shouldn't even quibble about. We should go for it. Alcohol, the same thing. I think under age drinking, to be honest with you, is our next press because that's remaining stubbornly. It has plateaued for the years, and we need to press that and have some of the same things we did around tobacco apply there. But that's my impression of what has made a difference, and when I'm hearing teachers talk about alcohol addiction, when I'm hearing -- or substance abuse -- when I'm hearing parents now talk more about it, I'm hearing a lot of the information we've been trying to roll out start to come from people's lips out in the public, and that's an indication to me that that probably is a factor. But one thing we really do monitor is what's the perception of the danger of these substances, that measure. And, again, what we see if that increases in a particular year we can almost anticipate there's going to be a decrease in subsequent years. DR. JUDSON: Thank you. DR. REZNIK: Reverend Sanders. REV. SANDERS: Thank you very much for your presentation. I'm especially appreciative of the Access to Recovery strategy in terms of appreciating the individualistic nature of addiction. In that regard though, when I look at the statistics and your reference to the way in which injection drug use continues to play a major role in the spread of HIV, I wonder where SAMHSA is these days in terms of continuing to advance, you know, the research, continuing to advance looking at models around clean syringe initiatives. I know a few years ago there was a lot of evidence that there was some hope in terms of maybe helping in terms of the spread of HIV. It ends up being complex because obviously injection drug use is something that you want to figure out how to get people into treatment in relationship to, but at the same time, you understand that those who are injecting drugs are a big part of what's perpetuating the problem around HIV. I know some good research is being done, and I want to know where you are no in that. MR. CURIE: I know that we're working in close partnership with NIDA on an ongoing basis in terms of taking a look at what's really working in terms of a science based approach to stop the spread of HIV infections and, again, intravenous use is a major mechanism that's used. So we're continuing our partnership there and helping educate providers in what they need to let folks know as they come into service to try and help them deal with it even before they're in treatment or as they're engaging in treatment. So we've continued those efforts with NIDA. REV. SANDERS: This is a short follow-up. I think that one of the strategies that is important to consider -- and I know some people at NIDA have already been working on this. So this is a model of, you know, a bridge to treatment. MR. CURIE: Right. REV. SANDERS: Because very often the community that's involved in injection drug use is under the radar screen of a lot of our traditional strategists for bringing folks into treatment settings, how you identify them, how you develop the ability even of putting them in, and it seemed that there is some evidence. MR. CURIE: Well, and again, one of the major links we have to bringing that evidence to the front lines to provides is through the addiction technology transfer centers I mentioned. DR. REZNIK: And Dr. Sweeney. DR. SWEENEY: Thank you. Mr. Curie, as I was listening to -- I'm an internist, geriatrician, and the question that I have to ask you has not been well formulated, but I would still like you to comment on it. It's something I think about every morning almost driving to work past a large men's armory, which is a shelter in Brooklyn, New York. And one of your mission sis a life in the community for everyone, building resilience and facilitating recovery, and then you look at the programs and issues and you have co-occurring disorders, mental health system transformation, HIV/AIDS and hepatitis, and then we've talked about mental illness and drug use, and I want to add lack of preparation for life skills. And the reason I say this is because this looks like a model that we used to use a lot in medicine that we worked only for people's recovery, and we did not have a system in place as physicians and other health care providers for helping people to die, for example, with dignity. So what I'm asking is: is there any thought about relooking at having a place for people in the community that might not be a shelter, but more like a place that's long term for people who will not recover, and to have the facilities for them to make their life -- maximize any potential they have, but to do it in a sheltered environment, not a state hospital, but something that replaces the state hospital. Because many of the people who are in the street now, homeless, in fact, have mental illness, do, in fact, have mental illness. So I'm asking is there any thought to doing it another way. We have whole industry of homelessness care that has been built up since the state hospitals have been -- so the money is being used anyway to take care of this population, but in a very ineffective way, and whether or not there's any thought to redoing this and rewording the goals so that those people who won't recover, who are not going to be able to live independently can get the supportive care in a custodial environment or treatment custodial environment, mental health and all of the services they need, but be not warehoused in shelters, et cetera. And then an unrelated question is: do you have any follow-up on how buprenorphine treatment is going? MR. CURIE: Okay. Thank you. I think what you're bringing up here describes well the conundrum we're all facing in the field, and I think recovery is actually a major part of the solution of what you've just described. I think it's how we need to clarify and define recovery and that people are at different levels of recovery. There could be people who may never fully recover as we might define recovery of getting back to the point of having a full-time job, be reunited with family, develop that life in the community that we're talking about. On the other hand, there are people that I've seen both on the addiction side and the mental health side that are living those lives now that ten, 15 years ago, 20 years ago we thought they would have no shot at living that type of life. So I think framing things in terms of recovery helps us to begin to describe the end game of what our responsibility is as a public health, to be thinking in terms of more than just the initial intervention. Your point is extremely well taken though, and I think it is something we have to grapple with, and that is there are some individuals who may never recover at that level. So we need to then, in whatever system that we are funding and working with, be thinking in terms of what supports are needed to help an individual at their point of need of recovery to help make sure they don't slide back further, but that they're at the point of optimum functioning. And I like what you said. We don't want to go back to warehousing. We don't want to go back and just find let's put these folks in an institutional setting and we're meeting their basic needs and they're kind of segregated from the rest of the community, but what models are out there that you can wrap around supports with people and perhaps there may be different levels of setting depending on where their level of need is. But I believe recovery should be viewed as people reaching, continuing to reach the next level of recovery and they're in a recovering process, and I think that's how we need to think about it, and I think that begins to address also what you're thinking of and talking about because we can't ignore individuals who aren't attaining that level. In fact, we need to prioritize those individuals in our process. Does that help in terms of at least conceptually I know I'm talking here about how I think we need to implement this. The other thing I would go back to is the state hospital. My initial background in mental health, I was responsible for the ten state hospitals in Pennsylvania, and three of those institutions were closed while I was three. We learned through the years that we kept the money in the system when we closed the institution. We developed supports and housing supports, and wrap-around supports for people coming out of the hospital depending on their level of need. I think where we got in real trouble, when you turn the clock back 20, 25, 30 years ago and people were given a bus ticket and some medication and told, "Here's a doc you should look up when you get to your old neighborhood," or whatever, and that perpetuated the homeless problem. So, again, I think if we're going to do resilience and recovery right, we're going to put the right supports around people and meet them at their point of need to help them move to the next level of recovery that's possible for them, and I think that's how we have to implement it. Buprenorphine, I haven't received the latest data in terms of outcomes. I mean, I'm hearing good things in terms of results. I do know that we have I believe it's approaching over 3,000 physician offices trained. So the network is ever increasing. The capacity has increased, and everything we're hearing so far is looking like it's very much on track. I'm thinking it's something we may want to bring to higher profile as we move along because I think it's one of the best ways of increasing opiate addiction treatment. Doing it through the out-patient setting, I think it does fit with our goal of facilitating recovery and doing it in a way that is also less stigmatizing. DR. REZNIK: I think you, Administrator Curie. I was going to ask Dr. Annelle Primm to take questions, but we've run out of time. So I want to thank Administrator Curie -- MR. CURIE: Thank you. DR. REZNIK: -- and all of the presenters from this morning for a wonderful treatment section. Before I turn the program back to Joe, I do think that Dr. Primm will be here. So if any of the members have any questions, she has expressed willingness to address those questions personally, and again, thank you for a wonderful morning session, and thank you, Joe. (Applause.) MR. GROGAN: I was just going to ask the members to be in their seats by 1:00 p.m., and for members of the public, there is a cafeteria on the other side of the floor when you walk out past the elevators. Thank you. (Whereupon, at 12:00 noon, the meeting was recessed for lunch, to reconvene at 1:00 p.m., the same day.)
Afternoon Session (1:05 p.m.) CO-CHAIRPERSON SULLIVAN: It's now time for introduction of motion for action by the committee, and we will ask each subcommittee chair to present any motions that they wish the committee to take action on.And so we'll start with Prevention. MR. MASON: Thank you, Mr. Chairman. The International Committee will have one motion that we're going to put forward, and I think that we'll make copies available to members of the council at some point, I think, in the afternoon. There's a draft which we'll circulate, but it's a resolution to eliminate taxes and tariffs on donated medications, tests, and other materials used in the diagnosis and treatment of HIV disease, is the title of the resolution. And I won't read the whole thing, but I'll read the result because you're going to get copies of it, but it talks about the fact that there are tariffs and taxes on drugs that increase the cost and, therefore, reduces access to people who need them who can't afford them. So it says, "Be it hereby resolved that PACHA requests the Secretary of HHS to aggressively pursue policy options that will lead to the elimination of all taxes and tariffs on free, reduced price, or donor funded medications, tests, and other materials used in the diagnosis and treatment of HIV disease." Thank you, Mr. Chairman. That will be our only motion. CO-CHAIRPERSON SULLIVAN: Very good. Thank you very much. The Treatment and Care Committee, is David in the room or Dr. Reznik? Well, we'll wait until he returns. The Prevention Committee, Dr. Sweeney. Are there motions you'd like to put on the table? DR. SWEENEY: Thank you, Mr. Chairman. The Prevention Committee does not have a motion. We have a much broader agenda than a motion, which I have been told we cannot put forward at this time. I think you have it at your seats. Does everyone have a copy? MR. GROGAN: Yes, everybody should have gotten a copy. DR. SWEENEY: It's a draft of principles of the HIV/AIDS Strategy Prevention Subcommittee, and it is not a motion, but a plan which we will need to discuss in much greater detail than a resolution, and we respectfully ask that everyone reads it and be prepared for our discussion when our Chairman or Co-Chairman -- thank you -- gives us the opportunity to do so. CO-CHAIRPERSON SULLIVAN: Very good. Thank you very much. And our third chair -- let's see. Dr. Reznik has not returned. MR. MASON: I don't think he has a motion. He told me he didn't have one. CO-CHAIRPERSON SULLIVAN: Oh, fine. We're informed that he does not have a motion. So that covers that item. We're now at the time for 1:10, that is, positive youth development and healthy choices. We have Assistant Secretary for Children and Families, Dr. Wade Horn, whom I had the pleasure of working with when I was Secretary when he was Commissioner for Youth, Children, and Families. And his biographical sketch is in our book, and he also was one of the founders of the National Fatherhood Institute that focuses on increasing the relationship between fathers and their children and trying to preserve the family structure. So we're very pleased to have Wade Horn here who is going to tell us about positive youth development. Dr. Horn, welcome. DR. HORN: Well, thank you very much. First of all, it is a great, great pleasure and honor to be with you again, Dr. Sullivan. I had the pleasure of being in this room, I think, on a number of occasions when you were gracing the halls as Secretary of HHS. For those of you who don't know, he's the person who offered me my first job in federal service. It is always a great pleasure to be with you. You are one of, I think, the most important and influential figures in health today, in the public health arena, and it is always just an honor to be with you. So it's great to be here. I know some people here like Joe on the committee and Anita and so forth. So it's great to be with all of you as well. As Dr. Sullivan said, I'm the Assistant Secretary for Children and Families here at HHS, and as such, I've been asked by Joe to spend a little bit of time talking about strategies for dealing with HIV/AIDS prevention when it comes to youth. And so today what I'm going to do is begin by highlighting some statistics, which I guess as most of you are all too familiar with related to the incidence and prevalence of HIV/AIDS among youth, then talk a bit about the necessity of providing clear messaging to young people on ways to prevent the transmission of HIV/AIDS, and then talk a bit about positive youth development. And I understand that I've got 20 minutes or so and then there will be some opportunity for questions and answers; is that right? Great. As I'm sure I don't have to tell members of this committee, every day about 8,000 lives are lost to the AIDS pandemic around the world. Millions of people are, in fact, affected with the HIV virus, half of which life in Africa. An estimated five percent of those infected with HIV are children under the age of 15. In the United States more than 38,000 young people between the ages of 13 and 24 have been diagnosed with AIDS since 2000, and more than 10,000 young people have died from AIDS. In 2003 alone, an estimated 7,081 young people were living with AIDS, a 37 percent increase since 1999 when roughly 5,000 young people were living with the disease, and in 2003 an estimated 3,900 young people received the diagnosis of HIV/AIDS, representing about 12 percent of the persons given the diagnosis during that year. And although young persons account for only about two percent of the more than 524,000 total deaths of people with AIDS in the United States, I think, since 2000, I think that we all can agree that that is two percent two many. As President Bush has noted, and I quote, "HIV/AIDS is a direct challenge to the compassion of our country and to the welfare of not only our nation, but nations all across the globe. It's really one of the great challenges of our time. This disease leaves suffering and orphans and fear wherever it reaches." So given the magnitude of the problem for young people, Joe has asked me to address the following question: how can we spur behavior change so that young people can avoid becoming infected with HIV/AIDS? My answer to that question is by adopting the same strategy that the President has adopted for preventing teen pregnancy and sexually transmitted diseases more broadly, and that is what we need to do is to find ways to empower teens to make healthy, responsible decisions for themselves, including healthy and responsible decisions when it comes to sexual behavior. In most cases that means encouraging young people with a clear and consistent message about the importance of remaining sexually abstinent until marriage. That's because abstinence is the only 100 percent effective way to avoid pregnancy and sexually transmitted diseases, including HIV/AIDS. And by sending you a clear and consistent message about the benefits of abstinence, we can help bring down the numbers of young people with HIV/AIDS. Now, the medical and social science literature is clear that the earlier a teen begins sexual activity and becomes sexual active or what researchers call their sexual debut, the higher the number of lifetime sex partners that person will have, and the more sexual partners one has over the course of their lifetime, the higher they are at risk for contracting a sexually transmitted disease, and of course, having a sexually transmitted disease is a risk factor for HIV transmission. So the key to helping young people avoid HIV/AIDS, as well as other sexually transmitted diseases, is to help them delay the onset of sexual activity, preferably until marriage, but certainly until they are at least out of high school. President Bush believes that abstinence and abstinence education is, in fact, a prudent strategy when it comes to combatting unwanted pregnancies and STDs, including HIV/AIDS, because it sets a high cultural standard to which young people can aspire, and in contrast to some who counsel resignation to the issue of early sexual activity by our young people, the President believes and at the core of abstinence education is the idea that young people, in fact, can control their behavior; that at its core abstinence is about empowering young people to live healthy lives so that they can avoid all sorts of health risks, including HIV/AIDS. As the President has said, "When our children face a choice between self-restraint and self-destruction, government should not be neutral." So the value of abstinence education is it presents a clear and consistent message when it comes to sexual behavior. As a psychologist I know that the best way to influence behavior is to provide clear and consistent messages about that behavior. When messages become confused, so does behavior. An authentic abstinence message is one that presumes that teens can, in fact, control their sexual desires and impulses. Unauthentic abstinence messages, in contrast, presume that kids are victims of those desires that are beyond their ability to control and that the best we can do is hand them a condom or some other form of contraceptive to lower the risk of either pregnancy or sexually transmitted diseases. Now, of course, this is kind of a "please don't become sexually active, but just in case, do this" message. Now, it's interesting. We don't use that "please don't, but just in case" message when it comes to other kinds of high risk behaviors for young people. We don't say, "Please don't drink alcohol when you're under age, but in case you do, we're going to teach you how to drink it safely." We don't say, "Please don't smoke cigarettes, but in case you do, let's talk about using low tar and nicotine cigarettes." We don't say, "Please don't use illegal drugs, but just in case, we're going to teach you how to use a bong so that you don't spill the bong juice on your lap," which by the way, was an actual message given in a book in the 1970s when in the 1970s we were confused about the need to give young people clear and consistent messages about no use when it comes to illegal drugs. So what we need to do when it comes to a variety of risks is be clear about what it is we want them to do. Imagine if you will for a moment the following scene. I travel a lot as I'm sure, Dr. Sullivan, you do and many people here on this panel do. I've been married for 28 years. Imagine the next time I go on a trip. My wife meets me at the door on the way out. She hands me my briefcase, and she says, "Honey, we've been married 28 years. I know you love me and I love you. I know that you trust me and I trust you. I trust you will make good decisions for yourself while you're on your business trip, but just in case, I put a condom in your briefcase." That is the kind of confused message that I think we give our young people when we say, "It's not a good idea for you to be having sex when you're 13, 14, 15, 16, and 17, but just in case, we're going to teach you how to use condoms." Clear and consistent messaging is important if we want to influence behavior, particularly if we're trying to prevent the behavior from occurring in the first place. Now, clear and consistent messaging is especially important when it comes from parents. Parents are pretty good about giving clear and consistent messages in a lot of arenas. They're pretty good about being clear and consistent about things like the value of hard work. Parents don't say things like, "Gee, you know, we'd really like you to work hard, but here, let me give you some lessons in how to sort of like shirk your duties." They're pretty clear about messaging when it comes to honesty. They don't say, "Gee, we would like you to be honest, but boy, we're going to teach you how to lie so you don't get caught." Parents are pretty clear