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tv   Global Efforts to Combat Alzheimers Disease  CSPAN  January 5, 2018 4:45pm-6:43pm EST

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watch the communicators monday night at 8:00 p.m. eastern on c-span2. next, the house hearing on global efforts to combat alzheimer's disease. national institutes of health officials and alzheimer's rchl and treatment specialists review initiatives in other countries. representative christopher smith chaired last month's hearing. come to order and good afternoon everybody. i apologize for the delay. we had a series of votes and we have one later too, so i do want to get right to it and thank you for being here. today's 47 million people in the world living with alzheimer's disease and other forms of dementia. more than the entire population of spain by the alzheimer's disease international. the number of victims who have
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alzheimer's is projected to or likely to double every 20 years, we are in a race like few other diseases because it is proliferating so fast throughout the globe and according to dr. maria bernard, the deputy director of the national institute on age who will hear from momentarily, the number's estimated to grow to 15 million by 2050 as populations around the world age. predominantly it is a one of the byproducts of all of us aging and there seems to be a higher procliffty the older one gets and it's been estimated that once somebody reaches 85, the chance of some form of dementia is one out of two. it's a very serious problem. the total estimated global cost of addressing this condition today is $818 billion but as early as next year it is estimated that this cost will rise to at least $1 trillion per
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year and it will go up from there. as we all know, alzheimer's is a cruel disease robbing its victims of their memories and identities, robbing their family and friends of the person they know and love. it is excruciatingly painful for someone to lose themselves gradual little and i have spoken myself to many individuals, especially those with early onset with young families and are dealing with the agony that they know it is progressing, there is no cure. there are drugs, five of them so far and others that are in the pipeline that treat symptoms but there's no actual cure and so it is very tough and it takes a very heroic person to cope and manage with that. we also know that the families have to deal with a very painful ordeal as well. the caregivers, the loved ones, the family and friends. in 1999, along with congressman now senator ed markey i cofounded the congressional task
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force on alzheimer's disease which i still co-chair today to bring this disease to the forefront of the congressional agenda, to advance support for federal research and to increase awareness. the task force worked in partnership with the alzheimer's association to unanimously past the project act 375 which established an advisory committee of private and federal experts to work with the secretary of hhs to comprehensively assess and address alzheimer's research, institutional services and home and community based care to identify a goal modifying therapy for dementia by 2025. today there are over 170 members of the house and senate in the task force. this year we worked very hard in a bipartisan way to get an increase of some 414 million to the alzheimer's research funding at n.i.h.
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under hhs tom coles leadership, the 2018 bill was enacted. it was passed in september of this year including the $400 million increase for millions disease research at the national institutes of health. this would bring total funding to $1.8 billion. currently funded at 1.4 billion. n.i.h. spending on alzheimer's research is almost tripled since fiscal year 2015 when 589 million was allocated for such research. shockingly the majority of people with alzheimer's or other forms of dementia have not received a diagnosis so they are unable to access the care and the treatment of symptoms that they so desperately need. this is true in the developed world but it's intruer in the developing world. michael sflan points out in his testimony today that detection and diagnosis are a stubborn
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problem everywhere. research shows that most people currently living with dementia have not received a formal diagnosis. he will testify and high income countries, 20% to 50% of denvementia cases are recognized and documented in primary care. this treatment gap is certainly greater in low and middle-income countries. without a diagnosis, there can't be treatment care or organized support or the opportunity to volunteer for clinical research. of course, even when alzheimer's or other forms of dementia are diagnosed, care is too often fragmented, uncoordinated, and unresponsive to the needs of people living with this condition. in response, last congress i absoluted the health outcomes -- introduced the health outcomes planning for alzheimer's act of 2015 to provide medicare coverage for care planning session for patients newly diagnosed with alzheimer's disease, for family caregivers or legal representatives.
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in recognition of this great unmet need, there were garnered 310 co-sponsored. ultimately an amended version was -- an improvement in the -- for final rule for calendar year 2017's physician's fee schedule. of course, alzheimer's robs its victims not only of their memories but also of their awareness, but also their lives. in the "american journal of public health" research surveyed of years of life lost versus years of death between 1995 and 2015 annual deaths due to alzheimer's complications in the u.s. alone rose from 20,607 in 1995 to 110,568 in 2015. during that period, alzheimer's rose from the 14th leading cause of death among ailments in this country in 1995 to number six in
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2015. for the record, this is my fourth hearing i've chaired on alzheimer's disease. on june 23rd, 2011, we hold a hearing on strategies to combat the effects of alzheimer's. we heard a hearing on the g-8 dement dementia skpu dementia summit and beyond. in 2014 on the actual summit report from the g-8 and now today's hearing, of course. today's hearing is intended to examine existing and potential options for prevention and treatment of this often -- this always-devastated disease, and the harrowing statistics cited earlier would be much worse in developing countries if they had accurate identification of alzheimer's and records of victims and of deaths. as our hearing testimony will demonstrate, there is hope for alzheimer's patients, their families and friends. there is a surge particularly for research. for example, a research team
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from columbia university's medical center in 2013 said they had finally traced alzheimer's to its early developmental stages. a discovery that they believed could lead to more effective treatments. in science, translational medicine two years ago, australian researchers explained a noninvasive ultrasound technology that clears the brain of neurotoxic amyloid plaques, structures responsible for memory loss in patients. the science and institute for regenerative medicine in zurich said they were amazed to find their patients treated with the highest dose of an antibiotic drug experienced an almost complete clearance of the amyloid plaques that prevent brain cells from communicating leading to reversible memory loss and cognitive decline. our witness today will tell us about the advances in the world
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in this, and we have two tremendous witnesses and experts who are doing their best and their staffs to make sure that we get there sooner rather than later. i would also just point out for the record this congress, i've joined my colleagues in introducing the bold act which would establish centers of excellence. and it is designed to really take this to the -- to have congressional support for this effort in a more robust way. and i have introduced a law that passed last year in the house that deals with the wandering issue. we know that when alzheimer's or autism individuals have the bracelet, they're found usually within 30 minutes. when they don't and they go wandering, it can be catastrophic if not cause of death from drowning and a whole host of other reasons if they are not rescued from that wandering. next week i will reintroduce the global brain health act to
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increase research on prevention and treatment of autism, hi hydrocephalic condition and alzheimer's. this would encourage the building of treatment capacity for caregivers in developing countries and support increased international cooperation in research and implementation of strategies on prevention and treatment. i'd like to now yield to dr. barra for any opening comments he might have. >> thank you, mr. chairman. thank you for having this hearing. it obviously is incredibly important. any time you can say neurotoxic amyloid plaques in congress, that's a good day. as a physician, i'm trained in internal medicine, taking care of alzheimer's patients. the urgency of addressing this issue and, you know, looking for ways to mitigate the disease but also ultimately looking at ways to reverse and cure disease are
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obviously our ultimate goals. you know, i think we often focus here domestically on what we need to do to help address this issue. i work pretty closely with our alzheimer's association. i think the alzheimer's association has done a wonderful job of elevating the level of dialogue but elevating the dialogue on why this is a global epidemic. often when we think about global health we're thinking about the communicatable disease that's are out there. but there really is as, you know, there are more developed nations around the world, we've got to spend more time thinking about the impact of noncommunicable diseases like alzheimer's disease. as we start to think about the public health approaches, from my public health background, there's a number of things that are the low-hanging fruit, lifestyle modifications. things you can do to slow down
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and mitigate disease. a second step is building the public health infrastructure? the global community to help families and patientings manas d navigate the disease. i think we'll see the coming tidal wave as people live longer in the global community, the lack of infrastructure and the lack of readiness to manage this tidal wave of folks with dementia and alzheimer's. i look forward to hearing from witnesses. we can quantify the direct costs of alzheimer's, but then also the indirect costs of alzheimer's in terms of both the patient as well as the impact on families and caregivers. and then ultimately, you know,
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part of the reason why i am such a strong advocate for making the investments in the nih and making investments in research is the return on that investment if we are able to find a cure or even better therapies to mitigate disease and slow down disease is going to be, you know, pretty significant. if we don't we will be spending billions upon billions of dollars on the back end. this is not just a u.s. challenge. this is a global challenge. mr. chairman, i think this is incredibly timely topic, i look forward to hearing from the panelists. thank you. i yield back. >> thank you. i would like to now yield to mr. donvan, ranking member. >> thank you very much, mr. chairman. thank you for conducting this very important hearing. many of the things this committee does deals with diseases and things people are suffering from that we don't suffer from now in this country.
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when i came to congress two weeks later at 58, i had my very first baby. a mother describes her as my very last baby, by the way. all the sudden maternal health and infant health, prenatal care became so important to me because it was personal to me. and i always say on yellow rose, catherine -- she hit the birth lottery. she was born on may 19th, the same days tens of thousands were babies were born. she was born on staten island, new york city, and has had every one of her vaccination, every one of her well visits. children born that same day who didn't hit the birth lottery didn't have the same advantage she did. that's one of the things this committee has done that's been personal to me. i am also the only son of an alzheimer's patient.
