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cc >> Thank you for joining me for Wednesday Nite at the Lab at UW Madison Biotechnology Center. Tonight, we welcome Dr. Pete Shult, director of the Communicable Diseases Division and Emergency Laboratory Response of the Wisconsin State Laboratory of Hygiene which is located here on the UW Madison campus, actually right next door to the Biotechnology center. Dr. Shult received his PhD from the University of Wisconsin Madison in medical microbiology. He has 30 years of experience in clinical and public health microbiology with service in private university and public health sectors and directs statewide emergency laboratory response during disease outbreaks and public health emergencies including bioterrorism. He currently serves on a number of local, state, and national public health planning preparedness and response working groups dealing with pandemic influenza, bioterrorism, and emerging and vaccine-preventable diseases. And I find tonight's seminar on vaccines quite timely. Some of you may have watched PBS last week, Frontline in particular aired an episode called the "Vaccine War." So it's an ever interesting topic, and certainly I think with PBS highlighting, yet again tonight's seminar should be fantastic. So please join me in welcoming Dr. Pete Shult to Wednesday Nite at the Lab. ( applause ) >>

Peter Shult

Thank you, Nadia and thank you all for attending. I suspect there will be a little interest in the topic here. And some of the objectives, actually there are two main objectives. I want to give a public health perspective on the importance of vaccines. I'm a lab director, I work on a lot of the vaccine-preventable disease outbreaks, I've seen the effects of the disease in the absence of vaccine, and I want to come from that perspective because so often when we hear about vaccines, it's most often in a negative light. There are problems with them, we'll talk a little about that. We heard a lot about them, usually in a negative way, with the 2009 H1N1. They didn't come soon enough, why did we need to get them, and so on and so forth. What I want to do is recast this in a more positive light from a public health perspective, but I also want to recognize some of the ongoing challenges and controversies that do exist and they absolutely exist and they are absolutely having an impact on public health. What I don't want to do, I'm not a clinician so I'm not going to make the recommendations on these vaccines. The debating, there's going to be a lot of feelings about this in the audience. I'm not going to debate in the detail of some of the things I'm going to present. I certainly can point you toward resources, either for or against vaccines, that you might want to look at. As a starting point, one of the resources is, and it's a safe one again from a public health and a scientific perspective, going to the CDC's website, and specifically their vaccine website, you're going to be able to branch out into a lot of different sites that will give you authoritative, science-based information about vaccines. You can also Google vaccines and vaccine controversies and vaccine problems. And, as I tell my students on campus, I'm a professor here, you do so at your own risk, and you have to sort of filter the information you're going to get to get the balanced view here. I'm going to be talking about the public health importance of vaccine. Just kind of set the table a little. Just a simple definition here about public health. In its purest sense, and as I'll point out it's a relatively young discipline, it's about preventing disease. The fact is we do a bit of preventing disease when you look across the total breadth of public health, but most often we're responding to problems that have occurred and that's where we probably get the most spotlight put on us. But when we look at this definition, the key words here are preventing disease and disability, and also we're doing this through organized community effort. I mentioned the science or discipline of public health is relatively new. And you go back to about 1850 where it really has its roots. And where I've highlighted in red are the key elements that help those of us in public health carry out our science and our craft. Birth of epidemiology, that is monitoring and studying disease progression through communities and activities to prevent disease really began in the 1850s. Germ theory, which provides the basis for microbiology or understanding the organisms that cause infectious disease, was developed in the 1850s through 1890s. At about the same time the science of immunology, which is very relevant to how we respond to vaccines, was developed at about the same time period. And through then really the golden age for public health occurred through the late 1890s into the 1900s, 1910 and so on, where our key elements of hygiene were developed. Things that we take for granted now and we can rely on relatively safe foods, safe water, we learn basic concepts of food preservation, basic hygiene and so on. But vaccines have turned out to be one of the key elements of public health in combating infectious diseases. I want to point out, and as I go through the talk I'll make certain comments just to counter some issue about vaccines, and one of the issues has been, we don't need vaccines, if we just practice good hygiene we'd be able to prevent a lot of these diseases. And the fact is for many of these that just isn't the case. It goes beyond hygiene and without vaccines we would have problems here, and I hope to demonstrate that over a number of the slides. The outcome of public health and the outcome of all the elements of the discipline of public health I think are well demonstrated in the slide that shows the death rate for infectious disease in the United States from the 1900s to almost 2000. And you can see it was more or less a precipitous decline in infectious disease as we went through the last century. The notable exception being this peak that occurred in 1918 that I think now most people recognize as the great influenza pandemic or Spanish influenza. And it was really based on the impact that that pandemic had that a lot of our response to the 2009 H1 was predicated. The impact on death rate was also accompanied by an increase in life span of almost 30 years, 30 to 35 years. Right around the early parts or through this progression through the 20th century. And what we've known throughout history, the biggest