about things like integrity, like the value of compassion for others. When it comes to sending messages about their sexual behavior, however, parents are often less likely to understand how important it is for them to also be clear and consistent in their messaging to their children about sexual behavior. Now, there's lots of reasons for this, but in part it's because parents are unaware often that they are, in fact, the most important influence on their children's sexual attitudes, values, and behaviors. There's a study published in Adolescence, for example, that found in a sample of college students that parents were rated as more influential than friends, siblings, church, and school in shaping their opinions, beliefs, and attitudes about sexual matters. A study recently by the Centers for Disease Control found that 59 percent of teens say their parents are their role models for healthy and responsible relationship, and 45 percent of teens said their parents influenced the decisions about sexual matters more than friends do. Indeed, a study by sociologist Arlen Thornton published in the Journal of Marriage and Family found that teen attitudes towards premarital sex tend to mirror the attitudes they pick up from their parents, and especially their moms. So the bottom line is this. If we want teens to make healthy choices about high risk behaviors, including sexual behavior, we need to communicate a clear and consistent message about what we expect from youth, and that message needs to come from parents, from community based organizations, from the popular culture, and yes, even government. Now, having been dubbed the Chastity Czar by a few people in the media, it will come as no great surprise either as a reflection of that title or from the beginning of my talk that I am a strong proponent of abstinence and abstinence education for young people. Having said that, I also recognize that contraceptive services can play an important supporting role in reducing the risks of HIV/AIDS among those who are already sexually active. In fact, HHS channels large amounts of federal funding into contraceptive services and programs. Coupled with state fundings, HHS currently spends an estimated $1.7 billion on a wide variety of contraception promotion and pregnancy prevention programs through such programs as Medicaid, Temporary Assistance for Needy Families, Title X Family Planning, and the preventative health and health services block grant. But while acknowledging that condoms have a role to play in preventing the transmission of pregnancy and STDs, including HIV/AIDS, we should not confuse what we should do when it comes to intervention with what we should do when it comes to prevention. And I think this is the problem at the core of the controversy when it comes to working with young people. We confuse prevention with intervention. We do something different to prevent young people from taking drugs in the first place from what we do when they are already taking illegal drugs. We do something different with people who have started to abuse alcohol than what we do to prevent them from getting involved with abuse of alcohol in the first place. And it seems to me that we need to separate out the prevention strategy from an intervention strategy, and I think we can look to Asia and Africa for some lesson here. Uganda. As you know, Uganda is the only country in sub-Sahara Africa that has achieved a substantial decrease in HIV/AIDS infection, from 30 percent to ten percent today. Among pregnant women, the rate of infection has dropped from 21 percent to six percent, and among Ugandan women 15 years and older, those reported having, quote, many sexual partners, unquote, dropped from 18.4 percent in 1989 to 2.5 percent in 2000. Now, while Uganda has a multi-pronged strategy, encouraging abstinence until marriage, including faithfulness, encouraging faithfulness within marriage and condom use among high risk groups, there are some who look to Uganda and invert the pyramid, who say the success of Uganda is really about condom distribution as opposed to A and B, abstinence until marriage and faithfulness within marriage. When, in fact, if you talk to those who are responsible for implementing the Uganda model, as I have and as I know many of you have, what they will tell you is that they are not going into junior high schools and having condom races with young people. When they talk about condom distribution, they're talking about distributing condoms to high risk groups, prostitutes, for example. And that's what I mean by an example of a strategy which is not confusing intervention and prevention. Prevention, they understand they need to be very clear with young people about the value of staying sexually abstinent until marriage, and for those who are married to be faithful within marriage. But for those who are engaging in behaviors which we know are a high risk, they don't say "condom." I've never heard of that word. But they're very clear of the difference between intervention and prevention. In addition, I don't think we should give up on young people simply because they have become sexually active. Because I believe that contraceptive services ought to be available to those who are sexually active doesn't mean that we should say once you become sexually active that is the only possible intervention. I'm a psychologist. I believe people can change. You know, psychologists don't make money by having clients come into their office and saying, "Gee, you have a problem with X? Well, I guess you're going to have a problem with X for the rest of your life, nothing we can do about it." But we presume that people can change their behaviors, and if we believe that abstinence until marriage and faithfulness within marriage is key, then why would we say to somebody who is sexually active, "Gee, I guess that's an option no longer available to you"? And so part of what we should do with the sexually active is still give them a message about the best and healthiest choice for themselves and not simply assume that once someone has lost their virginity, once someone has become sexually active there is nothing we can or should do about that other than provide them with contraception, as important as providing them access to contraception is. And the good news is that the abstinence message is taking an effect. According to the CDC, 53 percent of all American high school students, a majority, now report being sexually abstinent, up from 46 percent in 1991. Now, that's interesting because you've heard the argument. I guarantee you have. There's nothing you can do about this. These are trends that are just going to continue. There's not one thing any of us can do. We can wish all we want, but we now have empirical evidence that you can change trends. You can change social trends. And one of the ways you change social trends is you develop clear and consistent messaging about healthy choices and different ways of behaving and not simply say, gee, once someone is engaging in a certain behavior or once a social trend emerges there's nothing we can do about it. So without a doubt, in my view, abstinence education plays a central role in promoting the sexual health of teens, but a commitment to abstinence doesn't occur in a vacuum. Rather, decisions about responsible behavior are made in the context of quality connections that teens have with their families, with schools, with religious organizations, and with their communities. In fact, most of the social science literature confirms that the more teens enjoy positive relationship with their parents, with other adults in their community, with religious and community based organizations, with their schools, the more likely they are to avoid all sorts of high risk behaviors. This is why the Bush administration has adopted a positive youth development approach when reaching out and supporting young people. When we do more to empower youth, we release their potential to make good decisions for themselves. That is the core of a positive youth development perspective. But this is not the way generally government or we as a society approach young people. Most of the time we approach young people as if they were a series of problems to be solved, and so we say, "Gee, we've got a dropout problem. Monday let's send in a dropout prevention program." "Oh, gee, we've got a smoking problem. On Tuesday we send in an anti-smoking program." On Wednesday, we say, "Gee, we've got a problem with delinquency." You send in a program for anti-delinquency. And each of these is important. I am not suggesting that they aren't, but youth are more than just a series of problems to be solved. They are like the rest of us. They are complex human beings that have assets as well as challenges that they face in their lives, and what the positive development perspective says is that while helping them to make good decisions about specific high risk behaviors, including not to engage in sexual activity, that we also have to empower them. We have to build their connections with family, with schools, with community based organizations, religious organizations, and we have to treat them in a way that makes them feel competent, empowered, and belonging. This doesn't mean, again, that we shy away from encouraging them to avoid drugs, alcohol, and sexual activity. Of course we should. There's a place for each of those programs even on Monday, Tuesday, Wednesday and Thursday, but as we build these programs, we should always build communities that understand the need to support young people, empower them, give them the sense of competence, give them the sense of belonging and empowerment. And that's why in the State of the Union address in January President Bush proposed a three-year, $150 million program to help families, schools, and faith based groups reach out to young people who feel isolated and alone, because we know those are the youth that are most at risk for these behaviors. And so the President and the First Lady are talking about the need to give youth quality connections and are seeking ways to strengthen a variety of positive youth development programs throughout our nation and in local communities. So it seems to me that these are the two most important components that we have to address in helping young people make good decisions to avoid HIV and AIDS. The first is to help them understand the importance of staying sexually abstinent, preferably until marriage, but certainly at least until they get out of high school. And secondly, we need to wrap abstinence education programs into a broader, positive youth development perspective so that youth will not just avoid risky sexual behavior, but make good decisions when it comes to other kinds of high risk behaviors as well. The President recently said this. He said, "The decisions our children," and may I add here "teens," "make now will affect their health and character for the rest of their lives, and when they make right choices, they are preparing themselves to realize the bright future our nation offers each of them." I couldn't have said it better myself. Thank you. (Applause.) CO-CHAIRPERSON SULLIVAN: Questions, comments? Hank. DR. McKINNELL: Well, thank you for a very well thought through presentation. I suspect you've done this a few times. That's good. Let me introduce you to Dr. McIlhaney. He and I have had discussions over, I guess, about two years now, Joe, very polite and very nuanced around the kinds of issues you raised, and the reason it has sharpened my thinking is neither of us comes from the extreme. It's hard to have a discussion between the abstinence only and the condom only folks. That just doesn't create progress. And I do agree there's confusion at the core, but I don't think it's so much prevention versus intervention as it is the concept of personal health versus public health, and in personal health it is all about health and values and making the right choices. I absolutely agree with you. In public health, however, it's much more about risk reduction. Now, that doesn't mean you can't have an intelligence targeted strategy and a prevention strategy for some and an intervention strategy for others. The problem is they're all sitting in the same classroom, and you can't tell one from the other. And I guess to conclude my kind of thoughts here, I'd ask you your reaction to a study that has recently been done, and I have a little note in my desk that says, "In God we trust. All others, bring data." And the data I saw recently was a study by researchers at Yale and Columbia who looked at two groups, some who had taken an abstinence pledge and others who hadn't, and what I found interesting about that is the behaviors were different. They were the same in that 88 percent did engage in sex before marriage in both groups, but those who had taken the abstinence pledge engaged later. So there was an impact on onset of sexual activity, but were less wise in the choice of condoms and awareness of sexually transmitted diseases. So I wonder how you react to that kind of data and the broader issue, which I think really is a public health issue. It's certainly a personal health issue, and we should all be advocating those values, certainly as parents, but from a public health perception, I'm not sure if it translates one to one. DR. HORN: Well, first of all, I actually think that what you have in your desk is a -- the first person that said something close to that was the late Gene Shepard who said, "In God we trust. All others pay cash." (Laughter.) DR. HORN: It's hard for me to comment on a study that I haven't seen, and what I would do is actually invite you to send me that study and I would be happy to share my reactions to you in writing, perhaps even to the rest of the committee if you felt that that's appropriate. I do think that it creates confusion when one presents the same information the same way to a mixed audience, some of whom are sexually active and some of whom are not, and that's the point I'm trying to make, is that when you come in with a single message -- I mean everything that I know as a psychologist and everything I know from the empirical literature when it comes to things like advertising is you have to segment your audience, and different messages mean different things to different subgroups. And it seems to me that we all can agree that a group that is sexually active is in some ways different than a group that is not sexually active, and if we accept that there are at least these two groups, why not start to think about ways of giving different messages and different messaging to them as opposed to assuming that the same messages are going to work with everyone. And so that's my first reaction to what you say. The second reaction to what you say is that -- and, again, I'd love to see the data in this study, and I'd be happy to react to that -- were it only the case that the only thing that the group -- the only messages that the group that got abstinence education, were it only the case the only messages they got from the onset of this study to when the follow-up data were collected was an abstinence message, but turn on the television. Go listen to some music. Go to the theater and look at movies. What we have is we have a popular culture which sends a very clear and consistent message to young people. Sexual activity among young people is the norm and there are no consequences. That's the message. It's clear and it is consistent. The only difference between the group that got the abstinence education and those that didn't is somewhere along the line they had a little bit of a voice that said, "Do you know what? It's not true it's the norm and guess what. There are consequences." And so you know, part of this is how much, you know, sort of counter-messaging needs to happen to help protect young people from behaviors which we know place them at risk. One of the programs I run is the TANF program. One of the fast tracks into poverty, long-term poverty is to have a child out of wedlock. It seems to me that we need to be very clear about protecting oneself from that possibility. So you know, it would be nice if we actually could do a study where some people got a clear and consistent message about abstinence and some people didn't, but unfortunately that would require that we take the young people out of the popular culture which surrounds them every single day with different kinds of messages. CO-CHAIRPERSON SULLIVAN: Dr. Yogev. DR. YOGEV: You know, it's interesting. I agree with you and yet I disagree with you, and the reason why -- DR. HORN: My wife says the same thing. DR. YOGEV: Yeah, I know. But you already raised me to a high level which I'm not sure I'll be able to stand. (Laughter.) DR. YOGEV: Because I like your wife because my wife would give me a condom after she send me to my way. It would be even a bigger show of trust in what I can do, and it seems like your wife is not as trusting as mine. (Laughter.) DR. YOGEV: But you want to empower. I do agree with the lesson on empowerment. We treat them like a bunch of problems and we empower them, but somehow you stop one step short of fully empowering them. You know, is one study that was mentioned that was just recently published in Archives of Adolescence, a study on those who commit to abstinence who misinterpret what oral sex and anal sex mean, and they increase because they did keep abstinence. Uganda, which you just mentioned, which is a great example and we should follow, it was true for the beginning, and even there it was really more of the "be faithful," but recently at least one study is suggesting that we need an extension of it, and unfortunately there is almost two groups, those who go and say, "Well, well, abstinence? We need condom," and those who say, "Forget condom." I am fortunately to talk to my kids and say that. By the way, there is today in Washington Post that 60 percent of those graduated from high school have sexual activity already and 20 percent, 25 percent will have at least four partners by that time. So there is no question in my mind that your message of abstinence is very important, but to suggest that you go to these people that you want to empower against the whole popular culture, that they will not be able to learn when to use the condom and giving the condom is giving up on everything. Aren't we short a little bit in our perspective and really come with the whole package? Talk about abstinence, increase abstinence, empower the parents because I agree with you. Unfortunately I'm in a part of Chicago that only the single mom is not always there. So it's really up to us to help, but if we take one of those factors out, the abstinence and just the condom, you're right. We're doing wrong. But if we do only abstinence and ignore that it doesn't work in the next ten generations till we get the change that you're talking and continuing that, we're going to do wrong to the public, and I would encourage a little bit a combination of the two in an appropriate way because I'll just give you anecdotal example. In one school in which we were asked to leave because of abstinence ground, which is not allowed to talk about condoms, we found out that increasing sexual activity which is not normal after that because they are doing abstinence. DR. HORN: Well, I appreciate your thoughts, and I'm a child psychologist. What I care about is helping kids arrive in adulthood healthy and reasonably happy, reasonably productive, doing the best they can with whatever potential God has given them. And my job as a child psychologist is from birth until that moment when they enter into adulthood to try to systematically reduce the amount of risks that would prevent that from happening, and I guarantee you two big risks is if you arrive in adulthood with a sexually transmitted disease, many of which are incurable, some of which can kill you or will kill you, or if you become pregnant before you become an adult and ready to take on that experience, and so my job is to try and prevent as much of that from happening in childhood and adolescence as possible I believe that part of that is being clear and consistent in your messaging about whether or not young people should be making choices that provide increased risk for them. It's interesting that you talk about giving them all of the information because I do -- you know, I also was a college professor. I think it's important to give people information and help them make good decisions for themselves. I don't think it's important for us not to be neutral about that. I don't think we say here's all the information. Now I really don't care. We've done a gun safety course with you and we don't care if you use that. I have no opinion if you use that. If you're going to go rob a bank, you know, we have to have a value attached to it. It does well as doing gun safety. Give them all the information. You know, I speak to some young people groups, many of whom have been through the so-called comprehensive sex education. I have yet had a single person raise their hand in all of my talks. My guess is you're all going to now give me, you know, millions of testimonials to the opposite, but I have not had a single youth yet raise their hand who have gone through competence sex education who could tell me what human papilloma virus was. or that could tell me that condoms provide according to the CDC no protection against it or that could tell me that almost all cases of cervical cancer are predated by human papilloma virus. Now, it's interesting to me. You know, are we really giving our young people all of the information they need? And so you know, it seems to me that, yes, we need to respect young people. We need to give them information and all of that, but there also are values that it seems incumbent upon us as adults in the society that also we give to our young people, and I think one of the things that we have to be clear about is the extraordinary risk to the future of young people if they become sexually active and either get a sexually transmitted disease or become pregnant. So I'm glad we agree. I actually think we agree a great deal. CO-CHAIRPERSON SULLIVAN: Thank you. Did you have a short follow-up? DR. YOGEV: No, I just wanted to say we agree. It just is exactly what