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my mother died the year before i was elected after suffering for four years. i was blessed -- i had hear until she was 89 years old. her mother died when she was 9. i always say i had my mother for 50 more years than she had her own mother. i watched this woman become someone i didn't know. a woman who was always calm, who became violent. a woman who would sit and stare when you would speak to her because she could no longer speak or understand what you were saying. i learned a lot about the disease. not as much as my friend, dr. barra, but about the proteins that grow on people's brains and how advancements that were in medicine now, finding ways to slow the protein growth down. maybe stop it altogether, maybe at some point actually have medication that could remove the proteins from people's brains that may cure the diseases, is our hope. i know that we gave the national institute of health in the cures
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act to help find advancement and cures for things like alzheimer's. i wanted to tell my personal story so i could tell you how much i appreciate you being here and how important this is in a global health environment, but how personally it's touched me. so i thank you both for being here thank you. thank you, mr. chairman. >> thank you very much. let me introduce our distinguished witnesses. again, thank them for their tremendous leadership beginning with dr. maria bernard who serves as deputy director of the national institute on aging at the national institutes of health. dr. bernard serves as the principal adviser to the nia director, working closely with the director in overseeing approximately $2 billion in aging research conducted and supported annually by the institute. dr. bernard co-chairs two department of health and human services 2020 objectives, older adults, and dementias, including alzheimer's disease. we'll hear from dr. roger glass,
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who i'd point out is also from new jersey originally, from somerville, new jersey. he serves as the director of the fogerty international center, associate director for international research at the national institutes of health. dr. glass has maintained field studies in india, bangladesh, brazil, mexico, china, and elsewhere in the world. he has received awards including the prestigious charles shepherd lifetime scientific achievement award presented by the centers for disease control, and the charles -- dr. charles marie award for the national foundation for ineffectious diseases in the developing -- infectious disease says in the developing world. two witnesses and welcome to our subcommittee. doctor? >> good afternoon, chairman smith, representative barra, representative donvan. i'm happy and honored to represent the national institute on aging, one of the 27
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institutes and centers at the nih. we at the nia leave nih's alzheimer's disease research, and as deputy director, i bring my experiences and academic geriatrician. i could very much empthieathizeh the comments about the illness and personal impacts on families. when i saw patients on a daily basis, it was heartbreaking, to see the affect on the patient and importantly to their family members and to recognize i didn't have much that i could brick to t bring to the care of those individuals at that time. it's encouraging to be at nih at this point and to see the blossoming of more and more information that's developed with global partners, that will hopefully get us to the point that we will have a prevention or cure for this illness. we have over the decades supported a number of international studies that have led us to a greater understanding of the illness. i will spend what time is jag
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indica -- is allocated to me to briefly highlight three of those. first, we're making significant advances in our understanding of the course of alzheimer's disease from our health and retirement study. this is a 20-year-old national sampling of older adults in the united states, people 50 years of age and older who we've followed through to their death. and it has allowed us to see the natural course of aging, as well as the natural course of the development of alzheimer's disease. this study recently had a new component added that's an international component. the harmonized cognitive assessment protocol or hcap. we have the hope that if we can get researcher across the globe to harmonize the way they go about cognitive assessments, we will be able to better understand the course of the illness and to sort out the genet genetic, social, and environmental influences that impact alzheimer's disease. we're supporting the deployment of hcap in hrs or health and
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retirement study-lime studike sn england, mexico, china, and south africa. this will provide unprecedented scientific opportunity. a second need is for means to make the diagnosis of alzheimer's earlier than the current standard when the person has cognitive and functional problems. there are many promising new findings, particularly as a result of something called the alzheimer's disease neuroimaging initiative or adni. adni is a worldwide collaboration with organizations in europe, japan, australia, taiwan, korea, china, and argentina. adni has led to the identification of biomarkers, proteins and images of the brain that allow us to measure the onexcept prago onset and progression of this disease. a decade ago, the only way you could definitively say that someone had alzheimer's disease or has alzheimer's disease was by autopsy. now we can see in a living brain
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the deposition of amyloid plaque and tangles in an individual and follow its course before they have clinical symptoms. as we make progress of validating this and other biomarkers, we hope to translate this into useful clinical tools. third, nia supported investigators are conducting prevention and treatment trials that are global -- have a global reach. one such study that's received quite a bit of attention is the dominant autoimmune disease trial involving the largest group of early onset familial alzheimer's disease. approximately 300 extended family members in the country of colombia who shared a rare genetic mutation that guarantees by middle age they'll have alzheimer's symptoms. the trial focuses whether an anti-amyloid drug can prevent or delay the onset of cognitive decline. we are very grateful to this family and all participants in the alzheimer's disease and
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related trials. they are true heroes who have allowed us to learn and continue to learn about this disease. my patients would tell me they did not want to live to grow old for they did not have their cognitive capacity because they did not want to become a burden to their families. we with global partners are working diligently to develop answers to their concerns. the global rise of alzheimer's pr pr prevalence is urgent, and we're trying to diminish this disease as rapidly as panel. thank you for allowing me to testify. i look forward to your questions. >> thank you very much, doctor, for your testimony and insights. dr. glass? >> thank you, and good afternoon chairman smith, acting -- ranking member barra, and distinguished member donvan. i, too, had a father with alzheimer's. and i sympathize and went
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through the same experience. i'm roger glass, i'm the director of the fogerty international center at the national institutes of health. i'm honored to join my colleague, dr. bernard, in discussing how we're confronting the global burden of alzheimer's disease. diseases like alzheimer's and like flu and ebola know no boersd. peop -- borders. people throughout the world suffer from the disease and will benefit from treatments and cures. we need to find the brightest minds everywhere to assist in this endeavor, as well as to identify populations with unique environmental or genetic risks because the high-quality research that we do doesn't happen only in the united states, it happens elsewhere. in order to take advantage of these international situations, we need the best trained scientists with high ethical standards, with good data management capabilities, with laboratories capable of conducting the research that's
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absolutely essential. fogerty international center at nih facilitates building these research partnerships, leading to building capacity for researchers internationally to create the next generation of scientists who will address the alzheimer's condition. these scientists who will address the problems in the future are just being trained today. as dr. bernard mentioned in her remarks, nia is supporting the study in colombia of an extended family with a genetic mutation for familial alzheimer's. this family is now center stage for much of our research on alzheimer's cures and preventions. this partnership began in the early 19 points in when an american investigator, ken kozad, at harvard, met dr. francisco lopera, a young neurologist.
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me to had a patient with alzheimer's and found the patient's father and grandfather had alzheimer's. because of his curiosity as a young physician, not as a researcher, he searched out and ultimately developed a short of 5,000 people with this genetic problem. it was from this conversation six years later of these american and colombian investigators that they began a decade-long collaboration to look and see what they could learn about the epidemiology and genetics of alzheimer's. this investigation has proved incredibly fruitful, beyond our wildest expectations. in the 1990s, these doctors received a grant from fogerty to work together. by 2004 and 2007, the national institute of aging and fogerty were both engaged in supporting this collaborative research. and this research involved not only following up on the cohort but training people in laboratory methods, in building
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capacity so that we could actually conduct quality research under the best ethical standards in the field. at the same time it engendered collaborations between communities that were invested. these were not patients in colombia, these were community participants in research. a big difference. preparing to conduct -- to conduct high-impact research is critical to the fogerty agenda. and what began as a partnership between these two scientists, individual scientists, is now the cutting edge of what's become $100 million clinical trial. the first in the world for early prevention of the progression of alzheimer's disease. it's a unique study that couldn't be done anywhere else. this cohort is an incredible finding and discovery of dr. lopera. he's an essential part of the
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research team, as is his laboratory in medellin, colombia. colombia's not unique in this. while the topic of today's discussion is alzheimer's disease, the fogerty center has been involved in many neurologic problems search as the research on cerebral malaria, neural hiv, a hydrocephalus in uganda. chronic psychotic disorders in tanzania, and stroke outcomes in zimbabwe, just to name a few. fogerty supports -- takes science where the problems are and where the opportunities are for the most rapidly accelerating advances in research. we also are concerned and developing true partnerships for research and advancing capacity building. like dr. lopera, who's a unique
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investigator in a unique setting with a unique population of this familial alzheimer's disease, leading us to hopefully more rapid cures. from this partnership and with nih support, we're already advancing discovery research. we're already working in basic research in colombia in collaboration with the u.s. the group in colombia are now an integral part and essential part of the u.s. research endeavor on alzheimer's. and the results of this endeavor both for the u.s. population and for the population in colombia and around the world will all benefit from this activity. fogerty is essential for building these international collaborations, and we work closely with nia and with other institutes at nih to do this important international collaboration. thank you very much. >> dr. glass, thank you very much for your testimony and leadership, as well.