impact of infectious disease has been in children, on infants and children. And, in fact, at the turn of the century infant mortality rates were approaching 20%, and childhood mortality rates, less than five years of age, were up around 25%-26%. And we're nowhere near that in the United States. We're at 1%, probably a little less, and some of that is due to infectious disease, a lot of it isn't. So really public health, in general, has had a huge impact on infectious disease. And then when you break out some of the key elements of public health, again vaccination really does rise to the top for a number of the diseases that were major killers of children. I highlight this reference. There was a series of articles in the morbidity and mortality weekly report in 1999 that highlights the 10 great public health achievements in the United States. They chose vaccination and control of infectious diseases as two of these. This is worth reading because it's really interesting, not only for this topic, but for a number of the other elements of public health. To get started then, we're going to be talking about vaccines, and then I want to explore a little, what is vaccination? And to start out we often intertwine or use the terms vaccination and immunization. Immunization is the process by which the human immune system prepares itself against an attack by a microorganism or a foreign substance. It can do this in one of two ways. Either be naturally exposed to the microorganism, and therefore quite often you will have disease, or you can do this in an artificial way, that is develop a vaccine, which is essentially defined here as a preparation of a killed, weakened or fully infectious microbe or their products given to produce or increase immunity to a particular disease. The idea being, by using a vaccine we get all the benefits and stimulate all the benefits of the immune response without suffering the impacts of the disease. And I'll say at the outset and I'll mention a number of times, all vaccines have some side effects. Some vaccines have more than others. Some individuals suffer more severe side effects than others. But it's like any other pharmaceutical, any other drug, there are side effects here. And we'll explore some of those. But what it will come down to, and I'll mention this a number of times through the talk, is risk versus benefit. And I hope to convince you that overall the benefit of the vaccines, to us as individuals and certainly globally, far outweigh the risks. And we'll be exploring a number of those risks. There are many different types of vaccines. I don't want to go into a lot of detail here. But I do want to point out the area here I have highlighted in red. It's obvious, we know one of the major reasons for vaccine is to protect the individual from the disease. We understand that. But what a lot of people don't understand that you also protect the community through a herd immunity that you can develop by the vaccine. If it's a successful vaccine, the more people you can vaccinate and you eliminate the number of susceptible people should the real disease emerge, and that's very important. And it's going to one of those side effects that we'll talk about a little later on. People who choose not to vaccinate themselves and vaccinate their children certainly are going to have that personal effect, but if there's a high enough number of those people, they absolutely have an effect on the community at large. And keep in mind, in our communities there are a large number of people for various reasons, cancer, they're immunocompromised in some way, they've undergone transplants, they often cannot take some of the critical vaccines, they rely on herd immunity to protect them from certain infectious diseases. I just have this slide up there as a historical perspective. It overlaps the one I showed you earlier. The only point I want to make is actually work in vaccines and the theory behind vaccines and the first attempts at using vaccines began well before that period of public health. Before we even knew what microorganisms were, before we understood the importance of our healthy immune system and so on, these were experiments that were done empirically. And Edward Jenner is really a true father of vaccines here. And that occurred during just prior to the 1800s. This is just a list of diseases for which we do have vaccines. We're going to explore this in a little more detail, but I want to point out that these vaccines have been being developed for many years. A number of the ones that were developed earlier in the last century we still use but they've been significantly modified. They've been made more effective, their side effects have been much reduced, and we continue to produce vaccines even up to today. Now this slide ends at 1999, but we've had vaccines being produced, either modification of existing ones or new vaccines, throughout the 2000s on up to 2008, and I'd anticipate we're going to continue to have them as we move forward. Now, first question, how successful have vaccines been? And to answer this there are a couple criteria for success that I want to discuss. The first point to realize when you're talking about whether a vaccine has been successful or not is at an individual level. If I get a vaccine, has it prevented disease in me, the individual? From a public health perspective, we certainly want healthy individuals but we're also wanting a lot of healthy individuals which equate to healthy communities which equate to a healthy world. So the public health, and again go back to the definition of public health, is about a community effort in improving the health of the community. And some of the criteria for success I have listed here we're going to talk about as we talk about some of the vaccines. Everything from containment, that is getting the diseases down to a level that we're willing to live with. Through elimination in a set population. Getting rid of disease that's endogenous to that population so that the only disease that will occur there is that that is brought into the population. On out to eradication, removing it in its natural state. And we've only done that to one disease and that's smallpox, and we'll talk about that a little because it's important to understand the lessons learned from smallpox. Now the other thing that I want to mention, at the individual level that's where the issues with vaccine safety arise. And again, we're going to talk about some of the