Transcripts For CSPAN3 Global Efforts To Combat Alzheimers Disease 20171213

It would be nice if we had a cure. There are certainly cultural differences rather than keeping people at home than institutions. We have supported research on care givers in the Spanish Language. The way you make a clinical diagnosis based on history is linked to the terms that are used for dementia and for the disease. I think its an area where we are learning but not breakthroughs and such, just in the quality of care giving. I understand that. My mother suffered for four years. A woman from trinidad and from ghana treated my mother like they were their mother. We had thanksgiving with these two women. My mother passed go years ago. The toll it takes on people. Almost my mother had this innocence about her. It was everybody around her who was suffering. Is reck cognition is just as important. When you are successful and you do develop a treatment or a cure another one of my fears is as we spoke about Global Health and child health or even Prenatal Health is that we are not getting those things that we do have now for our children to some of those developing countries, those folks who dont have to resources we have. We suspect we probably have the same problem in finding treatments and cures of getting whatever is developed to folks in less developed areas of our world. Do you see that as something that i know we have to find the treatment and cure. Once we do getting it to folks outside of our own country. I suspect this will be more readily available than places in other parts of our world. As you see with. I think part of it is how do we train care givers to give the quality of care your mother got from these two women . My father was in exactly the same situation. That quality of care and how we train people to provide this is essential. Some of this we learn through global collaborations. On the other part, can the interven interveinte interventions we carry abroad we have a whole thing of taking what we learned and implementing it in developing countries. We learned how to prevent mother to child hiv. It has not reached all of the pregnancies and mothers. If you plimiss one youll have child in need of treatment for life. I think one other thought, one is that he developed methods to treat without needs to revise shunts in every few years. You cant take them in for repeat surgery. Through two procedures he ada adapted, one to open the outflow and the other to cauterize the spinal fluid and decrease the flow and decrease the input. He could a single operation without the revision. That operation is now being used in the United States to treat our children. It is through that Research Done in yuganda, seeing the need in that country to bring that Technology Home to our own children. It is another benefit of reverse technology transfer, learning from the developing world these kinds of lessons. It will make American Children survive better as well. Since everyone mentioned a doctor and youre the only two to antony is a friend. I remember him saying if you find a cure for alzheimers the amount of money that we gave nih in the 21st century cures act, it will pay for itself the amount of money we spend on treating this disease. I thank you both for your work, the people who will benefit. Thank you all. Thank you. Let me conclude and ask you, the 2017 action plan, on november 13th we know the Gates Foundation announced 10 to 0 million for alzheimers research. Your opinion of the action plan and the steps is a government approach for yourselves. Do you feel it will be tran transformational . I think as they age they realize its a risk that is before them as well. So their investment is really appreciated and shows the broadening of global interest in this endeavor. I think the fact that there is an action plan is also wonderful recognition of the problem globally. It remains to be seen how this will be rolled out. The fact that its there and recognized and recognized by so many partners is an awakening to the importance of the burden of this disease for all of us globally. Thank you. I would just support what my colleague has said. We think it is something that needs all of the best and brightest minds put towards it. What we observed there are more and more scientists with who walmart can collaborate. Thank you for your leadership. Thank you for being here today. If there is anything else you would like to add. Thank you so very much. I would like to welcome to the witness table our second panel who serves as Research Professor and director at alzheimers disease Family Support program at the school of medicine. He was Principal Investigator of a controlled trial funded for 20 years. The results have been published widely. She has expanded her Research Focus to include the person with dementia and their Family Members which gives regular concerts in new york city. It is for the global alzheimers platform, a foundation that centered nonprofit devoted to enhancing the speed and equality for which they developed. He held several leadership positions including bp for neuroscience and Early Clinical Development and leaders of the team. He also serves as member of the board of governors and a member of the board of directors based in australia. Then well hear from michael whose honor with a very big impact based in bwashington d. C. He was part of the Public Policy division of the alzheimers division while known as grass roots organizer he has also been faculty for International University Public Policy and is actively the World Health Organization Strategy Group and is advancing the policy agenda with u. N. Based opportunities. Thank you for being here. If you would begin. [ no audio ] i got into this field because my mother had dementia. My family did not cope very