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let me just ask with regards to imaging, which you mentioned a moment ago, doctor. what kind of brain image regular we talking about? cat scan, mri? obviously that is not available in most developing world settings. >> right. >> and how -- since there is such -- large numbers of people never get a diagnosis, about 50% or less in the united states, how quickly is this technology being advanced so more people will get a definitive word earlier on so some of these drugs that, again, only deal with symptoms can be applied to mitigate the ssymptoms? >> what i was describing as opportunities with imaging and looking at proteins are meant to be in the research setting currently. they are being refined, and we're beginning to look at things in the blood, the
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prospective i peripheral blood. changes in smell, the development of depression symptoms years before a person actually has dementia, as things that will help us to be more precise in making that diagnosis clinically. it all comes together to help us. we don't quite have something that can be translated directly from the research lab that is anything better than we currently have in terms of looking for symptoms right now. >> just let me ask -- you know, you mentioned, dr. glass, about the uganda and the situation with hydrocephalic condition. we have a bill that would driveway that ne address that need. and there's a non-shunt intervention to help people who have water on the brain, and it's amazingly effective. not much by way of having to redo it. you mentioned risk factors. obviously january ticgenetics i
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factor. we know that. one thing that's a big focus. which you talk about environmental risk factors, we know that in the area of autism, environment does play a very serious role. nih has chronicled that in its reports. i'm wondering if other areas of investigation are being pursued including toxic chemicals of various kind, lyme disease. i chair the lyme disease caucus, as well, and it's a -- if you could speak to the environmental side if you would. >> from the environmental perspective, yes. we have a number of studies that are looking at various environmental ctoxins that may e
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contributing to the problems with the development of alzheimer's that's particularly assisted by projects that are looking at people in the long term and what has happened to them. we're also looking at education, looking at diet. looking at geographic location. all of those may contribute. i honestly do not know specifically interest lyme diseas-- specifically about lyme disease. we could get back to you on that. things seem to be associated with the frequencies in which groups have alzheimer's disease. >> dr. glass, do you want to -- >> i don't know of other risk factors for alzheimer's, although hispanics have an increased risk and an earlier presentation. for other neurologic disease we know about infections like malaria and hiv, heavy metals and exposures.
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we know about foods in africa, for instance, like maniac, with a cyanide, that has poisoning, and fetal alcohol. there are other toxins. for alzheimer's, don't have those yet. we could look and provide the information. >> i would appreciate that, for the record. you know, the international response has become increasingly aggressive and robust. in 2012, w. h. o. released a study, we met with dr. margaret chen, former director general. she had a real heart for this as do so many others at the w. h. o. in 2013, the g-8, now g-7 without russia, committed to more research funding. that's france, germany, russia, ito ita italy, and of course the united states.
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the newest action plan, paho has a plan -- the pan american health organization. people seem to be coming up with action plans, and that's great. but how well are they being implemented? are they countries like we are -- we're tripling our nih funding. a bipartisan effort. again, i mentioned tom cole, the chairman, doing a wonderful job. he's got a heart for this. the alzheimer's association never lets up in pushing this and having a great impact. in my own state, christine hopkins is the alzheimer's ambassador. we all have one. she is constantly in contact. that's a great way in advocating for patients and caregivers. katy maclin is the director in our area. i was just at a march for alzheimer's in bradley beach. there were over 1,000 people. the alzheimer's association here, they'll be submitting testimony, as well, really pushing for the private sector to come up with money.
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augmented and leveraged by the public sector money. are the others doing it as well? is japan? is germany? the uk? the other g-8 -- the more affluent countries, coming up with the resources so synergistically we'll see a great surge in research? >> i could certainly say that we track what's happening internationally in something that was developed jointly with alzheimer's association, something called the international alzheimer's disease portfolio, that allows us to see across the globe what's going on. it currently has more than 8,000 projects representing 30 funding agencies, 11 different countries. we also work through the department in being shopsive to what the world health organization -- responsive to what the world health organization is doing to work across the globe in alzheimer's projects. and we are aware that various countries have developed plans as we have. i would defer to my colleague, dr. glass, for further
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elaboratio elaboration. >> most important risk factor is age. we see aging of the population around the world which is why this has become such a tremendous problem as we look forward. i think it's because of that aging that many groups including the japanese and english, have invested in this heavily. i think as new diagnostic methods become available so you can actually make a proper diagnosis, the importance of alzheimer's globally will be observed in each of the countries that does the surveys. with the improvement of diagnostics that don't require a dead brain that will be able to understand the prevalence and increasing incidence over time. >> two questions s. the. is there a best estimate if things don't change why we'll be by 2025 and 2050? i gave one estimate.
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there are highs and lows, all guesstimates. do you think we will reach the goal of a disease-modifying therapy by 2025? the g-8 push, the push with nnap -- the nap athe bill. is there enough critical mass to get us there? >> i was going to say we're very grateful for the additional resources that have been provided. and again, as a clinician, i'm excited because there's been the opportunity to invest broadly. basic research that will better help us understands what's happen i happening with the illness. explosion of recognition of genes related to it. we knew from only knowing four genes to little more than a decade ago to more than 24. lots of clinical studies. 100 or so. results coming out in the next years that will help us understand which direction we need to go. enhancement of population-based studies that will help to answer some of the questions that you
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were asking about toxic exposures and social factors, et cetera. i think there's great momentum going on. we'll have to see. >> i would concur. we have more tools to research alzheimer's today than we've ever had. when my dad passed away -- we have imaging techniques which are extraordinary, genetic entrees to the disease, animal models that allows to test new drugs. we're in a position better today than ever before to accelerate the advance. the fact that we have so many clinical trials and drugs being test tested could -- if any of them -- delay the progression of the disease, they will have a huge impact on the cost of care. i think in the short run we have clinical trials that are ongoing now. also the trial if colombia, if successful, we will all benefit.
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if it fails, it will tell us that we're barking up the wrong tree, and we need to find other targets that would be more susceptible for new drugs. either way, i think we're on a -- on a roll that we've never had before, and the opportunities are clearly before us. >> as i mentioned, i'll be reintroducing the global health care act -- global brain health bill next week. it deals with autism, alzheimer's, and hydrocephalic condition. referencing what you spoke about, dr. glass, it concerns me that u.s. aid -- and i've had conversations with mark green, the new administrator -- it's important that we do infectious disease, communicable diseases. but brain health has been left to the cdc and diplomacy, not to the actual assistance at the country level. my hope is that we will be able to get this bill passed and moving in the direction of funding those initiatives, as well. dr. barra?