elements of vaccine safety, some of the controversies here. On a global basis, I will make the statement that when you look at the millions, tens of millions, hundreds of millions of people who have been vaccinated, the relative number of people who suffer serious adverse effects or have had problems is very, very small. And you look at it on a global perspective, vaccines are safe. It's when you get down to the individual, there can be problems. And most people and a lot of the controversy is centering around impacts on individuals or small groups of people. And we'll talk about that. Oh, gosh. We've got them all. Okay, effects of immunization in the United States. And what I have listed here, you don't need to look at all the detail here, but these are the key immunizations, vaccinations that we give our children in the United States. And these are data when you compare the pre-vaccine era to 2005. First of all, notice the trend, they're all sloping down to the right. And if you look at the Y axis, this is a logarithmic scale. So we're going from 10 million cases down to one case. So even for some of these vaccines which don't seem to have a real steep slope, we're still, in some cases, preventing millions of cases of disease or hundreds of thousands of cases of disease. Then you can look at a number of the diseases that have bottomed out in 2005. We no longer have smallpox. We have minimal, only the rarest cases of diphtheria. Polio, endogenous polio no longer occurs in the United States. And we'll talk a little more about that. Measles, endogenously, that is, sustained transmission in the United States, no longer occur. All of that because of vaccines for those respective microorganisms. And all of these diseases have that varying slope to the right. You can look at this in numbers as well for a number of these that show accumulated data of baseline information that was taken from the 20th century, and then compare it to 2001. And all you have to do is compare the numbers. There's been a dramatic impact on a number of these diseases. And, again, a number of these diseases, without vaccine simple hygiene alone would not have had this impact. Now, talking a little more about the successes. The biggest success in history is smallpox. And there's a huge history here you can follow. If you go to the CDC website, you can read a lot about it. It is one of the oldest diseases of mankind. It is one of the most feared. And when you accumulate mortality throughout the period of human history that it was present, few diseases had as much impact. And those who survived often suffered very severe after effects, significant scarring, and like so many infectious diseases, the real target population were the very young on through childhood. And with a mortality rate with 30%, even up in close to the last days that we had smallpox circulating in the world, there are few diseases that were that bad throughout history. We had our last case in the United States in 1949. As I'll point out, we had universal vaccination and looking at the age spectrum in the audience, many of us did have our smallpox vaccine. That was discontinued in 1972 when we were getting very close to eliminating smallpox globally. And it should have been relegated to the textbooks at that point except the concern now, which arose with the concerns of terrorism and specifically bioterrorism, a real concern that there are stocks of smallpox that still exist outside of the hands of secure scientific or government laboratories. So it's out there for us to worry about a little in public health. And obviously now we have many generations, or a number of generations who are totally susceptible to smallpox because we haven't been vaccinating for three or four decades here. In controlling it, and the next slide will show you a great reference if you want to get into the history of what went into this. Key to its control was the vaccine. We had mass vaccination globally, and then as the amount of smallpox was reduced, we backed off on mass vaccination and went more to a search and containment type strategy where certain cases would be identified, you would try to vaccinate that case, contacts of that case, contacts of the contacts. It was called ring vaccination. And this was critical in ultimately eradicating smallpox. The other point was vaccines cannot act alone. As good as they are, you still need other community containment measures. When you're sick, you need to be isolated from the rest of the population, either by yourself or forcefully, so you cannot transmit. If you've been exposed to a disease, you need to be monitored to see if you're going to develop that. And this can be done by keeping you secluded. And this was done throughout the period of smallpox eradication. All outlined in this book. And the reason I put this up here, it's an interesting resource to read about because they really do cover the scientific, the political, the economic of what went on in the latter years of the eradication. As a scientist, as a public health professional, it is also a blueprint for how we will move forward for other diseases that might be candidates for eradication. And there are a number of these. I have a couple lists here. There's a World Health Organization priorities for eradication. I'm going to talk about polio, that's why it's highlighted. But measles and neonatal tetanus is on that list, as well as some other diseases for which we don't have vaccines but because of their ecology and their natural history could potentially lend themselves to being eradicated on a global level. The Carter Center has indicated a number of targets for eradications as recent as 2008. Heading that list, they're acknowledging that we're very close to eradicating polio. Their primary targets now are measles, mumps, and rubella. And we're going to talk a little more about measles. These have been chosen, and I can't go into the detail here, there are certain characteristics of a number of these diseases that really lend themselves to being eradicated. Humans are the only host. They often cause a very identifiable disease. We have a very effective vaccination, and a whole host of other reasons why, like small pox, these might be candidates for eradication. And these are efforts that hopefully we're going to read about as the years go on here. Now the one I wanted to highlight briefly was poliomyelitis, and, again, looking at the age distribution here, many of us remember it. We were either