Francis.txt <time begin="00:00:00.50"/><clear/>[ Music ] <time begin="00:00:03.46"/><clear/>>> This is a great crowd

Francis.txt <time begin="00:00:00.50"/><clear/>[ Music ] <time begin="00:00:03.46"/><clear/>>> This is a great crowd and I'm thrilled to be here. <time begin="00:00:15.58"/><clear/>Welcome and thank you for coming to the third of our four Voices <time begin="00:00:26.18"/><clear/>from the Vanguard lecture series. <time begin="00:00:29.18"/><clear/>My name is Pat Thomas, I'm the Knight Chair in Health and Medical Journalism at Grady College. <time begin="00:00:35.28"/><clear/>These lectures are a collaboration between my program and the UGA Center for Tropical <time begin="00:00:41.22"/><clear/>and Emerging Global Diseases headed by Dan Colley. <time begin="00:00:45.29"/><clear/>And we are also very grateful for the financial support from the President's Venture Fund. <time begin="00:00:51.25"/><clear/>Dan really wanted to be here but he's in Kenya <time begin="00:00:56.95"/><clear/>with some snails right now, he studies the schistsomiasis. <time begin="00:01:01.61"/><clear/>If you've been here before, you know that the speakers <time begin="00:01:04.84"/><clear/>in this lecture series are not just researchers and thinkers, <time begin="00:01:09.57"/><clear/>but people who are taking real actions that will save millions of lives around the world. <time begin="00:01:16.81"/><clear/>Tonight you'll hear from Dr. Don Francis, one of the most important figures <time begin="00:01:21.60"/><clear/>in the 25-year history of HIV/AIDS. <time begin="00:01:25.74"/><clear/>He'll talk for 40 or 45 minutes or so, then take questions, and after that we invite you <time begin="00:01:32.63"/><clear/>to join us next door in Demosthenian Hall for a reception. <time begin="00:01:37.63"/><clear/>At the first international Page 1 Francis.txt AIDS meeting back in April 1985 in Atlanta, Don Francis was one <time begin="00:01:46.26"/><clear/>of the most controversial speakers on the program. <time begin="00:01:50.04"/><clear/>I remember because I was there. <time begin="00:01:52.95"/><clear/>He had alienated many of his colleagues at CDC and in the government by insisting <time begin="00:02:00.88"/><clear/>that Francis already knew enough about this dangerous virus called HTL3 at the time, <time begin="00:02:09.88"/><clear/>to make specific public health recommendations. <time begin="00:02:13.47"/><clear/>At that time, Dr. Francis was on the warpath about screening donated blood <time begin="00:02:19.60"/><clear/>to make sure people wouldn't be infected by transfusions. <time begin="00:02:23.96"/><clear/>He was also urging gay men, who were the epicenter of the epidemic at that point, <time begin="00:02:30.67"/><clear/>to be tested with a newly available antibody test and to have sex only <time begin="00:02:36.10"/><clear/>with people whose antibody status matched their own. <time begin="00:02:40.87"/><clear/>More cautious government authorities thought these recommendations were premature, even rash, <time begin="00:02:48.17"/><clear/>and that Dr. Francis was out of line to suggest such things. <time begin="00:02:51.89"/><clear/>So it came as no surprise soon after the meeting when I heard that he had been transferred <time begin="00:02:57.74"/><clear/>to San Francisco where he would be an advisor to public health officials there. <time begin="00:03:03.81"/><clear/>But he stayed true to form and he pretty much angered the gay community in that city <time begin="00:03:09.82"/><clear/>by insisting that the popular Page 2 Francis.txt bath houses be shut down. <time begin="00:03:15.58"/><clear/>In his words, they were nothing more than amplification systems for this virus. <time begin="00:03:21.51"/><clear/>Now chronicling all of this, was a man who was in the pressrooms with me and other people <time begin="00:03:27.64"/><clear/>at that time, Randy Schultz, <time begin="00:03:30.16"/><clear/>the San Francisco Chronicle's only openly gay reporter -- probably not its only gay reporter, <time begin="00:03:37.55"/><clear/>but openly gay was pretty rare at that time. <time begin="00:03:40.92"/><clear/>So in 1987 Randy published his seminal book, And the Band Played On. <time begin="00:03:46.53"/><clear/>This is still the most influential book ever written about HIV/AIDS. <time begin="00:03:49.84"/><clear/>And the hero of that story, as many of you know if you've ever read the book <time begin="00:03:55.03"/><clear/>or seen the movie, was Don Francis. <time begin="00:03:58.91"/><clear/>Now Francis left CDC in 1992 and went to a large biotech company south <time begin="00:04:04.02"/><clear/>of San Francisco called Genentech. <time begin="00:04:05.85"/><clear/>And there he became the clinical leader of the company's pioneering efforts to develop <time begin="00:04:11.58"/><clear/>and test a vaccine to prevent HIV infection. <time begin="00:04:15.83"/><clear/>The company abandoned this effort however, in mid 1994, <time begin="00:04:20.42"/><clear/>after the federal government pulled back from an earlier commitment to test this vaccine <time begin="00:04:27.90"/><clear/>on another one in trials large enough to show whether they really worked or didn't work. <time begin="00:04:33.13"/><clear/>Now companies were leaving this field, there Page 3 Francis.txt was a lot of depression about the prospects <time begin="00:04:38.66"/><clear/>for an HIV vaccine, but Don Francis was not a person to ever take no for answer. <time begin="00:04:46.41"/><clear/>So he teamed up with some of the scientists who had invented this vaccine <time begin="00:04:50.40"/><clear/>and he started a company called VaxGen, a spin-off determined to organize and carry <time begin="00:04:56.67"/><clear/>out a clinical trial that would answer the question, <time begin="00:04:59.86"/><clear/>do we have a vaccine to prevent AIDS or don't we? <time begin="00:05:03.08"/><clear/>In January 1997, I began researching a book about the quest for an AIDS vaccine, <time begin="00:05:09.64"/><clear/>and within the first two months, I lived in Boston at the time, <time begin="00:05:13.61"/><clear/>I had interviewed about 30 people on the east coast. <time begin="00:05:18.05"/><clear/>now nearly every one of those people wanted to talk to me <time begin="00:05:21.25"/><clear/>about Don Francis' crazy idea of starting VaxGen. <time begin="00:05:26.29"/><clear/>And people told me that he was delusional, living in a dream world if he thought <time begin="00:05:32.05"/><clear/>that he could raise the $18 million that Genentech wanted upfront in order to free <time begin="00:05:37.93"/><clear/>up their patent protections on the vaccine. <time begin="00:05:41.83"/><clear/>Now in March, I headed west to do some interviews on the west coast, and in Seattle, <time begin="00:05:46.22"/><clear/>I think the first people that I talked to there said, "You know what, Don Francis <time begin="00:05:51.91"/><clear/>and his partners have raised that money." <time begin="00:05:54.52"/><clear/>Well I thought this probably can't be true. <time begin="00:05:57.58"/><clear/>Anyway, I interviewed Don on Page 4 Francis.txt March 26, 1997 on a rainy day when I had horrible laryngitis <time begin="00:06:03.52"/><clear/>and he was on a lunch break from an advisory board meeting <time begin="00:06:07.24"/><clear/>to the UC regents I believe it was. <time begin="00:06:09.72"/><clear/>And I was stunned when we sat down to talk and he told me, "No, <time begin="00:06:13.71"/><clear/>we didn't just raise $18 million, we raised $27 million to launch this trial, <time