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>> thank you, mr. chairman. dr. bernard, you talked about longitudinally following older americans and so forth. as you're building this data base and looking at that data base and now adding in folks from around the world to the data base, what types of patterns potential reemerging? >> thank you for asking that question. what we're seeing is in the united states at least at that t the incidence may be decreasing in the united states in population. whether it's because of better education, better blood pressure control, better nutrition, we don't know. we're seeing other sorts of things -- like we're being able to determine that if you make it to age 70 without cognitive impairment, that
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as a man, a without one out of chance of developing alzheimer's disease. as a woman, a one out of three chance. there's a socio-economic status relationship. you know, the higher the socio-economic status, the longer one puts off developing an alzheimer's-type denvermenti. there's a social component. we're looking forward to further disen tangling that. >> do you see a pattern with level of educational attainment? lower rates of alzheimer's disease in folks with higher educational attainment? >> it appears that the -- that there is a correlation. the racist of developmete of de rate is lower, the age at which you develop is older. there seems to be some sort of
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protective or beneficial effect of education. >> when i used to practice medicine, i would tell patients do crossword puzzles everyday. it wasn't -- wasn't just something i was telling them to do. in terms of exercising your brain and going to distant memories and -- >> yeah, yeah. we have a number of studies where we're trying to disentangle what makes the difference. whether it's doing the crossword puzzles, brain games, et cetera. we don't have definitive evidence that that's truly impactful. we do have one study, called the active study, that demonstrated that if you trained people in a particular component of cognition, that that was beneficial for that component. like speed of processing information or memory, things like that. but it's not clear that it truly can put off dementia. we have the agency of health research and quality and national academy of science, engineering, and medicine to look at that very carefully recently. their assessment was that we are
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not yet at the point that we can say definitively that those recommendations will make a difference. it certainly can't be harmful. particularly if they're enjoying those things. i do the same things, as well. >> dr. glass? do you want to add anything? again, when we do medical research, we're creating a huge data base and looking for patterns. in terms of risk stratification now and as we try to come one better diagnostic tools, what are some of the -- outside of family history of alzheimer's, what are some of the other risk factors we ought to be thinking about and educating the public on and certainly educating physicians on as well? >> certainly it appears that people likely to develop an alzheimer's-type dementia are people who live a longer period of time, the people who may not
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have as high a level of education, people who had problems with high blood pressure and diabetes, and that's the reason some of the populations that are considered to be underrepresented populations in the united states may have a higher prevalence, as dr. glass alluded to. there may be some role for past significant head trauma, things of that sort. >> we haven't definitively seen those patterns emerge out of the data base? >> there are risk factors we've seen. whether they are modifiable risk factors is the question. >> okay. >> let me ask, congressman -- dr. barra, the -- even within the colombia cohort which comes from a single founder, there are genetic mutations that have been introduced over the last 200 years so that the age of onset, speed of progression, are
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idiosyncrasy, differences, that we can understand by linking the genetics with the phenotype and progression. we can learn about the genetics by plotting those individuals. i think when we deal with the melting pot of the united states, with genes that have been mixed from all over, it's much more difficult to do. i think that we'll learn a lot more from this cohort and others that have familial modifications. >> with a family history of alzheimer's disease, what is the risk of developing alzheimer's disease? can we say definitively? >> what we can say is that if you have the apoe 4 gene, there's a high risk of developing alzheimer's disease. if you have an -- an amyloid protein mutation, 1 or 2, those
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are associated with early onset alzheimer's disease. they tend to be auto somal dominant. meaning that likely you'll develop alzheimer's disease associated with that. that's with the colombian coh t cohort. just simply a family history, yes. if you have family members who have had alzheimer's disease-type dementia, you may be at greater risk, as well. whether it's related to one of those other genes that we've discovered of late or a combination or environmental factors or social factors, not totally clear. >> in terms of risk stratification, patient presents with the family history of alzheimer's disease, how readily available are the genetic testing and -- again, just to try to think about risk stratifying? >> so i think that there are private entities that are available that can do the genetic testing. we certainly have the alzheimer's disease centers set up to bring people in to
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participate in research programs and some of these centers are focusing on people who have genetic risk. i would again put a plug in for people to be involved in such things things. we need a diversity of people to understand how it will present in different groups. >> and do we know, are there prospective studies going on now where you're taking folks with a confirmed diagnosis of alzheimer's-type dementia, taking their family members and privilege foll looking at them -- >> we have studies that people by biomarkers, they have the changes in the brain, the genetic abnormality, but they are not yet symptomatic. we're looking at various interventions to try to make a difference in their outcome. to that degree, yes. >> at this stage with what we
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know, there's nothing that prevents us from educating our health care work force. if someone has the family history of alzheimer's disease disease, you know, they ought to look at those other mitigating factors, manage their diabetes a little bit better, you know, look at the other lifestyle changes. you know, look at alcohol consumption and -- up, again, the other mitigating factors that may not prevent them from developing alzheimer's disease but may slow down the evolution of disease. look at maintaining brain activity. whether it's through -- brain games or crossword puzzles or maintaining physical well being. those are all reasonable interventions that we can do that have a cost benefit but also, you know -- is that an accurate statement? >> i think that's a fair statement. that national academies and the agency for research and health quality study that i referenced said we do not yet have
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definitive evidence. but there's encouraging -- though inconclusive evidence, that controlling blood pressure, hypertensive has an effect. and the possibility of cognitive engagement. yes, i would hope my colleagues, your colleagues, would do all of the things mentioned, as well as encourage patients to think about getting involved in a clinical study. >> great. i could ask 100 more questions, but i'll yield back. thank you. >> mr. donvan? >> now that dr. barra has made dr. glass and myself feel comfortable about asking about family history of people with a person who has parents with alzheimer's disease, this is an education to me. i wanted to ask about -- we were talking about studies and diagnosis. doctor, i remember when they said you needed an autopsy to do a diagnosis. i remember that.
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are we advancing also in how we're treating patients now with alzheimer's as we're waiting for studies to conclude and -- and how advanced have we gone? i can't believe what you said in your testimony about identifying four genes ten years ago or so, now we could identify 24. that's an incredible advancement for the person on the panel who's not a physician. has our treatment gotten better as your studies have advanced and developed? >> we unfortunately do not have a true treatment. we have drugs that can slow down symptoms for a period of time, but it doesn't change the course of the illness. at the same time that we are vigorously looking at that prevention or cure, we're also supporting research looking at being more effective at caring for the individual with alzheimer's disease and for their caregiver. on the nih campus last month
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there was a summit on caregiving with 500-plus researchers, caregivers, people living with dementia. it was edifying to hear them reviewing what's there and noting that we have a lot of interventions that are effective and can be generalized. some 450 recommendations came from the study. we are sifting through and seeing what we can do to further enhance things. i would like to think that we are further down the road in terms of paying attention to issues of caring for individuals with caregivers and there's room for further improvement. >> anything to add, doctor? i'm sorry. >> not really. it would be nice if we had a cure. there are certainly cultural differences in giving care and keeping people at home versus institutions. definition that people use -- we've supported research on caregivers in spanish language because the way you make a
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clinical -- a clinical diagnosis based on history is linked to the terms that are used for dementia and for acceptance of disease. i not that's an area where we're learning -- but not breakthroughs, as such. just in the caregiving, quality of caregiving. >> i certainly understand that. i mean, my mother suffered for four years, as i said. a woman from trinidad and a woman from ghana treated my mother like she was their own mother for four years. these people became part of our family. we still have thanksgiving with these two women. my mother passed two years ago. and the toll it takes on people -- it was almost like at some point my mother had this innocence about her. she didn't understand what was going on with her body and mind. it was everybody around her who were suffering. so the emphasis, dr. bar sara s it, too, the recognition and focus on caregivers of
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alzheimer's patients are just as important as caring for the patient. when you are successful and we do development a treatment or cure, another of my fears is -- i spoke earlier about global health with maternal health and child health. even prenatal health. that we're not getting those things that we actually have here now for our children to some of those developing countries, those folks who don't have the resources we have. i suspect we'll have the same problem after success for finding treatment and cures for alzheimer's at getting whatever is developed to folks in less-developed areas of our world. and do you see that as something that -- i know to concentrate on finding the treatment and the cure, but once we do, getting it to folks outside of our own count country. i suspect folks in our own country, this will be more
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readily available to them than places in other parts of our world. as we see with immunizations for children or prenatal care for a mom, my fear is that after you're successful we might have the same problem getting the resources to the folks who need them outside of our own country. do you see that as an issue? >> let me make two comments. i thought it was thoughtful about your mother. i think part of the issue in caregiving is how do we train caregivers to give the quality of care that your mother got from these two women. my father was in exactly the same situation. that quality of care and how we trained people to provide this is essential. some of this we can learn through global collaborations. on the other part of your question, can the interventions that we develop in the united states be carried abroad? we have a whole agenda at fogerty at implementation science. of taking what we've learned and
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implementing it in developing countries. we've learned, for instance, how to prevent mother-to-child transmission of hiv. in many countries, this has not reached all the pregnancies and mothers. if you miss a pregnancy, you'll have a child born with ahiv who will need treatment for life. in the strategy, that's become a priority for our research of taking what we've learned and implementing it in developing countries. i think chairman smith, one other thought -- since you mentioned dr. whatevrf, one of global health values from his research is they've find methods to treat hydrocephalus without having to revise shunts every few years in children in developing countries. you can't take them for repeat surgery. through two procedures that he's adapted, they were known but mixed together, one to open the
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outflow of cerebral spinal fluid, the to other cauterize the fluid that produces the sfx, spinal fluid. he could decrease the flow, increase the outflow, decrease the input, and so he could do a single operation without the revision. that operation is being used now in the united states to treat our children with hydrocephalus. it's through the research done in uganda by an outstanding american neurosurgeon seeing the need in that country to bring that technology home to our own children. it's another benefit of -- i would say reverse technology transfer. learning from the developing world these kind of lessons. it will make american children survive better with hydrocephalus, as well. >> since everyone mentioned it, doctor, and are you the only two doctors i know besides dr.