touched by it in our families, remember it, remember friends having it, remember relatives having it, were among some of the firsts to receive the vaccinations and so on. And these are some of the images that I think we became familiar with. The children in the braces and the wheel chair. FDR who actually really led the effort for the ultimately to get the vaccine was that produced by the mid-1950s that brought polio virus under control. And then I think the most incredible image is the iron lung which was, literally, the only way a number of these patients were kept alive. Some of these graphics are taken for, we mentioned that other PBS documentary. There was one in 2009 called the Polio Crusade from the American Experience Series. You can get the DVD. I'm not sure if you can get it online yet, but that is a tremendous hour's history of the vaccine development and how we brought polio under control. And the impact that had on through the '50s during the summer where kids couldn't go to the swimming pools anymore, and during '51 and '52 where we suffered the most significant epidemics in the United States. I'm not going to talk about a lot about polio virus, but basically the main concern with it is its effect in a small number of those who were infected with the virus paralysis, either of the limbs, the legs, the arms, in more severe cases respiratory muscles, gastrointestinal muscles, a rather substantial death rate when you did have paralytic poliomyelitis, and sequelae that could last in the acute illness out for months or years, and then there's elements of that disease in those who were severely affected that can come back many decades later. And there are still people who are coming down with some of those post-polio syndrome symptoms even now, decades after that would have been infected. If you look at poliomyelitis in the United States, we start in 1950, and you start here because this was really the peak when we were seeing paralytic polio. And you see the impact of the vaccine. First the inactivated vaccine and then the live, oral vaccine. A point I didn't make, and it gets back to hygiene, the real irony here is the paralytic disease tended to affect older children and adults, those who were affected later in life, that is as older children and adults, because hygiene got to be so good throughout the 1900s infants didn't get the disease anymore. When young infants, when polio virus was widely circulating and young infants were infected at a very young age, they were, essentially, mostly suffered relatively mild disease, some did go on to suffer paralytic disease but not a very high percentage. Even much less percentage than as you became an older child, on into young and even middle age adulthood. So clearly this was a disease that really emerged as hygiene got better. And without vaccine we would have serious and continued serious issues with polio virus. Interesting with it then, and let me go back to the previous slide, we've started out with an inactivated vaccine. This was a dead vaccine but then there was an oral, live, attenuated vaccine. It was intended to better mimic the disease with a very minimal risk of actually causing severe illness. And when you compared its effects to when we had wild type polio, there really was a very small number of people who suffered severe effects. But by 1980 when we had our last indigenous case, what happened is we were still having cases of polio in the United States but the vast majority of these were actually being caused by the vaccine itself. This attenuated vaccine was reverting to a form that could cause paralytic polio. Now you look at those numbers, there's only ones to tens back compared to when we had 20,000-30,000 cases, hundreds of thousands of cases elsewhere in the world. But since we weren't seeing real polio, this was an unacceptable risk. So by 2000 we stopped using the oral polio vaccine in the United States and currently only use the inactivated form. But there should be zero risk now of getting poliomyelitis indigenously in the US. Although, as I'll point out, there's still issues elsewhere in the world. I put this up there, don't read it. These are immunization schedules. If you're really interested, and we'll talk a little more about this later, on what the vast array of immunizations, of vaccinations that our children get and we get throughout life, go to the CDC website. We'll come back because this is one of the touchy issues here. We are getting a lot of these. And we're getting a lot in a very short time period and we'll explore that. I put this up here only to show you we still continue in the United States to immunize for polio, and actually we're immunizing throughout the world. And the reason is it has not been eradicated. However, if you look at this map, and I'll show the website this comes from because now you can monitor this essentially on a weekly basis as we go down the road to eradication, we currently have four endemic countries. Endemic meaning polio is naturally occurring and transmissible within that country. There's sustained transmission. These countries are Nigeria, Afghanistan, Pakistan and India. The same four countries have kind of been stuck here, suffering hundreds to a thousand, maybe 1500 cases a year. We can't get over that final hump to eradicate the virus in these countries. And then if you look, there's other surrounding countries that are suffering epidemics in cases that are spillover. People who are coming into their country infected with polio virus and then infecting susceptible individuals. That fact that we have what will probably be a long-term war in Afghanistan really makes, in my opinion, fairly remote that we're going to be eradicating it at least in Afghanistan. There's issues in these other countries as well. But the good news in this in 1988 there were 350,000 cases of paralytic polio in the United States. Last year there were 1600 cases. We're on track so far this year to perhaps come under a thousand cases globally. That is an incredible effort and although it's not eradicated, we have made a big dent. The problem is it's still out in the world, the rest of the global population is still at risk because it can come here. So we can't let down our guard and stop vaccinating. And one of the issues has been, look, we have a number of these diseases, I'm going to show you a couple others really quickly here, they're such low level in the US, why are we taking the risk with vaccinations?

