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tv   1988 AIDS Protest at the FDA  CSPAN  November 3, 2018 9:29am-11:01am EDT

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people, stands set up to parade, and there was a dinner, worth $25 a person, a lot of money in those days. opla.s a big ho kind of impressive. in the middle of the desert, london bridge, whoever would have thought that? >> our cities tour staff recently traveled to lake havasu city, arizona to learn more about its rich history. learn more about the city and other stops on our tour at you're watching american history tv, all weekend, every weekend on c-span3. on october 11, 1988, aids activists occupied the fda headquarters in rockville, maryland to protest for improved treatment and care.
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history tv,rican the johns hopkins bloomberg school of public health posts a forum, marking the protest's 30th anniversary. two panels and aids activists and medical experts discuss the events that led to the fda protest, and talk about the immediate impact on aids care and the legacy of the confrontation for the medical field. this is about 90 minutes. >> summit events are impactful in the moment, and some of them, their legacy becomes clearer overtime. was october 11, 1988, 30 years ago today. welcome to the johns hopkins bloomberg school of public health for an anniversary seizing control of the fda. i'm the vice dean of public health practice and community engagement here at the school, and the scenes that we showed from the protest were from this
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fantastic documentary "how to survive a plague." i am really excited for the discussion we are about to have, and i am just going to introduce it because we have some fantastic people, including some of the leaders of the protests, some of the soon-to-be leaders of the fda talking about that event, what it meant at the time , and its legacy for the future. knowledge brett of senator van hollen's office. thank you for coming. and i want to thank all of you for attending and for watching online and c-span as well for the coverage. wanted to tell you that i am the author of a book that coincidentally i found here on publicium, called the health crisis survival guide, which talks about crises that affected public health agencies
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at different points in history, including seize control of the fda. in putting together this book, i had the incredible opportunity to work with mark harrington, who is here today, and one of the activists behind the protest and a real legend in the field of access to medications. i am going to read from what he wrote about this day in a sidebar in the book. on october 11, 1988, act up members from around the country made their way to the block like fda building, perhaps 1500 activists surrounding the building. groups from each city and affinity groups from active new york mustard in the entrance before a double row of county cops. each group has its own visual signature, signs, and themes. 176 activists were arrested. the news coverage that evening was comprehensive and sympathetic. we were on all local stations -- abc, nbc, fox and cnn.
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this coverage of the demonstration was overwhelming. we made the front page in boston, baltimore, dallas, houston and miami, and were well chicago, detroit, san francisco, st. louis, tampa, tucson, and washington, d.c. ran a section, aids coverage was favorable. among community newspapers, the coverage was euphoric. a turning point in the aids epidemic had been reached, it in fighting for the rights of people with aids, we were the vanguard of a larger movement to patient's rights, find cures for all diseases. mason, thisi is our gettysburg. we have a lot of heart and bloodshed against us. we can take it. the victory will be ours. this was an extremely important protest. toare now going to talk here
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people him made it happen and talk about its legacy. we will do this in two panels. i will introduce the moderators and they will bring up the fantastic speakers. i will start by introducing dr. chris biro, the inaugural desmond m2 to professor in public health and human rights at the johns hopkins numbered school of public health. he is the founding director of the university's center for public health and human rights. [applause] well, thank you so much, josh, and it is really wonderful to be here. we are going to have the first panel to talk about that time and that period. i will introduce the panelists send us to come up in a moment, but for those of us who were
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active and engaged in that time, it is an unforgettable period. i think many of our students will fit into this category who were not in the world yet or who were very young in 1988, it is hard to imagine what an extraordinary moment in time this was. the end of the reagan presidency, the epidemic had been ravaging the country and increasingly the world for a number of years. the only drug you heard in that clip was azt. it wasn't working. huge number of young people were dying and had this extraordinary sense of the about what needed to change. that that needed to change was at the federal level. s think what marked act up' extraordinary impact was several things that we will talk about. i will just say, it was the
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passion, the commitment, the intensity but also the smart, savvy and really the extraordinarily skillful youth -- skillful use of the tools of advocacy and activism to impact change. must also just disclose, before i go to introducing our panelists, that my late partner and i were part of act up new york when i was a medical student there, and then act up baltimore. this event is a benefit for aids action baltimore, and there are surviving members of act up baltimore and aids action baltimore. africa, thein south struggle continues. so i would like to first bring and -- to joiny me in welcoming them. aides and longtime gay-rights activists, and one of
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the founding people of tag, the treatment action group, which was really the center of the scientific expertise within act up. he has been on the board of anf ar for many years, founded in educational website for people living with hiv. he is a fellow at harvard in their institute of politics, and one of the leading people in "how to survive a plague." that was you on the roof just now? peter is also the guy on the route. northrop was a journalist by trade and a longtime activist. she was in mainstream journalism before getting involved in act up. she was on good morning america, cbs morning news, and then she became an activist. with87, she was working the hedrick institution for lesbian and gay youth, giving aids education to teenagers.
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she joined act up early on, eventually leading meetings with hundreds of people. she was arrested more than st.imes, including at the patrick's church demonstrations. and because media is such an important part of this activism, she was one of three designated spokespeople for the fda protest. so we are really blessed and honored to have you both with us. please join me in welcoming them. [applause] >> peter was my date for the st. patrick's cathedral. [laughter] >> we had to go in as couples. >> catholic couples. i'm wondering if we shouldn't start by going back to that time, to that fall, october 1988, and ask you both to
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reflect on what it was like? what the sense of urgency, the challenges you faced and what led to the decision to seize the fda? foremost, it is worth underlying the fact that this was seven years into the crisis. very late. the first cases of hiv-aids were in 1981. there were some brave activists from the get-go. aids organizations formed early on, but as far as taking to the streets, it was sporadic. most of the national lgbt rights groups were a little frightened of playing an outside game of rocking the boat. they focused on inside games.