well. The dementia probably drove us apart rather than bringing us together. I decided to try to figure out whether there was a way to help families like mine to cope better with the illness. I was lucky enough to meet four women who were working at nyu working as volunteers. I decided to try to run a Clinical Trial of what they were doing. So i wrote a grant proposal and was funded until 2010 to study an intervention that was based on what these women had been doing. The intervention is a multicomponent intervention and it is individualized for the needs of every care givegiver. It starts with an assessment then theres an individual counseling session, the point of which is the help the caregiver to understand his or her need from support of Family Members, friends and formal support. Then there are four Family Counseling sessions with Family Members that the caregiver nominates as important to him or her. So there are six counseling sessions. Since it can last as long as 20 years we thought it was important to provide ongoing support. So other parts of the intervention are recommendations that the caregiver run a support group that is run by organizations like it. Also we are available for what we named. So any caregiver or Family Member who participated in our study was able to dowel the counselor at any time for as long as they stayed in the study. It is compared to what people were able to get at the time. It was the Family Counseling. We think the Family Counseling was the key ingredient in this package in the multicomponent intervention. What were some of the benefits we were able to demonstrate . We were able to show that the first thing that happened is that the primary caregiver was more about the support. It lead to significantly reduced symptoms of stress, improved caregiver physical health and by those changes all through improving families for support for the primary caregiver we were able to keep the person at home a year and a half longer than the people who got our usual care. It is a really powerful intervention and the 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 we pu published in Health Affairs. It is a population of about 5. 5 million people. That factoid was brought to the attention of the governor of the state of new york who allocated to Family Support programs of now i am running one. I think our program is really while we have to the part of it is improving social support for the family caregiver. I think everything we have done has been about social support. It is something that doesnt necessarily cost a lot of money. I think in any country that would want to learn how to would Want Health Care providers to learn how do that could be done at a relatively low cost. So because of our success even before the Health Affairs article we did the three countries study in the u. S. , u. K. And australia which reduced depression in care givers even though all of the patients in the study were getting an approved drug for dementia we have done a study that have done similar findings. We had done a study in spanish harlem which is showing the effects of this intervention. Im here to say theres something right now that works. It can help people with the disease. I think while we are waiting it is to do the best they can to improve quality of life. So some of the more recent interventions that im involved with, you mentioned that i founded in 2011 is a very relatively inexpensive intervention. They rehearse for concerts and learn new songs. So people with dementia are learning 18 new songs, finding support but giving pleasure to the community. I think what we can do right now is to improve social support for family care givers and people with dementia. Thank you. That is so encouraging. I would like to put the article as part of the record. I have the list of testimony of all of the articles. Im happy to send it. Well look it up. Thank you. Thank you chairman smith. It is a pleasure to follow dr. Middleman. I wish i could report we have been more successful up to know. I can tell you what we have been trying to do. Medicine alone is not to answer. So the programs that dr. Middleman and people like her are developing will be an integral part. So the alzheimers Platform Foundation was founded by Patient Advocates to help speed the completion of high quality Clinical Trials of potential new therapies. Its the belief that we will be able to make progress in alev alleviating the suffering caused by alzheimers disease. Gap has found eager partners. It is for the alzheimers disease network. Australia has a network and we have partnerships developing in other regions around the globe. Before joining i was for 14 years where i was responsible for clinical testing for several potential new including two that reach large global studies. Before that i had an academic career in new york where we also did smaller scale studies. Both of the compounds that reached the testing were very prom promising. They did some aspects but neither showed sufficient efficacy as medicines for prescriptions. The four trials we did included 4,694 patients. These were conducted in 31 countries. Approximately 21 at sites in western europe, 9 at sites in mexico and south america, 8 at sites in Eastern Europe. From these experiences trying to develop new medicines i would 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 of the countries where they have worked we found a high degree of interest in cooperations from health authorities, patients and families. Its not difficult if you go into any of these countries the find people who are eager to contribute to try to develop a treatment. Its just a matter of trying to show them what it is they can do. I would say in spite of limited efficacy it is pretty widely used globally. We were using it as add on