The reason is this

because we have it elsewhere in the world and most of the problems that we're having with a number of the vaccine-preventable diseases started with imported cases coming into the US. This is the website, it's the global polio eradication site. And this website's sponsor, there are multiple agencies working on this. WHO, World Health Organization, Centers for Disease Control and Prevention, UNICEF, Rotary International and others. And this is kind of a website dedicated to monitoring the eradication efforts. There's other diseases we've all grown up with that we've had similar success in the United States in bringing under control. I show here pertussis which that vaccine was first made available in 1940 and since then we have been knocking down the number of pertussis cases. Measles, the vaccine came out in 1963, and the number of cases in the US dropped off the table and we've kept them really low. Same with mumps where we had the vaccine in 1967. Now I'm going to come back to these diseases in a few minutes to tell you all isn't rosy with them. We still continue to have outbreaks, and there are reason for that occurring even in the United States. If you look globally, we're having similar success but not to the same magnitude. So if you look at the number of cases of measles, and again these are rough estimates, you can see a downward trend in the number of cases that coincides to the upward trend in the use of vaccines. And then you can see the different countries who have active immunization programs. Those in blue are actively immunizing to a high level for measles. Those in the red and pinks, not so much so. The current global figures, it's estimated around 150,000 to 200,000 deaths. The reported cases are underreported here by a factor of a hundred. Estimates are actually 15 to 20 million cases of measles occurring worldwide. Similar data with pertussis. Whooping cough, which if you saw it, I think a number of you did given your age. I got to see it professionally in unvaccinated children and it's horrible. I got to see it in my family when we lived over seas. It was a modified version. They were vaccinated, they still got it, and it was only a little less horrible. I was pretty certain they weren't going to die, but it is something that went on for weeks that has kind of burned into my mind. When you look, same trend with pertussis throughout the globe, same positive trend in immunization. Same countries not really able to immunize a large part of their population, and there are still a substantial, almost a quarter million or more, deaths due to whooping cough, pertussis, throughout the world. And, again, the number of cases is underreported by about a factor of a hundred here. So that's a good news/bad news thing. We're making progress globally, but there is a lot of measles out there, there's a lot of pertussis. I didn't show you the data for mumps, there's even more mumps out there. And any of those diseases can be brought to the US. Well this kind of segues now into talking about some of the challenges and controversies. Hopefully to this point you're buying on somewhat that vaccines have been a tremendous public health benefit. They will continue to do so as they're used more and more globally. But there definitely are challenges and controversies, and a large number of these really are focused in the developing countries. When you look at infectious diseases, the threat is a global one. I showed you some of the figures for pertussis and measles. But if you look at infectious disease percent of mortality, these data are about four or five years old, there's roughly, and these are all underestimates, 15-20 million people die of infectious disease, minimum, globally. And again, that's a pretty substantial underestimate. That's almost a quarter, 20%-25% of total mortality. You look at the diseases, I think a number of these are familiar to everybody. HIV/AIDS, tuberculosis, a variety of respiratory illnesses, gastroenteritis, malaria and so on. On the right hand side, as has occurred throughout history, is we recognize in the United States at the turn of the last century the primary target and the highest morbidity, highest mortality, highest of incidence of the disease occurs in young to school-aged children. This is globally, this has been the case and still remains the case in the United States. And they bear a large burden of the mortality rate here throughout the world. I show this map. If you compare this with the ones I showed with measles and pertussis. The biggest issues right now are in the developing world. And this is based on gross domestic product, an economic indicator, and the biggest issues right now are in sub-Saharan Africa and throughout much of Africa and also areas throughout Southeast Asia, India, Pakistan, and so on. What I failed to point out on the measles, and it doesn't show up here, even in the developing countries there are resurgences of a number of the key vaccine preventable diseases, most notable, measles, also pertussis, directly linked because over the last several years people have been failing to immunize their children. So the major problems in the developing countries, the emerging problem is us sliding backwards in the developed countries. Another challenging controversy, most of you don't have handouts, but it's quiz time. There should be some diseases, really conspicuous because I haven't talked about them, they haven't showed up on any of our lists. Does anybody have an idea of what? There are three, the big three. Hazard a guess? >> Heart disease? >>

Shult