we said. We need to increase all of this information even with -- if you tell people that get cervical cancer you can die or whatever, more of them will choose not to have sex, but if you got to this point and make the decision which makes it difficult for you, here is the option to make it a little bit safer. That's all I'm asking for. CO-CHAIRPERSON SULLIVAN: Ms. Ivantic-Doucette. MS. IVANTIC-DOUCETTE: Thank you. I want to kind of follow up on a point that Hank had made a little bit earlier, this notion of personal health versus public health. You know, it seems we're talking about changing behaviors, and you probably already know this being a child specialist in psychology, but one of the speakers we had about a year ago talked about changing behaviors at the critical points in sexual attitudes and behaviors, is formed, you know, zero-three, three-six, and six to 14 years of age, and by that time your attitudes and personal ways of thinking about sexuality are already formed, and that that modeling begins in your family and your family of origin, which is why they're a key point. But what I hear happening is that we're putting a public health intervention on top of a personal health behavior change issue. So we're giving adolescents -- we're focusing and targeting our message, positive behaviors, to a group that's already past their attitude formation or development issue with a message that is counter-cultural at a point in development that they want to be like everybody else in society. So I'm just wondering what you're doing to deal with the parents, you know, to talk. If they're having serial marriages or unprotected relationships within their families of origin, the kids are learning those attitudes, you know. And I disagree that we're modeling integrity and honesty and things in our family. We cheat the government all the time on taxes and other things. Kids learn those messages subtly. They're subtle messages that are delivered on. So I just wonder are there interventions that we should be thinking about such as you were talking about earlier. Public schools, couldn't we be having parent forms that are mandatory to talk about that and not necessarily just target on our adolescents at risk with a limited message? DR. HORN: I think it's a wonderful observation and comment, and I agree with it completely. I think I just gave a talk about how to work with parents to help their kids make good choices in their lives, including good choices about sexual behavior, and what I say is start early and talk often. You know, a lot of parents think that, you know, if they've had the talk, you know, once they've done their job, and they often wait too late, and one talk doesn't do it. They need to start early. Now, obviously how you talk to a six year old about sexual matters is different than how you talk to a 16 year old, but it is very important for us to help parents and empower parents to be able to talk to their kids about this. Often why parents don't do it is they don't know how. They don't know how to bring it up. They don't know how to talk about it. Sometimes they don't talk about it because they're conflicted themselves. They look at their own behavior when they were younger and they say, "How can I, you know, kind of urge my kids to be sexually abstinent before marriage when I wasn't?" to which, by the way, I say to parents, "Have you ever lied? Have you ever told a lie?" And every parent says, unless they're lying, "Yes." (Laughter.) DR. HORN: And I say, "Well, does that mean that when you talk to your kid about being honest you say, 'Well, I can't talk to you about honesty because I've lied once in my life'?" I mean, it seems to me that, you know, parents' job is not to use their children as confessors, but to use their role as parents to help their children develop well, avoid high risk behaviors, and enter adulthood reasonably happy, healthy, and productive, and that's their job. And we've got to do a better job in helping them understand that and equip them with those skills. This department just did a Web site and a bunch of publications, forparents.gov. I think that's the Website address. That gives parents tips about things like conversation starters, how to talk to kids about these various issues and so forth. And so I think that we do need to do a better job because you are right. If all we do, particularly in the context of this sea of what I think are quite destructive messages to young people about early sexual behavior being the norm and there are no consequences for early sexual behavior; if we wait until the kids are in high school and simply give them a class, it helps, but it's not the whole answer. We need to start earlier, and we need to use all of the messaging that's possible, including pop culture. It's not possible to tell our kids just to turn off the TV 24 hours a day. I mean, I suppose there are kids that don't watch the TV, but you know, they do. My kids do, you know, and it's important that we try to challenge the popular culture to give different messages as well. CO-CHAIRPERSON SULLIVAN: Ms. Clements. MS. CLEMENTS: I'd like to go a little bit further with the parenting issue you're speaking of. I work in a community health center that provides care to groups of people who would not normally have access to care, and we do have an adolescent clinic, and most of these adolescents come from broken homes. They may have one parent. The parent that they have there does not have the lifestyle skills to even make the right choices themselves. Many of them are making bad choices. So when you talk about kids getting messages and getting all informed and doing the right thing based on what their parents are saying, many of the parents are not there either. So they cannot get that from their parents. I think that oftentimes the messages that we use for abstinence -- and I truly believe in abstinence, but I think that what we've come to do is to preach abstinence, and we're not teaching young people how to be abstinent. I can imagine that a young girl who has never had sex before, when first approached will very well say no, when secondly approached, may say, "Well, I said no," when thirdly approached will say, "Well, are you sure you love me?" and when fourthly approached is maybe going to go for it because she's not gotten the skills that she needs to stand up and say no and walk away. So you know, I think just saying no is not going to work. I think that just depending on the parents is not going to work because many of our parents aren't prepared themselves, and I agree with the empowerment piece that you speak about, empowering our children, somehow getting to that point to empower them to be able to stand and say no and feel good about it and walk away. DR. HORN: I agree with you. Let me just say a couple of comments in reaction to what you say. As Dr. Sullivan mentioned, I happened to found something called the National Fatherhood Initiative. In the interest of full disclosure, Dr. Sullivan was one of our founding board members. And the whole notion of that is to call men to a higher standard of behavior, including responsibility about their sexuality and also about being involved with your kids, whether you live with your kids or not, and the importance of being good models for your children and talking to your children about good choices. All of that is very important for men and women, as fathers and mothers. It's also why the President feels strongly about the healthy marriage initiative, which is to help couples form and sustain healthy marriages so that there's less family break-up. So we have to kind of do it all, you know. And I agree with you about it's not a "just say no" sort of message. The angriest I have ever gotten at any reporter in my life was recently People Magazine. They called me up. The reporter was very rushed, and I said to her, I said, "This is not just a 'just say no' campaign. It is about helping kids make good decisions about," blah, blah, blah. So what was my quote in People Magazine? According to Dr. Wade Horn, it's a "just say no" campaign. You know, it's exactly the opposite of what I believe and it sounds like you believe. It is more than that, which is why we're wrapping it into a broader sort of notion about youth development. So I start with the child. I'm very child centered. Children live within the context of families. Families live within the context of communities. Communities live within the context of culture, and when family, community, and culture are aligned, kids do well. When families and community and culture are all saying the same things, what happens? People generally kind of behave in the way that those messages are coming down to them. Think about the change. I may be much younger than you are, probably am, but I remember the days when nobody used seatbelts, and what happened? We had a change. Parents are now wearing seatbelts, insisting their kids wear it. Communities have all sorts of messaging about the importance of seatbelt use. In the broader culture, you know, you can have the most extraordinary, exciting, sort of crazy car chase movie, and what's the first thing they do when they jump in a car? They click on their seatbelt. You know, when all of that is aligned, you get behavior that is reflective of it, not completely, not absolutely, but you increase the odds tremendously. The problem that I have is right now those are not in alignment. Most parents do not want their 13, 14, 15 and 16 year olds to be having sex. Most don't. The problem is we have, you know, a broader culture that is far, far less clear about that, and part of what abstinence education is trying to do is to try to get in community organizations, such as schools, a message that is more consistent with what parents believe about sexual behavior when it comes to their kids. And a big challenge for this group, I hope, is that you will challenge the broader culture, the popular culture, you know, to stop sending these very destructive messages. CO-CHAIRPERSON SULLIVAN: Thank you. Yes, Frank, and then Monica. DR. JUDSON: I very much agree with the way you have framed the questions and the issues. I think where part of the misunderstanding comes from, well, some of it is just from people who politically don't want to understand or take a different position altogether, are essentially against whatever the Bush administration would come up with, and if they turned pro condom, they'd probably be against condoms. DR. HORN: You must be talking to my mother. DR. JUDSON: But I think one of the areas that I've been sort of critical about as a scientist looking at things broadly is that we'll see $180 million or something for abstinence, what are framed in the media as abstinence only campaigns. Most people don't have a clue what the real content of that message is, and I have to say I don't either. And then you find out that with no evidence of efficacy, that we're now going to 210 million or so, which will get translated into the negative press as despite no evidence of effect, the President now asked for a 40 percent increase, still probably not getting in the context that $200 million isn't a huge amount in the United States for anything. Then there's the overriding concern that we have for all of these programs that are intended to change human behavior and reduce human risks in adolescents. Whether the schools have the time to do that, whether they're effective, whether it's a pregnancy prevention, sexually transmitted infections, tobacco, substance abuse, when I look at the collision between the continuing testing and monitoring for reading and writing and so forth, that's become a huge time conflict in our high schools. They can't do all of this. And if the feds. come in with a program that offers a half a million dollars to deliver a so many hour a month program on abstinence or sexual behavior, something else has got to give, and the principles and superintendents will often claim that what's going to have to go is study halls for catching up on math and reading and other fundamental things. And finally there's the issue of whether that's ever the place to change adolescent behavior. The kids who are lucky enough to come from families who have the parenting values and skills and so forth that Jacqueline was referring to, they won't need those, and the ones who don't, you could argue it's not going to work. The impact just delivered by teachers are simply paid to carry out a government program for which a local school district gets paid, that that's just not an effective set of motivations or an effective context in which to change behavior of children from sometimes dysfunctional families. DR. HORN: I mean, those are very thoughtful comments, and I appreciate that. Now, let me sort of respond to a couple of things. First of all, it's not true there's no evidence that abstinence education works. There are at least ten published studies that I'm aware of, four in peer reviewed scientific journals that attest to the effectiveness of abstinence education in helping young people delay sexual onset. In addition to that, it is not true, it's just not true that there's this huge, huge alternative literature attesting to the effectiveness of comprehensive sex education. You know, we sometimes say there is not a great deal -- you know, there is not as much evidence as we'd like about the effectiveness of abstinence education, and I agree with you there is not as much as I would like, and we need to do more research into it to see whether the most effective ways to help young people be sexually abstinent, but we rarely challenge ourselves to produce this voluminous literature that people say is out there or assume is out there on competent sex education. It ain't so. ASPB here did a comprehensive review of what is available in the scientific literature of scientific, valid studies and so forth, and the results ain't great. They're quite mixed, a little bit of evidence for positive effects, some evidence of negative effects, and mostly no effects. So if you're under the illusion that comprehensive sex education has this great literature out there showing how effective it is, it ain't so. Now, guess what. When was the first national effectiveness study of the Head Start Program done? The last two years. In 1965 we didn't say, "Gee, we can't commit this nation's resources to helping poor people, poor kids arrive at school ready to learn because we haven't done enough studies yet." What we said in the political process is it is unacceptable; the status quo is unacceptable to have so many poor kids already disadvantaged in their education, and so we are going to commit this nation's resources to do something about it, and that's what we did. We created Head Start in 1965. If it is true that early and promiscuous sexual behavior on the part of young people puts a significant portion of our young people at risk -- and I read those statistics early on -- why in the world would we say, "But you know what? We really can't do much about it until we have, you know, 100 different studies that show unequivocally that, you know, these programs are absolutely 100 percent effective." It is a standard that is applied to this series of programs. That's an education which is a standard that is foreign to everything else I oversee, and I oversee $46 billion. The standard that is generally applied in government programs is we see an issue that is compelling and that we as a nation make a political decision, small P, to engage resources, public resources to address it, and we don't generally say, "And until we have unequivocal evidence of certainty of the effectiveness of the programs that we're going to hold off." If that were so, my $46 billion would shrink to about $1.70, and if I'm passionate about it, I apologize, but I am passionate about this. I believe that it is important for us. There are too many kids out there whose futures are being seriously compromised every single day, and as a child advocate I just can't sit back and say, "Gee, that's interesting, but we'll just kind of get there when we get there." I feel I have to say something. I could be wrong. I entertain the possibility that I could be wrong, and that's why I'm a strong supporter of evaluation studies, because I want to know what's effective, not just feel good stuff that I think is effective, and my guess is you agree with me. CO-CHAIRPERSON SULLIVAN: There's no question that you are passionate about it. (Laughter.) CO-CHAIRPERSON SULLIVAN: Dr. Sweeney and Dr. Green, and we'll ask you for brief comments if we can. We are almost out of time. DR. SWEENEY: I'll try very much to be brief. Thank you, Dr. -- DR. HORN: That was an instruction to me, I think. (Laughter.) DR. SWEENEY: Oh. I was at a luncheon a couple of weeks ago, and the keynote speaker was a woman who just sold her real estate business for $4 billion, and I preface it that way to say she's not a kook. She's unusual, and she wrote a book called If You Don't Have Big Breasts Put Ribbons on your Pigtails, and the subtitle of her book is "Use What You Have." And I bring that up because you talked about in the community, the family, the general society, and having the values aligned. In the community where I work, Bedford-Stuyvesant, Brooklyn, New York Times, 50 percent of males 16 to 64, unemployed; 50 percent of the men in the prison in this country, black males; dropout rate from high school, over 50 percent; and the numbers go on. Marginalized, racism, poorly educated, no hope for the future, low self-esteem. Use what you have. So I have in front of me a 16 year old who what she has is youth, a nice looking body, and she's sexually active. Do I use a public health approach or a personal approach on this young woman who asks me, "My boyfriend is coming out of prison. Can you tell me what I can do to get pregnant because I've been having sex since I'm 13 and I've never gotten pregnant, and I've never used anything?" So I raise that issue to try and show that the decision to talk about abstinence in the context of my community and my reality is very, very different from the picture that is often presented, and I would like you to comment on that. DR. HORN: Well, you're exactly correct. Kathy Eden has a book out. Kathy Eden is a researcher that went into Newark -- no, Camden, Camden, New Jersey. For those who are not familiar with New Jersey, that is not the garden spot of New Jersey. It's a very low income, very distressed, very much the same kind of demographics in terms of the horrible statistics you talked about when it comes to Bedford-Stuyvesant. And what she found was she found that young people were getting pregnant because they saw pregnancy and motherhood as the one avenue available to them for meaning. Now, that's interesting because it's really interesting sort of implications for that. If you say to that young woman who sees motherhood, pregnancy as the only avenue towards meaning, "Here's a condom. Make sure your partner uses it." What you're essentially saying is, "Guess what. The one avenue you have towards meaning in your life, we want you to use this and cut it off." But it's also a challenge to abstinence because it's the same thing. If we say to that young woman, "But be sexually abstinent and we're also going to stop you from having that one avenue you see in your life towards meaning," then there's nothing left for that young person, which is why I talk about positive youth development. While I would still give that young person a strong abstinence message, if we do it in isolation without understanding the need in that community to build structures that give those young people hope and optimism for the future, there's no motivation for them to either be abstinent or to use contraception because the goal is motherhood, any sense of meaning, or fatherhood, any sense of meaning. And yet we know that that young person, if that young person has a child out of wedlock at 15 or 16 or 17, the odds that they will escape that kind of economic destitution are very small. And so this is why I talk to much about positive -- at least I hope I talked enough about positive development because abstinence education is an important piece of what we have to do, and I hope people understand I am a strong proponent, but it's not the only thing we have to do, and if it's the only thing we do, we're not going to see the kinds of results, particularly in communities that have the kind of statistics that you describe. CO-CHAIRPERSON SULLIVAN: Thank you. And Dr. Green has a final question or comment. DR. GREEN: Yes, well, actually a comment. First, thanks for your presentation. I'm somebody who has spent a lot of time studying the Uganda model and writing about it. I wanted to make a comment about individual strategy versus public health strategy that a couple of people have raised. This is actually a comment from Norman Hurst who spoke to PACHA last year. He did the review of condom effectiveness for U.N. AIDS for 2003 and published his findings and studies in Family Planning last year. He has this to say. He said this in discussions in E-mail after his article. He says as an individual strategy, assuming he's talking about himself, a sexually active adult, if he was going to have risky sex, it would certainly make a lot of sense for him to use a condom. He essentially reduces risk greatly by using a condom rather than not using a condom, and then when he would consider the other option for a sexually active adult, fidelity, monogamy, at the individual level that might not seem like such a great idea because how does he really know his partner is being faithful. He could be faithful and his partner not. In fact, a lot of people use this as an argument against promoting fidelity. However, Norman Hurst says when you look at the level of public health strategy, things look a little different. Condom promotion has been the primary thing that we have funded and promoted globally in AIDS prevention, and in looking at the African data so at least in generalized epidemics, sub-Saharan Africa, and the Caribbean condom promotion has not yet, 20-plus years into the pandemic, paid off in lower HIV infection rates at the population level. In other words, promoting condoms and even higher condom user levels