Dr. Alan Hinman

Dr. Alan Hinman

KAREN TORGHELE: It is June 27, 2016, and I'm here with Dr. Alan Hinman, who is currently with the Task Force for Global Health, where he is director for programs in the Center for Vaccine Equity. Thank you for coming, Dr. Hinman.

ALAN HINMAN: Thank you, Karen.

TORGHELE: I am Karen Torghele, and I'll be talking with Dr. Hinman about the role of polio in the history of the Centers for Disease Control and Prevention [CDC] for the Global Health Chronicles Oral History Project. To begin, Dr. Hinman, would you tell us a little bit about your background before you came to CDC [Centers for Disease Control and Prevention]?

HINMAN: I went to Cornell University as an undergraduate, and then to Western Reserve University in Cleveland to medical school. I entered medical school in 1957. I graduated in 1961, just about the time that the oral polio vaccine was being introduced. I was in medical school and in clinical training at a time when we were still seeing cases of polio. At the hospital where I trained, 00:01:00Cleveland Metropolitan General Hospital, it was a center for northeastern Ohio for patients who needed to be put into iron lungs, respirators. I had a chance to see a number of patients in iron lungs, and I can describe those briefly if you'd like.

What they are, basically, is large metal cans with a diaphragm at one end attached to a plunger. The other end has a lid that can be removed, and it has in the center a hole where the patient's head comes through. The patient's neck was then swathed in a towel, so that it was in essence an airtight seal. When this was closed, the plunger at the bottom would pull back, and it would create negative pressure inside the can. And that would cause the patient's lungs to 00:02:00expand, bringing air into the lungs, and then the plunger would come forward and create positive pressure, which would collapse the lungs and air would go out.

This was a way of life for some patients. Some patients were fortunate in that they didn't have paralysis that prevented their breathing. Others had bulbar paralysis: inability to breathe only for a short time. Others spent years in iron lungs, and it was a really tremendous issue. Just imagine lying in a can for twenty-five years and being deathly afraid that the power might go off, because if the power went off the respirator would cease to function, and so might you. Now of course hospitals had emergency generators, but still, thunderstorms were a matter of great concern for people in iron lungs.

TORGHELE: Could they ever come out of those iron lungs?

HINMAN: Many people did. And the clinical pattern of polio is that you may have 00:03:00fairly severe paralysis and much of it may resolve over the course of several weeks or months. But then we have discovered recently, in the last thirty, forty years, that sometimes after many, many years, people will begin to have the same symptoms of weakness that they had when they had acute polio. That's called post-polio syndrome, and it probably represents weakening of the muscles that somehow got pulled in to reinforce the weakness that had been caused by the polio damage.

TORGHELE: So you, as a physician during that time, would be able to diagnose a new polio case, but a lot of physicians now wouldn't know how to do that.

HINMAN: We could diagnose that someone had a fever and acute or floppy 00:04:00paralysis. At the time, that was likely going to be due to polio. There are other causes, but when polio is in the community, that may be the most likely cause. But we depended also on laboratory tests to make the diagnosis.

TORGHELE: That gets us to the time that you were at Centers for Disease Control. And I wondered if you could tell us how you came to choose to be there, and how that worked for you?

HINMAN: I trained in internal medicine and infectious diseases, and my career plan was to be a hospital infectious disease doc. But there was something called Selective Service Act, or the draft, and when I graduated medical school in 1961 there was a very good chance that after my internship I would be drafted and be 00:05:00a general medical officer somewhere, taking care of gonorrhea and diarrhea and possibly gunshot wounds, including a year in Vietnam. Alternatively, you could apply for a deferment to complete your clinical training, but you had an absolute obligation then to go into the service for two years, but you'd go in as a specialist.

So I applied for a deferment to complete my training in internal medicine and infectious diseases, and I applied to the U.S. Public Health Service to the NIH [National Institutes of Health], which is what I think everybody did in 1961, with my second choice being the Communicable Disease Center or CDC, since, after all, I was going into infectious diseases. I got a letter back in the mail telling me that I was now a member of the Epidemic Intelligence Service [EIS], of which I had never heard. I came to Atlanta to the EIS course expecting to do 00:06:00my two years' government service and then to go back and be a hospital infectious disease doc for the rest of my career.

I got sent to the California State Department of Health, and it was the most incredible experience you can imagine. The day I arrived, I walked into the office in the morning, in the afternoon I drove out in a state car to Madera, a city in the Central Valley, with about fifteen thousand people, where one out of every six people had gastroenteritis, what they called "the don't knows." You don't know which end to put on the pot. It developed that this was caused by a gopher digging a tunnel that connected a field that was irrigated with partially treated sewage, it was called a sewage farm, to a pit where the housing, there was a housing for one of the fourteen wells, that provided water to the 00:07:00community. The water was not chlorinated because it was deep well water, virgin water. Most public water supplies in California at that time were not chlorinated, never mind fluoridated. They weren't chlorinated, and someone had removed the top of a sounding tube to check the water level in the well and had neglected to put the top back on. As a result, when this partially treated sewage flowed into the pit, it then rose up, got above the level of the end of the tube, and was sucked down into the well, spreading sewage mixed with water into the public water supply.

That was a really fascinating introduction to public health. In fairly rapid succession, I investigated California's first case of human plague in fifteen 00:08:00years and two cases of botulism associated with home-canned tuna, an outbreak of meningococcal disease at an institution for the retarded, an outbreak of tuberculosis, and I spent about five weeks in Honduras investigating a polio outbreak and helping organize a nationwide polio vaccination campaign. Well, this is just such an incredible experience. How could anyone ever think of leaving that? So, I never did leave it. Fifty-one years later, here I am.

