Peter Patriarca

CRAWFORD: Today is Wednesday, June 13, 2018. This is Hana Crawford for the Global Polio Eradication Initiative History [GPEI] Project, and I’m with Dr. Peter [A.] Patriarca [MD] in the broadcast studios of the United States Centers for Disease Control and Prevention [CDC] in Atlanta, Georgia. That’s a mouthful.

PATRIARCA: Yes.

CRAWFORD: Thank you for being here today.

PATRIARCA: Sure.

CRAWFORD: As we were talking about earlier, I will ask you to introduce yourself in a minute. But first, do we have your consent to conduct this interview and record it?

PATRIARCA: Yes, you do.

CRAWFORD: OK, great. To begin, would you state your name, where and when you were born, and then share a bit about your early life?

PATRIARCA: OK, so I’m Peter Patriarca. I was actually born in Oak Ridge, Tennessee, of all places, and if you listen closely when I talk you can hear some Southern twangs, right? I grew up in East Tennessee. I was very interested during my childhood in science. My dad worked for the Oak Ridge National Laboratory and devoted his career to the peaceful uses of nuclear energy—and this was during the Cold War. He was an inspiration to me.

I actually became interested in becoming a physician mainly because of the father of a friend of mine, who I got to know and who I talked with quite a bit, who really taught me that the most important thing about your career is your ability to get along with other people and to relate to other people, rather than what you did.

I ended up from there going to the University of Notre Dame. I majored in what was then called “pre-professional studies”—essentially pre-med [pre-medical]—then went to Tulane Medical School. Got very interested in pediatrics at the time, so I ended up doing a residency in pediatrics at the University of Colorado. While I was at the University of Colorado, I became especially interested in infectious diseases. There were two ex-EIS [Epidemic Intelligence Service] officers who I worked with very closely, Brian [A.] Lauer [MD] is one, and Neal [A.] Halsey [MD]. Neal Halsey is a name that’s well known in CDC circles.

I also, fortunately, ended up in—at that time it was called the Division of Immunization—in, at that time, the Bureau of State Services [Bureau of Medical Services, U.S. Department of State]. In particular, I was recruited by a wonderful gentleman by the name of [Walter A.] Walt Orenstein [MD, DSc (Hon)]. He recruited me, and I ended up matching there, but the reason, though, was that there was a mistake in the matching process, and where I was supposed to go was to work with Claire [V.] Broome [MD] in the Division of Bacterial Diseases [DBD]. Somehow, through the mistake, I ended up in immunizations. Well, that was probably the best thing that ever happened to me.

I worked initially in influenza, learned about outbreaks, learned about flu vaccines. It was really my first foray into immunization and vaccines. I ended up, for various reasons, transferring after my first year of EIS to what was then the Division of Viral Diseases [DVD] in, at that time, the Center for Infectious Diseases. I continued my work in flu, which in the meantime got transferred there. Then, fortunate for me, a couple years later, I got a call from Walt Orenstein and Alan [R.] Hinman [MD, MPH], who told me about a new opportunity back in the Division of Immunization that related to providing support for the polio program for the Americas. I signed up for that.

CRAWFORD: What did you know at that time about polio?

PATRIARCA: What I knew about polio was vivid memories. I was born in 1951, and so I remember, literally remember, how excited my mother was when the [Jonas E.] Salk [MD] vaccine became available, and I also vividly remember going to my elementary school when I was, I don't know, nine or ten years old, to get the sugar cubes with [Albert B.] Sabin [MD] vaccine. I remember the excitement in communities about the availability of those vaccines. From that standpoint, it was actually very meaningful to me. By that time, I also knew that most of the activity that was going on with polio was not so much in the U.S., of course, but in areas of the world that I was very interested in visiting. This was sort of a perfect opportunity for me at that time, and, really, that was my foray into polio. This was, more or less, about 1985 or 1986.

CRAWFORD: What would you be doing?

PATRIARCA: Well, it’s funny you should ask. One of the first things I did, believe it or not, is I took an intensive language course in Spanish because I was going to be working in the PAHO [Pan American Health Organization] region. Well, that actually got interrupted soon because there was a gigantic polio outbreak in Brazil in 1986. I was one of the people, actually, who went to Brazil. They were kind enough to speak English, fortunately, with me while I was there, but essentially, I spent about two months figuring out—trying to figure out—what happened, because this was one of the largest outbreaks ever recorded, and specifically for type 3 [wild poliovirus], which is one of the least common forms of polio.

More importantly, this outbreak suddenly exploded after a period of about five years in which there were almost no cases of polio at all in Brazil, because in the early ’80s, mainly through Albert Sabin—Albert Sabin convinced the Ministry of Health of Brazil to initiate mass campaigns with oral polio vaccine, just as were done originally in the ’60s in Russia, when these gigantic field trials were done by Sabin. Sabin convinced the Ministry of Health, “Let’s do the same thing.” Lo and behold, if you look at the epidemic curves of cases in Brazil during that time, it was amazing how well it worked.

The event that happened in 1986 was very concerning because essentially it was the first epidemic, and I can’t remember how many cases there were, but I know it was in the high hundreds. I mean, it was very impressive, and it was primarily in the northeastern part of Brazil, the tropical area of Brazil. Nobody could understand why it happened.

Part of what I did then, other than looking at the cases and mapping them and doing the usual sorts of shoe-leather epidemiology that I was trained to do, is—I also was interested to know whether the failure of the vaccine somehow played a role in this. Why was the vaccine, which had been so effective for so many years—why suddenly is there this outbreak?

That ended up leading to a whole series of side investigations—so, for example, looking at antibody levels to type 3 polio—and the net result of all that was that it appeared that the vaccine, for reasons that were not totally clear, was just not functioning very well against type 3.

CRAWFORD: Because it wasn’t an issue of coverage?