have not translated into lower HIV infection levels. Meanwhile the country that has most promoted the A and B options, Uganda, we've seen an unprecedented decline in national prevalence by two thirds. There are a couple of other countries, Senegal, Jamaica, a few other countries that have also given, you know, considerable emphasis to A and B messages, usually B more than A, but A being abstinence or delay, the primary message for youth. That has paid off. So things may look different depending on whether you're looking at an individual strategy or a public health strategy, and since we in this committee consider policy and allocation of funds to programs, we might do well to look at what's worked as a public health strategy. I don't know if you'd like to comment on that. DR. HORN: I am a great admirer of your work in this area, and I would have nothing to add to that. CO-CHAIRPERSON SULLIVAN: Dr. Horn, thank you very much for a very productive and very -- (Applause.) CO-CHAIRPERSON SULLIVAN: Our International Committee chairman, Abner Mason will now take the chair. MR. MASON: Thank you, Mr. Chairman. With your permission I want to first add one additional resolution which I overlooked. It was brought to my attention by one of my members that our committee has been working on a resolution on the ABC approach for some time, and it has taken us a while, but I think we have got a resolution that we're ready to bring forward and present to the full council. So I just want to add that. I only mention one resolution. So there's going to be two. Council members, you'll get a copy of it. You'll have obviously a chance to review it, but I just wanted to add that. I overlooked it earlier. It's now my pleasure to introduce Roger Bate, who is here to talk with us about taxes and tariffs on drugs, and Roger is the resident fellow at the American Enterprise Institute. He is Director of Africa Fighting Malaria. He's a fellow at the Institute of Economic Affairs, and those are just a few of his appointments. If you look in the binder, his list of books and chapters from books and academic articles and other writings are there for you to review, and what you'll see if you take a look is that he has done an extraordinary amount of work in areas that we work on. It's a pleasure for me to introduce him because he is one of these people who manages to combine a very, very keen intellect with a passion for helping people in some of the poorest parts of the world. That's a combination that we need to see a lot more of, and so with that, it's my pleasure to introduce Roger Bate. DR. BATE: Thank you very much, Abner. I think we have one or two technical issues to resolve, but it's my pleasure to be here. Thank you very much for inviting me to speak. Last month because of pressure from AIDS activists, academics, and others, Kenya dropped its ten percent import tariff in essential medicines. Today finance ministers from Uganda, Tanzania and Kenya are meeting to discuss whether that tariff should, in fact, be reinstated since it breached the consensus approach that was agreed in January when the East African and Customs Union came into force. A stake I would argue is access to essential medicines of thousands of the poorest Kenyans, and of course, as a precedent setting example, this will be important for many hundreds of thousands, even millions of people across East Africa because what is going on in Kenya is a microcosm of what I want to talk about today, which is the specific example, a specific problem of lack of access to antiretrovirals and drugs for opportunistic infections. And the particular aspect that I'm going to talk about is the imposition of taxes and tariffs on medicines and medical devices in many developing countries and the impact this has. While we're waiting for the slides to come up, I'll carry on because I can talk through the first bits. Ah, here we are anyway. We're very close. Few people in the poorest parts of the world have ready access to good medical supplies. In some countries, such as Uganda, that coverage is about 70 percent on average and is pretty good. Others, such as Nigeria, access is as low, and disastrously low, as about ten percent. Thanks very much. Thank you. The lack of access costs lives, millions of them, and probably the most important reason for lack of access is the significant poverty in these countries, and the resulting lack of health care infrastructure, but lack of political will is also an important factor and it's something that can be changed almost overnight. It is, of course, the sovereign right of any nation to raise revenues as it sees fit, but having said that, given that so many people in these nations do not have access to the most basic life saving interventions, it does seem odd to flat tariffs on the entry of these products and then tax them, perhaps the most regressive forms of policy intervention there is since it hits the sickest and poorest people in the land. It is my opinion and that of 16 NGOs at the moment from 11 countries and also the World Health Organization, which I'll move on to in a second, who have not signed up to our initiative, but who are broadly in support of that -- at least their economists are -- that these regressive policies should be repealed instantly. In our working paper, which was published just about two months ago, and it's very much a paper, the working paper, because it's being updated constantly as new data evidence arises. We look to essential drugs accesses as defined by the World Health Organization. The list we had to work from is fairly old data so that we could compare and contrast available, consistent tariff and tax data. There is a lot of information about the different types of categories. I learned more than I really thought I was ever going to about the categorization of pharmaceuticals and other products, but we use the harmonized system, look to the harmonized system which is produced by the Customs Corporation Counsel. And we looked at, settled on Chapter 29 and Chapter 30 categories of that system which looks at finished pharmaceuticals and the parts or the build-up chemicals to those pharmaceuticals. We found partial data from many countries, complete and reliable data for about 53. We simply averaged the various category weightings, which has led to some discussions about what should be the correct weighting, and came up with a single figure. Some country data was quite disaggregated; others is less so. We had a running debate with Richard Lang, who is an economist at the World Health Organization, who published a paper even more recently than ours, about two or three weeks ago. This paper which is great that has been published looks only at tariffs. Ours looks at taxes as well. I think that it's excellent that the World Health Organization has published this because it implicitly criticizes many of the member states of the World Health Organization, and for that reason it is courageous and correct to do so. Because of the details of the issue, there are many disagreements between Richard Lang and ourselves, but as always disagreement is great in scientific or economic discussions because it leads to further analysis and a race to be seen to be correct. So we hope that the conclusions of our paper are, and I think there's more evidence than there is at the moment, but it doesn't matter. Ultimately their conclusions and ours are the same, which is that these taxes and tariffs should be removed. So let's look at what we found. We have here -- actually I've already covered most of the points in that. I apologize for that -- 53 countries, as I mentioned. Okay. What did we find? Many of the poorest African nations impose substantial tariffs and taxes on medical products. As will become clear shortly, it is more important to look at the tariff rates than the tax rates. Taxes are no doubt regressive, and I have examples where there are significant problems with them, but it's the tariff numbers that are the most problematic in terms of denying access. Note especially near the bottom Nigeria and India. These are countries with large to huge populations, low access, and significant tariffs. There are some highlights in this or perhaps we should call them low lights, and Morocco, for example, has a subcategory of Chapter 30 medical products on bandages and gauzes, which is as high as 46 percent. The Democratic Republic of the Congo and Kenya have pretty high tariffs as well and other taxes. As I mentioned when I started speaking, the East African Customs Union imposes a ten percent tariff as of January. The one bit of good news that's been coming out relatively recently is India, which has incredibly high combined tariffs and taxes of 61 percent at its relatively recently budget reduced that to 20 percent, although there is still -- and I said this when I spoke to some of you about six weeks ago -- there's still some disagreement about how the new policy is being implemented since in some states the old tax rates, close to 60 percent, are still being applied. Much like the 22 countries which are party to the PhRMA agreement of the general agreement on tariff and trade in the Uruguay Round, the Southern African Custom Union imposes no tariffs on finished medicines, which is very good news, in fact, in all Chapter 30 items. Many countries have low tariffs, although any tariffs at all probably increase the probability for corruption, given the way the tariff payments are often collected. I can talk more about that later. Antiretrovirals for HIV patients are often exempted, increasingly so, which is good news, and we're trying to compile a comprehensive list of that, and I may ask for your help, the people in this room today, in terms of compilation of that data. But even where antiretrovirals are exempted, most drugs for opportunistic infection are not exempted, and neither are anti-malarial or anti-TB treatments, which are often as we know the deadly companion disease for HIV in developing countries. So celebrating the ARV exemptions is premature unfortunately, but the fact that the pressure on poor countries as well as their own enlightened self-interest, which of course is ultimately more important, has exempted products and shows that it can be done and further exemptions should be encouraged. It is important to recognize at this point that the funding raised from tariffs and taxes on medical products is not generally speaking spent on health care in these countries, although it is largely unclear, given the opacity of spending figures in many of these countries. Furthermore, even if it were allocated to health as some governments have argued both to myself and to many other people, it is not the most effective or economically efficient way to raise funds, and just on simply economic grounds, there are better ways of raising funds if you want to spend more money on health care. Our tentative, and I stress that it is tentative because of the changes in the data, quality of access data, but from our econometric analysis we found that income level was the most significant positively correlated variable determining access to drugs. Simply put, wealthier countries have far greater access than poorer ones. That doesn't require economics to tell you that really, but it does help that it is confirmed by the econometric analysis. However, tariff rates are highly statistically significant as a negative determinant of access. Countries with higher tariffs on average have lower access rates. The key finding, and I say this is tentative because of the way the econometric study and the quality of the data is concerned, but we found that roughly speaking a one percent lowering of tariffs could lead to an increase of access of one percent. And recall that for Nigeria, which has a 20 percent tariff rate, it only has an access rate to pharmaceuticals of ten percent, and India has a 16 percent tariff rate now, maybe higher than that; it depends on how it's being implemented, and only a 35 percent access rate. These countries, as I mentioned, are highly populous, and if this equation and relationship are causal, as we believe it is, scrapping tariffs would increase access for many millions of people. Sales taxes are negatively correlated with access much like tariffs. VAT, for value added tax, in this slide, but the relationship is not statistically significant. This is probably because tax payments are collected broadly across the economy, whereas tariffs are indicative generally of less free and hence less wealthy economies, but also because of the way that tariffs are collected, ships docking at night, charges collected in more ad hoc fashions can lead to, in fact, can stimulate forms of corruption. Furthermore, revenue is received by small, often more autonomous customs and excise units which makes bribery probably more possible as well. There is ongoing analysis which shows an interesting association between tariffs and corruption indices, but I haven't got room to talk about that now. But having said that taxes are not statistically significant, they are obviously detrimental, and they do place a burden on patients. We looked at the tax paid on the average cost of antiretrovirals for those people buying privately in South Africa, and it shows that that costs about $12 a month in tax rate. On that list or the list coming up -- sorry. I think I've gone too far. There we go. I'm sorry -- the list there shows what can be bought for an individual for their family from just simply the tax on antiretrovirals to private purchasers in South Africa. Antiretrovirals, of course, are very expensive medicines or comparatively expensive medicines, but even taxes on cheaper medicines still has an impact, and remember the Kenya has 22 percent tax on some pharmaceuticals and the rates vary depending on what type of products, but there's no doubt that this hits the most malnourished patients, and as with tariffs, sales taxes on these drugs are very regressive and should be repealed, and the World Health Organization agrees with us as well on that. It's not just the tariffs, but the sales taxes that should be repealed, too. Go on to that slide that we had a second ago. A less well documented problem is the non-tax and non-tariff barriers because although there is obviously a key input, drug safety is a vital issue. Rigorously tested new drugs or drug combinations is very fore. As we know from the discussion and debate for even of a generic, non-FDA approved fixed dose combination antiretrovirals, it seems that many countries are delaying unnecessarily the approval of new drugs. South Africa delays significantly. I think it says up there 39 months. So over three years. Namibia had the disastrous situation of requiring all reregistering of drugs approved before 1990 even though they had been approved in every single European country, America and Japan and other countries in the Far East. This is incredibly onerous and costly for those people trying to reregister drugs, which means that, of course, Namibia doesn't have as many drugs reregistered as it should do, and there are other examples. Just one from Nigeria there. That's about it. I will conclude by saying that I hope that Patrick can get behind this initiative, which is our no to taxes and tariffs on drugs and devices initiative. The World Health Organization independently, as I've already mentioned a few times, has published on this topic and agrees that these things should be removed. Increasing numbers of nongovernmental organizations are joining with us. As I mentioned, currently there are 16. Michael Marchman (phonetic) and Oliver Sabber at the Global Fund and Friends of the Global Fight are helping us gather information on drug access. Jack Galbraith has already provided one example to me of problems they have had, the Catholic Medical Mission Board, when distributing drugs where it's often not known that the tax and tariffs even on antiretrovirals have been repealed so that drugs are waiting in docks and causing significant problems. The Global Fund incidentally has an agreement which specifically states that the assistance financed from donations will not be taxed or have import levies on it, and we need more donations policy based along those lines to encourage countries to reduce or remove their tariffs entirely. And then finally, of course, since I last spoke on this issue about six weeks ago, the South African Department of Health is arguing for the removal of VAT on antiretrovirals and, in fact, on all drugs, which is very good news, although they're coming up against opposition because of the funding questions and where government spending or, rather, where government revenue is coming from from the treasury in South Africa, but at least that discussion is taking place, and as I mentioned, WHO has called for tariff removal, too. Senators Brownback, Landau, and Inhof have introduced a bill on affected diseases which takes up the idea in this regard, and Section 9 of the bill would encourage donations from the United States going to countries to remove tariffs and taxes. The bill argues that these interventions are not necessary. They only protect domestic industry and do not help the poor in those countries, and we certainly agree with that. I hope I can deal with any questions you may have. Thank you very much for inviting me to speak. (Applause.) MR. MASON: Thank you. Thank you, Roger. And now we'll take questions. We'll start with Dr. Judson. DR. JUDSON: Does PEPFAR have that within their requirements or agreements with the 16 or 17 governments that are partners in this? DR. BATE: As far as I know, it's encouraged, but I'm not sure that it is actually written into the agreement. I don't think it is. There may be people who know more. DR. JUDSON: Should it be? You were saying it should be, but is there anybody who can take the lead for that to see that American funding policy is adjusted? DR. BATE: I would have thought a statement from Patrick would have helped very much in that regard. No, I think that, in fact, one of the reasons the Global Fund has so many good provisions within it, especially notably in this regard to do the taxes and tariffs is because of input and pressure from the United States. So it does appear odd, and I apologize for not knowing the answer to your question. If PET IV (phonetic) doesn't, as I don't think it does have that, then it should, in fact, be instigated immediately. I don't see that there's any reason not to, at least in terms of pushing for encouragement of that. If deals are already in place, well, it would be unfair to withdraw those drugs, but where new deals are being done and new donations are being provided, it would make a lot more sense for these countries to repeal those taxes and tariffs. MR. MASON: Dr. Sullivan. CO-CHAIRPERSON SULLIVAN: Well, first of all, thank you very much for to me a very informative presentation because this is an issue I was not aware that existed. I have really two related questions. One is on average what percentage of the governmental revenues in these countries does the tax and tariffs represent. You know, that is, how important is it to these countries in terms of the revenue issue? And secondly, I think you're touched on really my second question, and that is what alternatives have been suggested or proposed. I think you mentioned Senator Brownback and Inhof had recommended the U.S. provide a substitute for those revenues that are lost, but this seems so counterintuitive. That is, why covenants would really be, in effect, preventing access to medicines of these citizens by imposing these taxes, but the question is how important to these governments would their treasurers say this is to them. DR. BATE: First, clarification on the Brownback, Landry, Inhof bill does not stipulate compensation for the countries if they move it to Britain. It's more to encourage them or more to say that U.S. funding should not be going to the governments that are, in effect, shooting themselves in the foot or shooting people in the foot. I think that's the impression. One of the advantages I mentioned of the debate that's going on between the World Health Organization economists and my co-authors is actually driven us to look at what revenues are delivered. I can't give you chapter and verse on all of them, but I know that from our analysis of the 53 countries that the highest revenue, and it is significant from -- and I can't tell you if this is just tariffs. I think it's tariffs and taxes -- is the Democratic Republic of the Congo, which raises eight percent of its revenue from tariffs and taxes on pharmaceuticals or pharmaceutical products in general, which is a substantial amount. And therefore, they will probably be in a potentially difficult situation where they could just remove it overnight and this may be an instance where they could be perhaps helped for the aid to compensate so that could be provided, but as I said, on the other hand, this is not an economically efficient method of raising revenue. There are more economically efficient methods, but in terms of capital gains taxes, income taxes, and corporate taxes which are doing the modeling, and I'm not a specialist in that area, but I understand enough as an economist to know that there are better ways of raising money. So therefore, in most countries it is much, much lower than eight percent. It is actually a fraction of one percent, but the DRC is probably an outlier in that regard. But it can come up to one percent, maybe even one to two percent of budget, and of course, within that budget you're dealing with turf. You're dealing with potential turf fights, you know, and so obviously there are some people, sub-departments who would actually lose out or perhaps members of those sub-departments who would lose out, and therefore, it hasn't been pushed through so far. But what is encouraging is that South Africa, for example, on its value added tax, we have seen that members of the Department of Health have said, yes, we'd like these taxes to be removed because we know that they're regressive. So the more pressure the more that is raised both in terms of carrot and stick, if you'd like. Say perhaps more A could be provided or perhaps there are better ways of dealing with raising the revenue, but for some