TORGHELE: Can you talk a little bit more about that outbreak of polio in Honduras?

HINMAN: Well, at the time, Honduras was not using polio vaccine. This was 1965. Oral polio vaccine had been introduced in 1961, but many countries in the developing world were not yet using it. It was sort of a typical kind of polio 00:09:00outbreak. There were, I think, in total about two hundred cases. I don't remember many of the precise details. I remember trying to get characteristics of age, sex, et cetera, degree of paralysis, but cases were occurring all over the country, it wasn't concentrated just in one place.

I also remember riding in a Huey helicopter delivering polio vaccine to different communities around the country, which for someone who is afraid of heights is not a particularly pleasant experience, because, I don't know if you remember what the Huey helicopters looked like that were being used in Vietnam, but they had a big open door and just a strap across the door. I was the only thing that was in the hull part, except for polio vaccine. I was holding on very tight. Honduras is mountainous country, and so you'd clear the top of mountain 00:10:00and then all of a sudden you'd be three thousand feet above the valley. It was an experience.

TORGHELE: You speak Spanish too, so you were able to communicate with the pilot.

HINMAN: Yes, well except that I didn't have any microphone connection.

TORGHELE: So he couldn't hear you?

HINMAN: No. What's to talk about?

TORGHELE: I'm assuming you were well-received. I don't know if that's always the case with the EIS officers.

HINMAN: As it happened, I wasn't there by myself. We had in my EIS class a physician epidemiologist from Argentina, and he and I went together. And fortunately, I'm fluent in Spanish, so it wasn't as big a shock as it might have been if someone showed up who didn't speak any Spanish. I had no issues of 00:11:00acceptance. The people in Honduras and the Ministry of Health were really very welcoming and cooperative, and I think we were able to provide some help to them.

TORGHELE: As far as the mechanism for how you got from CDC to Honduras, how does that work? Does the Ministry of Health request help from the U.S. and they refer you?

HINMAN: I believe the Ministry requested help from the Pan-American Health Organization, PAHO, and then PAHO in turn passed the request on to CDC. I was in Berkeley, California, not in Atlanta, but it was known that I spoke Spanish, and so they determined that I was a likely person to send. I flew from San Francisco to Washington to get an official passport and meet people at PAHO, and then down 00:12:00to Atlanta, and then from Atlanta to Tegucigalpa. I still remember, in trying to make plane reservations for this trip, having to spell "Tegucigalpa" for the person at the airline.

TORGHELE: When you started your EIS two years, you had some training, is that right, beforehand?

HINMAN: Yes. The EIS course at that time was about six weeks long, divided pretty much into epidemiology in the morning and biostatistics in the afternoon. Alex Langmuir gave almost all the lectures in epidemiology and led the epidemic investigation case problems, which were one of the main ways of teaching us to learn how to analyze data, how to categorize things, develop epidemic curves, that kind of thing. The statistics was taught in large measure by Robert 00:13:00Serfling, who was a statistician, and Virgil Peavy, who was another statistician. And Virgil was a really good teacher. He could make statistics tolerable and possibly even interesting, which is a tall order, quite frankly, for many of us. Virgil was a good old boy from Georgia and had been a lineman, I believe, at the University of Georgia, and was at CDC for more than thirty years and really a stalwart of training in statistics. He was organizationally housed in the training parts of CDC. There have been an awful lot of people exposed to Virgil Peavy in learning statistics, and I think every one of them remembers him fondly.

TORGHELE: And how was Alex Langmuir as a teacher?

HINMAN: He was effective. He was egocentric with some biases. Alex had done a lot, and so he could talk about things in the first person. And he did use "I" a fair amount when he spoke, but he also was clearly talking about something he knew about and felt strongly about. He had a really good picture, I think, of the context of events.

EIS is called the Epidemic Intelligence Service for a reason. It was, at the time, it was during the Cold War, and there was concern about the possibility of biological warfare. And part of the basis for approving the Epidemic Intelligence Service was to have trained epidemiologists around the country who 00:15:00might be able to recognize or suspect that some biological or chemical event was about to happen. The word "intelligence" was consciously, I think, put into the title of the entity.

TORGHELE: So he used that very effectively, it sounds like.

HINMAN: Yes. Alex also was effective in other ways. There was, at the time the EIS was formed, there was some competition between the National Institutes of Health and CDC. If a health department called CDC and said--We have a problem and we'd like some assistance, Alex would say, Okay, well, let me check with folks at NIH and see if they'd like to get involved in it. So he'd call NIH, and they, of course, were dealing primarily with planned research and protocols, and 00:16:00not really set up for reactive investigations. So they would say-- Well, why don't you go ahead.

The CDC and the EIS became, then, the go-to place for investigations. When MMWR was transferred from Washington to CDC, they began publishing notes about outbreaks and the occurrence of various issues in the country. Before that time, MMWR had been essentially a statistical compilation. But by putting text in and making it more meaningful, MMWR became a much, much more powerful entity, and remains one of CDC's main ways of communicating to the outside world.

TORGHELE: Remind us what MMWR stands for.

HINMAN: Morbidity and Mortality Weekly Report. I had the pleasure of serving as 00:17:00acting editor of MMWR for about three months in 1969.

TORGHELE: That must have been an interesting job.

HINMAN: It was a little nerve-racking. It's become, I think, much more nerve-racking now, as public health issues are much more in the public's mind.