begin="00:06:19.70"/><clear/>and we did it by talking to small groups of rich people in little conference rooms, <time begin="00:06:24.94"/><clear/>in Four Seasons, in Ritz-Carlton, and a Holiday Inn somewhere in south Florida." <time begin="00:06:30.04"/><clear/>Now I came away thinking that no one should ever count this guy out, ever. <time begin="00:06:37.03"/><clear/>The VaxGen trial began in June 1998 in the United States and Thailand, and on February 24, <time begin="00:06:44.32"/><clear/>2003, its final results were announced, and disappointingly, <time begin="00:06:49.26"/><clear/>the vaccine showed no overall ability to protect healthy people against infection. <time begin="00:06:55.59"/><clear/>But Don Francis was not finished. <time begin="00:06:58.72"/><clear/>Tonight, he'll continue the story picking up where I left off I think, <time begin="00:07:03.33"/><clear/>with a talk entitled Deadly Imbalance: Social versus Medical Value of Preventive Vaccines. <time begin="00:07:10.56"/><clear/>And here's Don Francis. <time begin="00:07:12.51"/><clear/>[ Applause ] <time begin="00:07:26.93"/><clear/>>> Thank you, Pat, very much. <time begin="00:07:28.58"/><clear/>Can everyone hear? <time begin="00:07:31.57"/><clear/>What I thought I would do, more than HIV vaccines, was to broaden this story Page 5 Francis.txt <time begin="00:07:39.03"/><clear/>about vaccines in general and really highlight the confusion that we have as societies <time begin="00:07:48.01"/><clear/>in general, and the confusion being broader in who actually speaks for the society at large, <time begin="00:07:56.70"/><clear/>both the U.S. society, but equally important to world society in terms of developing, of making, <time begin="00:08:03.92"/><clear/>adding the social value if you will, to vaccines in general for not only the United States <time begin="00:08:09.50"/><clear/>but the world as a whole since these are incredibly valuable tools. <time begin="00:08:17.27"/><clear/>And it's a bit of a sad story to be honest, HIV vaccine being only a small piece of it, <time begin="00:08:23.14"/><clear/>how with absence of the social value, one has real trouble in stimulating the private sector, <time begin="00:08:30.53"/><clear/>the mixed vaccines, to actually make them and see the progress that we've seen <time begin="00:08:35.28"/><clear/>over the years for infectious disease control. <time begin="00:08:39.50"/><clear/>So with that let me start, and there's really two points I want to make about vaccines. <time begin="00:08:46.27"/><clear/>Vaccines, as you know, you give to an individual before they're infected, <time begin="00:08:50.67"/><clear/>to prevent the disease occurrence in yourself later <time begin="00:08:55.53"/><clear/>after your immune system has recognized the pseudo infection that the vaccine gives you. <time begin="00:09:00.58"/><clear/>Hopefully without disease you get immunity and therefore your body thinks its been exposed <time begin="00:09:06.77"/><clear/>to the disease and you don't get in the future in your life. <time begin="00:09:10.26"/><clear/>So the clear public health goal of vaccine is to decrease or eliminate the disease in question Page 6 Francis.txt <time begin="00:09:17.31"/><clear/>to which the vaccine is targeted. <time begin="00:09:20.17"/><clear/>And realize everyone in this room has received probably close to a dozen vaccines <time begin="00:09:24.23"/><clear/>in your childhood, and we don't see multiple diseases because of that. <time begin="00:09:29.38"/><clear/>But what I want to add here, and this is the important theme of this talk, <time begin="00:09:33.07"/><clear/>is not only decrease or eliminate disease, but in the shortest possible time. <time begin="00:09:37.79"/><clear/>That is, we should be able to apply our scientific technology to make the vaccine <time begin="00:09:42.67"/><clear/>in the shortest time possible, and then ultimately apply the vaccine <time begin="00:09:46.88"/><clear/>to eliminate the disease. <time begin="00:09:49.15"/><clear/>And here is where on both of these how we break down to be honest. <time begin="00:09:54.52"/><clear/>So what I want to do is talk about this example of the delay that has occurred in looking <time begin="00:10:02.09"/><clear/>at past vaccines, and try to explore why we see this delay in both from the time of discovery <time begin="00:10:09.33"/><clear/>of the organism, to making the vaccine, <time begin="00:10:11.06"/><clear/>and importantly from the time the vaccine is made to the time the disease is eliminated. <time begin="00:10:17.40"/><clear/>And that's why really in my mind I use the term lack of social value, <time begin="00:10:22.19"/><clear/>that is we do not give value to vaccines. <time begin="00:10:24.52"/><clear/>Even though we don't suffer from these diseases, we don't look ahead in the future <time begin="00:10:28.69"/><clear/>to give the social value which will stimulate Page 7 Francis.txt the production of new vaccines in the future. <time begin="00:10:35.60"/><clear/>And in that, I will look extensively at the roles of both, the private sector <time begin="00:10:41.00"/><clear/>which traditionally has made vaccines, and the social value there is a return on investment. <time begin="00:10:48.43"/><clear/>And the public health people who generally make the recommendations and deliver those vaccines, <time begin="00:10:53.98"/><clear/>and how we end up with a lack of coordination, if you will; a lack of social value, <time begin="00:11:00.81"/><clear/>if you will, given by public health to vaccine development <time begin="00:11:04.54"/><clear/>that inhibits industry for making it. <time begin="00:11:07.42"/><clear/>And then because of this lack of value given to it, <time begin="00:11:11.92"/><clear/>I want to talk about why industry would make these decisions and be able <time begin="00:11:16.51"/><clear/>to cost the vaccine development, how much it costs to make any drug now. <time begin="00:11:20.59"/><clear/>And ultimately then if you're going to invest in it, this is what you have to invest, <time begin="00:11:26.45"/><clear/>and then deal with the costs on the other side of the risk benefit that is what it costs you <time begin="00:11:31.37"/><clear/>by delaying the development and ultimately the delivery of the vaccine. <time begin="00:11:39.23"/><clear/>This is all kind of a downer and I admit it. <time begin="00:11:44.08"/><clear/>This is not a good example of our society, as I think recently we've had many measurements <time begin="00:11:53.00"/><clear/>of the lack of our social wisdom, but this is just one of them. <time begin="00:11:57.25"/><clear/>But I'm going to put in here at the end a positive note how especially <time begin="00:12:01.30"/><clear/>when the money comes from Page 8 Francis.txt the Bill and Melinda Gates Foundation, <time begin="00:12:03.97"/><clear/>how there are changes especially in the less developed parts <time begin="00:12:08.09"/><clear/>of the world that have stimulated a change. <time begin="00:12:10.31"/><clear/>So I don't want to send you all out with frowns and gray faces. <time begin="00:12:14.14"/><clear/>We just say we have some real holes in our society <time begin="00:12:17.49"/><clear/>and hopefully we're fixing those holes much like the holes in a road. <time begin="00:12:23.18"/><clear/>Now let's look at this, this is the ocurrence of multiple diseases in the United States, <time begin="00:12:31.04"/><clear/>this is diphtheria, the measles, polio, and ultimately see AIDS coming up, <time begin="00:12:36.51"/><clear/>which carries on item for item at this