standard of care which did include the already aproverprov medicines. What we found is that over 90 of all of the study patients we found who had a diagnosis were already receiving a medication. Every country was over 70 . They available and they are used. It was interesting relative to dr. Middlemans presentation that assisting those with a. D. It is required because they have some impairment. They have to have a caregiver that comes to participate in the country. It was usually a primary caregiver were spouses while in the other regions the primary care givers were much more likely to be Adult Children or some other neighbor or person involved with the patient. Now i move onto some issues. I think its clear to what we heard earlier, we have heard of a lot of opportunities. This is a tough nut to crack. I spent 40 years at it. There is a lot of smart people out there working hard at it. It proved to be hard. I would like to give you a couple of observations about how the system could be a little bit better. I think developing drug molecules for clinical testing based on new findings could be faster. Basically the therapeutic imply ca ca implications. I think policies with those in the bio pharmaceutical industries of molecules accompanied by technology that is necessary to do clinical testing. If you take the history of our drugs to date it was found in 1976. The first was in the approved until 20 years later. It was a well known area. What we know about the structure of that protein was originally discovered in 1986. We still do not have a therapy although we tried but its a tough nut. I think also the conduct of Clinical Trials could be faster. Tre streamlining and review by ethics committees could reduce time. Its often bureaucratic nightmare. It is a human endeavor that will always have human elements in it. I think some of these are partly manmade problems. Many current clinical trieals ae for those that have everyday that they are at ricks for a. D. This is a risk for a lot of work going on for primary or secondary prevention. They are not diagnosed in the current Clinical Care environment. Such patients are not regularly identified. If they tell me there is lots out there but we cant find them readily for trials. I think it would provide direct benefit to patients. Those are my observe rationatio. Thank you for your testimony and your leadership as well. Good to see you. Thanks for the opportunity to appear before the Sub Committee today. I have been working with people with alzheimers and their families since 1986. Since 2011 owe have served to a. D. I. It is the umbrella for over 90 associations. Of historical note, it is worth noting that the Alzheimers Association and a. D. I. Share common founders. Four years after it was established by stone they established alzheimers disease international. So some sense of this was there even in the very beginning in the early 1980s. Our current work has put my associate in the middle of a burstover international earn ji and work streams that are moving it closer to Public Health priority. My plan with limited time is to hit the high points on what i think are key developments. Mr. Smith kindly sited the facts that i have on record as well. One possible fact that might be of special interest to the Sub Committee is a report on alzheimers disease in africa that is less than six weeks old that was published. It estimated there are 2. 13 persons with dementia. It is expected to roughly double every 20 years. I think it has been put to bed. Let me review some key Global Developments. There is a graphic in my testimony that tries to demonstrate this. Dementia is increasingly understood to be a life force disease by policymakers, not merely a disease of Older Persons, not merely complete and utter disability. Not necessarily they must be disabled and the latter stage of the disease persists. It is putting a different face on what it means to live with dement dementia. Even further to the left is representation of what the commission and others have recently found, that there is action to be taken on modifiable risk factors. Keep in mind that the population hell, personal results may vary. But its pretty clear it can be summarized simply is it is actionable and there are many examples of that going on around the world. Second important trend or Global Development continues, we continue to have detection and diagnosis although sited earlier, let me repeat this. Without doiagnosis there cant e treatment care or the opportunity to participate in research. I think some of our gap in research is the diagnostic gap. I think it should be of any interest 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 that in the americas in 2015 they adopted a an action plachb and 2017 just a few months ago they adopted a global dementia ageing plan. Taking an approach the action plans call on and will provide National Support for policies over the next five years to take advantage of our newer understandings of the dementia and to plan nation by nation a response across the spectrum of the disease. I know they have taken action. I will also note that in our view only one country has taken serious action on dementia without a Strong Civil Society push. It is almost as if we have a three legged stool here. It almost as they are important to mover f forward. Let me note that persons with hi alzheimers disease are using rightsov of persons with disabilities. 