TORGHELE: After your two EIS years, what did you do?

HINMAN: We decided we wanted to go overseas, so after a year in California, transferred to the Malaria Eradication Program, which had recently been transferred to CDC from USAID [United States Agency for International Development],and came back to Atlanta for training in malaria and malaria eradication before being posted to El Salvador, where I was charged with evaluating progress in malaria eradication programs in a number of countries in 00:18:00Central America and Brazil, Paraguay, Haiti and Ecuador. I spent about a year and a half in El Salvador doing that. The office got closed because of budgetary constraints, and I was fortunate that CDC agreed to sponsor me to get my MPH [Masters of Public Health], so I went to Harvard in 1967-'68, excuse me, '68-'69,and then came back to Atlanta in 1969, working in the viral diseases branch with Mike Gregg, who was the chief of the branch at the time. I spent a little over a year doing that and then I was offered the possibility of being state epidemiologist in New York. So I resigned my commission and moved to Albany, where we spent five years. Then, after a year or so as state 00:19:00epidemiologist, I was made assistant commissioner for preventive services, and that included maternal and child health, family planning, TB [tuberculosis], and nutrition.

After five years in New York, went to Tennessee, to the State Health Department, where I had much the same kind of position, in addition to which I had responsibility for the state public health lab. Then I got offered the position as director of the immunization division in 1977. Came to CDC, where I spent the next nineteen years.

TORGHELE: Tell us a little bit about the Immunization Division, how that came to be, and what was it like when you first started?

HINMAN: The Immunization Division started as an immunization activity in 1964, I believe, as a result of the passage of the Vaccination Assistance Act of 1963, 00:20:00which established a federal role in supporting state and local health departments in providing vaccines. It started as a fairly small activity, and I came in 1977 as the third director. It had been previously directed by Bob Shackleton, who was director for several years, and then John Witte, whom I succeeded. When I arrived, the division had about twenty-seven employees. The total budget for the program, including grants to states and purchase of vaccines, was thirteen and a half million dollars. Today, the National Center for Immunization and Respiratory Diseases has about four hundred employees and a budget of two or three billions of dollars, largely because of the Vaccines for 00:21:00Children Program. So it's grown a lot. When I left in 1987, the division had grown to perhaps a hundred people, but it's certainly undergone a major expansion, and the number of vaccines that are being dealt with has grown greatly. When I went in 1977, we were dealing with diphtheria, pertussis, tetanus, measles, mumps, rubella, and polio. We've since added another eight or so vaccines to the schedule.

TORGHELE: Now we're going to talk a little bit more specifically about polio. During this time and during the time in the '60s when you first came to CDC, CDC must have been continuing to do some work with polio. Can you talk a little bit 00:22:00about that? Were there acute outbreaks, for instance, and what was CDC's involvement? And how did they get involved?

HINMAN: CDC has been involved in polio since before Sabin oral polio vaccine was introduced in 1961. CDC had been involved in polio. I don't know to what extent until the time of the Cutter incident in 1955, when, just after the Salk inactivated polio vaccine had been introduced, it became apparent that some of the children who had received the vaccine, which was supposed to be a killed polio virus injected, developed paralysis, often in the limb where they had received the injection. Some of them had close family members who also developed paralysis, typical polio.

This created a major, major concern, and involved then rapid response from CDC 00:23:00and the Epidemic Intelligence Service. I think every EIS officer on duty at the time was involved in the investigation. Within about six weeks, they were able to determine how many cases of vaccine-induced paralysis there were, or contact spread, and the fact that all of these cases occurred in people who had received a vaccine from a particular laboratory, particular manufacturer. Further investigation at the manufacturer then revealed that the steps they had taken to inactivate the virus in the vaccine were not adequate. The way the Salk or inactivated polio vaccine was made was to grow wild polio virus in the laboratory, then inactivate it, typically with formaldehyde, and then inject it. 00:24:00And there was a part of the inactivation process at the Cutter laboratories that didn't necessarily get to every virus. I think it was an issue of filtration, so that some of the vaccine had living wild poliovirus in it.

The result of the investigation was that within, as I say, about six weeks, as I recall, the government was able to reassure the American public that polio vaccination was safe. It had been already shown to be effective, and that by removing this one vaccine from the market the problem could be taken care of. In many ways, I think that made the name of the Epidemic Intelligence Service, and I think made CDC, the Communicable Disease Center, much more a matter on people's consciousness.

TORGHELE: The Cutter Incident, did that affect the immunization rates after that?

HINMAN: At the time, the Federal Government was not really providing any assistance or any vaccines or vaccinations to states. There was, when the Salk vaccine was initially launched, there was a one-time purchase of polio vaccine for use in outbreak settings, but the Federal Government at that point had no formal role in immunization programs. They were deemed to be matters of state and local health departments and the private sector. It wasn't until the Vaccination Assistance Act of 1963 that the Federal Government got into the business of providing vaccines to state and local health departments. And polio vaccine was one of those vaccines.

TORGHELE: Was CDC involved at all in evaluating the vaccines themselves for safety?

HINMAN: Post-licensure, yes. The Food and Drug Administration [FDA] has the legal responsibility for assessing the safety and efficacy of vaccines. As part of the process of licensure, there are large-scale field trials, which look for adverse events associated with vaccines. And with the Salk vaccine, the Francis Field trials, they were called, were one of the largest clinical trials ever carried out, with, I think, a few hundred thousand schoolchildren in the United States involved in the trials. The Sabin oral vaccine was tested in, I think, a few million children, primarily in Russia, but also in the U.S.