PATRIARCA: No, it was not at all an interest in coverage. This is an example that Walt Orenstein refers to as, quote, “vaccine failure,” as opposed to, quote, “failure to vaccinate.” I was very intrigued by that and was trying to figure it out. I was still new to polio, relatively speaking, and so I spent a long time, both in Brazil and back in the U.S., reading the literature, looking into things like how polio vaccine was made—what are the titers of the individual components? How is that determined? I got very interested in the vaccine itself. One of the things I discovered was that the formulation of vaccines—of OPV [oral poliovirus vaccine] that was used in Brazil and, for that matter, in most parts of the world was different than the OPV that was used in the U.S., in terms of the ratio of the three types.

In particular, it turned out that the content, and also the ratio of the type 3 component in the vaccine used in Brazil, was substantially lower than the vaccine used in the U.S. One credible hypothesis, especially based on all the work that Sabin had done previously with both monovalent and trivalent forms, was sort of a simple idea: would it make a difference if we used the, quote, “U.S.” vaccine in Brazil, in a tropical area? We actually convinced the OPV manufacturer located in Brazil to make a new formulation that had a higher potency of the type 3 component, and we then compared that in a head-to-head study with the existing vaccine. The long and the short of it was that it made a huge difference in terms of seroconversion.

The way that we designed the study—and of course this is published. I can’t remember the citation, but it is published; all of this work is published—we actually also designed the study so that we could determine whether it makes any difference if a child had received none, one, two, three, or four previous doses. What we found was, in all instances, the seroconversion rate to type 3 was dramatically increased.

As a consequence of that study, not only Brazil, but WHO [World Health Organization] in general, essentially changed the formulation of tOPV [trivalent oral poliovirus vaccine] to match this new, increased potency of type 3. Now, whether or not ultimately that had an effect or whether that was just the luck of the draw—to me, it’s very intriguing that it may actually have made a difference, because if you look back at the epidemiology of polio ever since then, that was the last large, large-scale outbreak of type 3, was in Brazil in 1986. There were type 3 cases subsequently, but never an epidemic of that magnitude.

That’s what happened. That was my foray, and then that led me on to basically do other things similarly in the manner of trying to figure out whether we had the best tools or not.

CRAWFORD: A follow-up question: were there other formulations of OPV that you looked at around 1987, 1989 as you were looking at Brazil?

PATRIARCA: Well, the answer is sort of yes. Here’s what I mean: as a consequence of what I just described—I mean, there was a lot of background work that went into that. There’s an enormous literature. Dating back from the ’60s, there were books written about the manufacture of polio vaccines, both oral and inactivated, and how were they determined? How were they made? All those sorts of things. That literature, nobody had really looked at that for twenty years.

From that literature, it became apparent, at least to me, that it was important to very carefully regulate not only the potency of each component, but also the ratio. That ended up leading us collectively—CDC and also WHO and some academic investigators—to also examine other formulations of OPV. WHO ended up coordinating a very large clinical trial that was patterned after the one that we did in Brazil at the beginning. We did have similar results with the study—there were two studies related to that. But we did not see, for type 1, for example, the dramatic difference in seroconversion that we had seen earlier in Brazil for type 3.

All this work was more or less from about 1986 through, more or less, about 1992—after that, not much work was really done. Those were really the only studies that really sort of took a close look at the question of, do we really have a tool that can go on and achieve the goal of eradication? Our focus was sort of on the front end, sort of on the research side—in a practical means, to basically ask the question, do we have the tools available to us? Because there had already been the declaration to eradicate polio. The question that I was trying to—and it wasn’t just me; it was others who were interested in knowing whether the right tool—did we have the right tool? Can we use that tool efficiently? What ways could we speed things up, if at all? How could we make achieving the goal of eradication more efficient? That was really the key thing that I and some of the other people that I work with were really most interested in.

CRAWFORD: Who were some of the other people you were working with at that time?

PATRIARCA: Well, it was an interesting group of people, actually. One person who was really behind this, completely from day one, was Walt Orenstein. Walt was definitely a champion of this: figuring out this Brazil outbreak, which then led to the question of, do we have the, quote, “right” vaccine to work with?

Walt was also, interestingly, involved in work related to IPV [inactivated polio vaccine] as a consequence of having actually investigated an outbreak in Israel. During his time there, he was also exposed to—it really was a public health experiment that was going on. I mean, not experiment in a research sense, but sort of a natural experiment because there were areas in Brazil—sorry, not in Brazil, in Israel, and specifically the Gaza Strip—that actually had a combined schedule for polio that involved both OPV and IPV. Walt actually investigated that and was part of sort of an inquiry that was led by the Israeli Ministry of Health.

The upshot of all that was that that information was not easy to ignore. That was really the first really solid evidence, at least in my mind, in a so-called—I mean, Israel is not really tropical, but the areas of the world that we’re talking about were generally poor and underdeveloped and not at all typical of the U.S. or Europe. The idea that maybe there could be a combination schedule that would include OPV and IPV, maybe that was an idea that was worth considering. Walt Orenstein played a really important role in that, and sort of encouraged looking into whether or not IPV could have some role.

Related to that, one of the interesting things that we did, i.e., myself and a terrific IES officer, Bernard [J.] Moriniere [MD, MPH]—and I still don’t speak French—so Bernard actually ended up going to the Ivory Coast, Côte d’Ivoire, right, and the experiment that we designed was very simple. We asked the question, “If you took a group of kids and you gave them OPV at six weeks, ten weeks, fourteen weeks,”—which was the global schedule—"so they got three doses of OPV, and then when they were nine months old, to come for their measles vaccination, what would happen if you gave them IPV?”

CRAWFORD: What year was this?

PATRIARCA: It was either the late ’80s or early ’90s. It was late ’80s. I’d have to go back and look at the publication. All of this stuff I’m talking about is published.