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so it took a long time before and akramer lit a spark lot of anger and fear had built up by then. by 1988, there was a lot of death and pain and suffering going on, and most everyone that joined the movement did it for very personal reasons. they knew someone, they had friends, lovers, or they themselves were hiv-positive. in march of 1987, after larry's each. as that chapter, description fda action was kind of our national coming out. and today is national coming out day, i think. >> yes, it is. [applause]
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>> so act up and had various chapters at that point around the country. we had made a big splash at the national gay march on washington, and the act of new york chapter. after that, all of these chapters sprung up. a year later, we decided to target the federal branch that we thought was the most challenging as far as approving what we thought were medications , just waiting to save us. careers?anged >> i did, and i want to put this in more political context, because we have different experiences of that night. i agree with peers that a large portion of the membership of act up with people who personally were affected by the epidemic
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who were there to save their lives, but at the same time the group attracted many of us who came in from other movements, other experiences who saw it in a more political context. it was the end of the reagan of horror rivaled only by what we are going through today, of course. and i had grown up watching the civil rights demonstrations in the south, people assaulted by fire hoses and police dogs. i had marched against the vietnam war. i had worked in the feminist movement in the early 1970's, and when i left cbs news and went to work at the hatch act martin institute to do aids education to teenagers, something i never envisioned myself doing, i must say, i had covered the epidemic since the
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first cases in 1981 at these journalistic places, but when i went to patrick martin in 1987, i realized how little i knew. it was a great and immediate revelation to me, and what i found out was that the aids theemic was exactly like civil rights movement, the vietnam war, the feminist movement. it was about people in power who did not care about anyone else and were only trying to maintain their positions of power. i call it the self-perpetuating hierarchy. they were happy to have people die. they didn't care, whether they sent them off to war or let them die at home and didn't do anything about it, that is what it was about. so that brought me to act up very quickly, and it gave me an immediate sense of comfort in that room, because it was full of angry, iconoclastic smart
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people who were willing to get out in the streets and do something about it, and have a voice that was not available in more institutional settings. that was what was going on in that moment, and act up was so smart and so democratic and so able to figure things out with the whole group talking to each other that we identified the fda as an important target, because what we wanted more urgently than ,nything else was drugs effective drugs, drugs to save people's lives. so we saw the fda as a real stumbling block to that. one of the things that was said most often at that time was, the federal government will go into urgent dear to solve legionnaires disease when 20 people have been affected, and here we have thousands, tens of thousands, ultimately millions
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of people with hiv, and they are doing nothing. homophobia, because of this power differential, whatever. so that is what brought us to the fda and that is what was going on. extraordinary organized and thoughtful effort, and obviously i would love to hear your thoughts about the media strategy around it. i think that is a very, very special piece. peter, maybe from your perspective, the policy issues. the things that you wanted to see change that you called for. fda that daye the about for you, for act up? used -- wef, we've viewed act up's internal policy learning curve. andere still climbing it had not quite reached the full
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knowledge that we would feel we had grasped a year or two later. some of the initial issues, the ofth we were born, march 1987, azt came out. there was a very political, angry reaction that a placebo had been used in the trial that brought that to approval. we did not want to see those trials.future hiv drug withress was filled articles about various therapies that might protect people, that might stop the virus. some of them were approved overseas already for other uses, the buyers clubs had already launched in new york and other
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cities, importing some of these japan, because at the earliest part of the clip you ,aw me in front of a board offering it for sale in front of the fda. we were not -- we were naive, in a sense, of thinking that drugs to extend our lives were already out there and stock, largely because of an entranced government bureaucracy that had its way forts thing youomething years, where, know, it would take upwards of 5-10 years to get something
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approved and bring it to market, which we felt you should not be doing for a life-threatening disease. we wanted new regulations that would be very different than what they would use for nasal spray, and bring something to market much faster. demands, ande fortunately for us, the fda was already going a lot faster than usual by that point. with hiv drugs. with most of those regulations that we were demanding in about a year to year and a half after the demo. like a frightened deck of cards. i am sure we will hear from the next panel other perspectives on that, but i think the critical issue there, thinking back on it, was
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essentially that people's perception was the fda was there to protect people, and it had a very elaborate array of protections, and in the context of all these young people dying with only one drug that was not effective in a high-dose, azt was worse than not effective for many people. that did not seem to be the right paradigm at all. we have to open up access to people who are willing to take more risks. we are less risk-averse than the agencies we are meant to be protecting. that was very fundamental. strategy, we heard what i impacted was, -- we heard what a high effect it was, how impactful it was. was not anat impact accident, and that was very carefully planned and executed. the whole point of an activist group like act up is to affect
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change by public evaluation. -- public humiliation. you need both. we certainly like the inside strategy as well, but the point of an outside activist group is to shine a harsh spotlight on what we think needs to change or needs to be done. we have seen that recently with the kavanaugh hearings and people all over capitol hill, many of whom, by the way, are act up members who have taken their techniques and training to this current crisis. long line from the civil rights movement through vietnam, through feminism and doll of these movements, and still active today. so these are internal techniques. action, we this fda have people coming in from around the country, from all over.
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we made use of that. in what mark wrote, you heard the list of all these places, all these newspapers from all over the country that covered this. there was a reason for that. we set up a media strategy where we invited the national press -- believe me, no was more -- no one was more surprised than us when they showed up, delighted but surprise. had three designated people to speak at the podium. ito russo, who you saw a brief soundbite from, the author of the celluloid closet -- a fantastic guy who we lost some years ago. john thomas from dallas, also terrific, also gone. and me. then what we did, we surveyed the members of our group and found people from as many states as we could find and lined them
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lineust literally in a near the podium, where we were speaking and where the press was assembled. when we got up to the podium, we each spoke a little. nationalet to the press, over there is a line of andle from these states, they were each holding a sign of the state they were from. so you, members of the press, can go find someone from your home state to tell their personal story to your readers from your hometown, and connect all of this locally. forpress just looked at us a second, like what the hell is this? and then they just ran to that line of people. , and that istic how we ended up not only all national news, which
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we did, but in these hometown papers all over the country, because we had planned this, to supply them with their local people. >> students, did you hear that? [laughter] i wonder, in the remaining moments, we are now going to turn to legacy and talk about the longer-term impact. in the immediate aftermath and in the months and weeks, weeks and months to follow, how did this protest and the response shape act up and shape what came next? it must have been eventing of a watershed for the organization. >> it was. toean, i remember showing up the third or fourth meeting after the first demonstration, and there were already over 100 people in the room. this was early in 1987.