After a vaccine is licensed and in use, then CDC has an important role in monitoring safety. And it was in that light, I think, that in about 1963 it became apparent that there were rare occasions when people who received the oral polio vaccine developed paralysis, or people who were close contacts of theirs developed paralysis. This is called vaccine-associated paralytic polio. CDC was heavily involved in investigating. This issue remained heavily involved throughout the course of the use of oral polio vaccine in this country.

It developed that vaccine-associated paralytic polio occurred about once for every six hundred thousand first doses of oral polio vaccine administered. Almost all cases of vaccine-associated paralysis occurred associated with the 00:28:00first dose of the vaccine.

TORGHELE: A lot of people are interested in Jonas Salk and Albert Sabin and what they were like as people. Did you happen to know either of them?

HINMAN: I met both of them on several occasions. They were brilliant people, obviously. They had quite different personalities, also. I think Jonas Salk was much more, perhaps, introverted. He also I think, was viewed by many people in the field as not being a great collaborator, and he was criticized for publishing many papers with only his own name on it. Albert Sabin, on the other 00:29:00hand, was I think, a more collaborative person. Most of his papers had multiple authors.

They had a fundamental difference in their approach to immunization. Albert Sabin believed in attenuated live virus vaccines, whereas Jonas Salk believed very much in killed inactivated virus vaccines. This was reflected in the vaccines they developed, and they remained in competition, I think throughout their lives. They didn't appear together very often. I remember one time in, I think 1985, when at the Pan American Health Organization there was a discussion about the possibility of global polio eradication, and Albert Sabin and Jonas Salk were seated in the same row, with Alex Langmuir in between as sort of a 00:30:00buffer. Each stated that polio could be eradicated, but they had different views as to which vaccine should be used to do so.

TORGHELE: That must have been interesting to have them there together presenting their points of view, and having them differ so much.

HINMAN: They didn't speak a lot at that meeting, actually, but other people were speaking. They were, as I say, they were both brilliant, and Albert Sabin continued active in the vaccine area, essentially until the end of his life, I believe. I remember in the early '80s getting a call from Dr. Sabin, who happened to be visiting the Pan American Health Organization, and he had just 00:31:00learned that the Dominican Republic was going to carry out a mass campaign using DTP [diphtheria, pertussis, and tetanus] vaccine. At the time, there was a lot of discussion and debate as to whether DTP vaccine was associated with serious adverse events. So Dr. Sabin called and said--you've got to take advantage of this opportunity when they're doing a mass campaign with DTP to look at the likelihood of adverse events. While it wasn't his primary field of interest, it was an indication of his level of intellectual curiosity.

TORGHELE: It must have been a thrill to get a call from him.

HINMAN: Yeah. I had the pleasure also of interviewing both of them as part of a Delphi exercise on safety and efficacy of polio vaccines. They were really 00:32:00interesting characters.

TORGHELE: Sounds like they were. How was the decision made to use either the killed vaccine or the live attenuated vaccine, and when did that happen in relation to the other?

HINMAN: In 1955, inactivated polio vaccine was licensed, and was greeted with delirious joy because we were having, at the time, annual epidemics of polio in the United States. In 1952, we had more than twenty thousand cases of paralytic polio in this country in one year. Everybody knew someone who had had polio or had someone in their family who had had polio. Of course we had had, ten years before, a president who was afflicted with polio as an adult. The arrival of Salk's vaccine was a matter of headlines, and I think a ticker tape parade in 00:33:00New York City, even. The Cutter incident put somewhat of a damper on that, but then after that got thoroughly investigated, people went back to using IPV [inactivated polio vaccine] and the rates of polio in this country dropped dramatically. However, there continued to be outbreaks of polio, including in some areas where vaccination rates were fairly high. This was a result of one of the characteristics of the inactivated vaccine. The inactivated vaccine is given by injection. It induces protection for the individual who received the vaccine, and it's very good protection. If you're vaccinated, you've had a course of IPV, the likelihood of your developing polio, even when exposed to the virus, is very, very, very low.

However, there were still some cases occurring, and when the Sabin live 00:34:00attenuated vaccine, the oral polio vaccine, was introduced, it fairly quickly became the vaccine of choice in this country, and there were a few reasons for it. One of them is that it's easy to give. You don't have to know how to give an injection. You don't have to have a needle and syringe. If you can count to two, you can administer oral polio vaccine. The second is that as a live virus vaccine, when you swallow it, it actually multiplies in your gut. It sets up an infection with this attenuated virus, and this leads to the induction of mucosal or intestinal immunity, which then means that if you're exposed subsequently to poliovirus, it won't multiply in your gut, you won't be a part of transmission. 00:35:00It provides excellent protection to the individual, but because it multiplies in the gut, it's excreted in the stool and then passed on to people in close proximity. So there is also a community protection effect from the oral polio vaccine that you don't get from inactivated. So for those reasons, in the U.S. we fairly quickly switched from IPV to OPV [oral poliovirus vaccine]. Around the world, OPV quickly became the primary vaccine used. IPV was the only vaccine used in some Northern European countries, and many of them were able to get rid of polio entirely because they had such high immunization levels.

TORGHELE: Who makes the decision? How does that happen?

HINMAN: In the U.S., we have something called the Advisory Committee on 00:36:00Immunization Practices [ACIP], which was established in 1963 or '64. It is a body of fifteen members who are not government employees; they are independent experts representing expertise in infectious diseases, pediatrics, public health, these days also an economist, a representative of the public. The ACIP meets currently three times a year, I believe, either two or three, and reviews the evidence of safety and efficacy of vaccines, and makes recommendations as to their use. I think it has been a model for advisory committees in many other countries.