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barra, tony facci is a friend. and i remember him saying at one of our conference that's if we find -- if you're successful in finding a cure for alzheimer's, the amount of money that we gave nih in the 21st century cures act will pay for itself. the amount of money. i thank you both for your work. besides being here today, i thank you both for your work, the people who will benefit once you're successful. thank you all. >> thank you. let me conclude and ask you, if you could, the 2017 who action plan. on november 13th, we know the bill and melinda gates foundation announced $100 million for alzheimer's research. the u.n. itself has established the global dementia observatory to collate and disseminate key data from member states and support evidence-based planning and strengthening of policies, as well as health and social
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care systems. your opinion of the who action plan and the steps -- obviously a whole of government approach for ourselves. are you happy with it? do you feel this is really going to be transformational? >> first of all, we were delighted to hear about the gates contribution to alzheimer's. i think as bill and melinda gates age, they realize that this is a risk that's before them, as well. their investment is really appreciated and shows the broadsening of global interest -- broadening of global interest in this endeavor. i think the fact that the u.n. has a global action plan is also a wonderful recognition of the importance of this problem globally. and it remains to be seen how this will be rolled out. the fact that it's there and it's recognized -- it's recognized by so many international partners -- is an awakening to the importance of
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the burden of this disease for all of us globally. >> thank you. >> i would support what my colleague has said. we think that this is something that needs all the best and brightest minds put toward it. and what we have observed is that as other countries are putting resources toward it, there are more and more scientists with whom we can collaborate. that's only to the good of all. >> of course. thank you for your leadership. thank you for being here today. if there's anything else you'd like to add before we go to panel two? >> no, thank you. >> thank you so very much. i'd like to now welcome to the witness table panel our second panel beginning with dr. mary middleman, who serves as research professor at the department of psychiatry and rehabilitative medicine and director at nyu alzheimer's disease and related dementias family support program, nyu school of medicine, and the lagan health at nyu. dr. middleman was principal
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investigator of a randomized, controlled trial of the nyu caregiver intervention funded for 20 years by the gnanational institutes of health. the results published widely. the doctor has focused on intervention that's include the person with dementia as well as the caregiver. she's founder of the unforgetables, a chorus of people with denver aand their family members -- dementia, and their family members, that rehearses and gives concerts in new york city. then dr. richard moats, chief scientific officer for the global alzheimer's platform, g.a.p., foundation. a patient-centered, nonprofit organization developed to enhancing the speed and quality with which new treatment for alzheimer's disease are developed. he retired in 2015 from eli lilly and company where he held several leadership positions, including v.p. for neuroscience, early clinical development. and leader of the global alzheimer's drug development team.
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he serves as member of the board of governors for the alzheimer's drug discovery foundation. a member of the board of directors of cox state limited based in melbourne, australia. and senior associate editor for "the journal of the alzheimer's association." dr. michael splain, owner and principal in splain consulting, a firm with a big impact based on washington, d.c. immediately prior to starting the company, he was director of state and government affairs and the public policy division of the alzheimer's association leading its grassroots network to accomplish state policy priorities including comprehensive state alzheimer's plans. well known as an advocacy trainer and grassroots organizer, he's been faculty for alzheimer's disease international university public policy, and is active in adi's wort health organization -- world health organization strategy group and has an agenda
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with u.n.-based opportunities in new york and geneva. thank you all for being here, and please, dr. middleman, if you would begin? >> hi, is it on now? oh. thank you. i got into this field because my mother had dementia. i'm trained as a psychiatric epidemiologist. and when my mother had dementia, may family really did not cope very well. in fact, the dementia probably drove us apart rather than bringing us together. and after she died, i decided to try to figure out whether there was a way to help families like mine to cope better with the illness. and i was lucky enough to meet
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four women who were working at nyu, helping caregivers as volunteers. and i -- i saw what they were doing, and decided to try to write a -- to run a clinical trial of what they were doing. so i wrote a grant proposal to the nimh and was funded from 1987 to 2010, ultimately, by the nimh and the nia to study an intervention that was based on what these women had been doing at nyu. the intervention which we named the nyu caregiver intervention, is a multicomponent intervention and has utilized the needs of every caregiver. it starts with a comprehensive assessment of the primary caregiver. and then there's an individual counseling session, the point of which is to help the caregiver to understand the needs, her or his need for support from other
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family members, friends, and formal support. and then there are four family counseling sessions with family members that the caregiver nominates as important to him or her. and a final individual session. there are six counseling sessions in a period of four months. since alzheimer's disease can last as long as 20 years in an otherwise healthy person, we thought it was important to provide ongoing support. other parts of the intervention that provide support are recommendations that the caregiver join a support group run by the alzheimer's association or other organizations like it. and also we were available for what we named ad hoc counseling. any caregiver or family member who participated in our study was able to call the counselor at any time for as long as they stayed in the study! caregivers actually stayed in the study for more than 18
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years. in the time i was funded and because people stayed in the study for so long, i was able to demonstrate incredible benefits of this intervention were able to get at nyu at the time. and basically, the most important component that was not available to the control group in our original randomized control trial was the family counseling. so we think the family counseling was the key and most important ingredient in this package. in the multicomponent intervention. so what were some of the benefits that we were able to demonstrate? we were able to show that family -- the first thing that happened was that the primary caregiver was more satisfied with the support that he or she got from family members and friends. this then led to significantly reduced symptoms of depression, significantly reduced symptoms of stress. improved caregiver physical health.
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and by those -- by those changes, all through improving family -- support for the primary caregiver, we were able to keep the person with dementia at home on average a year-and-a-half longer than the people who got our usual care. so this is a really powerful intervention, and it's -- and its power is through social support. more recently, we were able to show that this intervention could save huge costs to the health care system. in a study that we published in health affairs in 2014, we showed that the state of minnesota, with a population of about 5.5 million people, could, if every caregiver got the nyu caregiver intervention save $996 million in 15 years. that factoid -- not all the other things i told you about, depression and stress and physical health, but that fact was brought to the attention of the governor of the state of new york, who because of it
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allocated $75 million to family support programs of which now i am running one. and i think -- and our program is really -- while we would have to do what is mandated by the state, is really the core of it is improving social support for the family caregiver. and i think that everything that we have done has been about social support. and that is something which doesn't cost necessarily a lot of money. and i think in any country that could -- that would want to learn how to -- would want -- health care providers to learn how to do this intervention, it could be done at a relatively low cost. and in developing costs often labor is cheap and pharmaceutical interventions may be very expensive. so because of our success, even before the health affairs article, people in other countries were interested in doing the study. we did the three-country study in the u.s., the uk and
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australia, which replicated our findings of reduced depression in caregivers, even though all of the people in the study -- all the patients in the study were getting denepazil, an approved drug for dementia. we have done a study in israel that showed similar findings. and we did a study in -- we are currently doing a -- finishing a study in spanish harlem, which is showing the effects again of this intervention. so i am here to say that there is something right now that works. that it isn't a drug, and it won't cure the disease. but it can help people to live better with the disease. and i think that while we're waiting for an intervention -- a pharmaceutical intervention, it is incumbent upon all societies to do the best they can to improve the quality of life of family caregivers and people with dementia. so some of the more recent interventions that i'm involved with, you mentioned the chorus, which i founded in 2011.
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is a very relatively inexpensive intervention. people with dementia sing with their family members. they rehearse for concerts. and they give concerts. they learn new songs, which is something nobody believed could happen. so people with dementia are learning 18 new songs for every concert. not only giving pleasure to themselves, not only finding support with other people like themselves, but giving pleasure to the community. so i think that what we can do right now is to improve social support for family caregivers and for people with dementia. thank you. >> thank you. that is so encouraging and thank you for your leadership and for providing this subcommittee with those insights. i would like to put that article, if you would -- we could find it and make it a part of the record. >> the health article? >> yeah. >> okay. i have a list of testimony of all the articles. but i'm happy to send it to you. >> great. we'll look it up and down load it and put it in. thank you. dr. moes.
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>> thank you, chairman smith. thank you for inviting me. it's a pleasure to follow dr. mittelman. most of my career has been devoted to trying to develop new medicines for alzheimer's disease and i wish i could report we have been more successful. but i can tell you what we have been trying to do and give you some thoughts about how we could maybe make that happier. but medicine alone is not the answer. and so the programs that dr. mittelman and people like her are developing are going to be an integral part of the management program for dementia forever, essentially. so the global alzheimer's platform foundation for which i now work is a not-for-profit organization, founded by patient advocates. to help speed the completion of high-quality clinical trials of potential new therapies for treating and preventing alzheimer's disease. it's the belief of g.a.p.'s founders, along with john dwyer, that only through rapid and rigorous testing of potential
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new treatments will we be able to make progress in alleviating the suffering caused by alzheimer's disease. the foundation has worked with academic investigators, government agencies, pharmaceutical companies and other organizations similar to g.a.p., outside the united states, to develop networks of clinical trial sites that can conduct studies quickly and with high quality. g.a.p. has found eager partners for our efforts in the european union, where there is something called the e pad network for the european alzheimer's disease network. in japan, a jpad network. australia has an apad network and we have partnerships developing in other regions around the globe. before joining g.a.p., i was for 14 years, as was mentioned, at eli lilly and company, where i was responsible for clinical testing of several potential new medicines for alzheimer's disease. including two that reached large global late phase studies.
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before lilly, i had an academic career in new york at mt. sinai school of medicine, where we also did smaller-scale studies. both of the compounds at lilly that reached late-phase testing were very promising scientifically. they actually did address some aspects of what is called the amyloid cascade hypothesis. but neither showed sufficient efficacy to enable a registration as actual medicines for prescription. the four-phase three trials we did, usually two trials for each new potential medicine, included a total of 4,694 patients with mild to moderate alzheimer's disease. and these were conducted in 31 countries simultaneously. approximately 40% of those seen were seen at clinical sites in north america. 21% at sites in western europe. 10% at sites in japan. 9% at sites in mexico and south america. 8% at sites in eastern europe,
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including russia. 7% at asian countries outside of japan. and 5% in south africa and australia. from these experiences with g.a.p. and lilly and a lot of years trying to develop new medicines, i'd like to share the following observations about the global burden of disease and give you some thoughts about how i think the process of medicine development might be made a little better. first of all, in all the countries were g.a.p. and lilly worked, we found high degree of interest. it's not difficult if you go into any of these countries to find people who are concerned about alzheimer's disease. and who are eager to contribute in some way to try and develop a treatment. it's just a matter of trying to show them what it is they can do. i would say that in spite of their limited efficacy, the currently approved medicine for alzheimer's disease are pretty widely used globally.