We compared two groups of kids—so all the kids got three doses of OPV, but then at nine months they either got another dose of OPV, or they got IPV. When you looked at the results, they were dramatically different. The kids who ended up getting IPV had absolutely phenomenal responses, particularly to types 1 and 3, which at that time were problematic because Sabin type 2 is a fantastic vaccine, mainly because, genetically, it’s very close to the wild type. It’s really types 1 and 3 that were problematic, and in this study, we showed that if you were to follow that schedule, one dose—one dose of IPV at nine months—it would phenomenally improve the seroconversion rate, and essentially every child in that group was completely protected.

A lot of people, when they read that paper, thought that that was a novel idea or a novel finding. It wasn’t. Albert Sabin proved in the early 1960s that if you follow an OPV infant and give them later on IPV, as a consequence of them having been primed with OPV, they will develop, essentially, a phenomenal booster response. OPV primes for IPV.

When you give IPV, you don’t have the problem of whether or not the child might have some other GI [gastrointestinal] illness going on that would prevent them from—their cells, essentially, in their intestinal tract, from being infected with OPV. That’s eliminated because you put the antigen in their arm. From an immunological point of view, it also makes sense, and it was actually Albert Sabin who first reported that. It was actually a replication, interestingly, of a study that Albert Sabin did. Albert Sabin thought that IPV was essentially poison.

I was also around during the time—I never witnessed their debates in person, but certainly Albert Sabin was not, in any way, a fan of IPV, and yet it was Albert Sabin who made that first observation, and so we just replicated it. It’s not that we were smart. We just tried—we were looking for efficiency. That’s what we were doing. Because the alternative to efficiency was to try to replicate everywhere what Sabin did in Russia in the ’60s, what PAHO did in the Americas, which is mass campaigns—

CRAWFORD: Did you look at Cuba, as well?

PATRIARCA: The short answer is no. I never really—Cuba never was on my radar at that time. I’m not sure why, but no. I think this is right, that Cuba basically had the same type of system with mass campaigns and so on, but I actually don’t recall, now that you mention it, reading anything about the Cuba experience. It was mostly the Brazil experience that was sort of in the front of my mind.

CRAWFORD: Did you look at monovalent OPV [mOPV] at all in the early—?

PATRIARCA: Yes, well, that’s actually a good question, and this relates back to the trial that I mentioned earlier that we did in Brazil. Your question relates to, actually, something very important which I forgot to mention, which is, as part of the control group in that study, we also administered monovalent type 3 as a control, actually. But what we found was if you gave type 3 alone, surprise, surprise, it works better, which, again, was proven by Sabin back in the day and relates to the fact that if you look at the formulation of OPV, even in the U.S., the amounts and the ratio of those three components are different, and the vaccine actually works better—each component works better when administered on its own.

Yes, that study ended up being sort of a more contemporary version of some of the studies that Sabin and others—and in particular [Mikhail P.] Chumakov in Russia—did during the ’60s.

I really can’t take much, if any, credit for any of this stuff; it’s not like this is a novel idea. The main thing that we were trying to do is basically figure out, is there a better way to build a mousetrap? That was the question that we were asking. At least in the studies that we’ve just discussed and that I mentioned, the answer is yes. There is, or there could be, a better mousetrap. There could be a way to make it more efficient. There could be a way to achieve eradication more quickly.

That’s what I took out of that experience, and there were a lot of people who believed that, but also a lot of people and groups that didn’t. They didn’t want to hear that. They essentially were wedded to what I’m going to call the, quote, “PAHO method.” That was sort of a—kind of an uncomfortable feeling, at least, that I had, and some others in the field who were also interested in the possibility—we were never saying, “Do it this way.” We were examining all of these questions strictly from the standpoint of research. Practical research, not basic research. We were trying our best to consider all options. We tried not to be biased. We did not do this haphazardly. We essentially recreated results that had been generated, even by Sabin and Salk. We were just trying to be very practical. We weren’t saying, “do it this way.” We were saying, “Hmm, what if you were to change your approach to do X instead of Y? Would that make a difference? How would the program be impacted?” That’s very important because once you start introducing an inactivated and injectable vaccine into a mass campaign, well, guess what? The logistics of that are hugely magnified. That’s a problem. But is there a way even to overcoming something like that—through research and development?

It was mainly, let’s do these studies. Now, this was early. A lot of this work that I’m referring to was really in the early days of the global eradication program. It was not as though things were great in—epidemiologically speaking, all over the world. There were huge outbreaks in different parts of the world, particularly in Southeast Asia at that time and also in Africa. The idea was, let’s, quote, “get ahead of the curve” before the curve gets out so far that there’s no turning back. Let’s look at these things now in a practical way, as a means of—as sort of an insurance policy. What if the global strategy, the mass campaign strategy, what if that doesn’t work as well as it did in the Americas?

Maybe it will. Northeast Brazil, I was there during the outbreak. It’s an incredibly impoverished, at that time, area. That’s very typical of these tropical environments.

We were really developing insurance policies. Our intent was not to upset the applecart, or make people upset or give mixed messages. That was not our intent. We were just trying to think of ways of doing things faster, number one. Number two, we thought that it would be useful to have an insurance policy. What you don’t want to have happen is to put all your, quote, “eggs” into the mass campaign basket and then ten, fifteen, twenty years later find that it’s just not doing the same thing as it did in Latin America.

That was really our intent, and we were doing that, quote, “on the side.” We were doing that as an R&D [research and development] exercise, separate from all the work that was going on with surveillance and improving surveillance tools and all the things that were going on, particularly in the lab: sorting out with very fine specificity, where are these viruses coming from? Are they linked? Is an outbreak in one country linked to another? All these important and crucial things that were going on—it had nothing to do with that. It had nothing to do with the incredible logistics that are required, with the cold chain and with mass campaigns and getting children to come during mass campaigns, convincing parents that this was to the benefit of their children, all the social mobilization and all that stuff—all that stuff is so important.