In recent years in the U.S., it has also taken on an additional role that is not 00:37:00the case in virtually any other country. And that is as a result of the passage of the Vaccines for Children Act, which provides free vaccine as an entitlement to children who are unimmunized, who are Alaska Natives or Native Americans, who are under-immunized, or who are on Medicaid. About half of all the children in the United States are guaranteed free vaccine through the Vaccines for Children Program. The ACIP now has the role, and has since the Vaccines for Children Act went into place in about 1994,of determining what vaccines will be included in the Vaccines for Children Act. As a scientific public health advisory body, they make a recommendation as to the use of a vaccine. If they recommend that it be used in all children, they then take a separate vote as to whether it should be 00:38:00included in the Vaccines for Children Program. If they vote yes, then that vaccine automatically will be covered, and the federal government has to find the money to purchase it and provide it.

TORGHELE: When the decision was made to switch to the oral polio vaccine, was there pushback?

HINMAN: I don't really know. I doubt that there was a lot, because the oral vaccine had been shown to be quite effective. And when it was first introduced, we didn't really know about vaccine-associated paralysis. And the ease of use, and the fact that it had this indirect community effect, made it not a hard decision. It became more difficult then later on, when in the United States, when we no longer had polio, but we still had cases of vaccine-associated polio, 00:39:00then the discussion became a lot more intense as to whether we should continue to allow five to ten cases of vaccine-related paralysis a year for the community benefits of oral polio vaccine. It was in 1997 or '99, I can't remember which, that the decision was made by the ACIP that we should switch to a combined schedule in which we gave two doses of inactivated vaccine first, which would induce very good protection in the individual who received it, and protect them from the potential of having vaccine-associated paralysis themselves when you 00:40:00administered oral polio vaccine as the third and fourth doses. This, then, would provide also the good intestinal immunity that helped provide protection throughout the community.

We did that for three or four years, and it worked. We got rid of vaccine-associated paralysis in recipients. However, there were still some cases of vaccine-associated paralysis in close contacts of vaccine recipients, so that led in '99 or 2000 to a decision to use only inactivated vaccine in this country.

TORGHELE: How was vaccine-associated paralytic polio characterized? Was that CDC? They must have had a role in that too.

HINMAN: This was a very important activity of CDC's, and of the ACIP, to monitor 00:41:00what was happening. CDC was very heavily involved in the investigation of cases of vaccine-associated polio, and the Polio Surveillance Unit at CDC was equally attuned to investigating cases of wild poliovirus-induced paralysis or vaccine-associated paralysis.

TORGHELE: How could they determine the difference between the wild and the vaccine-associated?

HINMAN: It was very difficult initially, and basically it was the epidemiologic circumstances. If someone received oral polio vaccine and two weeks later developed paralysis, or if someone developed paralysis whose sibling had received oral polio vaccine two weeks before and there was no polio in the 00:42:00community, then it became likely. We did not initially have effective laboratory tests to differentiate between wild and vaccine-associated paralysis. This came to a head in 1971, I believe, or '72, when there was an outbreak of polio along the Rio Grande area, the border between Texas and Mexico. A vaccination campaign was carried out, and a little girl named Anita Reyes, who had received oral polio vaccine, developed paralysis ten days later. The assertion by the parents and their lawyer was that this was vaccine-associated polio, whereas the public 00:43:00health authorities and the epidemiology suggested it was likely to be wild polio. Lab tests at the time were not conclusive enough to be able to say with certainty whether it was vaccine-associated or wild polio. The courts held that it was vaccine-associated paralytic polio, and that it was the responsibility of the manufacturers to ensure that the patient or the parents had been adequately informed of the risks as well as the benefits of vaccination.

If the vaccine is being given in a private physician's office, then the manufacturers could reasonably assume that there was an individualized medical decision being made, whereas vaccine given in public clinics was typically administered under standing orders by non-physicians and there was not an 00:44:00individualized medical decision being made as to the use of the vaccine. A result of that was the insistence by the manufacturers that the federal government, if they were purchasing the vaccine, assume the responsibility for notifying parents of the risks as well as the benefits of vaccines. And that's how we came to develop what were first called Important Information Statements and are now called Vaccine Information Statements, which are required to be used with every dose of federally purchased vaccine.

TORGHELE: And those are now also given to parents and people who are receiving the vaccine?

HINMAN: They are given to parents. Oh yes, the policy is that for every vaccine administered to a child, before the vaccine is administered, a Vaccine Information Statement is to be given to the guardian or the person with the 00:45:00child, and that they read and sign it.

TORGHELE: There's also a reporting system, Adverse Events Reporting System.

HINMAN: Yes.

TORGHELE: Can you talk a little bit about that?

HINMAN: VAERS is the Vaccine Adverse Events Reporting System, and it began in the late '70s as a consequence of I think, primarily the swine flu program and the occurrence of Guillain-Barre Syndrome associated with the swine flu vaccine, as well as, then, the insistence that we provide information statements to parents about vaccines. We developed a reporting system called MSAEFI, 00:46:00Monitoring System for Adverse Events Following Immunization. CDC took this on as an activity, and then in the 1980s when the Childhood Vaccine Injury Compensation Act was passed, that formally established VAERS, the Vaccine Adverse Events Reporting System, which now is dually administered by the FDA and CDC. This is, then, a system in which, in principle, vaccine providers are required to report to the system any adverse event occurring within a month after vaccination that they think might be associated with the vaccine. VAERS 00:47:00receives several thousand reports a year.