Infectious diseases, I'm sorry. >> Bubonic plague? >> No, actually fairly low down. >> Malaria. >> One. One of the big three. Two others? I'll give it. Tuberculosis, HIV/AIDS. We have no vaccine, why is that? Well first of all just to show you, these next three slides go through really quickly, and you can get more information on site here, but when you look at tuberculosis a full third of the global population is infected with tuberculosis. There are millions of cases here. The biggest threat now, although we have tuberculosis throughout the world, we have less of it in the developed countries, although we still have cases here, the biggest concern now are the multidrug-resistant strains coming and the extremely drug-resistant strains. And a number of these have made the news over the last years. So TB is the single highest incident infectious disease, or highest prevalent in any given time. A third of the global population is infected. Malaria and this is the area and malaria is a mosquito-born disease so its range is going to be dictated by where the particular mosquito resides, and through areas of South America and Africa and on an annual basis 300 to 900 million cases of malaria and probably right now current estimates over a million children die each year from malaria. We don't have a vaccine but there are a lot of other efforts to try to attack the mosquito populations. Put something between the humans and the mosquitoes, bed nets, cover up windows and so on. But even that's run into problems because with the wholesale use of insecticides and so on have met a lot of pressure from environmental groups and their environmental concerns. Right now, attacking the mosquito is the only realistic way we can kind of stem this. And then finally, HIV/AIDS and this is really our biggest and scariest global pandemic now. Throughout the world millions are affected. There are two million deaths, again underestimate, globally. The question is, why no vaccine? I could spend several lectures on this but there are a lot of reasons, it's not for want of trying. There are huge research efforts. But unlike a lot of the other organisms we've talked about, the organisms that cause these three diseases are extraordinarily complex in their makeup. They have many targets that your immune response has to deal with. They have very complicated ways they cause disease. And they have very cleaver ways, they hang out in your body sort of hiding from your immune response or constantly changing to stay a step ahead of the immune response. And then the immune response to these organisms is so complex no one has found the right recipe. What's that one target to get that can prevent that disease. And the efforts have been going on for decades here and likely will continue. And there are a variety, a number of other more common viral diseases and so on that we also don't have vaccines for, and bacterial diseases, all for, basically, the same reasons. And then I show this slide. Is this a reason for optimism or not? When you look out to 2030 here, when you look at the infectious diseases, you see the big three. And although we're on a very gentle downward slope, when you add up the projected mortality and then throw in some of the acute respiratory infections, which influenza is a significant one and a number of the childhood respiratory viral illnesses, they're projecting millions of people will still be dying from these illnesses for which we do not have a vaccine. These projections seem to indicate and the text that goes along with it, the feeling is it's not a strong likelihood we're going to have these vaccines. Vaccines are not perfect. I've already mentioned there are side effects to a number of these, and we'll talk a little about that in a few minutes. But we've had recent outbreaks of whooping cough in Wisconsin. The biggest outbreak in a number of years occurred in the United States. Largest outbreak in a number of years occurred in 2003-2005. When this was analyzed, when all was said and done, the main issues were, and we knew this for some time, the immunity following the vaccine, and the natural infection for that matter, is not long lasting. And we know there's a low prevalence of this disease circulating all the time. And we've been unable to, up until recently, revaccinate people because the vaccine was too toxic in older children and adults. They've developed a new vaccine now, the T-DAP. It's recommended we all get it if we haven't had it, particularly those of us who have children, who have grandchildren. It's the very young who are at greatest risk for whooping cough so we need to be protecting them. We had a major mumps outbreak in 2006. Heavily affecting the Midwest. And a much older age group than we were used to. What was curious, or it looked curious at the time, until once this study has been looked at or this outbreak has been looked at in some detail, again multiple factors in reemergence. Going to the bottom one, just like with mumps and I'm going to mention with measles, there's a worldwide reservoir of these bugs. So they're going to keep coming into our country until they're eradicated. With mumps, even two vaccines, it's a pretty good vaccine, but even when you get the two doses of vaccine, it only has 90% effectiveness. There are still people who are susceptible. And over time you accumulate these people who are susceptible, and when you crowd them together in college dorms or in a daycare setting or in a family setting, you're going to have outbreaks of mumps. And that's what happened in 2006. There's a big outbreak going on in the eastern United States now in New York and a region of New Jersey. Measles, and this is the scary one, measles, hands down, it's responsible for 40% of the mortality of all vaccine-preventable diseases in children. This is a nasty disease. Many of us, in fact, did suffer it through childhood. I had my bout with it. And it can be a life threatening disease, and a large number of people have severe after effects. A large number are hospitalized. We had a big outbreak in 2008. Again, Wisconsin was heavily involved with that. There's currently a big outbreak going on, or substantial outbreak, in Vancouver. Viruses were introduced during the Olympics, and now it is going through the population. The problem is, and if you look at the 2008 outbreak, we've been having these imported cases for some time, and we know, occasionally, these will get in fine susceptibles in the population and transmit to those individuals. In 2008, the vast majority of the cases were in children just in the normal community setting, in daycares, in school setting. What happens, these were imported cases that got loose in the community, and of those who have been studied, the real disturbing trend here is almost 70% of those who ended up coming down with measles, did not have the vaccine. The parents had chosen not to vaccinate them. And this is a trend that's being repeated over and over throughout areas of western Europe, Japan, much of the developed country. And, again, that's just highlighted on here. And measles is the biggest concern because it