countries it can be substantial. Perhaps DRC is way an outlier, but it can be substantial. CO-CHAIRPERSON SULLIVAN: I think that for any government official in these countries it would be helpful to perhaps not only challenge them, but provide them with some alternatives because they are always confronted with the issue of if, indeed, they should give this up, and I think we all agree with that. What are some of the alternatives that they could consider? Because obviously if they are significant revenues, that presents them with another problem. DR. BATE: I agree. In any governmental decision, as I said, it's the sovereign right of any nation to determine how it raises its revenue, and there will be tradeoffs. There's no doubt that some revenue is raised. Therefore, that revenue either has to be lost or has to be replaced in some other way. This can be done mutually in an economic tax method that would raise the revenue far more efficiently and far less regressively. But, of course, advice in terms of how to do that can be provided and aid perhaps as a short run measure to overcome the loss in revenue could be provided, too. Because ultimately it's not just the amount of money that's raised. I mean, that can be substantive, but the key point to realize here is that you're often dealing with small amounts, relatively small amounts of money, but you're dealing with uncertainty. You're dealing with the idea that a cargo of medicines turns up and perhaps the tariff on it is only $1,200, say, but the fact is that paper work has to be filled out, and you can end up having drugs sitting on docks for weeks because of that $1,200 because they're arguing as to whether it should be paid or it should not be paid because it's an exemption. In some instances it may be tens of hundreds of thousands of dollars, but the reality is most of the time its not that much money, but it leads to delay because it leads to uncertainty about are these exempted and those drugs not, and that's why a blanket repeal of these taxes and tariffs or at least in terms of the tariffs should be pushed forward, at least in my opinion. MR. MASON: Any other questions for Roger? (No response.) MR. MASON: Thank you. DR. BATE: My pleasure. Thank you very much. (Applause.) CO-CHAIRPERSON SULLIVAN: Indeed, we are ahead of schedule by about 35 minutes. Well, let me see. No, about 40 minutes, but let me suggest that we take a 15-minute break and we'll see if we are able to move up the rest of the agenda, and if so, we'll be able to finish early this afternoon. So we'll take a 15-minute break. (Whereupon, a short recess was taken.) CO-CHAIRPERSON SULLIVAN: We have sent an E-mail to Dr. Gottlieb, who is scheduled to present at 3:20. We've not heard back from him. So we may not be successful in having him come early. So I have one suggestion. If there are members of the public who are on the docket for presentation tomorrow who would like to present this afternoon, we would welcome that. We really have 20 minutes that we can devote to that. So are there any members of the public who would like to present? Yes, please come forward, identify yourself, and give us your testimony. You're very welcome. DR. MARTIN: Great. Thank you, Dr. Sullivan and members of PACHA. I'm Marsha Martin, Executive Director of AIDS Action Council and AIDS Action Foundation, and I'm very happy to be here to deliver AIDS Action's public comment. And, by the way, I was going to present tomorrow. So we were going to try the public comment that was going to be a PowerPoint. So you guys were going to get your first comment PowerPoint, but it won't happen. So you have our official public comment in this packet which we have given to you, which I just will tell you very briefly has information about the United States epidemic on your left-hand side, as well as some of the challenges around the appropriations recommendation, summary from our national organizations responding to AIDS, NORA Coalition, and then on the right-hand side you have what I'd like to talk to you about which has to do with AIDS action recommendation for reauthorization, changes to the AIDS drugs assistance program. There is a great deal of conversation going on about reauthorization and AIDS Action specifically is making a host of recommendations related to the AIDS drugs assistance program. But first let me just summarize for you areas where the community has had unprecedented, I believe, agreement around reauthorization, and we were hoping that we might be able to hear from you all and the administration on principles of reauthority, some next steps. But let me just share with you that the community is in agreement I would say in about nine key areas. One area is, of course, we want to see the act reauthorized. There are some people who think maybe we shouldn't reauthorize Ryan White, but we think it should be reauthorized. There is agreement around the primary of medical care that is inclusive of methodologies to insure access to care and treatment and insure adherence; that we would like to see formula allocations based on living HIV cases; that local planning and local decision making should be continued; that there is an agreement around an ADAP minimum eligibility to be set at at a minimum 300 percent federal poverty; and that there's substantial agreement regarding hold harmless recommendations, as well as agreement around the need to continue funding for under served communities and underserved populations. We would like to see increased and in some cases true coordination of federal agencies and resources, and we'd also like to see that there'd be some support given to helping to identify people who are positive, do some case findings, do some outreach and recruitment in an aggressive way, bring people into care, and then methodologies to help retain them in care. And these are areas that I think that if all the community organizations, national and local, were here today, you would find that there is agreement around these key areas and we would encourage the members of PACHA to join us in working toward seeing that some of those key areas are worked through in the reauthorization. One place that I will tell you where there might be some divergence of opinion is our AIDS action proposal for addressing the ADAP crisis. It's in your packet on the right-hand side, and we would like to encourage you to become familiar with our ADAP proposal. It asks for a baseline formulary. It asks for inclusion of all HIV related drugs to be on the formulary, as well as provide an opportunity for portability. And then finally, we are recommending that we move to an ADAP card that would provide information on formulary, collect health outcome data, and be a vehicle that we could use to start to monitor how well we're doing in the epidemic. So the materials are before you. We'd like you to join us, and we'd like you to take this ADAP card and put it in your pocket, and it has our goals for reauthorization of Ryan White. Thank you. MR. GROGAN: Thank you, Marsha. Thank you. CO-CHAIRPERSON SULLIVAN: Thank you very much. Dr. Judson, comment question? DR. JUDSON: I'm sorry. Could you come back to the microphone, please? Just a couple of questions. Is AIDS Action entirely about treatment? DR. MARTIN: No. DR. JUDSON: Ryan White? DR. MARTIN: No. DR. JUDSON: Is it also about prevention? DR. MARTIN: Absolutely. We are very supportive of prevention goals. DR. JUDSON: Okay. Then virtually everything you've requested here is for probably stable or increased funding for existing programs. Are there any programs where you would reduce funding because you feel they haven't been effective in accomplishing their goals and any new programs that you think would be more effective in preventing HIV? DR. MARTIN: Well, actually we make some recommendations. If you take a look at the left-hand side of the package I gave you, there are recommendations for changes and increases to the entire HIV portfolio, and they're based on work that AIDS Action has been doing over the last 15 years in monitoring the federal budget. And so we make a whole host of recommendations around the federal budget both for prevention, for research, and for care and treatment. I was just speaking to reauthorization of the Ryan White CARE Act because it's principally in front of us now. But, no, we have lots we could talk about in terms of CDC, prevention outreach, what our prevention goals are, targeting the conversation to where it really needs to be, and finally really addressing issues like testing routine and health care settings with informed consent and being very clear about what this epidemic looks like in this country and beginning to manage it as well as begin to control it. DR. JUDSON: Thank you. CO-CHAIRPERSON SULLIVAN: I'd also point out, Dr. Judson, the sixth bullet point in this brochure talks about prevention counseling. So that's part of it. Other questions, comments? (No response.) CO-CHAIRPERSON SULLIVAN: Thank you. Any other members of the public who would wish to present now to the committee? Yes, please come forward, identify yourself, and proceed with your presentation. MR. ARNOLD: Sorry, Joe. I misled you, but I guess I could get it out of the way, and I have one copy here which I can leave for you and put in the record. Most of you know who I am. I'm Bill Arnold. I'm the Executive Director of the Title II Community AIDS National Network here in Washington, D.C., and I'm also Director of the National ADAP Working Group. I have appeared before this group five or six times in the last few years. In fact, attached to this, which I will leave so it can go into the record, are my remarks here in 2002, 2003, 2004, and earlier in 2005, and substantially what I'm going to say now, which deals with the current ADAP funding crisis is the same thing that I've been saying before. So you will have heard it again. I've been watching the ADAP history from the glory days of the successful AIDS drug cocktails of late 1995 and early 1996 until today, which we are kind of referring to as the ADAP resources dismal swamp period in terms of resources. My remarks from addressing PACHA in 2002, three, four, and earlier this year are attached herewith and will be reentered into the record one more time. I suspect some in this room thought I was crying "wolf" in 2002 and 2003 when I kept referring to the funding shortage for ADAP. Unfortunately, I was not. My message today is no different than it was then, except it is some years later and the numbers of HIV positive Americans affected is larger and growing larger still. As predicted consistently over the last four years, the ADAP problem has continued, and it has worsened. Official waiting lists have appeared and grown. Unofficial waiting lists, which are sometimes referred to as, quote, extended applications processes, unquote, have shown up. Drug formularies have been reduced. ADAP eligibility has been reduced. Programs and patients' expenditures have both had expenditure levels imposed and caps installed. The pharmaceutical industry has helped carry the inadequately funded ADAP program for the better part of the last two years to well in excess of $100 million. In many cases, industry's extra rebates and additional ADAP crisis price concessions have helped keep the entire ADAP programs open, but at least our doors were open even if they were not able to expand to meet the real needs. President Bush found a much appreciated $20 million last year to rescue -- I put that in quotes -- 1,500 HIV positive Americans then reported on officially that waiting list. But ADAP programs now fear that this September when the President's 2005 funds expire these patients may have to be absorbed in the ADAP programs which now already have new people on new waiting lists. Should ADAPs make people who are waiting wait longer come September or should we just stop the medications for the people who are covered by the President's $20 million? We face the possibility of both federal and state Medicare-Medicaid adjustments and cutbacks which can force thousands of HIV patients whose medications were covered by Medicaid to look to ADAP for HIV drugs. There are serious problems on how ADAP will be able to interface with the new Medicare Part D drug coverage in a cost effective and a patient affordable manner. In the meantime, the CDC tells us that we have well over a million HIV positive people, a substantial increase in our official figures. We have extensive tested for HIV status efforts in progress, making use of new HIV rapid tests. However, we are in no better position to guarantee access to care and successful heart treatments to newly diagnosed Americans today than when I sat in the Secretary's Office in this building and said for the first but not the last time -- I think that was 2002 -- that there was no short-term answer to the HIV treatment access crisis other than short-term funding. MR. GROGAN: Bill, wrap it up. MR. ARNOLD: There's only three more paragraphs. It will show up in the record. Like I said, I said it all before in 2002, three, four, and five. Thanks for the opportunity to speak again, and who should I give this to? MR. GROGAN: Thank you. You can give it to me if you'd like. CO-CHAIRPERSON SULLIVAN: Okay. Thank you very much. MR. ARNOLD: Thank you. (Applause.) CO-CHAIRPERSON SULLIVAN: Are there any other members of the public who would wish to comment, who registered to comment? (No response.) CO-CHAIRPERSON SULLIVAN: If not, we are scheduled to hear from Dr. Gottlieb in about eight minutes at 3:20. So I suggest you take advantage of this to get coffee or make phone calls or talk among yourselves, but 3:20 we'll resume. (Whereupon, a short recess was taken.) DR. SWEENEY: Thank you, everybody, for being back more or less on time. It's our great pleasure to be able to present a talk, direct consumer marketing media messaging in HIV prevention, and we have with us Dr. Scott Gottlieb. And I know that we usually let you read all of this on your own, but I will just do a little, just one paragraph because it's noteworthy that Dr. Gottlieb is a former Senior Policy Advisor to the Commissioner of the FDA and to the Administrator of the Centers for Medicare and Medicaid Services at the Department of Health and Human Services. At AEI Dr. Gottlieb researches FDA and CMS regulatory policies. The development of new medical technology and political and clinical trends in medicine, Dr. Gottlieb is also the author of the new Forbes/Gottlieb Medical Technology Investor and Investment Newsletter. He's a graduate of Mount Sinai Medical School, and we present him to the group and thank him for being here. DR. GOTTLIEB: Thanks a lot. My bio says I worked at both FDA and CMS to make it sound like I had two distinct high level senior jobs, but in fact, I worked for the same person in both agencies. I conveniently leave that off. I was asked today to present on media and messaging in HIV/AIDS, to talk a little bit about the history of direct to consumer advertising in this space, and where I think policy could head to try to improve the kinds of communications that you're seeing in the marketplace. I'm not an expert in direct to consumer advertising by any means. I've worked on regulatory issues in this realm at FDA when I was there and spent a good deal of time thinking about how the agency could improve the framework for advertising to help make it more proactive or a more effective public health medium, usually by eliminating some ambiguity about what the rules were to give companies a clear pathway to try to do these things, and so I want to talk a little bit about that. But first, a little history here. I think one of the reasons I was asked to present today on this topic was some recent issues in the media with respect to some criticism of the DTC and the HIV/AIDS space. This was a headline on June 14th, just recently in the Los Angeles Times, which was a story in response to the AIDS Health Care Foundation, the nation's largest AIDS organizations with clinics in the U.S. and all across Asia and Africa, expressing disappointment in the news that the number of people living with HIV/AIDS in the United States had surpassed one million. And the warning came from Michael Weinstein, the president of this organization, and he blamed what he called, quote, mixed messages from Washington on preventive measures, but also said that responsibility lies with the drug companies, he said, whose, quote, high price direct to consumer drug advertising campaigns downplayed the seriousness of HIV, as well as with the FDA, that continues to allow this irresponsible corporate behavior to go unchecked. So it's a pretty strong statement, and I think, you know, that's one reason that we're asking this question today. What is the state of messaging in this space? Has it contributed to the growth in infection rates in this country? And what can we do to improve this situation? My own history here, this is an issue I had thought about a long time ago, back when I was a resident in training, and wrote an op-ed for the New York Times at the time. It probably goes back about seven or eight years, bemoaning what I thought at the time was too much hyperbole on the part of some doctors about their ability to, quote, unquote, cure AIDS. This was about the time that David Ho was on the cover of Time Magazine saying that he's going to cure AIDS, and I felt at the time that this kind of robust talk was contributing to some complacency in the HIV community, and I referenced in the New York Times piece a very personal episode where I was stuck with a needle in the emergency room, while working in the emergency room one night, and had to go on triple therapy for about three or four days until the patient was ultimately tested positive. And the three or four days was very hard. It was hardly a normal life. Now, granted you experience more of the side effects from combination therapy up front. Most patients adapt to the side effects, but it was anything but normal, and so a life spent on these drugs is anything but normal and shouldn't be postulated to be anything different by the media or by physicians, and that was really the thesis. And so I'm sympathetic to some of the views here, but I also think that history has changed with respect to both what doctors are saying and particularly with respect to what companies are saying. Now, that doesn't mean that there aren't occasional episodes where the FDA or the consumers feel that ad oversteps the bounds, and this is a very recent warning letter that was sent out by the Food and Drug Administration with respect to one ad. It actually quotes from the letter. It's actually an untitled letter, which is significant because it means that the agency didn't send it out as a true warning letter. Untitled letters at the FDA don't go through the same legal checks and balances, if you will, and some people would postulate that they don't carry the same legal weight. So things that to out as untitled letters sometimes aren't really enforceable, which is significant. But nonetheless, there was a feeling on the part of the agency, perhaps right -- I haven't seen the ad myself -- that the ads had been overly optimistic about what it was like to live with HIV/AIDS and be on triple therapy. So there are episodes even today, even more recently where ads are perceived by consumers and even by regulators to have crossed the boundary, but it's worth noting a couple of things. One, the number of warnings that have gone out on HIV/AIDS drugs, and I tried to do a count, but I didn't feel I had a full accounting of it and so I didn't want to present it here today, but it has gone down dramatically, and there really haven't been that many more recently. And more important than that, the rate of advertising in this space has really gone down significantly, and this is just some anecdotes, statistics showing the drops over the late '90s into the year 2000s. And the editor of Poz magazine, which is one that has benefitted significantly from this advertising as a financial matter, complaining in the media about the drop to his revenue because of the drop in advertising in direct to consumer advertising of HIV/AIDS drugs. And this is a quote from an advertising executive, again, trying to elaborate on why perhaps this has happened, and he postulates, as other people do when you talk to them in the space, that the companies themselves are reluctant to enter into marketing or advertising arrangements that go direct to consumers because of the backlash, which you saw from the Weinstein quote. I think that it's a little bit more complicated than that. I think this has become, by and large, a less competitive market for consumer advertising. More people are on more tailored regimens. So decisions are really being made by the physicians and not by the consumers, which are the people living with HIV/AIDS. So DTC doesn't matter as much in this market. There are fewer blockbusters. The marketplace is split among more drugs. So you're not going to spend as much advertising, and this is really consistent with if you look at the cancer space, for instance. We don't see a lot of cancer drugs direct advertising to consumers. Really most of it is physician directed because there's a lot of learning that needs to take place about how to tailor these cancer regimens, and most of the decisions are really being made by the physicians because these treatment decisions are highly specific. So you know, companies like Genentech don't advertise directly to consumers, and I think that's happening in the HIV space as it becomes less of a consumer choice about what drug you're on and more of, you know, a choice that's dictated by a pharmacogenomic panel or what have you. So there are multiple reasons why direct to consumer advertising has gone down, but we shouldn't discount the fact that, you know, it's not effective from an economic standpoint, but also from a sort of public relations standpoint because there is a lot of backlash in this space, and it seems like no ad really meets the threshold, the test of what is appropriate. You certainly don't want to pick a very sick person in the ad, but then when you depict a healthy looking person, that has usually caused criticism. I just wanted to back up briefly to talk about the experience