TORGHELE: Does the public have access to the results of that?

HINMAN: Yes. You can go to the VAERS website and see the results. It's very difficult to interpret the results, however, because children receive several vaccines at one time, so how do you know if something that occurs after receiving four different vaccines or five vaccines, which one might be responsible? It's also the case that the events reported to VAERS are events that occur after vaccination, not necessarily as a result of vaccination. In principle, if you are run over by a car the day after receiving a vaccine, that should be reported to VAERS. When we were using oral polio vaccine, a case of paralysis following administration of oral polio vaccine, DTP vaccine, and 00:48:00simultaneous administration of those vaccines would be ascribed, would be put in the column under each of the vaccines. Now, it doesn't make any sense that paralysis would be associated with measles vaccine, but that's the way the system works. So it has a lot of limitations, but what it can very importantly do is to provide an early warning system if something really unusual happens, or something you've never heard of before. As an example, the VAERS system was one of the ways in which the issue of intussusception following administration of the initial rotavirus vaccine in the United States was discovered.

The reporting didn't prove that there was a causal relationship, but what it did say was, This looks like it's not quite right, and that triggered then a very 00:49:00intensive and extensive investigation that was able to demonstrate that, in fact, the rotavirus vaccine was associated with an increased risk of intussusception of about one in ten thousand doses. And the vaccine was withdrawn.

TORGHELE: During your time in the vaccine division, did you have any interaction with the anti-vaccination people? Can you talk about that a little bit if you did?

HINMAN: Yes. In the late 1970s, there was an assertion in the United Kingdom that pertussis vaccine was causing permanent brain damage, and there was a Scots epidemiologist named Gordon Stuart who promoted this concept, and there were parents of children who had brain damage who thought that that was caused by 00:50:00pertussis vaccine. They formed an Association of Parents of Vaccine-Damaged Children, I think it was called. A fair amount of publicity, and this led to a dramatic decline in the use of pertussis vaccine in the United Kingdom, which was followed about four years later by a massive resurgence of pertussis.

The same concerns were raised in the United States and in 1983, '84, a so-called documentary was developed by Leah Thompson, a reporter at television station WRC in Washington, which was the NBC affiliate. It was called DTP: Vaccine Roulette, and it was a very clever juxtaposition of children who were horribly suffering 00:51:00from infantile spasms or other really heart-wrenching and totally consuming nature, brought this into your living room. Parents said--This is a result of pertussis vaccine, and then it would switch to, for example, Gordon Stuart saying, Yes, pertussis vaccine causes permanent brain damage. Then it would switch to someone like me saying that-- Actually, there is no evidence that pertussis vaccine causes permanent brain damage. Then it would switch to another picture of a terribly tragic event, a family whose entire existence was consumed by caring for this child with infantile spasms. Then it would switch to another mealy-mouthed bureaucrat saying, Blah, blah, blah, and it had a tremendous impact.

It was shown twice in Washington that week, and a piece of it was picked up by the Today Show. The American Academy of Pediatrics protested, and so they invited a representative of the American Academy of Pediatrics on the Today Show, so first they reshowed a clip of the assertions. Then the representative of the American Academy of Pediatrics said, No, actually, this is what the evidence shows. Then there was another little recap, a rejoinder. It had a substantial impact, and in particular since it was originating in Washington where there are a lot of people who are involved in the government. One of the 00:53:00people who watched the program was an attorney named Jeff Schwartz, who was working in Congress, I believe, for the Environment and Health Sub-Committee. He saw the program and though, Oh my goodness, that must be what my daughter has. So he called the station and was unable to get through. He kept calling back and finally they said--The lines are melting, so many people are calling. He said, Give them my number, and then people began calling to him.

A result was that he and two other people, Barbara Lowe Fischer and Kathy Williams, each of whom felt that their children had been affected in the same way, founded an organization called Dissatisfied Parents Together, DPT. This has 00:54:00since evolved into the National Vaccine Information Center, or NVIC, which is a very prominent web presence. And if you ask for vaccines or immunization, NVIC is one of the high picks that will come up on your screen. It sounds like an official entity, but it actually is primarily providing the negative aspects of immunizations.

TORGHELE: Where do they get their information to support their claims?

HINMAN: From VAERS, in part, and from cherry-picking studies.

TORGHELE: So that movement is still going on?

HINMAN: Yes, and in fact the vaccine hesitant or vaccine skeptic or anti-vaccine 00:55:00movement is spreading, not only in the United States, but around the world. There are a number of different organizations now, and a number of different reasons why people may not favor immunization. But it is a really serious concern for immunization programs, not just in the U.S. but, for example, in Zimbabwe about eight years ago they had a massive epidemic of measles with several thousands of cases and deaths among members of an apostolic community, which rejected immunization.

TORGHELE: How has it affected polio, this movement?

HINMAN: It's difficult to know. There has been concern about, for example, 00:56:00vaccine-associated paralysis when we were using OPV, but polio has not been a primary feature of the anti-vaccine movement. I think measles and autism, thimerosal and autism, these have been some of the primary concerns. Polio has not featured very much.

TORGHELE: I wanted to talk now about the polio eradication efforts, how that's going, how you feel about it, and who some of the people are who have been involved in it and other organizations, if you could talk about that a little bit?