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even then, i think the group knew that something special was happening. we had the potential to make history. it took a little over a year to build up that head of steam, to break out nationally, and we realized we had done it on that day. i don't want to step on the impact group, but i do know that we were out to change hearts and minds. we were out to guilt trip the entire country that they were letting thousands of americans die and the government was doing nothing. pollu look at this gallup of america's level of homophobia that they have been running since 1977, it is an old question now of whether gay sex should be legal or illegal.
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it is kind of a sodomy question. >> watch out, the supreme court is coming to get us again. >> they still ask it every year, because it is the longest span of polling they have on american views on gays. in 1977, the country was evenly divided on whether it should be legal or illegal, 46% each. with the aids epidemic, a backlash started that got really horrible. the illegal line kept rising and rising. it peaked in july of 1988. this was after the quilt had been rolled out in washington, so the quilt turned the line around. it peaked at 57% it should be illegal, and when they ask it again after the fda demo, after story,became a national that got wrapped up in all of this national press story line
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about how the community had set up its own organizations and was taking care of its own, this beautiful community response. we were part of a larger aids story, but we put it on the front burner. the next time they asked the poll, massive, massive drop in homophobia. a 21 point drop. that is a huge polling shift. the legal and illegal lines crossed. we kept those crossed in the right direction for the next five years. three years later, the nih aids research budget had tripled and gone over $1 billion a year. and other disease groups were complaining about a powerful aids lobby that was getting more than its fair share. that is what started on that day, and those tax dollars are the reason that i survived and millions are alive today, is that investment.
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so you cannot overstate the impact of what happened 30 years ago today. >> yeah, and by the way, those other disease organizations, once they got over their terms in thislly context -- they learned and started using some of the same techniques. i sometimes poignantly and with heart break describe the silver lining of the aids epidemic as a phenomenon that did decrease homophobia because it forced a lot of people out of the closet. particularly men in positions of power who hadn't hiding and could not hide anymore. and that made a lot of people in this country and around the world suddenly realized that they knew gay people who they
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had not realized they had known before, and that had a major impact. but all of this activism, all of this speaking of honest -- speaking up honestly, all of this confronting power has continued, and as i say has certainly manifested itself in the last few weeks. i hope it will continue to manifest itself as we go forward. that might be a beautiful way to wrap. would you each like a moment to may be specifically addressed the students -- specifically address the students and talk about the power of activism in your personal story? >> sure. most from 30er years ago is being very scared. well, you were on top of an overhang. [laughter] going into that, my count had
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collapsed that year, and i tried azt and it was still toxic, and i was on other medications from japan and that wasn't helping. so i really felt the clock ticking. disability and decided to spend whatever time i had left this beautiful family that was becoming the movement of its time and had the potential to change the dynamic. dynamics. and we were all in these affinity groups doing these beautiful visuals for the cameras and i had been looking that overhang. i had met frank young the month before to discuss our demands, so i had been in the building and as soon as i walked in the overhang was a target. [laughter] cops were about 100
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underneath it, so if it had -- collapsed, noad big deal, that is what you are saying? they were just protecting the doors. i had two friends and that the three of us walked toward the cops and they stiffened up with their batons, but we were five feet away from them and under the overhang, and they did a double hand clasp on other side and i put my foot in and i was launched vertically into the cops go -- umph, and there was the hanging of the banner and getting the crowd ruling. and -- rolling. and i got really bored after a while. but the michelangelo senior ally, head of the operation comes up and yells and says,
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peter, do not get arrested, we already but do on "crossfire" tonight with pat buchanan. [laughter] chris: so don't get arrested. peter: so i negotiated my way out of the front. ann: we can basically pick our spots for that, not getting arrested. but i want to mention, as peter said, the beautiful family. i had worked as a writer and producer at cbs news and other major news organizations, and i have to tell you that becoming an activist, working for a social service agency, so much more fun then working as a writer or producer at cbs news believable. -- unbelievable. i spent a lot of time at cbs calling my bosses intellectually bankrupt and i think i was ahead of my time in doing that. of activism, to be able to spend your time thinking
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about real issues, real solutions, actions, working with people that you admire and love, this action was 30 years ago and we all still know each other, we all still love each other, and we are always happy to see each other. and i run into act up colleagues around town, people i have not seen for decades and i am thrilled to see them. and i cannot overstate the gratification that you receive doing this work. and and being able to speak honestly. i remember one night at act up, a government official came to tell us that he really agreed with us and he really wanted to help us. understand needed to that he could not step away from the government and say any of this honestly, because he had to keep his job. and we looked at him and we said, yes, we hear you and we appreciate your support. we get it. but what you have to understand
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is we do not care about your job. we care that you speak out honestly about what is going on. and that should be your highest priority. and that is what we have found in doing this and it has made for a very happy life. i am enormously satisfied to have walked away from the mainstream media -- news, i now do a weekly tv show called gay usa, which you can look up and watch. which is just a nonsense a little cable show, but it turns out it is available worldwide and people watch it worldwide. and we get to speak up there too. so it is really the relationships and ability to fulfill your desire to tell the truth of that stays with me. thank you botho for your activism then and your ongoing engagement and activism. and also i want to ask everyone
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to join me in thanking these marbles. -- marvels. [applause] >> wow, thank you, very, very much. controlling the fda was a remarkable protest, but it was more than a protest because it caused a crisis and it was a crisis for the fda, crisis for the medical establishment, and that crisis led to change. it was not preordained that if you just booked to the fda that he would have these effects, it was the strategy you heard about from peter and ann and the work that some of the people in that panel did -- next panel did that made it more than a protest and turned it into the kind of crisis that led to major advances thatnd
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paved the way for rapid approval of really important therapies for hiv and other diseases. and how the crisis led to that change and the context for that change and the people who were able to use the crisis in a way to propel that change forward is the subject of our next panel. and this is also a great panel. right before i introduce them, let me say it is true that this is also a benefit for aids action baltimore. afterwards, you will have people, you have a chance to meet the speakers. and also, buy a book that we happen to have a poster of right here, called "the survival guide." it has a chapter on the aftermath and benefits of that will go to aids action baltimore. for the next panel, which includes david kessler, who gave me one of my first jobs in
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public health, i have always been a huge admirer and fan of his, as well as mark harrington, break gonzalez, who is just -- gregg gonzalez, who is a fantastic leader in his field today. , wesusan ellenberg, who will be more formally introduced, but who is also a friend of our families. so it will really be a fantastic talk. theing about what caused change and at the legacy of this protest. to lead the discussion i will ask dr. jeremy green to come up. with green is a professor of medicine and the history of medicine and the elizabeth -- and mcgehee harvey chair in the history of medicine here at johns hopkins. thank you so much. josh.: thank you so much,
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[applause] it is such a pleasure to be here at this event. and what a pleasure it was to good to experience that last panel. as a historian of medicine, i want to attest again to the fragility and importance of living history and how much we should attend to those who remember moments that slip away from us in some ways, even as much as they leave enduring trails in the history of activism and public health. and i noticed this in teaching my own undergraduate and medical students that as i get older as a teacher, the historical memory that i can assume from incoming students slips away and what the aids epidemic was, with the signifiers were, change with generations. and and want to point out as well that what we are celebrating today helps to reinforce a certain resonance i think came across in the last panel, the residence of the importance of attending to civil disobedience as a form of public health practice and as a form of democratic participation.