I can’t say we were not interested in that, because we were, because it’s very important. But the questions that we were trying to address and answer were narrow, and they were very simple in principle: is there a better way to do this from the standpoint of, number one, the vaccine as a tool, number two, we had two tools—would it be better if we could somehow bring them together? Maybe not—

CRAWFORD: Could you talk about the immunization schedule in the United States prior?

PATRIARCA: Prior to—?

CRAWFORD: Prior to bringing IPV into the schedule.

PATRIARCA: Yes, sure. The traditional schedule in the U.S. was three doses of Sabin OPV, which was trivalent—so this was after the monovalents got combined into the trivalent. Three doses at age two, four, and six months. Why two, four, and six? Well, part of that was historical. Part of that is because that’s when other vaccines are administered, according to that schedule. That was the schedule.

Prior to that, when IPV was around, during the period between the time that IPV was approved in 1955 to—I’m pretty sure it was ’61 when Sabin’s monovalent vaccines were approved, which they got—so during that five-year period, IPV was given, according to the same schedule.

That’s the schedule. In the U.S., and for that matter in Europe, for example, outside of the tropics and so-called industrialized countries, that’s a great schedule. Tremendous antibody responses. “Everybody,” quote-unquote, near everyone, develops antibody. There was never a question in the U.S., at least in my mind, that polio could be eliminated in places like the United States, Europe, et cetera, et cetera. That was never a problem. Nobody ever had worries about that because the response was so phenomenal.

But guess what? That’s not where the problem is. The problem is outside the U.S. The problem is along the tropics, around the equator. The conditions are just so different. The development of societies and the sanitation levels and the degree of sophistication and the cold chain and the vaccine delivery system—so I have no qualms at all that almost an entirely new system for delivering polio vaccine had to be, quote, “invented” in order to achieve the same results.

But one of the big differences, though, was that in tropical areas, even if you delivered three doses, you were still way below, from an antibody point of view, being able to show that the majority of kids would have had antibody against all three types. As a consequence of that—and we actually showed this in some of the other studies we did where we actually looked at the seroprevalence of antibody, how much antibody could we measure in the blood after one, two, three, four, five, six, seven, and so on and so on and so on? All the way up to as many as thirteen doses. If you look at that dose response curve, it’s almost linear. What that means is, you don’t really hit the high nineties until you get past ten doses.

What it meant was that the U.S. or European routine schedule, it’s not going to work. If you want to use OPV, you’re going to have to give as many kids as you possibly can as many doses as you possibly can. Every opportunity, you should give them a dose. Layered on top of that are mass campaigns, national immunization days (NIDs). You want to also do that.

Why do you want to do that? Well, you want to do that because if you are vaccinated—if millions, or whatever the number is, big numbers of kids are all vaccinated at the same time, the vaccine virus can be transmitted from kid to kid, so you’re suddenly sort of awash. It’s everywhere. Poliovirus is everywhere. That’s another reason to have these mass campaigns. But think about that for a moment. Think about giving ten doses of OPV to every kid, everywhere, including kids who are hard to reach, who don’t live in accessible areas.

Now, you have to figure out with a vaccine that’s labile, heat-labile—so now you have to figure out, how am I going to get this child who lives way, way out in rural areas, no roads, but—

CRAWFORD: Seasonal flooding.

PATRIARCA: Yes, seasonal flooding, you name it. How are we going to get ten doses into those kids? You essentially have to end up creating this massive system of having to deliver ten or more doses to every kid, essentially every kid. You have a vaccine that doesn’t work very well, you have this major cold chain problem, you have the logistics of getting the vaccine from point A to point B and making sure that it doesn’t lose its potency. Once you finally get it there, you have the, shall we say, social and cultural things that go into whether or not that particular village or mother or whatever the case might be, whether you can convince those people to have their children vaccinated. You end up with a massive, in my opinion, massive vaccine delivery—I hate to use the word “problem,” but it is a problem to have to create these different operational and infrastructural things in order to be able to achieve this. Guess what? That costs time and money, and a lot of time and money.

This relates back to what I was mentioning earlier: wouldn’t it be easier if you only had to give three doses of OPV and one dose of IPV? Wouldn’t that be easier? I think it would be.

CRAWFORD: To return to chronology a bit, in 1988, the resolution was announced.

PATRIARCA: Yes.

CRAWFORD: You were at CDC.

PATRIARCA: I was.

CRAWFORD: At that point. This is before funding came through the [U.S President William J.] Clinton administration in the United States. Could you talk about that time and what you were doing and where the conversation was, and also about the artifact that you brought in?

PATRIARCA: Yes. Yes. Yes, so I have this artifact. This is a copy of the very first Consultation on Polio Eradication that took place in Geneva in September 1988. I was there. I have the notebook to prove it. I also have here a copy of the very first—literally the first Plan of Action for Global Eradication of Polio.

This was, obviously, a very incredible time because momentum was building, and there were concrete discussions among many organizations—all the key global organizations, quote-unquote, “got on the bandwagon.” There was a lot of support for this. It was really led by the success in the Americas, in particular, in Brazil. Even in 1988, following the outbreak that we talked about earlier about the type 3 outbreak in ’86, that had all blown over. The quote-unquote “problem” with the type 3 potency that was used globally, that problem had been solved, because the UNICEF [United Nations International Children's Emergency Fund] specification, WHO specification, now called for higher potency for type 3. There was a lot more confidence globally in all regions, and among all the interested parties, the interested donors, that—guess what? We can do this. Let’s go.

CRAWFORD: Could you tell the story of how you arrived at that meeting? How were you invited? Who invited you?