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we were, of course, testing our therapies as add-on to standard of care. standard of care, which in most countries did include the already approved medicines, even though they have limited efficacy. and what we found was that in north america, western europe and japan, over 90% of all the study patients we found who had a diagnosis of alzheimer's disease were already receiving an a.d. medication. but in every country where we went, it was over 70%. i don't say this is typical of everybody in that country, because there's a lot of undiagnosed people. but they are available and they're used. it was interesting. relative to dr. mittelman's presentation, the primary caregivers assisting patients with a.d. as they navigated through the clinical trials process varied by region. that's required, because these people have some impairment that every study participant has to
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have a caregiver or somebody who comes with them to participate in the study. in north america, western europe, south africa, australia and japan, it was usually primary caregivers were spouses, about 70% in all those regions. while in the other regions, eastern europe, other asian countries and mexico, south america, the primary caregivers were much more likely to be adult children or some other neighbor or person involved with the patient. now i move on to some issues, and i think it's clear from what we heard earlier from the first panel, we have learned a lot about alzheimer's disease. there's a lot of opportunities, but this is a tough nut to crack scientifically. i've spent 40 years at it, and there's a lot of smart people out there working at it. very hard, every day. but it's proved to be hard. so i'd like to just give you a couple observations about how the system i think could be a little bit better. i think developing drug candidate molecules for clinical testing based on new biological findings about a.d. could be faster. basically, when you find some new bit of biology, the therapeutic implications are not always obvious, and it takes somebody who knows about what a
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medicine has to look like to make that translation. i think policies that facilitate communication and collaboration of academic scientists with those in the bio pharmaceutical industry could be helpful to enable more rapid discovery of high-quality clinical candidate molecules accompanied by the bio markers and other kinds of technology necessary to do clinical testing. if you just take the history of our drugs to date, the deficiency in alzheimer's disease was found in 1976, the first therapy was not approved until 20 years later and that was a well-known area of biology. what we know about abeta or amyloid, the structure of that protein was originally discovered in 1986. we still do not have a beta related therapy. although we have tried, but it's -- it's a tough nut. i think also the conduct of clinical trials could be faster. streamlining processes of study review, contracting with sites, review by ethics committees, and
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site certification could reduce time to completing clinical testing. it's often a bureaucratic nightmare to get these studies up and running. granted, this is a human endeavor that we'll always have some human elements in it. but i think some of these are partly manmade problems. many current clinical trials are designed for patients who are not yet demented, but have subtle clinical signs or bio marker evidence that they are at risk for a.d. this is a lot of the current work going on on either primary or secondary prevention. the problem is, those people are not diagnosed in the current clinical care environment. we've heard that earlier. such patients are not regularly identified in clinical practice and are very difficult to find for clinical trials. so if you go out to find them, the epidemiology tells me there's lots of them out there, we just can't find them readily for trials. and i think that policies that would encourage early diagnosis
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of at-risk patients would speed the completion of trials, as well as provide direct benefit to patients. so those are my observations. thank you very much for your attention. >> thank you so much for your testimony. and, again, for your leadership, as well. thank you. mr. splaine. >> good to see you. thanks for the opportunity to appear before the subcommittee today. let's push the button. thank you for the opportunity to appear today. i've been working with people with alzheimer's and their families since 1986. currently, i'm a consultant and since 2011, our consultancy served as the policy and advocacy adviser to alzheimer's disease international. a.d.i. is the global umbrella for over 90 national alzheimer's associations, including the u.s. alzheimer's association. of historical note, i'm a little bit of a historian, because i've been around. this whole panel has been around. it's worth noting, the u.s. alzheimer's association and adi share common founders. four years after the alzheimer's
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association was established by jerome stone and others, they established alzheimer's disease international. so some sense of this being a global issue was there even in the very beginning in the early 1980s. our current work with alzheimer's disease international is put my associate, kate gordon and myself in the middle of a burst of international energy and work streams that are moving on the issue of dementia and moving it closer to a public health priority that experts believe it needs to be. my plan with limited time is to hit the high points on what i think are key developments that have not been covered by other witnesses. the facts are stark, and in the introduction of the hearing, mr. smith kindly cited the facts that i have on record, as well. one possible fact that was not cited by the chairman that might be a special interest to this subcommittee is the publication of a report on alzheimer's
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disease in sub saharan africa that is less than six weeks old. that was published by adi. it estimates that there are 2.13 million persons with dementia in that region, a number that is expected to roughly double every 20 years. sometimes there's a belief that alzheimer's can't and dementia issues can't truly be global. but with the publication of that report, and the facts therein, i think that has been put to bed. well, let me review some key global developments. first of all, and there's a graphic in my testimony that kind of tries to demonstrate this. dementia is increasingly understood to be a life course disease by policymakers, not merely a disease of older persons. not merely a condition of complete and utter disability. although the public perception that a person with alzheimer's disease must necessarily be older and quite disabled in the
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latter stages of the disease persists. this opportunity to get diagnosed early and having early stage persons involved in the work of in many facets of the work is putting a different face on what it means to live with dementia. even further to the left in that curve that you have in your packet is a representation of what the lancet commission and others have recently found. that there is action to be taken by public health authorities on modifiable risk factors for dementia. keep in mind that population health, personal results may vary. we're talking about the health of the entire population. but it's pretty clear, it could be summarized simply as what's good for your heart is good for your brain, is actionable today by public health authorities. and, in fact, there are many examples of that going on around the world. second important -- second important trend or second
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important global development, we continue to have the detection and diagnosis as a stubborn problem everywhere. although cited earlier, let me just repeat what you sited earlier, which is this, without diagnosis, there can't be treatment, care and organized support, or the opportunity to participate in research. i think some of our gap in research is the diagnostic gap. and i think this gap should also be of interest to any health system as persons with impaired thinking and another chronic disease are expensive, because thinking is important to navigating complex health decisions and treatment regimens that are only frequently seen in deep crisis. third, i want to mention -- in fact, already mentioned before the committee, that in the americas in 2015, paho, adopted a regional dementia action plan. and in 2017, just a few months
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ago, the world health assembly adopted a global dementia aging plan. taking a right spaced approach, these action plans call on and will provide technical support for national government plans and policies over the next five years to take advantage of our newer understandings of dementia and to plan nation by nation a response across the spectrum of the disease. i note that 30 countries have published national plans and nearly 100 sub national governments, states or regional governments have taken action. but i will also note that in our view, only one country has taken serious action on dementia without a strong civil society push. it's almost as if we have a three-legged stool here where the advocacy, as well as the knowledge of the issues and advocacy capacity are important to move forward. on rights, another subject of great interest of this
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committee, let me note that persons with alzheimer's disease are in some cases using the convention on rights of persons with disabilities as a platform for action on care and support. dementia has been a special issue in the organization for american states, regional convention on the rights of older persons now out for ratification. and in a regional declaration on older person's rights by the african union. it has also been dementia and its consequences has also been a major topic in the ongoing work of the u.n. open-ended working group on the rights of older persons. last and i'll leave the rest to my written testimony, a broader community of interest in dementia as a social issue is emerging. it's taking many forms, such as the organizing of nearly 20,000 young professionals in indonesia around the issue of alzheimer's who don't have family experience, as well as issues being an agenda item at the
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world economic forum in davos or this week at the salzburg global seminar. also in the wake of the japanese tsunamis we saw for the first time, disaster authorities paying attention to the problem of alzheimer's disease. multiple international organizations help raise awareness during alzheimer's awareness month. and even pope francis made a major address on world alzheimer's day last fall. it's fair to mention that myriad scientific meetings in cooperation are increasingly becoming the norm. the world's largest scientific meeting on alzheimer's disease is hosted and will be hosted in our country by the alzheimer's association in chicago in july. it will be followed this year immediately by the annual conference of alzheimer's disease international. truly a global gathering. as i was preparing this testimony, my last thought is
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faces come to mind. faces of families such as my sisters, my aunt lee, my aunt marilyn, my mother in law. also faces of people like lucian and dy and even two women from yemen who started an alzheimer's association -- its fate unknown at this moment in yemen. i have to think about researchers in poland and the czech republic all over eastern europe that i've met and enjoyed their company. they're truly is a global -- there's a global view in my head. i also can't not mention that i'm here today principally because 3 1/2 years ago, my brother gave me a kidney, so thank you again, dan. i'm done. >> thank you to your brother. couple of questions, again, you are leaders you have made all the difference in the world.