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 declaration on Older Persons rights. It has also been dementia and also been a major topic in the ongoing work of the open ended working group on the rights of Older Persons. Last and ill leave the rest to my written testimony, a Broader Community of interest as a social issue is immerging. It taking many forms such as the organizing of nearly 20,000 Young Professionals around the issue of alzheimers whether or not he dont have Family Experience as well as issues being an agenda item at the World Economic forum. Even pope francis made an address last fall. It is fair to mention that scientific meetings are increasingly becoming the norm. It will be hosted in chicago and july and followed this year by the annual conferenceover disease international. Truly a global gathering. As i was preparing this testimony my last thought is faces come to mind. Faces of families such as my aunt lee, aunt maryland, all alzheimers care givers but also faces of people like two women from yemen who started anaheimeanahei an Alzheimers Association. I also had to think about researchers all over Eastern Europe who i have met and enjoyed their company. There is truly a global view in my head. I also cant not mention im here today principally because my brother gave me a kidney. Thank you again, dan. Im done. Thank you very much. Thank you to your brother. A couple of questions, youre leaders. You made all of the difference in the world. I think when people have a message that is well founded and back it up with data it gets action on capitol hill. As dysfunctional as people think congress is these days we are getting important things done. I do believe we will get there. It is no small achievement. I introduced the reagan act for years. Working alongside you and others we couldnt get even a markup. Now we are at the point where the money is flowing and we are talking about a tripling. So that burst that you talked about needs to become a sustainable surge for the sake of the patients and care givers. Thank you for your advocacy and others that have been instrew mental. I think we dont focus enough on how Health Systems could imploed. Care givers deflect a lot of those costs that would be born. Middleton, you know better than anyone so often is the spouse. Its a daughter or daughterinlaw that steps up. You know, that your work i hope, whether or not the who knew the surge that they are making, the 7 point which includes in it seven points where is it . Providing support for care makers, those living with dementia. It is one of their seven points. Hopefully they are listening to what you have done so they dont have to reinvent the blewheel. I neglected to mention that because we were so successful in these randomized control trials we and we were being asked to tree sprooid training and we were going all around the world to provide this training some tieps it was fun. We got a grant. People can receive training and how to provide the intervention online when they wish only in n english. One could imagine of this trang being given the down selling could be incredibly valuable we need to help families. How hafrd is it . At the moment it has a cost because it was developed with an sbir grant. I would be delighted to talk to you more online or offer line. We encountered another issue we thought was worth developing a solution for. We developed a Video Conferencing version which we are doing a trial of right now. I think of it as people who have Family Members who live in other countries, perhaps the adult child is living in new york and the parents are living in china or where ever, one could use it in countries and for people who have access to the internet to bring Families Together and to provide them and the primary caregiv caregiver. Are they accessing not that i know of. I think they are not just looking at made in america programs. I mean they are the Global Health organization. There are many to the level that we accept in the United States, Peer Reviewed journal, everyd evidencebased programs. So i think the task of the staff working on dementia did i say that clearly or not . That is a place where the United States government could frankly make a real difference with a couple of key people of the United States to either pothole or to w. H. O. Which is minuscule compared to what kind of rich resources we have. They are compiling and not reinventing the wheel. The wheel goes both ways. One of the things we get asked is can you help us access evidencebased language, Spanish Language programs that were invented and validated there other cultures because that is who we are dealing with as america ages demographically. It is multidirectional. You mentioned health system. Let me say that population ageing is global. It is really an opportunity for an ageing point of you. It would be to how we make investments as a people in Global Health and start to factor in not just the decide by disease approach but maybe with this theme of ndiseases and the link between brain lehealth and other health. And well follow up with you on that one. Thank you. Please take a look at our initiative build. The idea is Infectious Diseases are prevalent in africa the pan dem i d pandemic, all of those are being attacked but we leave out brain Health Except for diplomacy. You mentioned the african countries 2. 