HINMAN: Polio eradication is a topic near and dear to my heart. In 1988, I 00:57:00believe it was, or '87, I was an author on a paper called The case for global eradication of poliomyelitis. I have been a promoter of polio eradication since the early mid-'80s. I was a member of the technical advisory group for the Pan American Health Organization, and the Americas led the way in polio eradication. The Americas was the first region of the world to achieve eradication of polio and really demonstrate that it could be done, including in developing countries. I guess I've been involved pretty much from the beginning of the eradication movement. It has been a remarkable effort in part because of the private-public 00:58:00partnership that has developed, and Rotary International has been an extremely important player, and I think Albert Sabin had something to do with that. In 1985, Rotary International was beginning to consider what they might do to celebrate their centenary in the year 2005. The president of Rotary International at the time was a Mexican physician named Carlos Canseco, who had worked with Albert Sabin in the '60s, late '50s and '60s, when Sabin was doing studies on oral polio vaccine in Mexico.

Dr. Canseco and Dr. Sabin were talking, and Dr. Canseco was saying that Rotary was looking for a big project to celebrate their hundredth anniversary--And Dr. Sabin said--Well, why don't you eradicate polio from the world? All you have to 00:59:00do is give a dose of polio vaccine to every child in the world on one day and then you can eradicate it. Right. So Dr. Sabin was a very persuasive man and a brilliant man. So Dr. Canseco thought about this and held a meeting at Rotary's headquarters in Evanston, Illinois, to talk about the feasibility of this. Bill Foege, who was at the time director of CDC, was unable to attend the meeting, so I went as his representative. Another science kind of person, John Sever, a virologist at NIH, who also was a Rotarian, also was there, and we were charged with providing sort of scientific technical knowledge or views on the feasibility and desirability of Rotary getting involved in polio eradication.

Well, of course, it's not as easy as just giving every child in the world a dose of oral polio vaccine on one day. First of all, they need more than one dose. Secondly, it would not be feasible to do it all in one day, the logistics issues and vaccine supply, et cetera, would be prohibitive. On the other hand, you could do it, and so polio was a candidate for eradication. So Rotary decided that they would do it. They would support polio eradication. They would provide free vaccine to every country in the world, whether or not the country had a Rotary Club, for five years in order to achieve polio eradication. They then said--Well, how much is this going to cost? And they did some calculations on number of births in the world and number of doses that would be required, and 01:01:00came to an estimate of about a hundred and twenty-five million dollars as a requirement to provide free vaccine to every country in the world for five years. And they set about raising it, and they did.

They exceeded their target. In fact, as of today, Rotary has committed more than one billion dollars of support to the polio eradication initiative, and they have been a major, major player in the achievement so far. Not just through the money, but in some ways more importantly, through Rotarians themselves. There are more than a million Rotarians around the world. There are three thousand Rotary clubs, and the members--volunteer time. They volunteer equipment. Rotarians in the developing world tend to be the rising middle class, and they 01:02:00may be the owners of the brewery that has refrigerated trucks that can help transport vaccine. Hundreds of thousands of Rotarians have been mobilized to participate in mass vaccination campaigns. Although Rotary started as primarily just providing vaccine, over time, they have become much more technically involved in the program, and the leadership of the global polio eradication initiative now reflects WHO [World Health Organization], UNICEF [United Nations International Children's Emergency Fund], CDC, and Rotary as the primary movers.

TORGHELE: And Rotary is nonpolitical.

HINMAN: Rotary is nonpolitical, with the exception that Rotary understands the political workings, and Rotary are very important in assuring U.S. congressional 01:03:00support for the global polio eradication initiative. They hold a congressional reception every year in Washington and recognize polio heroes from among Congresspeople who are particularly supportive of polio eradication.

TORGHELE: Do they sponsor the people, they must sponsor the people who give the vaccines. I know that some have lost their lives in that effort.

HINMAN: Rotarians themselves volunteer in India, I think, by the tens of thousands to support campaign activities. There are now, I think, more than a hundred vaccinators who have been killed, murdered in the polio eradication initiative, primarily in Pakistan and in Nigeria. It's a tragic event. There are 01:04:00also a number of polio workers who have died as a result of traffic injuries and this kind of thing, but these deliberate murders are just really tragic events. There are some fairly effective approaches being taken now in Pakistan, for example, in that women in the community are being mobilized in support of the continued polio eradication efforts, and they can be quite effective in modifying behaviors, apparently.

TORGHELE: Excellent! So if Pakistan and Afghanistan are the only two countries now where eradication has not happened [NOTE: Since this interview, three polio cases have occurred in Nigeria in July-August 2016]

HINMAN: Pakistan and Afghanistan are the only two countries in which there is 01:05:00continued circulation of wild poliovirus, and Pakistan is the primary source of the virus. Afghanistan's cases of polio, many of them are attributable to viruses that originated in Pakistan. We do still have some areas in which vaccine-derived polioviruses are still circulating and can cause outbreaks of paralysis that is indistinguishable from polio caused by wild poliovirus. So the polio eradication initiative is not just to get rid of paralysis due to wild poliovirus, it's to get rid of all paralysis caused by polio, whether wild virus or vaccine-associated virus.

TORGHELE: Now there are three strains of the polio virus, and I understand that 01:06:00one has already been eliminated.