point. <time begin="00:12:39.12"/><clear/>And I want to really stress the left-hand side of this slide, which is this remarkable decline <time begin="00:12:46.61"/><clear/>in diseases that my parents, your grandparents, had as routine -- I think in my mother's aunts, <time begin="00:12:54.48"/><clear/>at least of her family, all but one of them got diphtheria and about half of them died. <time begin="00:13:01.24"/><clear/>So it was incredibly common that everyone in the United States got these diseases <time begin="00:13:06.46"/><clear/>and the reason tehy declined primarily were vaccines, and so they've had a tremendous effect. <time begin="00:13:11.86"/><clear/>So that's the good news. <time begin="00:13:13.62"/><clear/>And I want to take some examples of these diseases and show how the good news is good, <time begin="00:13:22.59"/><clear/>that is that we eliminated the disease; the sad thing is that once we had the tools <time begin="00:13:27.65"/><clear/>to eliminate this disease, we didn't do it as fast as we could. Page 9 Francis.txt <time begin="00:13:31.48"/><clear/>And the first one I want to deal with is smallpox, which is a disease none <time begin="00:13:36.17"/><clear/>of you have seen, but one of which I have either had the fortune or misfortune <time begin="00:13:40.22"/><clear/>of dealing a great deal with in my earlier days at CDC, <time begin="00:13:43.59"/><clear/>which really infected everyone in the world. <time begin="00:13:46.76"/><clear/>Don Hopkins at CDC wrote a book called Princes and Paupers or something like that <time begin="00:13:54.25"/><clear/>where he outlined the effect of smallpox <time begin="00:13:56.98"/><clear/>on especially the elite royalty of various countries. <time begin="00:14:02.88"/><clear/>Smallpox really killed -- it infected everyone and about 40, 50 percent of people died. <time begin="00:14:07.75"/><clear/>So you can imagine what that did to princes and paupers around the world. <time begin="00:14:11.47"/><clear/>And so everyone had scars on their face from smallpox, <time begin="00:14:16.21"/><clear/>and somewhere around 40 percent had died in any given family, including the elite <time begin="00:14:22.80"/><clear/>of all countries with princes and all people with paupers. <time begin="00:14:28.22"/><clear/>And had a huge effect on the history of the world as kings and princes and such died. <time begin="00:14:34.81"/><clear/>And interestingly, Edward Jenner, who I think is on the next slide, made the observation <time begin="00:14:42.89"/><clear/>that the only pretty faces in U.K. at the time were milkmaids. <time begin="00:14:48.96"/><clear/>They're the only ones whose face did not look like it received a shotgun blast <time begin="00:14:52.85"/><clear/>and had all these pox all Page 10 Francis.txt over, these holes. <time begin="00:14:55.80"/><clear/>But they had pox on their hands and he surmised that the teats <time begin="00:15:02.61"/><clear/>of cows had these lesions also, and that they remember getting these raised lesions <time begin="00:15:11.54"/><clear/>on their hand that produced a hole in their hand, <time begin="00:15:13.83"/><clear/>but they never then got smallpox on their face. <time begin="00:15:16.49"/><clear/>And so he surmised that if you touched the puss from one of the cows and giving <time begin="00:15:22.10"/><clear/>that to people may protect from smallpox, and this is actually the picture, a rendition of a picture <time begin="00:15:27.94"/><clear/>where he took a child and actually vaccinated them with the cow pox virus, <time begin="00:15:33.49"/><clear/>and then exposed this child to smallpox and the child did not come down with it. <time begin="00:15:38.68"/><clear/>So this was one of the earliest vaccines ever initiated, and it actually ended <time begin="00:15:45.30"/><clear/>up being the tool that we ultimately used for the eradication of smallpox around the world. <time begin="00:15:50.81"/><clear/>And this is looking at the number of countries with smallpox from 1967 to 1977, <time begin="00:16:00.05"/><clear/>and you can see that there was a concerted effort of the world to actually end smallpox <time begin="00:16:07.22"/><clear/>in their own countries, and then this was actually the beginning of the WHO program <time begin="00:16:12.78"/><clear/>that then began vaccinating kids all around the world. <time begin="00:16:16.71"/><clear/>And what we did then was search for cases in different parts of the world <time begin="00:16:20.27"/><clear/>and then vaccinate Page 11 Francis.txt extensively around them. <time begin="00:16:23.03"/><clear/>And so that was good news, we ultimately eliminated smallpox in the world, <time begin="00:16:29.29"/><clear/>and no one actually is using the smallpox vaccine anymore because the only hosts <time begin="00:16:34.33"/><clear/>for smallpox are humans, which is wonderful. <time begin="00:16:36.52"/><clear/>If you stop it in humans -it doesn't come out of an animal's feces, <time begin="00:16:39.81"/><clear/>and so we're able to stop the use of the smallpox vaccine <time begin="00:16:42.88"/><clear/>because of some toxicities associated with it and that there was no disease. <time begin="00:16:48.07"/><clear/>So the good news is that we eliminated smallpox. <time begin="00:16:52.58"/><clear/>Oh, now I'm stuck, and they're gone. <time begin="00:16:55.66"/><clear/>Because it will not go backwards I'm told. <time begin="00:16:58.68"/><clear/>But the good news was -- and I'll show you on a subsequent slide -- <time begin="00:17:01.31"/><clear/>[ Laughter ] <time begin="00:17:03.61"/><clear/>>> -- was that we eliminated smallpox, the problem was this was a delay <time begin="00:17:10.62"/><clear/>of literally decades, if not centuries, from the discovery of the vaccine and the proof <time begin="00:17:17.88"/><clear/>that it actually would prevent disease until the actual eliminating disease in the late 70s. <time begin="00:17:24.49"/><clear/>So there's a huge delay that occurred, and therefore literally millions and millions <time begin="00:17:28.92"/><clear/>of people around the world died needlessly. <time begin="00:17:31.37"/><clear/>And so there was this God awful delay that occurred and I went off to Africa and India <time begin="00:17:36.00"/><clear/>for the better part of what Page 12 Francis.txt three years chasing smallpox, and it's a horrible disease, <time begin="00:17:41.64"/><clear/>still killing about 30 percent and scarring and really decimating families. <time begin="00:17:46.51"/><clear/>But it was -- oh, look at that, thank you. <time begin="00:17:49.03"/><clear/>[ Laughter ] <time begin="00:17:51.04"/><clear/>>> That it was a huge time delay -- since I can't go backwards, I'll show you on a subsequent slide. <time begin="00:17:56.68"/><clear/>So there was good news and bad news on smallpox, also good news and bad news on polio. <time begin="00:18:01.64"/><clear/>Polio, a disease that when I was a child, there was no polio vaccine. <time begin="00:18:09.13"/><clear/>And this is a picture of Rancho Los Amigos in southern California of the iron lungs, <time begin="00:18:15.30"/><clear/>the severe part of polio, it would affect the lower limbs and go all the way up <time begin="00:18:19.51"/><clear/>and ultimately get your respiratory nerves and then the respiratory paralysis. <time begin="00:18:24.71"/><clear/>And so these were the earliest of respirators, these people cannot breathe <time begin="00:18:27.88"/><clear/>because polio has paralyzed their respiratory nerves, and therefore a vacuum process just <time begin="00:18:34.22"/><clear/>like