PATRIARCA: Well, yes. Part of the work I did, after having gotten, shall we say, my feet wet, literally and figuratively, in Brazil in 1986 with PAHO, was they needed somebody, WHO did, at headquarters level, somebody who had firsthand experience with the program in the Americas. There really wasn’t anyone from the PAHO system that was available at that time, so I was, like, a good, shall we say, second choice.

I actually started going frequently to Geneva from CDC, spending weeks at a time essentially organizing this meeting and preparing for this meeting within the context of the global program.

CRAWFORD: Were you working with [Ralph H.] Rafe Henderson [MD, MPH, MPP]?

PATRIARCA: Yes. Rafe Henderson was the head of EPI [Extended Programme on Immunization], as it was called at that time. He had responsibility over all of the entire program, which included, obviously, polio. He also had various staff members who were also there. There were people involved with the potency issue, so in other words, on the vaccine biologic side, there were people at WHO, who were concerned with that. There were also people who specialized in vaccine delivery. It was really sort of a consolidation of all of those groups of people, and then also interest on the part of other very important people who had had experience elsewhere in the world with polio—we were essentially all brought together for this meeting in 1988, and I was there.

CRAWFORD: You were asked to comment on the draft.

PATRIARCA: Yes. Yes. I did comment on the draft. One of the comments, one of the main comments I had, was that WHO in the EPI at that time was kind of an interesting position in the sense that they wanted to replicate the program in the Americas, which worked. They wanted to do that, but they couldn’t do that, because they didn’t have enough money or resources. Think about it. Think about giving every child in every country in every region ten or more doses of OPV. This plan really speaks to primarily the routine immunization of kids, which involves the typical schedule with three doses, to be, quote, “supplemented” by some of these other things, like National Immunization Days, like mass campaigns, like some of the things that had been done by PAHO. That was really the problem with this plan: all the right strategies were there, but from a practical point of view, there was a disconnect. The idea that you could achieve polio eradication with a, quote, “routine” immunization series that was not supplemented repeatedly—that was the other problem, repeatedly with mass campaigns in the style of PAHO, and Russia before that, and so on and so on.

That was the main problem. They knew that, but they couldn’t. I mean, they couldn’t, they couldn’t go to the donors with a grand plan that included, “Well, we have to give ten doses to every kid in the world, no matter where they are or where they live.” Can’t do that.

CRAWFORD: How did you know that they knew that?

PATRIARCA: It was mostly hallway [laughs] conversations. Right? This is our policy, but [whispering] this is what we think. That’s how it works.

CRAWFORD: Were there other people who you remember publicly pointing some of these concerns out?

PATRIARCA: Yes. Yes. There was, and actually still is, in different spheres of vaccination, sort of, shall we say, the “silent minority,” or people who rattle cages. There were other people besides me who rattled cages, one of whom was a guy named [William H.] Bill Foege [MD]. Another one, who actually continues, even to this day, playing a critical role in polio eradication, but who was, quote, “blackballed” for most of his time, is [T.] Jacob John [MBBS, PhD].

CRAWFORD: From India?

PATRIARCA: From India. It was actually Jacob John who showed, himself, in a series of elegant studies—a long time ago, in the ’70s and ’80s, he essentially proved, at least in the environment of India, that there was literally no way you could rely on a routine immunization schedule for children who lived in tropical regions such as the one that he did the studies in, which essentially was in Vellore, India. His argument was, if you think that you’re going to—just because you give three doses of Sabin’s vaccine to every child, if you think that that’s going to work everywhere, it’s not. He actually made that very clear. He also was interested in the role of IPV, in the same way that we were, so he also did studies looking at the combination of the two and was finding some of the same things.

At the same time, Bill Foege, in particular, was also confronted with essentially—in the literature and from speaking with people like Jacob John, and looking at some of the data that we at CDC were generating with our own studies—the three of us, essentially—another advocate, if you will, aside from Walt Orenstein, who publicly, I don’t think, could say that he was, quote, “with us,” but privately, I thought he did—but a public health official in Israel known as T.A. Swartz [MD, Professor, Department of Epidemiology and Preventive Medicine, Sacker School of Medicine, Tel Aviv, University, Israel], who actually invented the IPV/OPV combination schedule that was used in some areas of the Gaza Strip in Israel—all of us were on the, quote, “combined” approach bandwagon. We were.

We weren’t saying that it should be done that way. We weren’t saying that it would be easy. We weren’t saying that it would not be more costly. We weren’t saying any of those things. We were saying, “If you want the system to be more efficient, this is a way to do it.”

Once—and if—there was ever agreement for that, the rest of it becomes easier. What do I mean by that? After I left CDC, I’ve spent most of my career on the front end of vaccine development. How are vaccines made? What are their characteristics? How can you make them so that they’re more stable? How can you make them so that they’re more immunogenic, so you don’t have to give multiple doses? Things like that. Those questions—that I actually know a lot about now because I’ve been doing it for the last twenty years, almost. Nobody knew at that time—with IPV as an example, nobody knew how to make it cheaper, at higher yield, at lower doses, or add adjuvants, or any of the other things that are known now. But they could have looked into it as a parallel R&D effort.

CRAWFORD: Research and development?

PATRIARCA: Yes, research and development. That’s the purpose of research and development, is not only to develop something new that didn’t exist before, but it’s also, how do you make something good better? The technology existed. Yes, this was a long time ago, late ’80s, early ’90s, but the technology was coming into being that, had there been an R&D, a research and development effort to make IPV more cheaply, to make it more thermo-stable, to administer it through other means besides needle and syringe, had somebody paid attention to that or thought about it other than us, this small group, the entire eradication program could have been accelerated.

CRAWFORD: Were there alternatives to injecting inactivated polio vaccine?