1 million. That has the union been responsive at all . The African Union is one of only two in the world that that has an exfully sit rights policy. Hiem oe alzheimers has been part of that story. Unfortunately people with alzheimers disease are perceived as witches, demonic and governments like the government of ghana have literally disrupted witch camps. There is also as a region but i think its one of the most active in organizing around noncommunicable diseases by the Disease Alliance in other interested parties because thats becoming part of the reality of health in the reskbron region as well. Do you believe we are on track by 2025 or maybe even a cure or other countries like japan and china, the u. Conferment co the u. K. Coming forward to have that kind of focus . There is no doubt that in country that is have a large number of people youll find a lot of money being devoted to hiem rs reser. So i dont think that is the issue. I think theres a certain anounlt of discourageme amoun discouragement. It would help if we have these existing International Organizations actually make this a priority. It gives some credibility to these national ofrganizations t go ahead with International Cooperation and the sper excepti perception that it is a high priority globally. I think when we are trying to find people to participate if we have interventions these trials may seem more attractive to participate. I think its quite true. Its interesting for a brain disease to not more fully recognize the interplay is a little odd. It is hard for me to imagine that they would think that medicine without exercise and weight control is going to solve the problem. We just have to get an understanding that all of these things have to work together. I think from a standpoint the interventions provide a more immediate benefit for those who participate in the trials. And theish thu of brain images. We were involved there the development of some of those technologies when i was back in the pharmaceutical industry. I think it has assisted a lot in getting people entering into more uniform trials. It is in the absence of directly is much more limbed. There has been discussions about that. It is great to have a brain disease where you can act dluua see the pathology in life. Thank you chairman smith and members of the panel. My apologies. We got here as quickly as i could. I did not imagine that i would not have the opportunity to discuss alzheimers. I am delighted and i think thank the chairman again. You probably didnt imagine the direction i was about to go here. I would ask whether or not we do medical Research Well here in the United States. Yes. Relative to the world duo a pretty good job. The next would be would the designati designation the able as it related to medical uses . I think the answer if anybody disagrees with you youre rked to chime in. I think the answer has to be yes. Im a lawyer, no a doctor which means yall are smarter. As i lock i find medications that help wp blood pressure, anesthetics, misuscle relaxants. When you look up medical plants youll find literally hundreds. Might we be well served to review in the United States our scheduling of cbd oils to athrow research to be done because as i look for studies i find a lot of them. 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. 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 . I dont know that i can give you a complete answer to that question. Couple of comments, though. Youre quite correct that many current medicines are were originally discovered as extracts from the natural world, from plants or someplace else. And thats been the case throughout the history of the development of medicines. My own view and i just speak from a couple of companies that ive 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 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 the benefits and the risks, and its the nature of the Development Program that it should investigate both of those things. But if your point is that it would be a way kind of negatively on a company thinking about developing something where you have this whole other side path of trying to mitigate the risk, i think the answer is probably yes. Theres an inherent cost sure. Theres a cost, more studies, more time, more potential. You dont want to start out with a potential new medicine where you know right off the bat that its got downsides. Theres no arguing certainly that there are down sides. If im correct, and ill let each of the members of the panel speak to this, you dont get high. Its not even a side effect as its administered therapeutically, right . I think there are cannabinoid derivatives that do not make you high. Certainly, there are some that could. Im not trying to tell one side of the story, but anyway, i open the floor to either of you fine folks. Just comment on whether or not it might be easier and cheaper and 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. So 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, to go back to the chorus we founded, nobody believed when i started it that people with dementia could learn new songs, and theyre 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 learning new songs could have a major impact on neurologic function, we dont think about those kinds of interventions. I think what youre saying is brilliant and i appreciate it. Im 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 youre doing is commendable and i admire you. I simply submit that because one thing works doesnt mean another doesnt and i believe we have a regulatory scheme here thats draconian at best. I agree with you on that but i think what youre talking about is thinking out of the box. Yes, maam. Were not arguing, were agreeing. Yeah. Mr. Splaine. Im not a doctor, dont 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. Its ordinary practice in the absence of directly related therapies is much more limited. But its clearly a great advance to have a brain disease where you can see the pathology in life. Mr. Garrett. Thank you chairman, smith. 