of advertising at the agency because it becomes a question of, well, is this a good thing or a bad thing that advertising has gone down in this space. I would postulate a controversial statement that it's bad, that more advertising would be raising awareness and the lack of advertising, the lack of public messaging on the part of the companies is something that we should all bemoan. I'll get back to why I feel that way at the end, but just looking at some of the data that FDA has generated, by and large most of the data supports an important public health role for direct to consumer advertising to the point where when we looked at direct to consumer advertising when I was at the agency and even spoke about it in the community, spoke about it on Capitol Hill, spoke about it even to critics of direct to consumer advertising, it really never was a question of should we end it partly because the courts already spoke to that question and said very clearly that companies had the legal authority to engage in commercial speech under the First Amendment, but also because most people seem to have realized that there is a positive role for direct to consumer advertising, but that you know, where people tended to disagree is on what's appropriate, what kind of ads cross the line, what kind of ads represent fair balance. And so when you talk to consumers you definitely saw a trend towards the advertising, raising awareness in different diseases, prompting consumers to go into the doctor, prompting them to get tested, making them smarter health care consumers, and as the ads got better and as more ads were focused on disease awareness, and I think there was a very strong push in that direction today on the part of the companies, the learning that went on improved. And when you talk to physicians, again, you saw physicians confirming these findings. You also saw physicians complaining -- I think I left that bullet off because it didn't support my thesis. No, I'm kidding -- you also saw physicians complaining, you know, that they had to spend time talking to patients about the drug they saw on TV and why it wasn't appropriate, but that's not the worst thing for a physician to engage the patient in that discussion, and I think physicians who bemoan that are physicians who like to go in and out of the room very quickly or have a very limited amount of time to talk to their patients. I'm not as sympathetic to that as I am to the idea that these ads actually drove patients then to seek treatment or to see a doctor when they otherwise wouldn't have because one of the very difficult things in medicine is just to get patients to be aware of their own symptoms and conditions. Most patients are either very cognizant of it and come in all of the time or are just oblivious to it and only present when they show up in the emergency room with the heart attack or the perforated bowel or the bleed or whatever it is because they've never seen a doctor or really paid attention to their symptoms. So I think that's the background on just direct to consumer advertising in general. Now, when you look at advertising messaging and advertising in the space of HIV/AIDS, again, the literature bears out a positive role. So the first study looked at paid advertising for AIDS prevention, and this was done by the CDC, again, where they were recommending targeting certain populations, mostly young people, people who are at high risk with not so much direct to consumer advertising, but public health promotional PSAs, promotional ads, things like that, help seeking ads, disease awareness ads, and found a very positive role for them, and the other two studies, too, seem to bear out what I've been talking about. And most of the literature in this space really does support that, and where the literature tends to bifurcate is what kind of ads raise awareness the most, what kind of ads drive the most appropriate awareness utilization, behavior on the part of people. There's a lot of literature around whether shock ads are more valuable in terms of driving people to be tested or refrain from risky behavior than ads that aren't shock ads, you know, and things like that. That's where the debate usually lies, but there seems to be no question that there's a role for public messaging and perhaps also a role for advertising done appropriately. The problem, I think, is that as I said, not only do you have withdrawal on the part of the companies engaging in direct to consumer advertising in this space, which again raises awareness of this disease even existing, which it's hard to believe, but awareness in high risk communities is waning and the literature bears that out, but also there's a backing off on the part of some of the not-for-profits that early on in the AIDS crisis, which I'll show you in a moment, engaged in a lot of public health campaigns, a lot of public service announcements collaborating with broadcasters and other media outlets to get out a message about prevention, about seeking treatment, about using condoms or other appropriate measures to try to reduce the incidence of spread of this disease, a backing away from that to the point where recent investments, and this is one example, in public service types of campaigns have focused on raising people's consciousness about the international problem and about their willingness to help participate in international solutions, support contributions from our own government to foreign governments, and things of that sort. And this isn't the only example. There's been a couple of examples like this where the public service campaigns are very broad based ones that have been launched recently that have really focused on this kind of a message rather than on a prevention message or, you know, "don't engage in risky behavior" message here domestically. There's nothing wrong with this. This could be very helpful in raising the world consciousness to this disease and inspiring people to engage in practices and to engage in efforts that are going to help spread the blight or stop the blight -- excuse me -- but it's clearly a backing away from where we were in the '80s and '90s, and you can postulate all kinds of reasons why this would be, but I don't think the fact that all of the public service campaigns have been controversial and have been met with some resistance and the direct to consumer advertising and even the disease awareness that the companies did, again, was met with criticism or resistance. I don't think that should be lost in this kind of debate and a discussion about why this is now the trend and no longer to promote prevention and disease awareness here domestically and promote a message of not engaging risk behavior. So how can we get the message back on track, assuming we want to, and I think we do because I think there's an important role for public communications in helping to stop the spread of disease here in the United States. I certainly think that there's a role for direct to consumer advertising. As I mentioned up front, I think all of the literature on DTC ads in other spaces validates the fact that the advertising that the pharmaceutical companies engage in does, in fact, promote awareness, does, in fact, prompt people to come into their doctor, to potentially seek treatment, and in this realm to see testing, making people aware of the signs and symptoms of HIV diseases so that they might be aware that they could be infected just by doing their inventory of their risky behavior and maybe the early symptoms of HIV disease as opposed to waiting for, you know, full blown aids to set in and they show up with, you know, Kaposi's sarcoma or whatever the end stage manifestation of the disease is. So there is certainly a role for DTC advertising, and there's also a very important role for public service campaigns, and I think through Ryan White, in particular, we can explore those more aggressively, which I'll get to at the end. So what can we do to make DTC advertising a more effective tool? We've talked about some of the criticisms that's been levied against it, and certainly some of the ads that seem sort of irrefutable that they cross some boundary of what is smart advertising in this space if you're really focusing on public health messages. You don't want to show a robust person mountain climbing, you know, a 10,000 foot peak while they were on triple therapy. It's not going to happen. So that's probably not an appropriate ad. I think that was actually one of the ads that ran back in the '90s that upset people. I think there's more than the FDA can be doing to try and promote better advertising in this space, and I would hope that that would be part of the discussion of this Commission, to look at trying to promote some of those policy reforms at the agency as part of your overall agenda. So I think advertising promotes awareness. You want more speech, not less. The FDA doesn't have the authority to regulate the kinds of ads that people find the most effective, which are the disease awareness ads. It's really an FTC matter, and if the company is not making any product claims, it's not clear that it's really subject to any regulatory authority. But that said, those are the unbranded ads, if you will, the ads that just raise awareness about disease and about linkages between behavior and disease, things like that. But looking at the product specific ads, it could be useful if FDA had specific guidance on the issues that have prompted other ads to run afoul so they could issue therapeutic specific guidance just on HIV ads if they wanted to try to promote more effective ads and try to prompt companies to be more conscious of what the guidelines are here. So that's certainly one thing that the FDA could be doing. So product specific advertising, if you believe my thesis, product specific advertising is down because of the uncertainty in this field. And if you listen to the quotes from the advertising executives, that would certainly seem to confirm that, and so if there was less uncertainty here, that might prompt more companies to engage in more promotion that stayed within the strictures of what the agency felt were the boundaries or seems to align with what the community feels were the boundaries, and the other positive impact that the agency could have if it had product specific guidance here, therapeutic specific guidance is that it could help send a message to the marketplace and to political leaders who often criticize these ads that this is something that we want to promote as a public health matter, advertising in this space, appropriate advertising in this space. And so the agency is making an affirmative statement that there are ads, product specific ads, that could be helpful. So getting to the broader issue of how we can promote an environment of more effective public messaging tools generally, I think we can learn from successful campaigns in other realms. The Office of National Drug Control Policy, I think, provides one very recent effective model for working with popular media to engage in a public services type of campaign, public service announcement type of campaign. I think the PhRMA companies themselves, especially in the current environment, are searching for positive promotion agenda items, and certainly providing opportunity for public-private partnerships with the industry is something that this Commission could think about. And I think Ryan White funding generally should be focused on treatment and prevention, and prevention that also includes public service campaigns and public messaging type efforts. I think Ryan White should be focused on attacking the virus. It's a limited source of funding and there's a lot of infected people, and if we focus that limited money on attacking the virus, I think we can get a lot more bang for our buck, and by attacking the virus, I mean suppressing the virus with treatment and preventing the spread of the virus with efforts that promote behavior that will help mitigate its spread. So I wanted to just briefly touch on some campaigns that have worked in the past. This is just one from the Heartland, the Midwest AIDS Prevention Project. This was the largest nonprofit, community based organization whose sole mission was prevention of HIV transmission, and in 1996 collaborated with a number of other nonprofits in the area to target media towards high risk populations and worked in conjunction with some of the government authorities in the region. Another campaign that was deemed effective was one orchestrated by the Ad Council, again going back to 1988. This was launched at World's AIDS Day on December 1st, 1998, and consisted of some controversial ads that were probably more controversial the day than they would be today, but also some playful ads, some ads that would appeal to younger people, people in more targeted populations about not just promoting awareness of the disease, but promoting awareness about the kinds of activities that promote the spread of the disease. And I encourage you to look back at both of these. They're easy to find on the Web. It's interesting that these ads, most of the follow-up work that was done looking at that impact really validated the campaign and found it to be highly effective. Unfortunately in 2001, the Ad Council shifted the focus of its AIDS campaign from prevention through education to, quote, unquote, inspiring change through awareness with the launch of a new campaign. Now, that was done in partnership with the United Nations Foundation. So again, you see an effort of one that was focused on prevention awareness, had a little bit of shock value, targeted towards high risk populations, particularly young people, people in urban settings, pregnant moms who could have HIV and should go get tested, to focusing on more of an international let's collaborate, let's increase world awareness and world funding for this. Very important. You know, you wish both can go on simultaneously. Unfortunately you don't have a lot of partnership like the Ad Council, and when they shift resources from one thing to another you lose something in the process. A third campaign I just wanted to highlight, National Association of People with AIDS sponsors a national AIDS testing day, which is June 27th, incidentally, coming up, and a lot of companies support this. So this is a not-for-profit type of group collaborating with industry to pay for and promote a public services announcement. That, again, doesn't have any product specific information. Gilead is a big sponsor, and they don't have any product specific information in here, but again, promotes awareness in testing. So industry can and should be involved, and I think they want to be hopefully, involved in these kinds of partnerships. They have certainly shown a propensity in the past, and I think we should leverage that. And finally, I mentioned the Office of National Drug Control Policy. This was in 1999, the media campaign. There was a media campaign and related programming surrounding activities that were made possible by a unique collaboration among the Office of National Drug Control Policy, NBC and AOL arising from messages that came out of the National Youth Anti-drug Media Campaign. Basically ONDCP purchased advertising, and it required a pro bono public service match from the network. This was on NBC, and NBC created programming around what at the time was a popular teen NBC, T-NBC. I don't think I ever saw any of it, but apparently it ran on the network during Saturday morning when teens were more likely to be watching TV and also after school and had tie-ins with some on-line media where people could -- they had specific story lines in some of their shows, and then they would run a public services announcement afterwards and give teens a place to go for more information or to chat on line with experts. And this, again, was deemed to be a success, a little bit controversial at the time, but I think in retrospect most of the efforts that have been made to go back and look at it have really been laudatory of the impact it had. And then again, I had mentioned PhRMA companies are searching for a positive promotion agenda. You see PhRMA's code of conduct. You see industry announcing certain measures like a moratorium of one-year advertising by Bristol which I don't think is probably a positive solution, but there are positive solutions here, as I mentioned, with the FDA guidance and some of the public-private partnerships that could be pursued by a commission like this. Finally, I mentioned Ryan White, and I wanted to close on this point. I think the current focus, not to criticize a program that has been very successful and a very important public health effort undertaken by this country and a very compassionate effort, but certainly the current focus focuses a lot of money on overall treatment of the patient and a lot of ancillary health care that goes into not just taking care of a patient who's infected with HIV infection, but taking care of any patient. That's a noble effort, but it might not be the best effort when you have a limited amount of resources and you really want to target this program towards attacking the virus, and so how do you attack the virus? Well, you certainly attack the virus by suppressing the virus in people who are infected with it. Most of the literature bears out that even when patients continue to engage in risky behavior after they are on triple therapy if the virus is sufficiently suppressed, the propensity to spread it goes down dramatically, and so you're going to lower the incidence of spreading the virus, although you can argue by making them feel healthy, you'll put them in a position where they can reengage in risky behavior, but that's certainly not what you want to pursue as a public health agenda, keep people sick so that they can't spread a disease. But what you can do is couple the effort to suppress the virus with efforts to continue to raise awareness about behavior that could spread the disease, particularly in communities that haven't had as long of a history with HIV and aren't as aware of it, particularly the urban poor. Like any other infectious disease, HIV is becoming a disease of the urban poor, and where there is less experience with and less knowledge. So target public service messages there about what kind of behavior could propagate the virus, target messages about, you know, encouraging people to look for the signs and symptoms or know when they might have been exposed to seek treatment, to encourage people to seek testing, to encourage people to just get tested if they think they could have been exposed or could have been in a high risk situation, and encourage people, again, to come in and seek treatment and stick with treatment when they are sick. I think kind of agenda for Ryan White, one that focuses on attacking the virus would really line up the domestic program with the international effort that's underway, which is really targeting the virus. Especially in this country where there are a lot of other services available to support patients overall, not using the existing funding there to attack the virus, I think, is not making the most efficient use of those resources against AIDS. And why this ties in here is because I think when you talk about prevention and Ryan White funding, prevention there really means doing more to try to target high risk communities with a message of avoidance of risky behavior and more testing. So you get people who are HIV positive revealed so that they can get into treatment and live healthier lives and be less likely to propagate the virus. Thank you for your time. I think I'm a little bit short and so I'm happy to take questions. Thanks a lot. (Applause.) DR. SWEENEY: Thank you. We will take questions. We are a little ahead of time. Dr. Green. DR. GREEN: Yes. Thanks for your presentation. You mentioned in passing fear appeals, and you had a 1989 reference I haven't seen before, and I have just written an article about fear appeals. I'm wondering what's your reading of the evidence about, you know, do you feel that fear appeals perhaps combined with self-efficacy motivates and sustains behavior change or not? DR. GOTTLIEB: Yeah. As I said up front, I don't want to represent myself as an expert on advertising or promotional messaging of any kind. My colleague at AEI, Jack Calfey, would be very upset if I represented myself as the expert on that because he's the expert on that. But I did review the literature. I probably reviewed it selectively to be honest because I don't know if I had the totality of the literature, but the literature bears out the effectiveness of those kinds of messages. I don't know. Is that? DR. GREEN: Yeah. There's a meta analysis by Kim Witta, who is the co-author of my article. So, yeah, what you said is what the literature shows, even though it is a widespread belief to the contrary among AIDS experts. The second part of the question is the two ads deemed successful, did they lead to a decrease in incidence or prevalence of HIV? DR. GOTTLIEB: It was felt if you look at the analysis of the Ad Council campaign -- are you talking about the public services campaigns I mentioned? DR. GREEN: Those two ads that you said were deemed successful. DR. GOTTLIEB: Yeah, I think one of them I referred to was the Ad Council's campaign. There was analysis done there that found that to be successful to drive people towards behaviors, you know, greater awareness of the disease, more propensity to seek testing. And the other one where there was some follow-up analysis done was the Office of National Drug Control Policies Campaign with NBC, and that was seemed to have been successful in driving young people, increasing their awareness of drug related issues, driving them to have discussions on the subject. Those were the two where I actually had available and could make available follow-up analysis. DR. GREEN: Okay. So it didn't impact incidence or prevalence, but it motivated -- DR. GOTTLIEB: It motivated appropriate behavior. DR. GREEN: -- behavior and awareness. DR. GOTTLIEB: I think it would be hard to -- you're probably more the expert than me, but I think it would be hard to extrapolate from a single public campaign unless it was highly targeted and you had a very good control population to do that kind of analysis. DR. SWEENEY: I want to just see hands of who has questions. I know Lisa does. Dr. Judson, Dr. Sullivan. Lisa, would you yield to Dr. Sullivan, please?