PATRIARCA: The answer is yes, there were. It’s interesting to me that one of the things that has come out recently, like in the last ten years, which could have been done thirty or forty years ago, is to administer IPV intra-dermally. What that means is, you literally inject it into the skin. If you or anybody else who’s listening to this have had a skin test—

CRAWFORD: TB [tuberculosis]?

PATRIARCA:—for TB, that’s how it’s administered. The needle, it’s a small needle, it goes into your skin—not through your skin, into your skin. You make a small bubble, a bleb. That’s how the TB skin test works. Now, there are more modern TB skin tests now. There’s a blood test, all that stuff, but most people remember having that done. Well, guess what? You can deliver an inactivated vaccine in the same way, and one of the important, very important, series of studies that have been conducted recently, within the last few years, have been coordinated with WHO to look at the intra-dermal administration, just like a TB test, with IPV.

Guess what? That could have been done in 1990. Case closed.

CRAWFORD: But where was the conversation in 1990?

PATRIARCA: Well, the conversation in 1990 was, “We don’t want to hear this.”

CRAWFORD: Could you give an example of a meeting where that was communicated?

PATRIARCA: Yes. Yes, I can. There was a meeting in New Delhi, and I can’t—I should know, I should remember exactly what year that was, and now I’m blocking on it, but it was either ’91 or ’92. There was a meeting that was held in New Delhi to begin to talk about the possibility of having a combined schedule.

CRAWFORD: Who initiated the meeting?

PATRIARCA: Well, that was the problem—one of the problems. The meeting was primarily financed by a drug company, Sanofi [Sanofi, S.A., Société Anonyme]. Or its predecessor—it’s—I can’t remember. Like, Sanofi Pasteur, or Pasteur Sanofi, or whatever the—but basically, it was a French company. Sanofi was—it may have been the only, but I’m not sure about this, but it was one of the main providers of IPV. IPV at that time was not used in very many places. India, guess what, is a very populous country, right? Sanofi decided primarily to—and I can’t remember if they were the sponsor, but I know that they paid for most of the people to be there. The idea behind that was to introduce—not demand; introduce—concepts of why and how IPV could contribute to the eradication program.

For example, and following on to some of the research that I mentioned earlier that we did, CDC did, and that others did—so it was intended to bring public health officials, especially public health officials in India, where Jacob John had already shown that even if you give kids in India ten doses, guess what? They’re still not protected. India was the ideal place to begin to talk about this in public. It was.

As a result of that meeting—and to me, I mean, I remember giving a presentation at that meeting. My presentation didn’t consist of anything new; it wasn’t an argument that there should be a switch, “You must do this.” The message that I was trying to convey, and actually, most of the other people at the meeting were trying to convey, is that IPV could have a role. “This is how it could—,” not “It must.” It was presented in a way of, “Don’t you think we should think about this? Think about it, not dismiss it—think about it as a tool?”

This was also in follow-up to a previous similar meeting that was actually held in Jerusalem that talked about a similar subject. Essentially, does IPV have a role, a possible role, in polio eradication? The same people were there. It was essentially a replication. Those two meetings occurred in time within a year of each other, as far as I can remember.

What happened after that meeting was, in one word, nothing. Nothing. Nothing came of that meeting. Nothing. Well, I should qualify that. Something else happened. What happened to me, what happened to Bill Foege, what happened to Jacob John, is that, for lack of a more complete description, we were marginalized—all three of us were marginalized.

CRAWFORD: Can you explain what you mean? What that looked like?

PATRIARCA: Yes. What that looked like was being told directly, and I won’t say who here, but being told directly by multiple people—not including CDC, none of my supervisors, not Dr. Orenstein or Dr. Hinman. There was nobody at CDC who ever objected, as far as I know, to anything that I ever said or did. They were always supportive. That never happened.

But there were other people, who I won’t name here, who basically, in so many words, told me to shut up. “We do not want to hear this. We do not want to have people, especially scientists of your prominence—” So we’re talking—I don’t really put myself in the same category as Dr. Foege and Dr. John, but we were known, we were part of the global system. I was there, OK? I was there. Foege was not. Jacob John was not. I was. We were told, in so many words, to shut up. “We don’t want to hear this. You guys need to stop talking about IPV because we have this global eradication going on, and our vaccine is OPV, and our strategy is what was developed originally by Sabin, perfected by PAHO.” And they had a point here—further implemented in the Western Pacific Region [WPRO], so it was working there, too. It’s no small task to eradicate polio in China, let me tell you. That’s why. They pointed to all those examples as important. They were. Our point was, guess what? India is not the same. Guess what? Sub-Saharan Africa is not the same. That message was lost. They didn’t buy that. Basically, the three of us at least—there were probably more—me, Dr. Foege, Dr. John, forevermore after that meeting in New Delhi, we were marginalized.

CRAWFORD: Does that mean not included in meetings?

PATRIARCA: Yes. It means not included in meetings. That includes, “We don’t want to hear anything you have to say again anymore. Please shut up. We don’t want you to write any publications; we want you to get with the program. We don’t want to hear any more—any question.” It was not just an honest scientific disagreement, which is what we all have. We’re all scientists, all of us. That was what it was. We were asking questions—that’s all we were doing. We were not telling people, “You must do this.”

CRAWFORD: But the response you got, did that suggest that someone felt like you were pushing?

PATRIARCA: Yes, sure. Because it was really that timeframe, and this was around ’91, ’92, that people like us, people who question, who raise questions, who sowed any degree of doubt, who said anything that would scare off any of the donors—if we didn’t shut up, then eradication—it was almost like, “If you guys don’t shut up, we’re not going to be able to eradicate polio, so please shut up.” That was the message. The message got so loud in my ears that it—quite frankly, it was one of the main reasons why I ended up deciding to leave CDC and go work for some other part of the public health service, which first ended up being the National Vaccine Program Office [NVPO] for a short while, and then FDA [Food and Drug Administration]. That’s really the main reason why—that sort of pushed me over the hump of deciding to leave CDC, was the marginalization and what I perceived as the, not inability, but the refusal to hear any contradictory opinions or anything that could undermine or even question what was going on with the global program, which was now basically in full swing.