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and this is as true today as it was 30 years ago. and i know that our next panel will offer us new perspectives to approach of that question. i want to say that our second panel will look downstream from the event itself. and ask, how did you change the fda, how has it changed aid and public health practice and policy, how did it change the nature of grassroots activism in america and around the world? and this is an extraordinary group of panelists. i i am truly humbled to share the stage with them. and i would like to introduce our panelists and asked them each to speak for about five minutes or so. and then we look forward to a discussion altogether. and we will not be taking questions from the audience today, but there will be time at the reception afterwards. so first i want to do this in alphabetical order, as i mentioned come up and join us, in fact come all four of you. dr. susan ellenberg, professor
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of biostatistics at roman school of medicine in the university of pennsylvania. her research has focused on practical problems and ethical issues in designing, conducting and analyzing data for clinical trials. among her duties, she serves as a senior statistician for several clinical trials and inect doing -- directing aids research and serving at annual conferences on statistical trials. and she was director of the office of biostatistics and epidemiology in the center for biological evaluation and research at the u.s. food and drug administration, and as a first chief of the research grant of the division of aids at the institute of allergy and if excess disease. gregg is an activist who teaches at yale school of public health in the yield loss goal, where he codirects the global health justice partnership. he was a member of act up a
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boston, new york and cofounded the treatment action group and international treatment fairness coalition. he received his bachelor's and ecological and evolutionary biology from yell in 2011 and his phd in public health in 2017. he did not put this on his bio, but some of you may have noticed he received a genius award from the macarthur foundation just last week in recognition of his work at the intersection of human rights and public health practice and research. has alsoington received a macarthur genius award for his work in these fields. he was born and raised in san francisco, graduated from college in 1983, and member of act of new york, and he helped to lead the season and control of fda action in 1988. and along with colleagues from act up's treatment and data committees, he cofounded the treatment action group in 1992 and has been an executive
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director of tag. the data workgroup in new york state, ending the epidemic task force in 2015. and is a member of the clinical trials group. with hiven living since 1985 on combination and star viral therapy since 1996 and was awarded the macarthur foundation fellowship in 1997. trained as asler, pediatrician and lawyer, served as the commissioner of the food and drug administration from 1990-1997. he then left the fda to join the yale school of medicine as a dean from 1997-2003. the viceed as chancellor at the university of california san francisco medical school. and among his honors, he was awarded the public welfare medal from the national academy of sciences in 2001. and since you have all of raid yourself in a line, i will ask each of you to speak for five minutes or so and just specifically reflect on the
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legacies of that day, now 30 years ago today, both immediately for act up, for the fda, and the broader communities of patients, family members, health care workers and scientists brought together in the aids crisis, and more broadly for legacies in public health afterwards. mark, since you are on this end, i would like you to start first, then go down in order. mark: thank you so much aided thank you to the organizers for putting together this great commemoration. i can't help but thinking about the reagan years as the beginning of a long national and international nightmare that we are still living through. it was a continuation of the war on drugs that had begun in the 1960's and 70's, and when i think about what the aids epidemic represented in the 1980's when i moved to new york and i became involved in act up i think about the other communities that had already been suffering from racism from
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the prison industrial complex, from the war against drugs, and the disestablishment of asylum and the release of mentally ill people with no community care, the crack epidemic and the opiate epidemic, all these things were layered anyway that if you go to new york now and they are still actually there, but they are not invisible in some ways, yet these are all pieces of national unfinished business we have yet to address. and we are all part of a much greater set of movements for social justice and public health and human dignity. and so the role of act up within that framework was to catalyze, we recognized that a whole lot of social injustices came through and where you vote -- e voked in the suffering that aid caused. yt, there were only a few hundred of us active, and there was no way we were able to achieve national healthcare, or
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end the war on drugs or overthrew the legacy of racism. and violence. and yet, act of made efforts against -- up made efforts against each of those areas. you think about the pioneering work that the exchange group did and the strategies being used all over the world for battling opioid addiction and for helping drug users reintegrate into society, that was one thing that came out of act up. the continued activism on housing is one thing that came out of act up. so what we are here to talk about is one tiny piece of a giant mosaic of beautiful social change work at that act up took part in, could you but it to, and many organizations spun out of to continue doing work in his various areas. and as ann said come i think that work is incredibly relevant now, where we are facing political challenges that are very reminiscent of what happened in the 1980's. and even though people might like to sort of think that the
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1980's were not as bad, i mean, one of the reasons that we were able to get money for aids research was because the democrats were in congress and that is not the case now. so what were the legacies of the fda action in particular? i think that you can see it, it triggered an unfolding of incredible creativity and alliance between activists and scientists that reshape the way the medical research is conducted. particularly for infectious diseases and for hiv infection, and it led to a series of breakthroughs like the parallel track expanded access to medications that were not approved yet, but had promised, that reached tens of thousands of people between 1989 and 1992. and it led to accelerated approval which david, down the panel, was the author of, which would allow you to approve drugs based on a surrogate marker. at first they were approved on a surrogate marker that did not work, then later because of scientific technology we got viral load by 95 it is suddenly
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we had trouble company should therapy in 96. and the same kind of pressure theyact up put on the fda, put on industry and in the national institute of health to change the way that clinical trials were done. and allies like susan goldberg were critical in forming statistical sort of activist coalition to figure out newer and a smarter ways of doing clinical trials. and then i think the final part of the unfolding of what happened as a result of the fda is we got heart earlier than we would have otherwise. and then there are people like gregg who made an amazing conservation in sharing the lessons about the diploma of hearts with activists in south africa and around the world are the international treatment and fairness coalition. so from that one spark in the fda action, team a movement that has resulted in over 40 drugs being improved for the treatment of hiv and over 20 million people today with antiretrovirals. and those are just a few of the