DR. SHOEMAKER: Yes. DR. SWEENEY: Dr. Sullivan. CO-CHAIRPERSON SULLIVAN: Thank you. It's more of a question and a comment, and I would preface my comment by saying, first of all, I happen to be on the board of Bristol-Myers Squibb. So you should be aware of that. My comment is in response to your comment that the decision by Bristol-Myers Squibb not to engage in direct consumer advertising for a year is not a helpful outcome. So I guess my question is this. Well, I happened to have been at a board meeting last week. This was presented to the board and this was felt to be a responsible response to the criticism of the pharmaceutical industry for driving consumer behavior in a way that many have criticized in terms of consumers' lack of information for a variety of prescription drugs that are available. Having made that comment, I guess my question is: what would be a better way for the pharmaceutical industry to respond to the criticism that they have been subject to for direct to consumer advertising? DR. GOTTLIEB: Well, I'll tell you why I don't think it is a helpful response, and I was asked about this many times in many private discussions, and I've always been consistent in my view here. And unfortunately I was never asked by Bristol or would they have heeded my advice. But I think there's a lot of -- CO-CHAIRPERSON SULLIVAN: Consider yourself asked now. (Laughter.) DR. GOTTLIEB: I think there's been a lot of capital expended over the years and a lot of money spent, effort, good people putting their reputations on the line to support the notion that direct to consumer advertising could have a positive public health impact. I believe that's true. I believe the literature bears that to be true, but selling that idea hasn't been easy and still isn't easy. I think when a company issues a moratorium like this -- and I'm free to speak since I'm in the private sector -- I think it sets back the whole agenda. I think it says that advertising in the first year of a drug being on the market is so bad we shouldn't be doing it at all and there's no way to do it responsibly. And I don't think that's effective. I think that there is a way to do it responsibly. There is a way to do it where it doesn't drive marginal utilization, so that you don't expose people who might not be getting a known benefit from the drug to be subject to known side effects, and that's really your concern about, you know, maybe advertising in the early stages of a drug launch. I think there are ways to do it so that it's effective, and I think some companies right now when you watch TV, you've seen a change in the tone of the advertising, and some companies, I think are finding a much more balanced, effective message that's not turning off consumers, that's, I think, getting regulators excited that there's new ideas out there, that there's new ways to present information that could be more effective. So there is a right way to communicate information even after a drug is newly launched. I think the moratorium says that there's no effective way to do it, and it sets back the agenda of those who want to promote this as a public health tool, myself included in that camp, and it also denies patients the opportunity to hear effective messages. So if you believe there's a positive public health impact for messages even after a drug is newly launched, why shouldn't those messages be in the marketplace? DR. SWEENEY: Lisa Shoemaker. DR. SHOEMAKER: My question is: is there any kind of campaigns that you know of that are underway using famous faces? There's one called RADD, which is Recording Artists and Actors Against Drug Driving, and it's very "bring it home" kind of advertising. Why can't that be like used in this kind of field? The majority of the population doesn't have the intellect that's in this room when it comes to HIV and AIDS. So they are really unaware of what, you know, can and cannot happen to them, and that might be one way of grabbing them. They still have the "won't happen to me" attitude. So is there anything that's underway now that would be directed in that forum? DR. GOTTLIEB: I don't want to represent that I did an exhaustive survey of what's out there because I didn't, but I talked to people who work in PR and advertising in this space and didn't come across specifically what you describe because it would have been compelling. I would have been inclined to include that. So I just didn't see it. It doesn't mean it doesn't exist. But, you know, if four or five advertising PR executives couldn't think of it, it in all likelihood doesn't exist. DR. SWEENEY: Dr. Reznik. DR. REZNIK: I got caught multi-tasking, which is a bad thing. One, I actually do think that there is a benefit from direct to consumer marketing as far as the disease awareness, et cetera, goes, and I do appreciate that portion of your presentation. I think there's not a person at this table who doesn't believe that we need to prevent our way out of this disease, not treat our way out of this disease. My question is, and partly or mostly a statement -- I'll be honest -- is why would you use the Ryan White Care Act, which is the smallest of the three federal payer sources? After Medicaid and Medicare, it's little. It's two billion, but it's small compared to address a prevention advertising campaign when we have in my home City of Atlanta this fabulous thing called the Center for Disease Control with its hundreds of millions of dollars where something like that should be located. So why did you want to put it in the CARE Act? DR. GOTTLIEB: I thought you were going to say the FDA should pay for it. I think CDC should absolutely be doing this, but I think philosophically when you look at Ryan White, I think philosophically, and I guess I was taking a small shot at the philosophical beliefs behind the Ryan White Act and I'm not ashamed to admit that, but I think philosophically Ryan White should be aligned with attacking the virus more than it is today, and that puts a focus of that money on getting drugs to patients, particularly patients who have difficulty accessing drugs. But also as part of that, I think if you philosophically say that these resources are going to be focused on attacking the virus, I think a piece of that is prevention and needs to be prevention. It might not cost any money. It might just take the leadership of the program. I'm not sure of the regulatory ways to do this. It might just take the leadership of the program talking about it, saying for this Commission, saying part of the agenda should be thinking about these things. Maybe they were under the auspices of the Ryan White Act as ways to partner with not-for-profits that could engage in this and it wouldn't cost a lot of money or any at all, or maybe it's just a mandate to the different states from the Ryan White program to try to think about these things. I mean, it could run a whole gamut of effort on the part of that program to try to promote a positive message about prevention that I think would align the program philosophically with the idea of spending the money to attack the virus. DR. SWEENEY: Dr. Judson. DR. JUDSON: In think through the legitimate role of pharmaceutical companies in prevention or advertising prevention, I've just always felt that there was in most cases probably an unbroachable conflict of interest there, and I'm not saying this is bad. I totally believe in free enterprise and private market economy. But I think that all you can expect from, the best you can expect from a pharmaceutical company is that there will be situations in which promoting prevention or public health will also help them to increase market share for their products and perhaps even profit margins. And where those two goals come into conflict, you can't expect them to do it. I wanted then to make a couple of analogies between tobacco advertising, the tobacco industry, and the pharmaceutical industry, but start off right at the beginning saying the purpose of the pharmaceutical industry is to create products that make you healthier, where the unfortunate goal of the tobacco industry was to create and market a product that made people sick. So that's a very fundamental difference, but then getting back to some of the excesses in advertising that have occurred for HIV drugs and I think still occur, you said 1999. In march when I returned from our PACHA meeting and the last time I looked, there was a giant in the Denver International Airport ad that had been there for at least three years in one form or another showing an incredibly healthy, fit, tanned, presumably gay man rapelling off the side of a mountain, and it's still there. It was in 1999. And to me the best single analogy to that advertising were the Virginia Slims ads, where you're simply saying that having AIDS or HIV may actually be something good or desirable. There's certainly nothing negative whatsoever about the appearance of having HIV that was portrayed in that ad. If anything, everything about it was to be desired. So that's where you get into the roles of restricting advertising. You give a false impression or create, run counter to public health goals. Our true public health goal is to have massive, large scale, sustainable changes in human exposure behavior to the virus, and where tobacco was to reduce both supply and demand in both sides of the public health equation, in California tens of millions of dollars were converted into counteradvertising, and these clearly used the fear factors. They let you know that the tobacco industry directors and boards were not your friends and were not interested in your well-being in the long term. And then they tried to go to every negative portrayal they could, from showing a fetus smoking to your teeth falling out. Those particular views are really not too extreme for what HIV does to individuals, their fetuses and so forth, and whether truly portraying the negative outcomes that most people cannot afford to get HIV infection. This is another analogy. I was driving around Philadelphia not too long ago, and I saw that Pennsylvania has these signs up that say, "DUI, You Can't Afford It." The same thing would be true for HIV were it not for Ryan White or some of these other government programs. So I think the negatives, the huge negatives from economic to health to fetuses, we really, really have to restrict the laborization and promote the absolute true negatives that hopefully will encourage people one way or another to avoid exposure. DR. GOTTLIEB: Well, a couple of comments. I appreciate your thought very much. To start off on the tobacco companies -- and I'm by no means an apologist for tobacco companies as a physician, but you might as well accuse them of what they did, which was to try to get people to be long time users of a horrendous product not to make them sick because once they became sick, they couldn't use it anymore, and so it was more to get them addicted. but I'm very sympathetic to what you said, and you know, my own speech on this subject, harkening back to when I was a resident, I think, hopefully reflects that I, too, found the public message that the time to be counterproductive, promoting an overly optimistic picture of what it was to be on triple therapy. And if you think that writing an op-ed like that in the New York Times when you're a medical resident and you're criticizing your attendings is easy, it wasn't, and I got retribution for it, but that aside, I'm surprised that those -- well, I'm not surprised because you saw the Bristol letter that I put up, and that was a recent ad, but I think the number of ads of the kind you describe have gone down dramatically. I'm actually surprised that companies would still do it because they've had years of backlash at those kinds of advertising, but I think that's a place where, again, the FDA could step up and issue therapeutic guidance, if this is an important public health goal, if this is part of an important public health agenda. Because once the agency articulates in guidance what it thinks runs afoul of the law and what doesn't represent fair balance, it becomes very hard, much harder for companies to cross those boundaries. The lines become very clear. They're right. We used to talk about creating bright lines at the agency, and so as long as your bright lines were within the boundary of what the law says the agency could do, I think it pays for the agency to be engaged in that, and so that's someplace where I think a clearer statement by the agency could be helpful in helping companies not only avoid the ads that we think are violative, but also give them the comfort to engage in ads that we think are a positive public health effort. Getting to your conflict of interest issue, there's no question that there's at least the appearance of conflict of interest here if not an overt conflict of interest because the conflict is that the more patients that get diagnosed with HIV, the more patients who get on treatment, the more profits the companies make. That to me is a very healthy conflict of interest. I mean, you have it in the HIV space to an extent, and you probably had it early on. I don't think you have it as much today, but certainly if you make an analogy to Hepatitis C where Hepatitis C is largely a silent disease, people don't know they have Hepatitis C until they end up, you know, with end stage liver failure and only a certain portion of patients do. So there there is a real interest on the part of companies that make Hepatitis C products to get patients diagnosed early so they can get on those treatments and get cured of the Hepatitis C earlier in the course of their disease perhaps. And I think right now a lot of the treatments are saved for patients who become more ill with Hepatitis C. I think once you have on the marketplace a very easy treatment for Hepatitis C that could be given to patients early in the course of disease and knock it out without a lot of side effects, you're going to see disease awareness advertising go through the roof because once you diagnose the whatever millions of patients in this country -- I don't know the figure offhand -- who have Hepatitis C and you can give them a pill for two weeks and it goes away, there's going to be a company. The company that develops that drug is going to have a real, real financial incentive to get people to, you know, go to the doctor and ask for a Hepatitis C test. That will be a very healthy conflict of interest. And so I don't think the conflicts of interest are necessarily a bad thing. I think they help promote more effective communication in the marketplace. So I wouldn't discount the value of trying to tap into them and promote them along the pathway that you think is the most effective in the public health agenda. DR. SWEENEY: We have three questions: Hank, then Karen, then Jackie. DR. McKINNELL: Scott, I would agree with your statement that there's no benefit to companies running ads that make people mad. So clearly there is some area of what you call a boundary or a threshold, but the problem is there's no bright line or agreement on what those might be. I would not rely on government to solve that problem for us. The industry association, PhRMA, is now working on guidelines for direct to consumer advertising, in fact, what I prefer to call direct to consumer education, and I think there's a number of just kind of common sense points here. One is you should educate the physician before you educate the public. Now, it may well take Bristol a year to do that. Others may be able to do it a little more rapidly. So I'm not sure what the right time is, but I certainly do agree that we should be educating physicians before we educate consumers. If you don't want to see erectile dysfunction ads between six in the morning and ten o'clock at night, I think that's right. I happen to agree with that. So I think there's a number of common sense thresholds or boundaries, whatever you want to call it, that the industry is quite prepared to accept voluntarily. We're not quite sure what those are. So I guess my suggestion would be particularly in this field of HIV/AIDS what do you think those boundaries should be, and if you have some ideas, and I'm kind of speaking to the back of the room now, too, let PhRMA know, and we'll take a look at them. If they're reasonable, not portraying healthy people, apparently normal, healthy people in HIV/AIDS ads I think is absolutely right. People ought to not be misled by what they see. So if anybody has any suggestions, get them into PhRMA and you may well see them turn up in a code of conduct. DR. GOTTLIEB: I spoke to some -- back to your point about educating physicians, perhaps Bristol doesn't have as big of a detailed sales force as Pfizer, but -- (Laughter.) DR. GOTTLIEB: -- so it will take them a year to get around, but -- DR. McKINNELL: Just for the record, I didn't say that. (Laughter.) DR. GOTTLIEB: With respect to your statement about, you know, this group coming up with some consensus or the community coming up with consensus, I spoke to some D.D. Mack lawyers before I came here, people who practice drug advertising law in Washington, and they, you know, to a person said, "Well, I wouldn't want FDA setting the norms of what is good advertising because it's really not what their legal mandate is." They set boundaries. The boundaries probably fall at least in this space, maybe others, in a gap that isn't as narrow as what people here in this group would feel is appropriate or people in the HIV community or even the physicians community would feel is appropriate because what we might feel is inappropriate is perfectly legally permissible, and the FDA, after all, can only regulate up to the point of the boundary of the law. And so when I talked to the lawyers, they said to me, well, you should tell this group, you know, it's fine to talk about guidance from the agency, but you should tell this group that they should have that discussion. So I'm glad you said that, and I'm sorry I left that out of my discussion. I think you ought to follow it, too. DR. JUDSON: Well, as a physician treating AIDS patients for a long, long time, having a large clinic, I thought about that, and I actually don't think direct to consumer education about specific anti-AIDS drugs is very useful, and I think it's such a complicated area and there's so much literature bearing on it, more all the time, that to come up with recommended guidelines or treatment recommendations for HIV requires huge, knowledgeable committees, the input of a great deal of science, and that the direct ads really can't add to that. All they can do is provide patients with an extremely limited amount of information that's often product specific and that isn't going to help them receive the very best or recommended treatment. DR. SWEENEY: Dr. Judson? DR. JUDSON: Yes. DR. SWEENEY: You're out of turn. (Laughter.) DR. SWEENEY: Karen. MS. IVANTIC-DOUCETTE: Thank you, Monica. I took note that you are a proponent of DTC as a public health tool, and I myself am not sure. I don't know where really the boundaries are, but I wanted to call your attention to one of your slides that talks about the results of an FDA survey of 500 physicians in the U.S. about DTC and some of the language in there seems more positive, like there are more physicians that support DTC. At least I would take that as a positive spin. But you had a survey presented that said many physicians believe that DTC advertising can play a positive role. Do you have any information about the percentage? Some physicians thought that the ads made their patients more aware of possible treatments. Do you have any objective data on that? Many physicians thought that the DTC ads made their patients more involved in health care. What is "many"? And then 40 percent of physicians believe that patients understood them well. Does this mean that 60 percent did not feel the patients understood well, or what do you have as far as objective data with that? DR. GOTTLIEB: Yeah, I apologize. I don't have the breakdown of the numbers in front of me. I actually took this language from congressional testimony that was presented, and I did that quite consciously, and probably the Congressman had the back-up study available to me at the time. I just didn't bring it today. But I certainly didn't mean to mislead the Commission. The 60 percent that wasn't the 40 percent, not all of them felt that the patient didn't understand it, but they had various opinions that would indicate that. So they felt that the patients didn't fully understand the risks, didn't understand the risks at all, were overly optimistic about the benefits. So they had some kind of understanding that wasn't in sync with what the physician felt was a clear understanding of the drug's efficacy. On the other stuff I'd be happy to provide it or E-mail to have one on the Commission. I mentioned that I left off a bullet there about the doctors, which is probably the most negative thing you can have a study about the doctors, feeling that the - well, there were two things that were negative about the study. One, feeling that the patients didn't come away with a clear perception of the risks, which was part of that 60 percent, and that the doctors felt that they had to spend part of their patient interaction or a good part of the patient interaction in some cases trying to explain away the misperceptions so that the drug wasn't the appropriate drug for the patient when the patient felt that it was after seeing the advertising. And those were clearly the two most negative expressions that came out of this survey, but the survey is available publicly, and I'm sorry. I didn't mean to leave the wrong impression on the Commission. MS. IVANTIC-DOUCETTE: That would be great. If you could get that to us, that would be great. DR. GOTTLIEB: I did mean to make a point. So I guess it's the same thing. DR. SWEENEY: Jackie, and then Dr. Sullivan. MS. CLEMENTS: Okay. I have a real brief comment. You know, when it comes to direct consumer advertising, I think we need a fair balance because certainly my pretty face on an ad after 20 years of infection would