is such a very serious disease when it does emerge. So that's the natural segue into the last thing I want to go through here and that's people choosing not to be vaccinated or not vaccinating their children. And, obviously, this is where a lot of the controversy arises. Now, the opening statement I want to make, and you can find these statistics at the CDC. In the US the overall vaccination rates across the whole spectrum of vaccines children get is very, very high. For the key ones, DPT, diphtheria, pertussis, tetanus, measles, mumps, rubella, polio virus, it's over 90%. Excellent vaccination rate. When you get to the teens, the vaccines they're supposed to be getting and then the ones the adults are supposed to be getting, the rates of vaccination drop off the table. So we're just ignoring the older age groups here, but then that's kind of always been the case. So the good news is we have, generally, good vaccine coverage. The bad news is we're getting these groupings of the population who are choosing not to be vaccinated. And it's a particular concern with measles. And it was interesting for me, and I do a lot of work with influenza, the public early on about a year ago should have been scared to death about the emergence of 2009 H1N1. We were not only not scared to death, when we did get the vaccine in a far quicker time than anybody could imagine or plan for, only 20%-25% of the population has bothered to get immunized. So that's telling you a lot of things are going on here as far as our perception of vaccine. And this is what I want to talk to here, and just lay out the issues here rather quickly. And as we get near question and answer, if you want to weigh in on some of these we'd be glad to do it. First and foremost, the biggest issue is safety issues. I've characterized these, and I tell you I'm bending over backwards here to be correct and not to have missiles thrown at me. There are proven safety issues and I've already said some of these have side effects and I'll review some of the issues there have been with some vaccines. And I'm going to characterize other ones as unproven and debatable for this. I think the bigger core, and I would rework this slide if I had to do it all over, is the core problem, my opinion I think and public health opinion, vaccines have been so successful that we find ourselves today faced with a dangerous situation where we really have minimized the importance of vaccines. We don't see a lot of these diseases anymore and we have generations of parents who never will. A number of us, in fact, either suffered the disease or saw the disease in our children. Apart from those of us who deal with this professionally. We're losing the memory and the firsthand experience with a number of diseases. And I think that provides a backdrop for a lot of these issues which I suspect would not be issues a number of years ago. We do have lots of vaccines. There's a real issue here, are we getting the right information out to the public. I'll make a couple comments on that in a minute. And there's some of these others that I'll wrap up with in a few minutes. Great site for safety, again, is CDC website. Vaccine safety is obviously the elephant in the room here. There are definite safety issues with some vaccines, and I'll mention this in a second, but again from a risk benefit standpoint impact of vaccines on the population, overwhelmingly positive here. The question is, I don't know how much real realistic scientifically valid safety information people get about vaccines. Or I do know they don't get very much. There is an incredible infrastructure in place, and has been for the last two decades, to ensure the safety of vaccine from its development, and the development process can be years if not the better part of a decade, through FDA approval and it continues even after licensure with ongoing surveillance for adverse effects. And when these are identified, setting up studies to see if this is a real effect of the vaccine and what can be done about it. This is all outlined at the CDC website. Time doesn't allow me to go into this, but it is not appreciated, I think, how fully and carefully all along the way the whole vaccine development and use process is monitored and checked for safety. There have been past and recent safety related events. One of the most notable occurred in the earliest days of the polio vaccine where, and this was due more to the technology at the time, a lot of vaccine which was supposed to be inactivated was not inactivated and an actual live virus was given to thousands of children, hundreds of whom came down with paralytic disease. Despite that event, because it was early enough in the vaccine program, within eight to 10 days, they resumed vaccination and brought polio under control. A number of more recent events have occurred with vaccines for rotavirus, which is the leading cause of infantile gastroenteritis, it was in this country until we started using the vaccine, and is the leading cause globally. This is the website that brought this, again, to the forefront. There have been a number of television shows related, countless websites and documents on the side of vaccine, against vaccine, and everywhere in between. I put that one up there just because, mainly, it was the most recent, I reviewed it, I think the biggest complaint, not only does it address the controversy, it generated controversy about the controversy because the main complaint was it didn't give a balanced view. As I read it, the fact is it didn't. It really didn't. And the counter argument from a number of people in public health was a lot of the issues that were raised frankly don't need a balanced view. I don't agree with that approach. I'm a public health person and I'm 100% behind the vaccine and I don't believe a lot of the concerns or I'm convinced a lot of the concerns that have been stated aren't real concerns, and I think there's plenty of science to indicate that. But I think there has to be an effort to continue to provide balance and dialogue to talk these things through. Because the outcome in public health, letting it just slide, is we still got a public health problem here that we're going to have to start dealing with and we got to continue talking about this. Biggest issues, thimerosal in autism and MMR, measles, mumps, rubella, and autism. I just put these