a respirator with a tube, has to be instilled, <time begin="00:18:38.08"/><clear/>and so there were literally just rooms and rooms. <time begin="00:18:40.54"/><clear/>And I remember there was one hospital in San Francisco that I would drive by the kids, <time begin="00:18:44.31"/><clear/>and you'd see through the door, and see through the glass <time begin="00:18:46.55"/><clear/>and the windows all these people on these respirators. <time begin="00:18:49.10"/><clear/>And I did my pediatric training at LA County Page 13 Francis.txt Hospital and we had all of these stored <time begin="00:18:52.81"/><clear/>in the back and occasionally used them for Guillain-Barre and the like. <time begin="00:18:55.29"/><clear/>So it was just like a horrible disease. <time begin="00:18:59.44"/><clear/>And interestingly, in contrast to HIV that there was a great political pull <time begin="00:19:09.46"/><clear/>and push to do something about polio. <time begin="00:19:12.69"/><clear/>And unfortunately, the president of the United States at the age of 39, <time begin="00:19:17.54"/><clear/>well before he was elected, was paralyzed with polio <time begin="00:19:21.90"/><clear/>and was in a wheelchair throughout his presidency, although I think this is one <time begin="00:19:25.23"/><clear/>of the few pictures of him in the wheelchair, you'll always see him standing against something <time begin="00:19:29.18"/><clear/>or with someone, and he would never show in public <time begin="00:19:31.75"/><clear/>that he was totally paralyzed and in a wheelchair or crutches. <time begin="00:19:35.86"/><clear/>But this is Franklin Delano Roosevelt, and then he started from Warm Springs, Georgia, <time begin="00:19:41.69"/><clear/>the March of Dimes equivalance called infantile paralysis program at the time, <time begin="00:19:47.89"/><clear/>where you'd go to Warm Springs and elsewhere to get therapy for your polio <time begin="00:19:52.29"/><clear/>and also raise money for vaccine development. <time begin="00:19:55.70"/><clear/>It helps to be president of the United States when it comes to developing programs <time begin="00:20:00.95"/><clear/>for any disease and to be afflicted with the disease or personally affected with it, <time begin="00:20:06.62"/><clear/>unfortunately for several Page 14 Francis.txt things, we haven't seen that with the current administrations, <time begin="00:20:12.33"/><clear/>either the commitment or the affliction, I don't know which one you would wish for. <time begin="00:20:16.10"/><clear/>[ Laughter ] <time begin="00:20:18.18"/><clear/>>> I just got back from India a while ago, I'm going back again in a couple of weeks. <time begin="00:20:22.52"/><clear/>This is polio continuing in India, this young man was at a house where the child had polio, <time begin="00:20:30.03"/><clear/>but there's a massive immunization program going <time begin="00:20:33.22"/><clear/>on in the world right now to try to eliminate polio. <time begin="00:20:38.32"/><clear/>And how do we do that? <time begin="00:20:39.91"/><clear/>This is Jonas Salk as a young man who had the clever idea just growing up a bunch <time begin="00:20:45.24"/><clear/>of polio virus and killing it with chemicals and using that as the vaccine for polio. <time begin="00:20:52.90"/><clear/>And you see here the -- I probably have to read some of this, but this is 1985 and now 2009, <time begin="00:21:04.52"/><clear/>this is the progress towards polio eradication that now -- remember in that last slide, <time begin="00:21:09.10"/><clear/>Jonas Salk discovered the vaccine in 1955, this 1985, <time begin="00:21:14.43"/><clear/>and in 1988 the world health assembly makes a resolution to eradicate polio in the world. <time begin="00:21:21.05"/><clear/>1989, this has not been easy, he continued to do that. <time begin="00:21:26.50"/><clear/>This was the original target date for eradication <time begin="00:21:29.40"/><clear/>and we still have a few countries now with polio, unfortunately we've had a big setback <time begin="00:21:35.99"/><clear/>with the Muslim countries and Page 15 Francis.txt North Africa, especially in Nigeria <time begin="00:21:39.26"/><clear/>where they thought this was some family planning program.Well I can stop immunizing <time begin="00:21:42.56"/><clear/>and then Hajj followers marching across North Africa to Mecca, <time begin="00:21:48.85"/><clear/>spread the disease all the way to Mecca and then beyond all the way <time begin="00:21:52.47"/><clear/>to Indonesia, so we had to clean that back up. <time begin="00:21:54.78"/><clear/>And India continues, a little bit in Afghanistan, but hopefully we'll be able <time begin="00:21:59.95"/><clear/>to eradicate polio in the next few years. <time begin="00:22:02.24"/><clear/>This is the issue with India, in cases <time begin="00:22:11.04"/><clear/>of India, we see these massive amounts and then the program begins. <time begin="00:22:16.83"/><clear/>These are the mass immunization days all across India, which is a huge effort <time begin="00:22:21.67"/><clear/>as you might imagine, and we still have these few leftover cases, about 16 in [inaudible] <time begin="00:22:27.19"/><clear/>and 16 in Bihar last year. <time begin="00:22:29.39"/><clear/>So they continue to dribble on and it's a little tougher than smallpox <time begin="00:22:35.04"/><clear/>because you have to literally immunize every kid. <time begin="00:22:38.75"/><clear/>Here's now the slide that if I don't punch the button again, this is smallpox here, <time begin="00:22:45.39"/><clear/>the vaccine became quote commercially available some time after the 1900s. <time begin="00:22:50.43"/><clear/>It was eradicated in northern Europe and the United States between 1930 and 1953, <time begin="00:22:56.46"/><clear/>with the delay of 30 to 50 years between the vaccine to eradication Page 16 Francis.txt <time begin="00:23:03.94"/><clear/>that the worldwide eradication occurred in 1977, and so you end up with half a century <time begin="00:23:14.13"/><clear/>or three-quarters of century from the time the vaccine is available, <time begin="00:23:16.96"/><clear/>to the time it was eradicated around the world. <time begin="00:23:20.29"/><clear/>And you saw that slide just back there with all the polio cases from India, <time begin="00:23:24.66"/><clear/>you can imagine what decades of polio do to the little kids that you saw walking <time begin="00:23:30.13"/><clear/>on a stick in the previous slide. <time begin="00:23:32.06"/><clear/>Just drive along the streets in northern India, you see case after case of polio, <time begin="00:23:38.06"/><clear/>but really it's tough enough to be a child or a young adult in India, but you can imagine being one <time begin="00:23:43.08"/><clear/>with either one leg or no legs functioning at all. <time begin="00:23:47.45"/><clear/>And polio, where the vaccine in 55 took a 36 year delay to eradicating in north American and Europe, <time begin="00:23:56.11"/><clear/>and it looks if we're lucky, to be able to eradicate it <time begin="00:23:59.21"/><clear/>in 50 years in the rest of the world. <time begin="00:24:03.01"/><clear/>Now let's take the last disease, this is hepatitis B infection. <time begin="00:24:11.31"/><clear/>Hepatitis B is another virus spread by sex or blood sharing much like HIV, <time begin="00:24:16.65"/><clear/>but produces some pretty terrible diseases. <time begin="00:24:20.90"/><clear/>Here this is just the outline of it with 60 to 90 days from the time you get infected <time begin="00:24:27.77"/><clear/>to the time you turn yellow and you get jaundice, you