CRAWFORD: This would have been after 1991, after U.S. federal government provided $3.1 million?

PATRIARCA: Yes. Right. All the donors were on board. There was tremendous momentum.

CRAWFORD: When you say “donors,” who are you talking about?

PATRIARCA: Well, I’m talking about Rotary International. I’m not positive, but I don’t think the Bill & Melinda Gates Foundation was yet engaged. I don’t think they were. We’re talking about UNICEF. There were other countries, and I can’t remember the names of these places, but they were sort of the USAID [United States Agency for International Development] equivalent type organizations with other countries. I mean, and I can appreciate this. All those organizations wanted a common theme. “We want to support the eradication of polio. We think it should be done.” We collectively were all holding hands together, collectively think it should be done, in essence, like they did in PAHO. “This is the way it should be done. We’re behind it; we’re going to support it, and you’re either”—it’s like the old Ken Kesey, Electric Kool-Aid Acid Test [by Tom Wolfe]. “You’re either on the bus, or you’re off the bus.” I decided to get off.

CRAWFORD: Was there one particular event? How much time elapsed?

PATRIARCA: I mean, the big event was the New Delhi—if there was one event that really made a big difference, it was that. It was also when the whole program, both globally and within CDC—once the money started coming in that allowed the organization to be built, so the—at that time, the Division of Immunization, I think it was called, that Walt Orenstein was in charge of that, whatever the organization was called at the time [Division of Immunization, Center for Prevention Services, CDC], it changed names—that became a program-oriented activity. The research part that I was so interested in, they will tell you in retrospect, and even at that time, that there was still research going on. There was. Research about very practical things, like vaccine vial indicators that you could stick on a vial and you’d know immediately whether it was good or not. I mean, all that stuff is so important. But they didn’t want guys like me anymore. They didn’t want people who were interested in a better mousetrap. It was, “We have our mousetrap. It is good enough. Please shut up. We don’t want to hear about it anymore,” in parentheses, “If you don’t like it, why don’t you hit the road?” Full stop. The sort of small band of merry pranksters—me, [Robert A.] Bob Keegan [credential], [Robert W.] Robb Linkins [MPH, PhD], Mac [W.] Otten [Jr.] [MD, MPH]—this small band of people suddenly became this, relatively speaking, gigantic—it would get more gigantic as time goes on, this machine.

The machine was program-oriented. We are now going to do our job. Our job is to give as many doses of OPV to every child, every time, under any circumstances, any time we see them. That was the program, to flood the world by whatever means possible with OPV. That was the program. “If you,” they’re talking to me, “if you have other ideas, we don’t want to hear it. Go away.”

CRAWFORD: At this point, were you leading the Polio Eradication Activity [at CDC]?

PATRIARCA: Yes, I was. Yes.

CRAWFORD: Could you tell the story of how that began?

PATRIARCA: Yes. That began in—essentially around ’85, when Walt Orenstein and Alan Hinman asked if I would come back and do polio. I agreed to do that, so I came back.

That then led to a—literally almost a one-man show, i.e., me, going to investigate the outbreak in Brazil and figuring out the type 3 program and the vaccine potency problem, all that stuff. It wasn’t just me; I had a lot of support from—

CRAWFORD: Susan [E.] Robertson [MD] was one person?

PATRIARCA: Well, Susan Robertson ended up doing important IPV work in Senegal. She was actually involved with a researcher known as Philippe Stoeckel [MD], who unfortunately was affiliated with Sanofi. OK? Here’s the Sanofi connection again, OK? Senegal was an IPV user, because of its affiliation with France. The whole country, I mean.

CRAWFORD: Because those were vaccine-producers.

PATRIARCA: Right.

CRAWFORD: Or there were vaccine producers in France.

PATRIARCA: Right. Susan Robertson, actually, was part of a field evaluation of the clinical efficacy—not serologically—clinical efficacy of IPV.

CRAWFORD: Could you speak to the difference there and why that’s important?

PATRIARCA: Yes. The difference is, when you look at clinical efficacy, you actually compare people who get a certain vaccine—in this case IPV, not OPV, but IPV—versus nothing. Placebo. You then compare the incidence of polio in those two groups, so in the treatment group versus a control group. I’m pretty sure, but I don’t remember the details, I’d have to look up the publication that Susan had with her other colleagues in Senegal, but I may have misspoken when I said it was placebo controlled. It probably wasn’t, but it was organized in such a way that you could compare, for example, one dose with two doses versus three. Then you actually look at the number of polio cases, paralysis cases, that you have in these different groups. Well, she did that. What she found was that IPV, even in that situation—I mean, I’ve never been to Senegal, but I have been to Gambia and some of the other countries that are close by that have similar conditions—and that vaccine worked by itself. OPV was not used in Senegal.

You have the accumulation, then, of all these little different bits of pieces that, depending on where you sit—so if you’re, quote, “on the bus,” you bring up all the OPV stuff; if you’re off the bus, you acknowledge, at least, we would like to think—our little group of merry pranksters acknowledged, yes, Sabin’s vaccine is great. It’s wonderful; it’s fantastic. It got rid of polio in Brazil, wow. It’s wonderful. But guess what? It’s probably not going to work that well everywhere. That was our whole point. It was not “OPV is terrible, throw it away, we should convert to IPV. We should have a bonfire with all of Dr. Sabin’s work we should just burn it to the ground.” But that’s how we were perceived and treated. That’s what bothers me. It wasn’t just me, it was Bill Foege who was treated the same way. That shouldn’t happen.