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and i think your point, mrs. plane, about the importance of advocacy, when people have a message that is well founded and they back it up with empirical data, it gets action on capitol hill, as dysfunctional as people think congress is these days, we are getting important things done. i mentioned earlier, a tripling of the nih funding for alzheimer's and i do believe we'll get to there with the 2018 hhs appropriations bill. it is no small achievement. i introduced the ronald reagan breakthrough act for years and working alongside of you and others and we couldn't get even a markup and now we're at the point where the money is actually flowing and we're talking about a tripling, i should underscore a tripling since 2015 so that burst that you talked about needs to become a sustainable surge for the sake of the patients, the families, the
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caregivers so thank you for your advocacy, all three of you and others who have been instrumental. i think we don't focus enough on how health systems could implode over the next 20 year 30 years . caregivers deflect a lot of those costs that would be born and, doctor, you know better than anyone, with your work, so often it's the spouse or a daughter or daughter-in-law that steps up to the plate to take care of the alzheimer's patient. and your work i hope, maybe you would with answer this, whether or not the w.h.o. knew the agenda item, the surge that they're making, the new seven point which includes in its seven points, you know -- where is it -- providing support for caremakers of those living with dementia, caregivers, it's one of their seven points.
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hopefully they're listening to you in the breakthrough landmark work you've done so they don't have to reinvent the wheel. can you put on your mike too? >> i neglected to mention earlier that because we were so successful in these randomized control trials of which there has been more than one, we -- and we were being asked to provide training for providers mostly social workers but also nurses and people and allied professions and we were going all around the world to provide this training as far as israel, france, australia, sometimes it was fun but eventually it got to be too much so we got -- we got a grant from the nih to develop online training. so now people can receive training in how to provide the intervention online when they wish only in english and in australia at the moment but american english and australian
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but one could easily imagine how this training, which includes videos of both role plays and real cases of family caregivers being given the counseling could be incredibly valuable even if people didn't do the actual nyu caregiver invention as we developed it to have the training and to understand how to work with families to help them to support the primary caregiver. >> how hard is it to access that? could you give the web address? >> at the moment it has a cost because it's developed with an sbir grant, but it is available and i'd be delighted to talk to you about more online or offline. but in addition to that, we encountered another issue that he thought was worth developing a solution for, which is that very often families are dispersed and there could be a primary caregiver in miami, florida and the daughter in new york and the daughter can't participate -- couldn't
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participate in personal counseling or and felt left out of the care. so we developed video -- a video conferencing version of our intervention which we're doing a randomized control trial of right now. but i think of that as a potential for people who live -- who have family members that live in other countries, perhaps the adult child is living in new york and the parents are living in china, wherever, one could use video conferencing potentially in countries where and for people who have access to the internet to bring families together and to provide them -- them and the primary caregiver with the kind of support that they need. >> is w.h.o. accessing this -- >> not that i know of. >> i know a little bit about that work. i think they're not just looking at made in america programs. i mean they are the global health organization and there are many to the level that we
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accept in the united states random clinical trial, peer review journal, evidence based programs that were not invented in the united states. so i think the task of the very small staff working on dementia at the world health organization. did i say that clearly enough? >> how small? >> four, six. a place where -- where the united states government could frankly make a real difference with a couple of key people from the united states to either pothole or to w.h.o., which is minuscule dollars compared to what kind of rich resources we have could make a huge difference, but they are compiling and evaluating and not reinventing the wheel but the wheel goes both ways. one of the things we get asked all the time by a.d.i. as representing a.d.i. is, can you help us access evidence based
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portuguese language, spanish language programs that -- chinese language programs that were invented and validated in other cultures because that's what we're dealing with as america ages and changes demographically. so i think, you know, it's bidirectional, it's multi-directional. i also think that -- you mentioned health systems. let me just say, the population aging is global and it's really an opportunity for -- from a noncommunicable disease as well as an aging point of view, it may be an opportunity for this committee to insist on or take its own top to bottom look at how we make investments as a government, as a people, in global health. and take -- start to factor in not just the disease by disease approach but really maybe this whole theme of noncommunicable diseases going back to my testimony about the linkages
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between risk factors between brain health and other health. it might be an opportunity for the committee. >> great idea. and the idea of u.s. personnel, that's a great idea. we'll follow up with you on that one. >> thank you. >> please take a look again at our global brain initiative bill because infectious diseases are horrifyingly prevalent in africa but with bush's program which is about 5 million a year, arvs, the pandemic, it's not over but it's been mitigated and other malaria, all those diseases are being attacked as they should be but we leave out brain health except for the diplomacy at w.h.o. and elsewhere. let me ask you -- you mentioned the african countries, 2.1 million, has the au, african union been responsively at all? >> from a rights perspective, the african union is one of only two regions in the world that
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actually has an explicit rights policy for older persons and alzheimer's has been part of that story, because, unfortunately, in some pockets in africa, people with alzheimer's disease are perceived as witches, demonic, and governments, like the government of ghana literally disrupted witch camps developed as a way of stashing people who are clearly disabled from severe cognitive issues from alzheimer's disease or other dementia. there's some visibility. they've got a lot on their plate but i think population aging is becoming better known. there have been two regional meetings inside of a year of people interested in doing more about alzheimer's disease on the african continent that have included african union representatives. there's also country by country but also as a region, i hesitate
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to say but i think it's one of the most active regions in organizing around noncommunicable diseases and other interested parties, because that's becoming part of the reality of help in the region as well. >> let me ask, do you believe that we are on track to by 2025 to get a disease modifying treatment or maybe even a cure or other countries like japan and china, the uk, coming forward with sufficient monies to -- particular on the research side to have that critical mass manhattan project type of focus? >> there is no doubt that in the country that have a large number of older people, particularly japan and china and western europe, you'll find a lot of money being devoted to alzheimer's research. so i don't think that that is the issue.
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i think there's a certain amount of discouragement that comes with lack of more tangible success, but it would help if we have these existing international organizations like w.h.o. and oecd and so forth actually make this a priority because it gives some credibility to these national organizations that are trying to do something about this to go ahead with international cooperation and the perception that this is really a high priority globally. >> can i make a comment? >> yes, please. >> i think that when we are trying to find people to participate in clinical trials of new drugs, if we have psycho social interventions as well as we did in the three country study, there may be more -- these trials may seem more attractive to participants.
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>> i think that's quite true and it's interesting that for a brain disease to not more fully recognize the interplay between psychosocial and medical interventions is a little odd. it's hard for me to imagine in cardiology that they would think that medicine without exercise and weight control is going to solve the problem, but we just have to get an understanding that all these things have to work together and i think from a patient acceptability standpoint, the psychosocial interventions are much more tangible and immediate and provide a more immediate benefit for people who participate in these trials. >> and the final question, i do have others that i would like to submit to you, the issue of brain imaging that we discussed with panel number one, do you see that as a viable diagnostic tool going forward particularly for early on set? >> we were involved in some of the early developments of those amyloid imaging technologies when i was back in the pharmaceutical industry, and i
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think it has assisted a lot in getting more biologically uniform people entering into clinical trials. it's role that ordinary clinical practice in the absence of directly related therapies is much more limited but there's been discussions by that. it's clearly a great advance to have a brain disease where you can actually see the pathology in life. that's something we've almost never had for any brain disease in the past. >> mr. garret? >> thank you chairman, smith. thank you, members of the panel. i was in another committee and got here as quickly as i could. i did not imagine that i would have the opportunity in the foreign affairs committee to discuss alzheimer's and so i'm delighted that that opportunity has presented itself and i thank the chairman again. now having said that, i will tell you that you probably didn't imagine the direction that i'm about to go here. i think it's fair to say that a rising tide lifts all ships and i would ask rhetorically because i don't want to waste your time whether or not we do medical research well here in the united states. i think the answer is yes,
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relative to the world we do a pretty good job, right. the next rhetorical question would be, with the designation of a particular item as a schedule one controlled substance stymied the ability of entities whether government or private to research said schedule one controlled substance as it related to medical uses and i think the answer -- if anybody disagrees with me you're welcome to chime in. you can interrupt, but i think the answer has to be yes and so obviously some of you are probably miles ahead of me because i'm a lawyer not a doctor but as i look through a list of medications derived from plants i find medications that help with blood pressure, with malaria, with pain, with dysentery, with antitumor agents, sedatives, muscle relaxants, inhibitors, when you look up medical plants you'll find a list that is literally in the hundreds. the question that i have for
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members of the panel is, and i'm not arguing in favor of any panacea or any overarching wonderful solution, but might we be well served to review our scheduling of cannabinoids to allow the research to be done because as i look for studies that relate to cbd oil and alzheimer's specifically, i find a lot of them and they all come from the netherlands, australia and great britain and we've tied our own hands behind our back with an archaic legal structure that denies the opportunity to find potential cures or at least aiding elements by virtue of the stigmatization of a particular plant. the question is, could we further potentially better outcomes and at least addressing symptoms if we were to free the circumstances that currently stymie the private sector and even public monies from being used to research cannabinoids?