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things that came out of that 30 years ago today. um, i listened to ann with great interest. i was nothing like ann. i was never an activist. i had. sympathy for a lot of movements i never went to a march. i never even had written a letter to the editor when i joined at the division of aids, i joined after working for several years in the national canister institute -- cancer institute, a few months before the action at the fda. and i had some moments of wondering what i had gotten myself into. i was a strong advocate of rigorous research, clinical trials, that was my area. and the people that i was working with within the nih and the outside in the investigators, the clinical investigators, who were clearly very dedicated to this work. we were all pretty fearful of
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what this group was going to do. we felt that it wanted to turn the research paradigm upside down and as you saw in that clip, and there were certainly a lot of people who felt that way, just give us the drugs. if you saw the movie, the dallas buyers club, but the drugs out and we should be able to try them. so i was, you know, i was not really prepared to engage with this, but then a year later i went to the international aids conference in montreal in 1989 and act up was there. and they still looked scary to me, they did not look like people who are going to listen to me at all, but they were giving out sort of mimeographed sheets with something called the aid, the act of the treatment research agenda. grabbed a copy and i
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ran off to look at it. and i was a little afraid of what i would find. but what i found was almost everything in there was about a sensible -- as sensible as you could get in this situation. it was not crazy demands. what this group wanted was clear to me, was efficient but humane research and most of the things that they were calling for, to make trials more humane, was no reason we cannot do the trials. that way was just a little different from what had people had proceeded. so i brought up back and i circulated it around to some of my colleagues and we had some discussions and i will cut you that everybody was excited. it turned everybody in that room into an activist. from that minute i was an activist. came toers of act up the meeting, i do not know how they found out that we were talking about this, because we did not circulate it to anybody from act up, but they came and while they kind of try to be a little bit fierce and like, you
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know, they had bet the rallies, it was clear that their heart was in the right place. there was a lot of enthusiasm, we scheduled another meeting and at the next meeting we had twice as many people and after that we had twice as many and he said we had about 100 people coming to these meetings. some of the clinical people started to trickle in. and in the meantime come i was facing my own sort of activism within the government because most of the clinicians within the and ih were still very resistant -- nih were still very resistant to opening up to the activists. they were confident that they just wanted to turn -- overturn everything, but i could see what they wanted was good research, research that was -- that was going to give the right answers. but maybe more efficiently than we had been able, than we had been able to do it. so i remember at one point win that aids clinical trials group was still closed to the
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activists, but the statisticians were meeting with them, we had a retreat in the division of aids and i went wearing an act up sweatshirt. and it was not well-received by diddivision director, but i activist and i was pleased with how things went. i think the fda was listening and gradually the rest of the clinical community started to listen too. and i think that the accelerated approval regulations that got put in place, it was sensible. i think this was the best model of activism that could possibly have. and not all activism is the same. not everybody has been like that act up group that really learned about how to, or was really interested in learning about how things, how to do things the right way, but faster.
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1988, i'm a pediatrician in the bronx. and i am teaching at columbia and i invite frank young, who was commissioner of the fda at the time, sees the fda action was taking place and i must have invited him if a month after that. and my recollection is he gets up at the podium and the first thing he says is just, just and for your own safety, stand clear of me. and he thumped on his bullet-proof vest. and i do not know why i took the job following frank young -- [laughter] but i never wore a bulletproof
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vest. narrative and the you have to understand i mean, i love these guys and -- but the havetive that sees the fda the protest and the fda a year later, two years later, folded. and everything was fine. maybe we should keep the narrative. there is something glorious about that, but i am not sure that that's the whole story. wasuse in the end, this about, from my point of view, when we got to the fda this was about finding drugs that worked. this was about the science and coming up with the right policies. right. and this was not about, i mean, i never for the moment felt that the fda was under siege. feel thereeel -- did
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was a public health crisis of enormous proportions. and i remember several key, you know, pieces early on that i think helped. build,you really have to policy really makes a difference. obviously, policy makes an honest difference. and i will hope i can show you in a moment why. but the great, the really great true legislator, the great edward kennedy, back in even before 1979, had come up with an idea about conditional drug azt was and it's true done as a full-blown clinical trial with 107 days, if i remember, on drug. and there was a placebo group. and we could argue whether it
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was in public interest, because in 107 days we had was or whether the drug worked, but that was based on survival as the endpoint. senator kennedy had an idea about the condition approval on a drug based on more limited data and he proposed that in 1979, and it did not go anywhere. remember when i got the agency, that idea had stuck with me and i went to bob temple, who is the national resource, at the center for drugs and knows more about drug regulation than anybody in the country. and i said the average approval time for aids, not just for aids drugs for any drugs was 30 months and i said that is too long,. if that is something here in conditional approval that we can do? bob, you have to know when you are commissioner you have a certain influence, but there is enormous resources that you have to bring along and bob went and
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thought about it and said, yes, if we can, we can create a policy that if you can show an effect on a surrogate endpoint and you validate that surrogate endpoint as being predictive, ehen you can improve -- approv a drug based on that surrogate endpoint. and require confirmatory evidence later. right? so i got bob, then he became the advocate for what was named as conditional approval. federalwe put it in the register and we changed the name, because we knew that insurance companies would use conditional approval as a way not to pay for something, so we called it accelerated approval. but then we needed the data. nihphilip issa was at the studying ddi and pediatric populations -- in pediatric publications, and i remember