know, infrequently as a child Page 17 Francis.txt <time begin="00:24:34.98"/><clear/>and maybe a third or so of the individuals actually turn yellow and you can tell. <time begin="00:24:38.35"/><clear/>So it's a relatively mild disease with very little mortality when it comes <time begin="00:24:42.22"/><clear/>to the acute case of hepatitis that all of you would be fearful of. <time begin="00:24:46.51"/><clear/>But this is the real challenge, that the chronic infection that occurs literally years <time begin="00:24:52.78"/><clear/>after the people become carriers of the virus and then develop cirrhosis or cancer of the liver, <time begin="00:25:00.80"/><clear/>somewhere in the neighborhood of 30, 40 years after infection. <time begin="00:25:06.11"/><clear/>And that is a huge mortality when you talk about 15 to 25 percent of the individuals are going <time begin="00:25:11.63"/><clear/>to die of their chronic disease, really what I would call the modern disease like HIV <time begin="00:25:16.63"/><clear/>that has a long incubation period from the time of the infection to the time <time begin="00:25:23.35"/><clear/>of the actual manifestation of disease and death. <time begin="00:25:28.81"/><clear/>Well let's look at this, here's again a wonderful vaccine, <time begin="00:25:32.01"/><clear/>this is the first recombinant vaccine where we didn't have to grow up virus, <time begin="00:25:36.27"/><clear/>but it was done by a private sector company, Merck, <time begin="00:25:40.29"/><clear/>who figured out a way to inactivate the virus. <time begin="00:25:43.24"/><clear/>This is cases in the United States '78 to '95, it was licensed here, <time begin="00:25:49.41"/><clear/>we finally started screening pregnant women and vaccination of babies here. Page 18 Francis.txt <time begin="00:25:54.19"/><clear/>And then infant immunization now in 1991, this is ten years, in the United States, <time begin="00:26:00.44"/><clear/>ten years from the discovery of the vaccine until it was actually recommended <time begin="00:26:04.92"/><clear/>and then adolescent catch up immunization another three years after that. <time begin="00:26:09.96"/><clear/>So a remarkable time from a very effective vaccine <time begin="00:26:14.06"/><clear/>that literally can eliminate the hepatitis B virus infection with little problem, <time begin="00:26:18.84"/><clear/>and yet this huge delay from the time that it was licensed and to the time it was used, <time begin="00:26:24.82"/><clear/>and that's in the United States of America. <time begin="00:26:27.24"/><clear/>This is the rest of the world with the -- ah. <time begin="00:26:30.04"/><clear/>[ Laughter ] <time begin="00:26:32.06"/><clear/>>> Okay, that was the rest of the world with the -- oh, thank you -- <time begin="00:26:35.56"/><clear/>I've got two buttons here and I can't, you know, all these years of education and I can't figure <time begin="00:26:39.38"/><clear/>out which button to push in order to go forward or backward, so I apologize. <time begin="00:26:43.80"/><clear/>But -- ooh, I did it even twice, going back. <time begin="00:26:45.36"/><clear/>Gee whiz, I keep going back, I must have hit about -- there we go. <time begin="00:26:55.32"/><clear/>Now I'll try to be better, thank you. <time begin="00:26:59.93"/><clear/>And the places in massive need of hepatitis B infections were 60, <time begin="00:27:04.96"/><clear/>70 percent of the population infected with hepatitis B virus, is central Africa, <time begin="00:27:09.50"/><clear/>and this means that no Page 19 Francis.txt vaccine program exists there at all. <time begin="00:27:12.83"/><clear/>So it took us years to even apply it in a county like the United States and now what 30 years almost <time begin="00:27:19.42"/><clear/>after the invention of the vaccine, it is still not used in parts <time begin="00:27:24.08"/><clear/>of the world where it is needed the most. <time begin="00:27:27.02"/><clear/> <time begin="00:27:28.25"/><clear/>So why do we have these delays? <time begin="00:27:30.95"/><clear/>Why do you have major disease occurrence causing horrible situations and tools necessary <time begin="00:27:37.00"/><clear/>to develop them, or indeed an interest, a virus that we know causes it, <time begin="00:27:43.40"/><clear/>and we could make a vaccine, but we haven't even made the vaccine yet? <time begin="00:27:47.81"/><clear/>And I think it's relatively straightforward, now that I've been in the government <time begin="00:27:51.97"/><clear/>in the private sector, both making and using these kinds of product, <time begin="00:27:56.16"/><clear/>I think I can give some sort of approved overall view that you find the virus, you need to figure <time begin="00:28:05.49"/><clear/>out what part of the virus immune system is directed towards, make candidate vaccines, <time begin="00:28:12.53"/><clear/>use them in animals and see if they work, and then once you've developed the vaccine <time begin="00:28:16.56"/><clear/>in humans, actually apply that vaccine. <time begin="00:28:20.29"/><clear/>It's simple, no? <time begin="00:28:21.60"/><clear/>You figure out what the virus is, figure out what the immune response is, <time begin="00:28:25.26"/><clear/>figure out how to make a vaccine safely, try it in animals and then humans, <time begin="00:28:29.01"/><clear/>and then public health takes Page 20 Francis.txt it and gives it to the people and the disease goes away. <time begin="00:28:32.76"/><clear/>Really remarkably straightforward, this is not complex politics <time begin="00:28:36.98"/><clear/>in reality, this is simple science. <time begin="00:28:39.07"/><clear/>And it's all driven by social value, that is what the people <time begin="00:28:42.49"/><clear/>in this room think is important will be done because people will ultimately drive this <time begin="00:28:46.80"/><clear/>through either political pressure or funding or something else. <time begin="00:28:50.85"/><clear/>So that's the process and I say social value is the key here to drive it. <time begin="00:28:56.60"/><clear/> <time begin="00:28:59.23"/><clear/>Let's now start from that and work our way down. <time begin="00:29:02.53"/><clear/>Who makes vaccines? <time begin="00:29:04.92"/><clear/>Where is the expertise -- so starting down this pathway that actually will develop them? <time begin="00:29:10.25"/><clear/>And it really is in two places; one is places like this, the discovery of the agent, <time begin="00:29:15.41"/><clear/>the figuring out what the immune response is, what the immunology is, <time begin="00:29:18.43"/><clear/>what would be the logical vaccine, and then private pharmaceutical companies take that on <time begin="00:29:24.01"/><clear/>early in the development path. <time begin="00:29:26.43"/><clear/>Now it's important for you folks in university to realize that universities by and large do not make <time begin="00:29:31.01"/><clear/>these products. <time begin="00:29:33.07"/><clear/>Many times the government thinks if they dump more money throughout NIH it will come <time begin="00:29:36.50"/><clear/>to universities and universities will make vaccines. <time begin="00:29:39.87"/><clear/>But I think there's an Page 21 Francis.txt important split here between university academic research <time begin="00:29:46.57"/><clear/>and actual product development, this is a wonderful report by McKinsey and Company, <time begin="00:29:52.73"/><clear/>of the World Bank, and let me read this because I think this is really worthwhile. <time begin="00:29:56.99"/><clear/>The public sector institutions involved in vaccine R&D are