up here, I'm not going to talk about these. There are rafts of literature at any of the websites I gave you, and you can follow any string to get the detail. I will summarize it by saying in the scientific community, and in the legal community, the controversy has been laid to rest. The people who still believe there is the linkage, it hasn't been laid to rest. Although I got to say there is an overwhelming amount of scientific data, epidemiologic studies that simply do not support the link here between either the measles, mumps, rubella vaccine and autism or thimerosal. But there are a lot of other issues. Even if those had been laid to rest, and I don't think they have, there are a number of other issues here as well, and a lot of these are articulated in that documentary. Are we giving too many vaccines too early? And that argument will be made. And if you start talking to the immunologists and the microbiologists, the amount of antigen, that is that part of a microorganism or what we put in as a vaccine that we mount our immune response to, the amount given in most of those vaccines pales to what we are exposed to naturally from the minute the child goes through the birth canal and eats their first food, either whether it comes from the mother or their first hard food, we are absolutely swarmed with things that are foreign to our bodies. So the immune system is active all of the time. That is the argument against. Too many vaccines given at the same time. Many more vaccines need to be thoroughly studied. And there are a lot of them. 14 are currently given to the children. A stated need to look at some of the other additives. Then there's other issues here. One's a parental choice and this raises its own kind of interesting argument. Do you have the right to refuse vaccination for your child knowing you have an impact on the society's herd immunity? And that's a fun one to fight with because the individual, the protective mother, is going to say I'm worrying about my kid. Public health is going to say you got to be worrying about the entire community because we're protecting each other given our immune status. And then, at the extreme, and I'm pretty sure this is kind of a minority view, vaccines are produced purely for corporate benefit. I just want to show this slide. This gives you a visual determination that within these early age groups here there is no doubt children get a lot of vaccines on a very condensed timeframe. I'm trying to find my cursor here. So this is the typical time where you're giving most of the vaccines. These are all the vaccines that are being given. And those of us who are parents who gone through repeatedly for that two, four and six month, there's no doubt they get a lot of them. They get as many as five at a time. And this practice has been called into question. They cost a lot of money. Although I'm not sure there are a lot of safety nets, both through private provider, through the federal government, through the state government to make sure vaccines are covered. The one that has struck me, and I throw it out there, and this is what I really like to debate is scientific resources versus social media. Where are we getting our information? My particular favorite is influenza and this is a list, I've given talks for influenza for 20 years, talk about the vaccination, and these are a short list of issues that are raised why we don't get our influenza vaccine and only about 25%-30% of the population does, in a good year. We only vaccinate 70% of the elderly, 35,000 of whom die every year from seasonal influenza. So to me that's disgraceful. But these are arguments. You can debate and you're going to believe what you're going to believe here. But it's an issue out there that needs to be dealt with. Finally, the last thing I want to talk about here is one other thing is the ethic issue here, and this is a whole other realm. Our most recent vaccine is the human papillomavirus, which is interesting over the last couple decades certain subtypes of human papilloma have been linked to essentially 100% of cervical carcinomas in females. It is caused by a virus. It is caused by a virus that we now have a vaccine for. But the effective time to give this vaccine to prevent the infection that can lead to the cancer is when the individual is as young as nine years of age. Nine to 13 or 14. And I'll tell you as a parent I'm public health guy, that one hit you as well. You want to do discuss something controversial, this is it. And now we have the vaccine has been approved for boys as well so they can do their part here. So there's going to be no end. I put this up there not only to inform you that's out there, but there are going to be other vaccines and other public health interventions for a number of the other sexually transmitted diseases. And we're going to have to deal with that given the young age that our children are becoming sexually active. And for those of us as parents, or depending on your religious beliefs and so on it's going to be quite a balance for what the public health needs have to be. So I want to end on this slide then. I've gone over, hopefully I've convinced, on a global scale and a historical scale, I find it hard to argue against the value of vaccines. I don't know who could. That's my personal view. But there are issues here related to safety, related to the ethics, related to should I be commanded to take my vaccine, what role, what say do I have in this? I put this up here. I don't hear anybody or at least only a very small group of people saying do away with all vaccines. I think a lot of people are saying we need to re-look at some of this. I'm saying we've looked at a lot of these things, people want more data here. In any event, they're going to need to be the dialogue. I don't know how much of that will happen after the meeting here. That starts getting into heavy ethical issues and way heavy scientific issues that go beyond my hands-on knowledge here. But I want to end pointing out that vaccines are a good thing but to reap and continue to reap the full benefit, we've got to confront some of these problems so we don't continue to slide back like we're doing in parts of the world now for measles and some of the other vaccine preventable diseases. So with that, I'll stop. Thank you for your attention and I will handle questions. ( applause )