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 alzheimers and so im delighted that that opportunity has presented itself and i thank the chairman again. Now having said that, i will tell you that you probably didnt imagine the direction that im about to go here. I think its fair to say that a rising tide lifts all ships and i know thats a cliche, and i would ask rhetorically because i dont want to waste your time, whether or not we do medical Research Well here in the United States. I think the answer is yes, 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 youre 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 im a lawyer not a doctor, which means you all are smarter, 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, antitumor agents, sedatives, muscle relaxants, watch me mispronounce inhibitors, right . When you look up medical plants youll find a list that is literally in the hundreds. The question that i have for members of the panel is, and im not arguing in favor of any panacea or any over arching wonderful solution, but might we be well served to review our schedules of cannabinoids to allow for research to be done, because i look for studies that relate to cbd oil and alzheimers specifically, i find a lot of them. And they all come from the netherlands, australia, great britain, and weve 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. 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 . I dont know that i can give you a complete answer to that question. Couple of comments, though. Youre quite correct that many current medicines are were originally discovered as extracts from the natural world, from plants or someplace else. And thats been the case throughout the history of the development of medicines. My own view and i just speak from a couple of companies that ive 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 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 the benefits and the risks, and its the nature of the Development Program that it should investigate both of those things. But if your point is that it would be a way kind of negatively on a company thinking about developing something where you have this whole other side path of trying to mitigate the risk, i think the answer is probably yes. Theres an inherent cost sure. Theres a cost, more studies, more time, more potential. You dont want to start out with a potential new medicine where you know right off the bat that its got downsides. Theres no arguing certainly that there are down sides. If im correct, and ill let each of the members of the panel speak to this, you dont get high. Its not even a side effect as its administered therapeutically, right . I think there are cannabinoid derivatives that do not make you high. Certainly, there are some that could. Im not trying to tell one side of the story, but anyway, i open the floor to either of you fine folks. Just comment on whether or not it might be easier and cheaper and 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. So 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, to go back to the chorus we founded, nobody believed when i started it that people with dementia could learn new songs, and theyre 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 learning new songs could have a major impact on neurologic function, we dont think about those kinds of interventions. I think what youre saying is brilliant and i appreciate it. Im 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 youre doing is commendable and i admire you. I simply submit that because one thing works doesnt mean another doesnt and i believe we have a regulatory scheme here thats draconian at best. I agree with you on that but i think what youre talking about is thinking out of the box. Yes, maam. Were not arguing, were agreeing. Yeah. Mr. Splaine. Im not a doctor, dont 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 thats made more challenged because there is a prevailing theory of alzheimers disease in the United States and in the United States science establishment that, although respected in other countries, theyre investigating along different lines. For example, mr. Smith, i dont want to correct you except i will. I would add the republic of korea to your list of very engaged countries about alzheimers also from a Research Point of view. Their drug mechanisms of action, remember alzheimers has three parts, it has plaques, tangled and inflammation. Theyre almost completely zeroed in on inflammation and its something thats almost completely not ignored but not a mainstream in the United States. I think thats just its just something to think about is the prevailing theory keeping this out of consideration rather than schedule one. Last, our language about alzheimers treatment is most unfortunate in that somewhere in the 1980s, we started talking about disease modifying drugs and mere symptomatic treatments. And we have minimized social interventions, we have minimized 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 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 weve developed in alzheimers about symptomatic treatment versus disease modifying treatment and i think that too is a barrier to people thinking outside the box. So its those other things that are going on in the alzheimers scientific thinking, not so much that its a schedule one problem. Well, let me, at the 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 . Its 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 were burning oil as we develop wind and solar. Its getting from point a to point b. Let me ask you this and im 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 doesnt 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 leaning forward. There may be some areas that i didnt get into where theres 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 alzheimers disease. I think they knew quite well that it was a very bad disease and were willing to work with 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 dont need to get federal government permission to get the precursor . If you want to work with quinine i mean, anyway. Thank you for being here. Again, im 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 its an all of the above and open mind and look at what works and what doesnt. Thank you, mr. Chairman