primarily focused <time begin="00:30:01.26"/><clear/>on basic science knowledge diffusion, <time begin="00:30:04.34"/><clear/>rather than single mindedly solving applied development problems <time begin="00:30:07.51"/><clear/>to ensure large scale consistent production. <time begin="00:30:10.65"/><clear/>That's an important sentence, complex, but universities are discovery pieces <time begin="00:30:15.11"/><clear/>and they do research and discover, <time begin="00:30:17.00"/><clear/>whereas industry is really, someone complained, that it's so highly focused. <time begin="00:30:20.93"/><clear/>But now that I've been in industry it's wonderful, this is a product, you move it along, <time begin="00:30:23.94"/><clear/>see if it works, and if it works make lots of it, sell it and make money. <time begin="00:30:27.23"/><clear/>The incentives in the public sector reinforce this knowledge focus <time begin="00:30:31.60"/><clear/>and are generally inconsistent with efficient production of commodities. <time begin="00:30:36.99"/><clear/>Let me put that into very simple terms. <time begin="00:30:39.63"/><clear/>If you're in a university, your output is knowledge. <time begin="00:30:44.80"/><clear/>The measurement of that output really are the manuscripts that you publish in journals. Page 22 Francis.txt <time begin="00:30:48.87"/><clear/>If you're industry, you're out for the product, and the measurement of the success <time begin="00:30:56.03"/><clear/>of that product is how much money you make from that product. <time begin="00:30:59.60"/><clear/>Very divergent, although complimentary in terms of making vaccines actual goals, <time begin="00:31:05.33"/><clear/>and what the key message here is don't expect universities to make vaccines. <time begin="00:31:11.41"/><clear/>That's not their output and they may want to get the IP for it and move it on, <time begin="00:31:16.13"/><clear/>but somebody else has to develop it, and that somebody else has to have the skills <time begin="00:31:19.50"/><clear/>for actual development versus research. <time begin="00:31:22.78"/><clear/>So here again, is the scientific discovering university, some sort of industry or something <time begin="00:31:29.55"/><clear/>like making development or then you actually drive it. <time begin="00:31:33.27"/><clear/>And it's the lack of social value that really kills this one here in the middle in terms <time begin="00:31:40.20"/><clear/>of taking university discoveries and moving them onwards. <time begin="00:31:44.24"/><clear/> <time begin="00:31:45.29"/><clear/>Why do I say that? <time begin="00:31:47.34"/><clear/>Because I think there's low social value given to vaccines by both industry <time begin="00:31:54.87"/><clear/> <time begin="00:31:56.23"/><clear/>that follows social value and profits, <time begin="00:31:59.40"/><clear/>and therefore is not very interested in making vaccines. <time begin="00:32:02.38"/><clear/>We used to have a dozen pharmaceutical in the industry developing vaccines in this country, <time begin="00:32:07.26"/><clear/>and we're down now to just a Page 23 Francis.txt couple. <time begin="00:32:10.34"/><clear/>And unfortunately, they're not valued by society, but really the pull factor here <time begin="00:32:16.85"/><clear/>to making a market for it because we're very reticent about using vaccines and it takes <time begin="00:32:22.51"/><clear/>that long for us to take a vaccine and actually deliver it to the people. <time begin="00:32:28.22"/><clear/>Now why is that important? <time begin="00:32:30.29"/><clear/>Industry thinks of the profits they make per year per investment. And if they're going <time begin="00:32:35.55"/><clear/>to put a big investment, and I'll get into that, into a product, <time begin="00:32:38.80"/><clear/>they want the return on that investment fast. <time begin="00:32:41.92"/><clear/>And you say these ugly industrial people. <time begin="00:32:45.42"/><clear/>Guys, I guarantee you that you and your families have money in these industries in some sort <time begin="00:32:52.83"/><clear/>of a portfolio that someone has that is gaining money for your future, <time begin="00:32:58.36"/><clear/>investment in pharmaceutical industry. <time begin="00:33:01.03"/><clear/>And their goal is to increase the value of that portfolio. <time begin="00:33:05.19"/><clear/>Their responsibility is to increase the value of that portfolio and make good drugs. <time begin="00:33:09.30"/><clear/>It is not to save the world from vaccines. <time begin="00:33:12.00"/><clear/>So don't blame the pharmaceutical industry. Their goal is to make your portfolio better <time begin="00:33:17.72"/><clear/>and indeed hopefully make the health better, but following social value of what we will pay for. <time begin="00:33:24.21"/><clear/>And my conclusion here is that it's Page 24 Francis.txt better not to make vaccines if you're <time begin="00:33:27.95"/><clear/>in the pharmaceutical industry as I'll get into in a second. <time begin="00:33:31.63"/><clear/>So the public health role here is very interesting. <time begin="00:33:36.12"/><clear/>As a public health doctor, I consider myself a public doctor, and as a career person <time begin="00:33:41.08"/><clear/>at CDC in Atlanta, I was giving value to vaccines, I think they're wonderful things <time begin="00:33:46.48"/><clear/>and we've got to go out there and deliver them. <time begin="00:33:48.37"/><clear/>So we recognize the value of vaccines, but we're always talking <time begin="00:33:52.89"/><clear/>about how they have to cost a nickel. <time begin="00:33:56.66"/><clear/>Almost always. Pharmaceutical industry is ugly, they try to charge 2, <time begin="00:33:59.39"/><clear/>3 dollars or 5 dollars for these things, and so they're ugly, <time begin="00:34:02.89"/><clear/>so let's just go head and get it down to a couple of dollars. <time begin="00:34:06.70"/><clear/>And then there's very little political value to say that either through taxation <time begin="00:34:10.38"/><clear/>or through other society paying for these things, that they should come <time begin="00:34:14.23"/><clear/>through with the money necessary to deliver. <time begin="00:34:17.51"/><clear/>Now look at this, this is a very interesting graph for [inaudible] in WHO that looks <time begin="00:34:23.89"/><clear/>at vaccines from different parts the world. <time begin="00:34:27.82"/><clear/>This is divided in the industrialized countries here and developing countries here. <time begin="00:34:33.19"/><clear/>And this is the population, this is the disease burden that follows the population that most Page 25 Francis.txt <time begin="00:34:38.36"/><clear/>of the disease burden is in the developing world. <time begin="00:34:41.18"/><clear/>And now let's look at the vaccine market. <time begin="00:34:43.92"/><clear/>The vaccine market is 82 percent <time begin="00:34:48.01"/><clear/>of the $6 billion vaccine market is in the industrialized world. <time begin="00:34:52.54"/><clear/>And 90 percent of the investment in vaccine development comes from the industrialized world <time begin="00:34:58.83"/><clear/>to make money on this 82 percent of the market that really only accounts <time begin="00:35:03.90"/><clear/>for about 10, 15 percent of the disease. <time begin="00:35:08.11"/><clear/>There's a real imbalance here that you have all the disease in the developing world <time begin="00:35:12.98"/><clear/>and all the profit on this side of the ocean, <time begin="00:35:15.88"/><clear/>and therefore vaccines will be developed if at all for here. <time begin="00:35:21.69"/><clear/>This just