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having a meeting with my friend ity, who sat on one side -- was a formal meeting. and he was on one side of the table, i was on the other side from tony and we both had our staffs. and i remember at the end of the meeting he, saying, we need it. well, i remember getting on the phone with the ceo of bristol-myers squibb and saying, we need your data, because he was working with issa. because in the data burst all my, did not understand, they had data to validate, again it was not a great marker but cd4 as correlated with that. what you did not hear in the first panel was, i mean, the real success was the activists came to the table and learned the science, as well as the scientists, and together we
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worked through a series of drugs to see which ones really worked. we were willing to take certain risks based on trying to validate surrogate markers. and by 1995, we set out a policy and is said to the drug industry, if you can show an effect, we will approve the drug within days or weeks, not months. and that policy, it is amazing. you come up with a policy and of the industry actually followed it. and they followed it to the t. and then within, you know, several weeks, three prohibited as got approved. i will say that, if we can talk about a follow-up meeting, when two, orame in for part maybe later. but policy makes a difference, science makes a difference, activism had its role, but that
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is what drove -- but that is not what drove in the ned the piece of you need the data and you need the science and you need the policy. so, as genes over used to say, i hate to be the skunk in the garden, but the little bit of triumphalism about the story which i do not think is true, the history of the fda was based on tragedy, the elaborations with the authority was based on the cell phone, the vaccine contamination, we know all these stories well, decade after decade of tragedies that led to increasing scope of the agency's powers. industry hated this. industry hated this. in the early 1960's, when the amendments were passed that said the efficacy had to be part of the fda's powers in addition to safety, they said, this is going
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to destroy innovation. and then they kept the drumbeat of for many years. but the agency lumbered along with its new authority and amendments until we arrived. and we said the fda is killing us. and in a certain sense we wanted the drugs out on the market faster and we wanted smart trials, we wanted humane trials and we wanted access and answers, but something else was listening. that brings us to a historical moment, but it is the people who are in power now who have been sort of enemies of the regulatory state since the reagan administration. who think the fda should be small enough to strangle in the bathtub. and this is not under the trump administration, there is the 21st century cures that passed last year, side by obama in his last months in office. it takes all the reforms we
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asked for and pushes it to the verdict extreme. so we see shorter trials, smaller trials, less information about the drugs we put in our bodies, and it costs more and more. so we opened up a pandora's box back then, because we were desperate. there were people from the manhattan institute and other think tanks, but right to try is nothing like parallel track, where we asked for clinical research to be ongoing as we made it drugs available to people who did not qualify for the clinical trials, because they lived too far away. right to try opened up the floodgates to remedies to be put in the market and give it the patients without any sort of recourse. and no legal recourse if they are harmed. so we did a lot of great things, but there were other people listening in the corporate world, and libertarian think tanks, and we dodged some of the bullets around the current fda commissioner. we could've had one of peter
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teal's acolytes, who said the market can decide these things, but we are in a dangerous moment and i think that this discussion about how this is part of a struggle that reaches back into our history, we need to see it also reaches forward. and i want new drugs out as fast as possible, but i do not want to sacrifice needing to know how they work. and part of the danger of the moment at the fda is we operated on false premises. peter singer -- by the time it it to d4t, i voted against on the panel, because. then the inhibitors came about and we also do relax to because we finally had drugs that work and were clearly effective. but by that time, the 21st century curis, the proposals came through that kept pushing the envelope, faster and faster, less evidence, less rigorous. and now we are at a place which you know to rep. katko: is, it has a drug for muscular
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dystrophy, it was approved a year ago. 12 patients on a randomized study on and validated surrogate markers and mr. woodcock at the fda, who i have great respect for, made a hurtful case on why they did the right thing -- heartfelt case, they did the right thing, but i think they did the war on thing. as an activist i think it is going backwards, when the fda has made so much progress. david: but you change the course. >> we did that. david: advisor understand that. to bere are many reasons a -- but i am delighted at the diversity of opinions here, because that is good history. i also think it is important to actually sketch out these differences and how we remember the past. jeremy: i want to think for a moment, gregg, you left us on a note of considering some of the
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unintended consequences of this action and engagement, in which of the terms of engagement have been distorted to something which aids activists would not recognize themselves, even though they are being used in the same terms. i am wondering if the rest of you would comment on intended and unintended consequences of this engagement as well. well, i think one good 2ample is the cox inhibitors where we had a new case of a color that were based on the surrogate marker, where people said they did not hurt as bad and they never ran out the child to see what were the long-term effects. and it turned out people died because they had bad cardiovascular effects. and i do not even think they used the accelerator approved a hundreds of think thousands of people had effects from that, and there are many
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classes of drugs where not even accelerated approval, but the pressure the fda is under to improve rapidly when there is a multi-hundred million dollar industry investment, sometimes if you can change the thought leaders in the field you can change the field without actually having the science that is required. and one of the good things about sort of the public nature of aids research and the fact that there is community involvement in every layer of the research, and there is public and informed immunity expertise, as well as providers and non-drug companies researchers like actg and elsewhere, means aids research and handled in a transparent fashion and if there is debate about endpoints, there have been debates all along, look at the treatment and prevention trials and how long it took to get treatment for all because it required randomized controlled trials to start treating everybody, even though tony couch he and people said we can
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never do such a trial, then suddenly such a trial was done and global guidelines were changed. now we have treatment for all because we have randomized rigorous proof and that was forced by those activists and also the world health organization, they wouldn't adopt hard for all unless there was evidence from rct. s that is an ecosystem that was createdo. and a lot of other disease areas do not have that. and millions of people suffer because drugs get approved on inadequate evidence. >> you could almost say it is the american way. because, i mean, the mantra is the following. i want access, i want access to it now, the government should not be involved and not stand in the way. but if something goes wrong, i can assure you the same people who are saying that are going to say, where was the fda? right. so i am going to test your memories for a second.