not do much for prevention, but it might do something for care and treatment and access to care and adherence to medication. So I think that it does serve some benefit to those one million people, you know, that are living with HIV, trying to remain healthy and the hope that they can remain healthy with the meds that are out now. So I think we need a fair balance. DR. SWEENEY: Dr. Sullivan. CO-CHAIRPERSON SULLIVAN: I just had two quick comments, one for Dr. Gottlieb and one for Dr. McKinnell. DR. GOTTLIEB: Is this about the sales force? (Laughter.) CO-CHAIRPERSON SULLIVAN: And that is you mentioned the desire of having FDA perhaps give more guidance to the tobacco industry about advertising, and the reality is that the Congress has prevented the FDA from doing that. The FDA has wanted to have some regulatory authority over the tobacco industry, but by congressional action, the FDA is prevented from doing that. And I guess for Dr. McKinnell I just wanted to ask him if he has the remotest idea which companies he has in mind that might do a better job of direct to consumer advertising. (Laughter.) DR. SWEENEY: I just wanted to say Lisa had asked whether or not there was anyone famous doing ads for HIV medications, and the answer is yes, and I don't know if you know the Magic Johnson Bristol-Myers -- no, Glaxo. Oops, I didn't mean to say that. DR. GOTTLIEB: Is that still going on? DR. SWEENEY: I didn't even mean to say who it was. Never mind. Anyway, one of the issues with direct to consumer advertising, and you might want to comment because I'm one of those physicians who feel that the patients who come in and want the little purple pill when they really should take a Tums is really an issue. But what happened with the Magic Johnson ad was that in a community where health literacy is a really big issue, where people misunderstand, where they're distrustful of the medical community to start with, people thought when the ad said that Magic Johnson had no detectable levels in his blood, they thought it meant cured, and so when you are doing direct to consumer advertising and you have one message that's going out there, you are not taking into consideration the various levels of linguistic educational and cultural competency and can miscommunicate information or mislead people, and there are actually people now who think either he was never positive or that he's been cured of HIV. So that -- DR. BENY PRIMM: Or that he was has some special medication. DR. SWEENEY: Yes, that's right. That is the other one. So that I on television said that I thought the ads were detrimental and that they should come down, and they were changed, but not before the damage was done that undetectable means cured. So I would like you to comment on that, please. DR. GOTTLIEB: Well, I think that's getting to the question of what is permissible from a regulatory standpoint. I can't comment whether that kind of statement runs afoul or whether the FDA even issued a warning letter on that. And if it doesn't cross the boundary of what's legally not permissible, whether or not it conforms to the consensus of the community, and a statement from a Commission like this or the consensus guidelines from PhRMA, whatever it might be about what the messaging should be, and I think if you really are serious about looking at trying to promote more positive advertising in this space you need product specific, therapeutic specific advertising because the issues here are so much different than they are in a lot of other diseases where a statement like that wouldn't necessarily have a negative impact. But certainly you're right. A statement like that in this space could, probably does have a negative impact because of misunderstanding that it breeds, and it might not represent fair balance. Just an observation on the DTC issue with physicians, I think I'm still practicing, and I certainly have my share of patients who come in and ask for certain drugs by name, and I think it's just a reality of life certainly because the courts have clearly spoken to the companies that do this. I think it's going to be a growing reality of life because as you see the pharmaceutical companies moving into more specialty focused product areas with more of the marketing isn't to patients but to doctors who made decisions about prescription information, you're going to see more and more the primary care drugs being delivered maybe even over the counter, but certainly by companies that are more engaged in consumer products. And the consumer products companies aren't going to have big sales forces. They're not going to sell drugs to physicians. They're going to sell directly to consumers. And so I think when you look at the spectrum of advertising that we're facing in the future, the next ten or 15 years, it's going to be by different companies. It might be outside of the regulatory purview of the FDA because more of these primary care drugs will be driven over the counter, and I think it's going to increase, not decrease. And I don't think it's going to be the actors who are advertising a lot today. I don't think they'll be the ones advertising ten years from now because they'll be out of the primary care drug space, which is the space where you want to be advertising to the consumer and not necessarily to the physician. It's just an observation. It doesn't impact this discussion, but I think as physicians if we're really annoyed by these ads, we should be speaking publicly as physicians about what we feel is a positive message. I think that can have a lot of impact certainly when the AMA speaks because it's not a regulatory issue, although people would like to make it a regulatory issue. It's not. And when the regulatory agencies step in, they are often running afoul of the law, and certainly if it's an OTC product, the FTC has very limited authority there. And so if we don't want patients coming in asking for products by name, we need to be speaking out as physicians in the community. DR. SWEENEY: One last comment from Lisa. You have the last word. DR. SHOEMAKER: I just wanted to clarify myself when I was talking about RADD and famous faces. I wasn't necessarily saying about people who were infected with the disease, but also to have behavioral changes, like RADD is talking about drug driving, to not drive drug, that kind of thing, which brings everybody into the realm that there's a possibility that if you don't change your behavior you could get this disease and also use it as a key for testing, to get people who are famous faces to get tested and say this is important to have done. So I wanted to clarify myself. That's what I meant. Thank you. DR. SWEENEY: Thank you very much, Dr. Gottlieb. (Applause.) CO-CHAIRPERSON SULLIVAN: Thank you very much, Dr. Sweeney, and the Prevention Committee for a very helpful presentation. It's now time for any final comments or wrap-up for the day, and David Reznik has a comment. DR. REZNIK: I do, and it's not actually related to -- it's something I want people to think about tomorrow. I just came from the HRSA International AIDS Society clinical care update where there was 400 physicians and mid-level providers, mostly physicians there getting trained on the latest information on HIV and AIDS. And at the faculty dinner I had one of the most interesting conversations I think I can remember, and this is what I want people on the prevention and treatment committee to think about for tomorrow. There's a very prominent physician from the National Medical Association who was at the faculty dinner, and he was concerned that the Public Health Service guidelines and the International AIDS Society treatment guidelines were too low and that there was a problem with more than one, multiple of his patients and his colleagues' patients getting reimbursed for treatment. These people had insurance. They're written antiretrovirals, but the insurance companies weren't paying. So he is in charge of coming up with new recommendations for the National Medical Association on treatment guidelines, and the reasoning behind this was that the man -- let's just use one example -- the man was not willing to disclose his status to his wife. I think that the two groups have got to get together and we have got to address this issue. This was not just a sidebar conversation. This was a significant conversation in front of people like Michael Sagg and others that were there, and I think it's an issue that we must find a way to address. CO-CHAIRPERSON SULLIVAN: Thank you very much. Dr. McKinnell and then Abner Mason. DR. McKINNELL: Yes, I would encourage the Treatment and Prevention Committee to find a way to get on the table the issue of routine testing because it really seems to me crazy. Somebody was here talking about a needle stick late at night. It seems crazy to practice medicine not knowing someone's HIV status in today's world. It's like trying to practice medicine not knowing somebody's blood pressure. DR. REZNIK: We've got the CDC guidelines. I mean, we need to reinforce it. I agree with you completely. DR. McKINNELL: But in the county hospitals there is no testing unless people ask for one. So it should be routine unless people opt out. So if you don't want to have your blood pressure taken, just say, "No, thanks." But it should be routine that people are offered HIV testing. DR. REZNIK: It says, "Know your numbers." And that's one of the things that we need to do. DR. SWEENEY: Dr. Sullivan, may I just address that? Hank, would you -- I just said Hank because Dr. McKinnell just brought up that he wants us to talk about routine. I will ask all of you to please read the prevention outline before tomorrow because it's on there. It takes about ten minutes to read it unless you're a slow reader like I am, and it's on there, routine testing. DR. McKINNELL: Well, that's great, but why can't we talk about it? DR. SWEENEY: Oh, we can tomorrow. We're going to tomorrow. DR. McKINNELL: But we can't make it a resolution, you said? I missed that maybe. DR. REZNIK: We'll work on a resolution because I've said twice here and I imagine at some point I'm going to get fired from my health system, but my health system, the Women's Urgent Care Center, the Urgent Care Center, and the emergency room do not do rapid testing. These are at risk, old CDC target individuals who are going undiagnosed. Now, I understand that something is up with the CDC. They are going to do some kind of new outreach, but it doesn't materialize, and as far as I'm concerned enough is enough. We must have at least -- and we're talking about doing routine testing in private doctors' offices or in public health studies. This is an old target. This is an urban public health hospital system, and it's not just Atlanta. It's Chicago, it's New Orleans, it's all over the country. MS. CLEMENTS: I'd like to say that in North Carolina in a community health center we're trying to, we would like to do routine testing. We can't afford the tests. CO-CHAIRPERSON SULLIVAN: Just a comment I would like to make. MS. CLEMENTS: Cost is an issue. CO-CHAIRPERSON SULLIVAN: Is that this committee previously heard from, I guess, one of the companies, OraSure, and I think we in some way endorsed the availability of the oral test as a rapid test, but I gather what you're saying is that that -- and there may be other oral tests, too, or rapid tests -- are not affordable. Is that what you're saying? MS. CLEMENTS: Well, our clients can't pay for the cost, and the community health center cannot budget the cost. The Health Department gets a few tests from the CDC. The State Health Department gets a few from the CDC that's distributed across the state, but it's not enough to give to the community health center to do routine testing to all the clients that present there. So it's a cost issue. CO-CHAIRPERSON SULLIVAN: This is a legitimate topic for tomorrow's discussion as a follow-up to what we've done. DR. REZNIK: I just wanted to add at SAMHSA we had the presentation today, and it was very proud that they had distributed 200,000 tests. That's nothing. MS. CLEMENTS: That's nothing. DR. REZNIK: I mean, that's the point. We're not where we should be with testing. MS. HALL: Dr. Sullivan, those tests cost about 13 to $15 per test and for the SAMHSA you have to have a SAMHSA grant to be able to access those test kits. DR. REZNIK: And the training is issued there, too. MS. HALL: Yeah, the training is issued. That's easy, but we are doing it, and it's costing quite a bit. It's moving from $9 to $15. CO-CHAIRPERSON SULLIVAN: I think Co-chair Smith has a comment, yes. CO-CHAIRPERSON SMITH: It would seem to me that we might want to craft something in the form of a resolution, tie it to the recent CDC numbers that are increased above where any of us thought they were, and make it a matter of priority. CO-CHAIRPERSON SULLIVAN: Dr. Judson. DR. JUDSON: Well, I think this is a battle, Hank, that's been partly won, and it has been won over time, but a few things remain to be done, and I think there's general acceptance at CDC level and most other prevention areas that there should be basically at most opt out provisions for HIV testing within almost all areas of routine care. And this has occurred. I know that my wife, for instance, who had no risk factors was tested for HIV at age 45 through Kaiser. Ten years ago they had already moved to that, and we have done so through most of Denver Health and Hospital Services. It became a routine opt out for all OB-GYN patients, OB patients eight or ten years or so ago. I think the advancing HIV prevention program for CDC clearly has that as one of their three or four key new areas. It is being generally accepted as standard of care. That's where you win that battle, is when all of the regulating or certification agencies accept that as standard of care. And then the final step is that the payers are there. So that has to be taken payer by payer. Kaiser will pay for it. Most HMOs will pay for it as soon as it becomes standard of care, and they are evaluated on it. If Medicaid and Medicare have not done that, they should. We should see that that's done. CO-CHAIRPERSON SULLIVAN: Well, I clearly think this needs to be addressed by our committee tomorrow because if the cost is $13, that's no greater than routine blood tests that are readily available. So clearly for something that makes a big difference in the lives of people, this would seem so. Are there other -- oh, yes. MR. MASON: Not on that subject, but it's just a process issue. For resolutions, if we can get them to people, some people wanted to have resolutions in advance of tomorrow. So if we can do it, we'll distribute them either later today or at the hotel tomorrow or how do you want to? A couple of people asked me about it. We have two resolutions, and now it looks like there may be a third one that hasn't been drafted yet. MR. GROGAN: Well, depending on when you can get them to me, I could send some over to people's hotels, I suppose, but at the very least I could have them ready the first thing in the morning to people when they come back here. MR. MASON: Okay. MR. GROGAN: Just let me know after the break when you think you can give me a copy. MR. MASON: Okay. CO-CHAIRPERSON SULLIVAN: Dr. Yogev. DR. YOGEV: As long as we're talking about standard of care, I think we need to really seriously take the other element out, too, which is pattern of notification. This is one of the few diseases that we can save a lot of patients by pattern of notification, and that should become an STD. We should make it a disease and not a political entity. I would love to see the prevention people adding that into the discussion. CO-CHAIRPERSON SULLIVAN: Dr. McKinnell. DR. McKINNELL: Just to ask that a little more broadly, if your goal was to reduce infection rates to zero, what would you do? We should have an answer to that question, and surely it would be testing. Surely it would be tracking. It would be all of these things we're talking about. So let's look at what it would take to reduce infections to zero. CO-CHAIRPERSON SULLIVAN: Dr. Sweeney and then Dr. Green. DR. SWEENEY: We agree, and it's in there. DR. McILHANEY: Wait until you read it. It's really good. You're absolutely right. DR. SWEENEY: There are things in there that you have mentioned, and there are things that you haven't mentioned, and there are things in there we're not sure once you see them you'll want them in there, but they're in there. DR. GREEN: I had a comment about partner notification because Dr. Yogev mentioned this. In my book Rethinking AIDS Prevention, I have a description of Jamaica's program of partner notification. They've been doing this for years even though few other countries do this, and the people who notify partners of those found to be HIV positive pose as preventive educators, and there were no complaints. There was no evidence that anybody had been sort of outed or, you know, that their status was made known to others in the community because they did it that way. So it can be done. CO-CHAIRPERSON SULLIVAN: Thank you. Yes, Dr. Yogev and then Dr. McIlhaney. DR. YOGEV: On a completely different topic, can I make a request to have less speakers at the meeting and more time for questions? I think we did a disservice to Dr. Reznik to be today the person who cut. The most important part for me is the discussion about the topic, and what happens too often too many of us cannot express, ask questions, which helps at least for me much more than something that's too many topics. CO-CHAIRPERSON SULLIVAN: If I might respond to that, I agree with you. I see two issues there. One, I think our speakers did not take too long for their presentation, but I think many of the questions were too long and with the statement, et cetera. But also many of the speakers took too long, I think, in their answers. So the time was eaten up. So I think if we might ask the committee in the future to try and be sure that your questions are concise, and, Joe, if you could give guidance to our speakers that for the question and answer period hopefully they could give us concise answers and not really very long dissertations because that really does take time away. Thank you. MR. GROGAN: I also give them all guidance about how long their presentations should last and have a fair amount of feedback with them about what they're going to say and how much material they need to present. So I try and make sure that they leave time for Q&A, at least 15 or 20 minutes. Sometimes people don't pay attention to me and they go over. (Laughter.) MR. GROGAN: I know that's really hard to believe for everyone here. CO-CHAIRPERSON SULLIVAN: I think if you get a gavel and a sword for the Chairman, we'll take care of that problem. Dr. McIlhaney. Yes, Ms. McDonald. MS. McDONALD: Well, hello, everybody. I'd certainly like to concur with limiting the speakers. It seems to me that we as a body don't get a chance to do enough real work. I think that we certainly love the presentations and the presenters, but I also would love to see us work in equal time to really work on some very, very key issues, and so I just will offer that as a suggestion. CO-CHAIRPERSON SULLIVAN: Okay. Thank you very much for that comment. Are there any other comments? (No response.) CO-CHAIRPERSON SULLIVAN: Then I will see if our Co-chair Anita Smith has comments. You will be in charge tomorrow, so you might give us any guidance for tomorrow, and then Joe will close us out. CO-CHAIRPERSON SMITH: Okay. Thank you, Dr. Sullivan. Thank you, fellow committee members, for sitting through a long day. It was a full day. I think we had good discussion, a lot to think about. I'm going to go back and resurrect those America Responds to AIDS advertisements that I think came out from CDC under your administration, Dr. Sullivan, based on this last presentation. There's a lot of good information that's already out there that could maybe be reused. As we think about tomorrow, please do read the Prevention Committee insert that's in your notebooks. It's in the left-hand pocket at the front. If you don't have it, please see Dana or Delta because it's very important for you to take a look at that. We will start tomorrow morning according to schedule, and we'll be inserting something, I think, on the agenda relating to testing day, National Testing Day. Just a reminder for all of us and what's being planned. It's timely. It's next week, and something we all need to be thinking about and participating in. Thank you. CO-CHAIRPERSON SULLIVAN: Thank you. Before Joe comments, let me just make this comment. I think these comments you have just made are very helpful, but in spite of the issues we raise, I think today's discussion, presentation was really a very productive one. So I don't want anyone to leave feeling otherwise, but we can improve on this by being more concise. But I do think that this was an excellent day that we had. Thank you. Joe. MR. GROGAN: I just have one relatively minor announcement, which is that in the next couple of days PACHA will be unveiling a new Website which I hope will be much more visually appealing and useful for the public and for the members, allowing the public to register for meetings rather than call and get routed through phone trees to figure out if they actually have registered for the meetings and registered for public comment, and try and get some good links to various other HIV/AIDS resources in the federal government. So it's not active today, but it may even be active tomorrow, and in the next few days or week or so, it will be up and running, and I would encourage you to check it out yourself and let me know any suggestions or comments you have on how to improve it because I'm trying to update it from what it was in the past. I don't think they've been updated, you know, in ten years maybe since it was last improved upon. So I hope you take a look at it. Thank you. CO-CHAIRPERSON SULLIVAN: Dr. McIlhaney, a question? DR. McILHANEY: May we leave our things here? MR. GROGAN: Yes, you can leave your binders here. CO-CHAIRPERSON SULLIVAN: If there are no other questions or comments, thank you. We're adjourned. (Whereupon, at 4:50 p.m, the meeting was adjourned, to reconvene at 8:30 a.m., Tuesday, June 21, 2005.)
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Last Revised: August 10, 2005