looks at the cost of the vaccines. <time begin="00:35:24.28"/><clear/>When I said we'd try to drive the cost down, look at what is paid for example here, <time begin="00:35:29.80"/><clear/>with measles vaccine in the low-income countries, 14 cents per dose. <time begin="00:35:35.52"/><clear/>It costs you a dollar to put it in a bottle. <time begin="00:35:39.80"/><clear/>So the industry is losing money because it's just grinding down and grinding down the price <time begin="00:35:45.05"/><clear/>of these things so the WHO and UNICEF, your holiday cards can buy it. <time begin="00:35:51.19"/><clear/>And even the high-income countries, you only spend 15 bucks per dose. <time begin="00:35:56.44"/><clear/>Now next time you go to McDonald's Page 26 Francis.txt you'll spend $15, the people who complain <time begin="00:36:01.30"/><clear/>that $15 is too much for a vaccine that will prevent all of these diseases. <time begin="00:36:06.54"/><clear/>So this is a WHO statement, let me just summarize it, that the low <time begin="00:36:11.13"/><clear/>or uncertain demand for vaccines and the lack of return on these vaccines <time begin="00:36:15.54"/><clear/>and the continued hammering of industry to get the vaccine <time begin="00:36:19.40"/><clear/>down drives industry out of the vaccine business. <time begin="00:36:22.90"/><clear/>And I want you all in the next few minutes to put yourself on the board of directors <time begin="00:36:26.77"/><clear/>of a company that has to make a decision if you're going to invest in the research <time begin="00:36:31.93"/><clear/>for a vaccine versus you're going to invest in another drug to increase erections. <time begin="00:36:39.04"/><clear/>[ Laughter ] <time begin="00:36:41.06"/><clear/>>> Let me hold on a second, my telephone is going to ring in a little. Let me shut it off. Now let me just deal <time begin="00:36:48.45"/><clear/>with you sitting on this board and you are being asked to invest in this stuff <time begin="00:36:54.39"/><clear/>and see how much it cost actually of your money from your company. <time begin="00:36:59.14"/><clear/>This is just one example of the flu vaccine recently licensed a couple years ago <time begin="00:37:05.11"/><clear/>in the United States where there is public information on it, <time begin="00:37:08.49"/><clear/>but the RND for the vaccine costs $145 million, and then the manufacturing $200 million, <time begin="00:37:15.05"/><clear/>so a total of $345 million to take one vaccine from the bench in the discovery <time begin="00:37:21.43"/><clear/>of academic research to Page 27 Francis.txt actually making the vaccine <time begin="00:37:26.97"/><clear/>through the development process and available to the market. <time begin="00:37:31.18"/><clear/>So what it costs to bring a vaccine to market, everyone will agree it costs somewhere <time begin="00:37:35.40"/><clear/>between 200 and $500 million in 12 to 15 from the time that you bring it <time begin="00:37:40.99"/><clear/>into a company and then you get it out. <time begin="00:37:44.67"/><clear/>To be honest, this is what it costs to develop a drug, a vaccine, <time begin="00:37:49.08"/><clear/>or any other drug in the pharmaceutical industry. <time begin="00:37:51.46"/><clear/>It's a very expensive process with lots of work. <time begin="00:37:54.98"/><clear/>You start with your initial discovery and then you get into animals and then you get <time begin="00:37:58.35"/><clear/>into humans and face three trials and you've got thousands of people, and it costs this kind <time begin="00:38:02.55"/><clear/>of money in order to do it, that's just a fact of life. <time begin="00:38:06.42"/><clear/> <time begin="00:38:07.66"/><clear/>So if you're going to make a vaccine -- let's say that this side of the room comes <time begin="00:38:15.45"/><clear/>to the board of directors of the company, you guys are at top of the board <time begin="00:38:19.16"/><clear/>of directors, and you guys are the scientists. <time begin="00:38:21.59"/><clear/>And they come to you and they say, "We would like to make a vaccine for the disease X, <time begin="00:38:30.19"/><clear/>and this is our plan for it and this is how much money it's going to cost." <time begin="00:38:34.58"/><clear/>This side of the group comes to the board of directors and says, Page 28 Francis.txt <time begin="00:38:37.91"/><clear/>"We have a drug for erections," or whatever you want, "We have our development plan and we want <time begin="00:38:44.81"/><clear/>to develop this because we think this is an important drug that we'd like to develop." <time begin="00:38:51.25"/><clear/>And you guys at the top are going to have to make the decision. <time begin="00:38:54.20"/><clear/>Well look here, this is the total revenue in billions of dollars per year <time begin="00:39:05.22"/><clear/>for a few drugs that I just chose. <time begin="00:39:09.47"/><clear/>This all ten vaccines that we market in the United States, <time begin="00:39:14.36"/><clear/>it sits up there at about $6 billion. <time begin="00:39:17.14"/><clear/>This is the market for the less developed countries that make $1 billion. <time begin="00:39:23.49"/><clear/>These are two drugs, one to lower cholesterol and the other to decrease heartburn. <time begin="00:39:30.84"/><clear/>Some of you in this room probably take these drugs. <time begin="00:39:34.00"/><clear/>Good drugs. <time begin="00:39:34.96"/><clear/>Important drugs. <time begin="00:39:36.34"/><clear/>But this side of the room wants to develop another one of these, <time begin="00:39:40.77"/><clear/>and this side wants to develop a vaccine. <time begin="00:39:44.85"/><clear/>You guys on the board of directors have really only one choice. <time begin="00:39:48.98"/><clear/>You look at the potentialthis is divided into a dozen different lines, <time begin="00:39:53.84"/><clear/>so nothing comes above $2 billion here. <time begin="00:39:57.67"/><clear/>You make a choice. <time begin="00:39:58.75"/><clear/>I'd rather have you guys develop your erection drug or something, <time begin="00:40:01.95"/><clear/>and you guys lose and you Page 29 Francis.txt guys win. <time begin="00:40:03.82"/><clear/>And that's not an ethical issue, <time begin="00:40:08.36"/><clear/>it's not a scientific issue, it is just one of social value. <time begin="00:40:12.44"/><clear/>We pay money for these drugs and we don't pay money for the vaccines <time begin="00:40:16.36"/><clear/>that make it a significant market. <time begin="00:40:18.32"/><clear/>So this lack of social value ends up really being very expensive. <time begin="00:40:26.13"/><clear/>You end up without the social value and lack of political leadership. <time begin="00:40:30.70"/><clear/>They interact, so you end up having continued disease occurrence in the long run. <time begin="00:40:37.03"/><clear/>And these are the costs; continued disease occurs, <time begin="00:40:40.37"/><clear/>which is terrible as I showed you on polio and these huge delays. <time begin="00:40:45.85"/><clear/>And equally important in a public health sense, the increased infected pool, <time begin="00:40:50.16"/><clear/>that the longer you delay the control of a disease, the more people get infected, <time begin="00:40:55.96"/><clear/>the more source of infection for others, <time begin="00:40:58.01"/><clear/>and you end up having more disease more difficult to control in the future, <time begin="00:41:01.82"/><clear/>so it compounds itself with time. <time begin="00:41:04.47"/><clear/>And then lastly, you end up with a very limited market for vaccine, little social demand <time