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i remember a meeting, didn't hat weike the video ta saw, but it was a meeting in my office, in my conference room. maybe 1994, 95. july 1994. ok. so we are going to see this. and i remember it was a group of activists, some at the table, right? and some in the audience. they came in to see me. and, um, you want to say what? what was that, what is your memory of that meeting? >> we told you not to improve the phase 2b study that had georgia 25 patients in it where they do not have enough sample size to show whether the drug was good, when we already knew 96% of the drug was excreted in your urine. and we were urine -- and we were worried that the drug dose was
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sub optimal and we wanted larger trials before it was approved and industry without and built up a sample size and did the trials. [laughter] [applause] >> ok, basically the message was the following -- ok? would you stop approving these drugs so quickly, we do not have data on dose, we do not have data on combination, we do not know how to use the drugs, and would you hold the industry's feet to the fire so we get the data? did i get the message right? >> and the samples? >> ok, they wanted the data. those are the same activists, right -- >> a little chastened by reality after the first five nuclear sites came out in the number of there kept going up into was no scientific validation for combination therapy at that point. >> but it is also fair to say, and i never fully understood, i was just -- my head was down, i
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was trying to get the data and it was trying to get the drugs, in it was trying to get the policies through. but the activist community was not of one mind. right. being fair? in some ways i couldn't even keep -- there were arguments within the activist community --t i mean, i mean >> i mean, so i remember another meeting where marty delaney and i were on a panel and david was a setting somewhere on the ucb table, but we were screaming at each other, east coast versus west coast, not against fda, but because marty, who is no longer with us, was like, where you guys talking about more evidence? we can get the drugs into figure out how they work. maybe a little bit crude approximation, but we were saying, no we want access and
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answers. and i was telling this to david earlier, i think there is a libertarian streak and marty that had more faith in the ability to figure out later, but we felt burned by these combinations and we assumed the next competition of drugs was going to be there to provide improvement. marty always said, what is the future hold for us? and i said, we are going to be dead, because i do not think that the inhibitors would make a huge impact for us. we were pessimistic, but without we could balance access and answers. and you know, we had a very serious fights with colleagues about what should that balance look like. >> could i just? answer to to -- the have the pendulum swung too far today -- to has the pendulum swung too far today, the history of fda relation is always this pendulum. but the pendulum tends to correct.
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but you are right, sometimes people get hurt until that pendulum, you know, gets -- or swings back. overreact will always a little and it will swing back when something happens, but the thing that gives me confidence there is ag that group, day in and day out, of the susan ellenbergers or the josh sheriff demings -- sharp fsteins, or the bob temples, who are not in the spotlight. sometimes they are called the federal bureaucracy. who care about the federal health mission. and they get pounded from all sides. but as long as, you know, people are willing to serve and taken that heat. and be well trained and take on
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these difficult jobs for relatively little in financial reward. hope that those pendulums do not swing too far and always readjust. >> over the last 20 years there has been a series of legislative acts aimed at at least for some part of it to get the fda to move faster. had fi idelma, and we idah, and we had the 21st century cure act, which is just the latest, and they all have components of, you know, how can the fda make things go faster, when can we get by with only a single trial, when can we get by with, you know, marker data, when can we do this and that? time, i think the fda takes these legislations and it
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may, and these acts, and then figure out how to deal with it. and for the most by think they have been able to maintain, you know, strong science. bob temple is still at the fda and i think he is still exerting influence and i think he is still regarded in the way that you were, david kessler, when you were there. he will not be there forever, but i do think that as long as we don't have the bureaucracy --t could totally destroyed be destroyed by any administration that wants to do away with regulation, ifo comfortable that we will not get too far. that the pendulum will not swing too far. jeremy: these are metaphors of history. cycle, it is a pendulum, straight line going up or down, i think that as we consider the legacies of this moment, right,
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i think that we can --- all of these frames have already come into this discussion. what i would like to ask you about as you think about the way that science and activism are co-located in this discussion, because david you mentioned that what happened here as activists came to the table, susan, you mentioned a story in which you as a scientist did not think that you were an activist, and then you found yourself wearing those act up sweatshirts. how does that interaction, the role of a science-based regulator that is accountable to its public, right? something that either david as you suggested earlier, may not have been inflicted by civil disobedience as the glorious narrative gives it, or great -- gregg and mark as you said, required civil disobedience and that engagement between science and the public is responsible to just require forceful
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intervention by those stakeholders that are involved and must be heard. how do you think these complications work out in a way that we think of grassroots activism today and its continuing role in engaging with public science? >> heart problems get solved by people. people who are willing to step up to the plate and -- policies and drugs, they don't happen just anonymously. it is because people dedicate their lives to making those things, to finding effective drugs, or finding the right there has gotean, to be listed in the audience today who is going to come up with a new way to do clinical trials that will advance that field. there will be a regulator who
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certain data,in in certain clinical trials, and by looking at the signal and following that signal, he will be able to save thousands of lives if they will raise their hand. and members of congress, some are better than others, but in general may want to advance and they want to help people -- for the most part. [laughter] but look, we still have a private system of drug development and we have to recognize that. yes, the nih can play a role, but it is still pharmaceutical companies funding this. and we have to recognize that that too is part of the system. mark: we need publicly funded drug companies so that we can address the diseases of the poor. [applause] mark: we need a right to
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science, so people's health needs get the appropriate investment and health research and social science research to address the disparities that continue to afflict and deform our world. if there is one thing we have learned from aids activism it is the political will can be generated by constituency, but if you look at a disease like tuberculosis, which has been treatable since before i was born, and we have had an effective pre-and post exposure prophylaxis for that disease in the form of preventive therapy, also since i was born, and the fact it is not being used and there are researchers in this room who are try to figure out ways to make it happen in a month, instead of in nine months or 12 months, yet there is no funding for the kind of research we need to accelerate progress in preventing and treating this infectious killer of people around the world, shows we have a lot of work to do in terms of social justice within biomedical research. so for every age trial that is ofe, there is like one 20th
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it done for tuberculosis, yet that is killing more people, so were not doing a good job mobilizing resources that are necessary and we need public health research. brazil has a public health company, why don't we have them to make generic drugs when predators come along to raise the price of promethazine to $1000 they kill. it is a question of political will. we have to think about the long game and when donald trump is out of power and democrats are back in congress, we have a new generation of politicians and we need to educate them about the needs of science and public equity and public investment in science, to save lives. [applause] i think that the scientific community still has lessons to be learned. i think that the reason west ebola epidemic was a real eye-opener, because many of the same issues came up and early,
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but this time it was not the community who was demanding to throw anything at us, it was the physicians, it was the people who were going in to try to treat it, who said we do not know whether any of these things work, but we have to give people something and we are very resistant to the idea of doing study, -- doing a actually see how things work. makingave a lot to do in sure that the whole scientific and medical community understands the importance of doing research to actually get answers. having a hundred drugs, this is the key lesson i think that gregg talked about, that the activist learned very quickly. having a bunch of drugs in the medicine cabinet when you do not know which one works, or if any of them work, is useless. you have got to have the research to show you what works. and the people who pushed the 21st century cure ad come if you have a child who has a terrible
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cancer and there is, they have failed all of the treatments, you can understand the desire of that person to have access to whatever else is out there, but that just leads ultimately to a medicine cabinet full of drugs that nobody knows what works. and somebody's. or who is desperately ill five years from then will not know which drugs to pick out to save their child. so i think that we have to keep the medical community in mind as well. >> donna melvin said that before the panel that we should have more education and activism in our schools of public health and medicine. gregg: and when i come face-to-face with a patient with a dystrophy ls, their rhetoric is the fda is killing us. and they do not take the next step that we did and act up and say, how did the clinical trials work, why do we need evidence, what is randomization?