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>> i don't know that i can give you a complete answer to that question. couple of comments, though. you're quite correct that many current medicines are -- were originally discovered as extracts from the natural world, from plants or someplace else and that's been the case throughout the history of the development of medicines. my own view and i just speak from a couple of companies that i've worked with, yeah, it would be a -- certainly a consideration if -- if you were talking about trying to develop a scheduled substance as a new medicine that means you got to do other studies, abuse liability and potential harm, you know, we used to have a saying, no side effect, no drug. so usually medicines have some unwanted effects along with the desired effects and the important part about any
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medicine development program is that you fully understand both of those so that in the end if the judgment is that the benefits outweigh the risk that at least that can be approved with an appropriate labeling of all of the benefits and the risks and it is the nature of the development program that it should investigate both of those things but if your point is that it would be a weighed negatively on a company thinking about developing something where you had this whole other side path trying to mitigate the risk, i think the answer is probably yes. >> there's an inherent cost -- >> sure. there's a cost, more studies, more time, more potential. you don't want to start out with a potential new medicine where you know right off the bat that it's got down sides? >> there's no arguing certainly that there are down sides. if i'm correct, that hemp extracted you don't get high.
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it's not even a side effect as it's administered therapeutically, right? >> i think there are cannabinoid derivatives that do not make you high, correct. >> there are some that you could. i'm not trying to tell one side of the story, anyway, but i open up the floor to either of you fine folks to comment on whether it might be easier or more cost-effective to study potential positives if the scheduling regime in the united states were relaxed to allow more efficient and cheaper and more ready studying. >> i actually think that one of the benefits of psychosocial interventions is they have absolutely no negative side effects. i would go in the other direction. if i were try to do things that were unusual i would try to figure out what nonpharmacological interventions could have major impact. for example, nobody believed
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when i started that people with dementia could learn new songs and they are learning new songs. this is a medicine that has no potential side effects. in fact, we did a video and one of the caregivers said forget about pills, just give me this. now imagine if singing could have a major impact on neurological function and we don't think about those kinds of interventions. >> i think what you're saying is brilliant and i appreciate it. i'm an all of the above kind of guy and what might work well for one individual or entity might not work as well for another but what you're doing is commendable and i admire you. i simply submit that because one thing works doesn't mean another doesn't and i believe we have a regulatory scheme here that's draconian at best. >> i agree with you on that but i think what you're talking about is thinking out of the box. >> yes, ma'am. we're not arguing, we're agreeing. >> yeah.
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mr. splain. >> i'm not a doctor, don't play one on television. a couple of thoughts. i wonder whether is it schedule one or are there other things that prevent this kind of imaginative thinking about experimenting with these substances. so couple of thoughts on that. one is, we do have pretty strong not invented here ethos in the scientific community and i think that's made more challenged because there is a prevailing theory of alzheimer's disease in the united states and in the united states science establishment that, although respected in other countries, they're investigating along different lines. for example, mr. smith, i don't want to correct you except i will. i would add the republic of korea to your list of very engaged countries about alzheimer's also from a research point of view.
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their drug mechanisms of action, remember alzheimer's has three parts, it has plaques, tangled and inflammation. they're almost completely zeroed in on inflammation and it's something that's -- it's not ignored but it's not a mainstream in the united states. i think that's just -- it's just something to think about is the prevailing theory keeping this out of consideration rather than schedule one. last, our language about alzheimer's treatment is most unfortunate in that some where in the 1980s we started talking about disease modifying drugs and mere symptomatic treatments and we have minimized social interventions, we have minimized the drugs we have by calling them mere symptomatic treatments. i would submit, what is insulin? a mere symptomatic treatment? yes, but it also -- what do people want when they live with a disease? i can tell you first hand as
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somebody who has lived with disease, we want treatments that allow us to get on with our lives. so i think sometimes the language and holding out for -- this is why i get really uncomfortable about will we have a cure by 2025. we have this language we've developed in alzheimer's about symptomatic treatment versus disease modifying treatment and i think that too is a barrier to people thinking outside the box. so it's those other things that are going on in the alzheimer's scientific thinking, not so much that it's a schedule one problem. >> well, let me indulgence of the chair very quickly submit that while we search for a cure in the interim we should also be searching for treatments, right? it's an all of the above not a one or the other, and so while we hope one day to move away from fossil fuels, in the interim we're burning oil as we develop wind and solar.
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it's from getting from point a to point b. let me ask you this and i'm leading intentionally because i can here, would you not agree that schedule one designation inhibits research and makes that more tedious and costly for those who might be interested in engaging in it? i was actually addressing that -- >> i have never had any clinical candidate that i was responsible for impeded in its development by scheduling. that doesn't mean somebody else might have and honestly, in my time in the pharmaceutical industry, most of our interactions with fda were actually quite helpful. they were leading forward. there may be some areas that i didn't get into where there's some adjustments that need to be made but i will tell you -- they were actually quite forward thinking in their treatment about approval processes for alzheimer's disease. i think they knew quite well that it was a very bad disease and were willing to work with
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any sponsor that came to them with any reasonable proposal about how to develop a treatment. >> but if you want to work with willow bark you don't need to get federal government permission to get the precursor? if you want to work with quai nine, you don't need to -- anyway. thank you for being here. i'm not suggesting this is a panacea just that we should get out of our own way and thank you all for thinking outside the proverbial box. i think it's an all of the above and open mind and look at what works and what doesn't. thank you, mr. chairman. >> thank you. >> i'll conclude. any comments or questions that went unasked, please if you could provide those answers. the idea of a goal that we developed with a bill and also the g7 isn't that it's -- it's to sharpen the mind as you know. that's why i've asked are we on
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the right path to either achieve it or come close and even coming close will be an achievement. i do -- dr. mohs, you make the point to develop truly effective ways to treat and delay on sets will require many studies, potential medicines, patient assistant technologies and a combination of approaches. we are doing that, right, or are we lagging in any of those areas? >> we are doing it. i think it could be done a little faster. the scientific uncertainty is still great and so the only way to tackle that is to accumulate knowledge as fast as you can and that requires a lot of -- >> how many compounds are being tested -- >> i think the last we checked there were about 30 something in phase three and in the 60 range in phase two and usually companies don't report earlier than that because it's so iffy
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it's hardly worth reporting. there's a lot. and that doesn't even take into account all the little labs and so forth around the world, but on problems like this you need a lot of ideas, you need a lot of studies to help resolve the uncertainty about those ideas and the communication from different laboratories to each other so they don't repeat and follow-up on unpromising areas is very important. >> i want to thank you again for your leadership, for being here today. and i thank you again. hearing's adjourned. >> wow. i did not see that. you're right. i didn't see that.
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[ no audio ] saturday, american history tv on c-span3 takes you to the american historical association's annual meeting in washington, d.c. for live all day coverage. 8:30 a.m. to 5:00 p.m. eastern. join us as historians and scholars talk about civil rights in 1968, watergate, and the rise of partisanship. commemorating civil war reconstruction and national parks, and the new birmingham civil rights national monument. live coverage of the american historical association annual meeting, saturday on american history tv on c-span3.
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tonight on a special presentation of book tv and primetime on c-span2, books from 2017 that focused on the u.s. military. authors include former president george w. bush and his book portraits of courage, and andrew carol writes about about general john pershing, mary jennings hager on her combat experience in afghanistan, retired admiral james stavridis writes about sea power. and mark moyer about the rise of special forces. book tv and primetime friday night at 8:00 p.m. eastern. sunday night on after words, federal appellate judge john newman looks back at his career in the book "benched," interviewed by richard blumenthal. >> as a judge of 45 years, having gone from that active
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life of making decisions and going to court and advocating a case, to judging, was that a difficult transition for you and did you ever miss the life of advocacy, so to speak? >> it wasn't difficult. it has been for some of what i've known. i've known people who have become judges and so disliked the decision-making process that they left the bench. i was an advocate. i liked being an advocate. i found it enormously challenging and satisfying. while i like being an attorney, i loved being a judge, because the opportunity to resolve disputes, large and small, they all matter to somebody, but some of them have a large political -- public significance and that's a very satisfying role. >> watch after words sunday night at 9:00 eastern on book
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tv, on c-span2. more than 200 young people recently participated in the annual uk youth parliament debate in the british house of commons. the two debates ahead are on lgbt rights and improving school curriculum. the speaker of the house of commons presides over the debate. >> the youth parliament will now consider the first motion of the day, protect lgbt plus people. the full motion is printed on the order paper. to move the motion, i call representing army welfare british forces overseas in germany, kate jones. please give her her welcome!

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