begin="00:41:13.09"/><clear/>for it, and therefore less industry incentive to make vaccines, which causes more delay <time begin="00:41:18.71"/><clear/>in the vaccines and the whole thing perpetuates itself for the future. Page 30 Francis.txt <time begin="00:41:22.69"/><clear/> <time begin="00:41:24.31"/><clear/>That's the end of the downer part of the talk. <time begin="00:41:27.16"/><clear/>It is indeed a very discouraging -- after someone like myself who's actually been <time begin="00:41:30.91"/><clear/>out there eradicating diseases and see the potential we have in biotechnology <time begin="00:41:34.63"/><clear/>to make vaccines, it's a shame that we are not better able to adjust those social values <time begin="00:41:40.86"/><clear/>so that we come some sort of more equal especially <time begin="00:41:43.74"/><clear/>for the less developed parts of the world. <time begin="00:41:47.31"/><clear/>And generally this is divided to two parts. <time begin="00:41:50.16"/><clear/>Push, that is you push the development of a product through an industry; and pull, <time begin="00:41:55.20"/><clear/>that you pull the product through industrial development <time begin="00:41:58.82"/><clear/>by increasing the price and increasing the purchase. <time begin="00:42:01.96"/><clear/>And both of these have been recently in place for the last, almost a decade now, <time begin="00:42:07.77"/><clear/>especially as a result of the Bill and Melinda Gates Foundation. <time begin="00:42:10.91"/><clear/>But there's quite a few, if you go back in history interestingly as I mentioned before, <time begin="00:42:15.14"/><clear/>at the bottom of this slide you see that the March of Dimes is the one <time begin="00:42:18.21"/><clear/>that really drove the development of polio vaccine with Jonas Salk <time begin="00:42:22.39"/><clear/>and Albert Sabin being the ones who developed the vaccine. <time begin="00:42:25.14"/><clear/>But before that, the Page 31 Francis.txt Rockefeller Foundation developed a yellow fever vaccine, <time begin="00:42:29.55"/><clear/>and before that Institut Pasteur in Paris had developed several of the vaccines <time begin="00:42:34.85"/><clear/>that we use still today in childhood vaccines. <time begin="00:42:39.56"/><clear/>But now it is really adjusting again, and it's very nice to see, <time begin="00:42:45.06"/><clear/>especially for the less developed parts of the world, <time begin="00:42:49.20"/><clear/>you see all of these various vaccine development public/private partnerships, <time begin="00:42:54.28"/><clear/>very much like the Rockefeller and the March of Dimes <time begin="00:42:59.68"/><clear/>where we have vaccines for tuberculosis, malaria. <time begin="00:43:02.99"/><clear/>This is us working on HIV and other hookworm vaccine initiatives that you heard from here, <time begin="00:43:11.54"/><clear/>International AIDS Vaccine Initiative in New York, the Malaria Vaccine Initiative in Dengue, <time begin="00:43:17.69"/><clear/>Pneumococcal, Rotavirus, and South African AIDS Vaccine Initiative. <time begin="00:43:21.34"/><clear/>Most of it funded by the Bill and Melinda Gates Foundation, but also from other sources. <time begin="00:43:27.93"/><clear/>And then we have what we've really seen also I think stimulated primarily by the Bill <time begin="00:43:33.26"/><clear/>and Melinda Gates Foundation, the setting of the global fund and like <time begin="00:43:36.33"/><clear/>and European Union donating huge amounts of money to actually pull vaccines in, <time begin="00:43:42.51"/><clear/>especially for the less developed parts of the world. <time begin="00:43:44.40"/><clear/>That is setting up a market Page 32 Francis.txt where they'd put literally now billions of dollars <time begin="00:43:48.69"/><clear/>into the purchase and delivery of vaccines in the less developed parts of the world. <time begin="00:43:52.35"/><clear/>So there is a market if somebody wants to develop it, <time begin="00:43:54.89"/><clear/>either the not-for-profit institutions I showed you on the previous slide, <time begin="00:43:58.68"/><clear/>or a for profit sector, that there is more of a market for these vaccines. <time begin="00:44:06.58"/><clear/>So in summary, I think that vaccine development is expensive, there's 200 to 500 million dollars. <time begin="00:44:13.46"/><clear/>It's slow, it takes really a decade or more. <time begin="00:44:17.79"/><clear/>The skills necessary to develop vaccines rest primarily with the private sector, <time begin="00:44:21.44"/><clear/>hopefully that's getting more into the not-for-profit now. <time begin="00:44:25.18"/><clear/>And the same costs and effort pharmaceutical companies can develop therapeutic products <time begin="00:44:30.58"/><clear/>that are far more profit than the vaccine. <time begin="00:44:33.79"/><clear/>Public health leaders are cheap and unwilling to pay reasonable prices for valuable vaccines. <time begin="00:44:37.92"/><clear/>I say that as someone who did that and indeed espoused that. <time begin="00:44:42.56"/><clear/>The lack of social value given to vaccines makes them unattractive products <time begin="00:44:46.49"/><clear/>for the pharmaceutical industry to develop, and vaccines, once they're out, <time begin="00:44:49.60"/><clear/>are often applied slowly and so the return on the investment is even compounded. <time begin="00:44:54.84"/><clear/>But there are positive Page 33 Francis.txt changes, <time begin="00:44:56.59"/><clear/>the public/private vaccine development partnerships having pharmaceutical <time begin="00:44:59.75"/><clear/>development expertise are being established, that was the list I showed you. <time begin="00:45:03.49"/><clear/>Funding is being provided most notably by the Bill and Melinda Gates Foundation, <time begin="00:45:07.38"/><clear/>and foundation support is driving public health authorities <time begin="00:45:10.24"/><clear/>to deliver existing vaccines through the pull process. <time begin="00:45:14.23"/><clear/> <time begin="00:45:15.49"/><clear/>So in summary, I think we have gone through an evolution here where in the past we relied <time begin="00:45:21.25"/><clear/>on foundations and social efforts to make vaccines, <time begin="00:45:25.74"/><clear/>recognizing there were terrible diseases out there, and we had some skills to make them, <time begin="00:45:30.21"/><clear/>and then we really let the private sector do this <time begin="00:45:32.44"/><clear/>without recognizing the private sector didn't have much enthusiasm as time has gone on, <time begin="00:45:37.61"/><clear/>and the tremendous biotechnological revolution <time begin="00:45:40.61"/><clear/>that has occurred is being directed towards very profitable products for cancer <time begin="00:45:44.85"/><clear/>and other diseases that are very important, however, it leaves a huge void <time begin="00:45:49.30"/><clear/>in the vaccine, especially for the third world. <time begin="00:45:52.22"/><clear/>And I think we're seeing some positive movement, especially stimulated out of Seattle <time begin="00:45:57.45"/><clear/>with the Bill and Melinda Gates Foundation Page 34 Francis.txt to actually try to readjust that both <time begin="00:46:01.12"/><clear/>from development of vaccines and the actual purchase of vaccines for the third world. <time begin="00:46:05.49"/><clear/>With that I will stop and we can deal with some questions. <time begin="00:46:08.21"/><clear/>Thank you. <time begin="00:46:09.51"/><clear/>[ Applause ] <time begin="00:46:18.01"/><clear/>[ Music ] Page 35

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