HINMAN: That's right. Type 2 poliovirus was last isolated in 1999, and a couple of years ago, the Global Eradication Certification Commission certified that Type 2 polio virus had been eradicated. Now, this has led to some changes in our strategy for the endgame of polio eradication, because the primary vaccine that's been used has been trivalent oral polio vaccine. It contains all three types of poliovirus. Type 2 virus has been the primary cause of vaccine-related paralysis around the world, not just vaccine-associated paralysis in the 01:07:00recipient or immediate contacts, but also it's the case that vaccine virus that's excreted in settings where there is a low level of population protection against polio may circulate, may recombine with other viruses and regain the ability to cause paralysis. This is called circulating vaccine-derived poliovirus or CDVDP, which you have to practice a lot to be able to say.

CDVDP that we have seen around the world, the vast majority of it is caused by Type 2 virus, so this has led to the notion that we should take Type 2 strain out of oral polio vaccine. And in fact, we just accomplished that over about a three-week period in April/May of this year. One hundred fifty-five countries 01:08:00around the world essentially simultaneously withdrew all trivalent oral polio vaccine and replaced it with bivalent oral polio vaccine. Now, because there is still some risk of Type 2 virus escaping from a lab or continuing to circulate as part of the CDVDP cycle, we preceded the switch from trivalent to bivalent by introducing at least one dose of injectable trivalent inactivated polio vaccine in all countries. That has not been completed as yet because of some production supply problems, but that's the strategy, introduce at least one dose of IPV, switch from trivalent to bivalent, and then ultimately withdraw all use of oral 01:09:00polio vaccine once we've interrupted transmission.

TORGHELE: All of those countries are cooperating with the plan?

HINMAN: Yes. It was, the switch, I think, was astonishingly smooth. The introduction of IPV has been more complicated, primarily because issues of supply. Some countries have not yet introduced IPV because of supply issues.

TORGHELE: That's pretty astonishing, though.

HINMAN: Oh, yes.

TORGHELE: That must have taken a lot of work.

HINMAN: It took a lot of work by a lot of people, and I'm happy to say that the Task Force for Global Health was, I think, involved in an important way in the introduction and switch, and supporting WHO and the Global Polio Eradication 01:10:00Initiative with support from the Bill & Melinda Gates Foundation.

TORGHELE: Well, as we wrap up, I know there are probably things we didn't talk about that you might want to-- events or people or both.

HINMAN: It's tough to know where to start. There's so much to talk about for polio. The last outbreak of polio in the United States, 1979, among Amish people. The virus originated from the Netherlands, members of Dutch Reformed Sect who traveled to Canada to see people who were relatives or other church members. In the U.S., the Amish population is distributed in several states, 01:11:00Pennsylvania having the largest concentration. And one of the characteristics of Amish society has been to encourage travel of young people to meet other young people, so that they can maintain genetic diversity in their population, because there have been some genetic diseases that have been more prevalent in Amish people because there was a lot of intermarriage. So taking trips to seek brides has been a part of society, and we believe that that's probably how the virus came to the United States from Canada. Young men going up to make acquaintances and becoming infected and bringing it back. Amish people did not vaccinate their children. They believed that if paralysis occurs, that's God's will. On the 01:12:00other hand, they didn't want to be viewed as threats to society, so ultimately, with a lot of effort, we were able to vaccinate about 75% of the Amish population in response to the outbreak, but it took a lot of work.

TORGHELE: And negotiating, I imagine.

HINMAN: Yes.

TORGHELE: Diplomacy.

HINMAN: It's a very decentralized church, so that it basically was almost church-by-church. A lot of public health advisors from CDC were involved in that. Two EIS officers, Marjorie Pollack and Melinda Moore, were very heavily involved in the investigation of the outbreak.

TORGHELE: And that was the last outbreak in this country?

HINMAN: That's right.

TORGHELE: And how long has the Western Hemisphere been without polio?

HINMAN: 1992, I believe. The last case occurred in a little boy in Peru.

TORGHELE: Some people have asked, since smallpox was eradicated, why is it taking what seems to be a lot longer time to eradicate polio?

HINMAN: There are a number of reasons, I think. Smallpox was a really dreaded disease. It also was a disease that was quite visible, almost everyone who was infected with smallpox developed a recognizable and ugly disease. Whereas with polio, for every two hundred infections, there may be one case of paralysis. It was easier to track smallpox than it is to track polio. It was also more feared. 01:14:00I think in many developing countries, polio did not occur so much in outbreaks as it did in individual cases of paralysis, so in many places was an invisible problem. It wasn't until we started doing surveys called lameness surveys, to go out and find, at the household level, where there were cases of flaccid paralysis-- that it became apparent how much polio there was because in many developing countries, children with paralysis just were left in the house and never made it into society; were never seen.

Another characteristic of smallpox was that when you vaccinate someone it leaves a scar, so you can easily tell if someone has been vaccinated, whereas with 01:15:00polio you don't know. Those are a few of the reasons.

TORGHELE: That's really interesting. What's your prediction about the possibility of completely eradicating polio?

HINMAN: It's going to happen. As of I think last week, we were at nineteen cases of polio thus far this year, compared to, I think, twenty-seven at this time a year ago. It's hard. It's hard work. It has required an extraordinary amount of very imaginative research, even at the very end stages of eradication, and it's just really astonishing to see what has been accomplished and what kinds of things have been happening. And we'll make it.

TORGHELE: I think so too. Thank you so much. This has been very interesting, and 01:16:00you've contributed a lot to these oral histories, and I know you have contributed a lot to the eradication of polio and other diseases.

HINMAN: We're going to do measles next.

TORGHELE: Okay, measles next. Well, thank you so much, Dr. Hinman.

HINMAN: You're very welcome.

TORGHELE: It's been fun.

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