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the questions we have to struggle with because we had drugs that were not working and it is clearly not just a bureaucratic obstacle that was our enemy. we taught ourselves, it is not happening in the context of other diseases, and drug companies fund 80% of patient groups or more in the u.s., so there is a different education happening that we are not aware of, we are not a part of. and other people are setting the agenda. we needee with donna, to embed activism in our training for future public health experts. but also in the undergraduate curriculums, because this is a history that is life and death. it might have been life and but it is also now, whether it is tuberculosis or als. these are serious questions, not just about historical interest -- of historical interest. it is worth knowing your past so you do not repeat it.
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jeremy: did you want to continue? -- would you have done david: what do you do about the $100,000 pill, drug that works today? gregg: that works? david: yeah. that is what we are facing today. we have medicine that can work. and the price tag is beyond reach. gregg: funny you should ask, because there is a young postgrad who is applying to medical school who worked with us, named alex, and he went to australia, europe and canada, he looked at the public programs as well in the u.s., and he looked at which drugs got reimbursed. we reimbursed for billions and billions of dollars of drugs taht are not reimbursed for by those bodies around the world and other industrialized
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countries. so importing a lot of money down the toilet. let's getdrug works, the evidence to do it and do analysis to show that the cost is worth putting it on the market. right now, we have weakening regulatory structures for drug approval and pay whatever, basically open floodgates for reimbursement for drugs that may be little more than placebos. so i do think that there are other places around the world that are trying to solve these questions about how much things cost and how effective they are and how much we know about them. the u.s. seems to be used to the american way, where we will pay as much as you want, we do not need to know if it works. that is the mantra we have gone. president dwight d. eisenhower seized tetracycline using eminent domain for the u.s. military after the korean war because there was a shortage. the state has the power to come in and sees a drug by many
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different means, but to get drug prices down it would require three things. one would be medicaid for all, because medicaid directors can negotiate drug prices. the second would be to look at what it costs to make the drug and with the delta between the making of the drug and the sales c judge thatp cost thousands, cost about $95 to make. so medicaid could negotiate those prices. and the third thing is there is going to be drugs that are expensive because they are complex proteins that have to be infused, those will be more expensive. and they need to be subjected to trials and if they have a cost benefit that is favorable, they should be paid for by the public sector through the medicaid for all. so i think the drug pricing problem is solvable it would be helpless to have a drug, or public-sector company to help bring down the prices of drugs. but i think it is a solvable problem. i do not know whether it is
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solvable in the united states. jeremy: so that is a great question for us to leave with. [laughter] i think that is exactly the quest and to leave with, what are the challenges and opportunities for political will and activism today that would change the face of epidemics the way that act up changed the face of the epidemic? please join me in thanking everybody. this was a wonderful panel. and join us for a reception afterwards. josh: thank you so much for that really vigorous discussion. i think proving your point, jeremy, that there are many ways to think about history and it is not yet written. i would say that the protests to seized control of the fda led to a crisis and that crisis is what gave opportunities for tremendous policy work and the
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work of dedicated people within the fda to work with activists to make a huge difference and there are many important lessons for us today. i will see you, somebody should write a book about that -- but anyway, i will see you outside for the reception. thank you all. [applause] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit] announcer: this weekend on american history tv. today at 6:00 p.m., on the civil war, historian peter carmichael talks about public reaction to photographs of the dead at the 1862 battle of the antietam, and the soldiers'perspectives. >> people were changed by a
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strange spell that dwells in the dead, in the eyes of dead men. he says this was a terrible fascination these people had with death. all thathotographs, they did was satisfy this morbid satisfaction. announcer: at 8:00 p.m. on lectures in history, professor kyle longley and president lyndon johnson and the vietnam war in 1968. >> here is one of the most powerful presidents who has transformed the country for better and for worse, giving up power to search for peace. it is pretty big. major step. and it all relates to what? what is the issue? vietnam. announcer: on sunday at 8:00 p.m. eastern on the presidency,ronald reagan's attorney general talks about president reagan's views on communism and his relationship with pope john paul ii.
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>> you had to people, both leaders, one in the secular world and one in the religious world, with parallel interests. and so when this parallel interests were obvious, as what happened in poland there where they were under attack, if you will, it was logical than for ronald reagan, particularly with his ideas about defeating communism, to cooperate. announcer: next weekend on american history tv, the world war i centennial. american history tv airs every weekend on c-span 3. this weekend, c-span's cities tour takes you to arizona. with the help of our cable partners, we look for the literary life and history of lake have the same. from at noon eastern, hear rick kingsbury as he shares the
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story of the city's early history from his book, "living at the end of old 95." >> we moved here lot, stock and barrel in february of 1965. 600e was somewhere around people and there might have been 20 homes. threer family, it was years -- i am sorry, three months before we finally got running water. and it was another, i think it was another five months when we finally got electricity. before wet was a year finally got a telephone. announcer: on american history tv, a visit to the dam which played a vital role in supplying water to millions in arizona and southern california. >> we have a million acre feet of water.
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it is about the hundred 26,000 gallons. enough to feed to families of three or four four year. ghosts to phoenix at tucson. today, at noon on c-span2, book tv. historyay on american tv on c-span3. working with our cable affiliatatatatat explore america. >> in 1988, two women set out to create a museum in new york city to pay homage to immigrants. to mark the 30th anniversary, they tell the story of the building at orchard street in new york lower east side. she describes how to has grown and developed. and uses stories of immigrants who give


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