CRAWFORD: Was [Donald A.] D.A. Henderson [MD, MPH] also around?

PATRIARCA: Yes. D.A. Henderson was actually the chairman of the TAG, the technical advisory group, for PAHO. Yes, he was there. It’s funny you should ask about that, because I actually—believe it or not, I didn’t even think about it until now—I never once ever heard D.A. Henderson say anything about IPV, ever. Whether he thought it was good, bad, or indifferent. I honestly don’t remember him talking about that.

CRAWFORD: That’s interesting. I remember reading a comment in my prep for this interview, where Donald Ainslie Henderson said that better technology would be needed.

PATRIARCA: Oh, yes. Yes.

CRAWFORD: Had you heard that, as well?

PATRIARCA: Yes.

CRAWFORD: I think I read it in a paper by Bob Keegan.

PATRIARCA: Yes, that’s right. Yes, thank you for reminding me. Yes, that also reminds me. We talked a little bit earlier about the first meeting in 1988 about global eradication. I will never forget what D.A. Henderson said. What he said in public at that meeting was, “We will not eradicate polio with this vaccine,” and “this” referred to Sabin, the oral polio vaccine. Henderson was not, I would say, a member of the bus people. He was not on the bus. Now, I said a few minutes ago I never heard him say anything, one way or the other, about IPV. That part is true. He never, unlike me, Dr. Foege, Dr. John—I mean, we actually talked about it. I honestly don’t remember him ever saying anything, either pro or con, about IPV. I just don’t remember.

CRAWFORD: Interesting. Two follow-up questions: were people talking about issues with IPV production and shortage of vaccine at all?

PATRIARCA: Yes. That’s actually a very important thing which I haven’t even talked about. The problem, one of the main problems at that time with IPV, is that it is unquestionably far more expensive to produce and to commercialize than the Sabin vaccine. There’s no doubt about that. That was one of the things, and rightly so, that the people on the bus kept talking about. “We can’t use IPV because it costs too much,” and all the other things: it’s hard to administer, it’s injected, all that stuff, which is all legitimate. But that’s a technical problem that was eventually solved, in the not too far-distant future from the late ’80s, early ’90s. There are manufacturing methods that have since been developed that have brought the cost of IPV way down to the point where, guess what? It’s now being used. Is it still more expensive than OPV? Well, sure it is. It involves a lot more steps. Purification and concentration and all these highly technical manufacturing things. It’s hard. It’s hard to make.

Yes, that was discussed. Yes, that was always recognized as a limitation by me, by Foege, John, and others. But our point was, guess what? Technology changes. New manufacturing processes are developed. There are a lot of big vaccine companies that do this for a living. Maybe they’ll figure it out. If they do figure it out, don’t you think we should think about it as a possibility? That’s all we were saying. We were not pounding drums. We were not renting those airplanes that you see on the beach with the big flag behind them. We weren’t doing that. We were [whispering] asking questions. That’s all we ever did. That’s it.

CRAWFORD: Which is part of your responsibility in the profession, right?

PATRIARCA: Yes, that’s right. Yes.

CRAWFORD: What about mucosal immunity? What about that argument?

PATRIARCA: Well, mucosal immunity is important, it is. OPV is better, it is. But it’s a matter of degree. It matters to your perspective. What is your perspective? Well, my perspective, my own personal perspective, is I don’t ever, ever want any child anywhere in the future to be paralyzed. That’s what I don’t want. To me, that’s my goal. Now, that’s not the same as—which may happen; I mean, it really is the goal to literally eradicate polio, so that it can’t even cause any infections. But to me, until you get there, the goal should be [that] no child should ever be paralyzed. To me that’s number one, always number one.

Could you eradicate polio with IPV? Probably not. I don’t think you could. It’s not just me; the literature supports that one of the clear advantages of OPV, shown in multiple different ways—scientifically, animal models, you name it—is that mucosal immunity, the secretory immunity that’s produced in the gastrointestinal tract, can unquestionably reduce—not eliminate, but reduce—the transmission of polio from one person to the next. It’s a real thing. Is it one hundred percent? No. Does it mean that IPV has no effect whatsoever? The answer is no. It’s all relative. But to me, it’s really—that is a critical difference between OPV and IPV.

Even today, I would never advocate IPV alone until there is no wild polio anywhere, OK? Only then would I personally agree, and scientifically agree, “OK, we’re done with OPV. It’s all IPV now, because there is zero—no, wild polio anymore. It doesn’t matter whether you have secretory immunity. It doesn’t matter.” I never, ever once ever even thought that you could get by with IPV only. That was the other thing that Bill Foege and I and Jacob John got flak for, because the implication was that we thought OPV should be trashed and replaced by IPV. No, we didn’t say that. We never did. Nobody ever said that.

CRAWFORD: You’re asking all of these questions. How did the marginalization impact you, personally and professionally?

PATRIARCA: Well, the marginalization ultimately had positive effects. Here’s what happened. As I became more and more and more uncomfortable in my position as the, quote, “leader” of the little tiny—like, five people—group that we had, as I was sort of increasingly being told—not by Walt Orenstein or Alan Hinman, but by the, quote, “global community”—

CRAWFORD: In 1991, 1992?

PATRIARCA: Right. Basically, the world—not CDC, the world community—basically said, “Shut up, we don’t want to hear from you anymore,” including the people in Geneva. Nobody wanted to hear me anymore. Then what’s the point of staying? I thought what I had done—not personally, but in terms of coordination and all the stuff we did—I mean, we did training programs, we literally developed the first computerized surveillance systems for polio. This was not the year 2018, where there’s a PC [personal computer] on everybody’s desk. That’s not the way it worked. When suddenly people treated me as though they didn’t want me around anymore, OK.

CRAWFORD: How did that feel?

PATRIARCA: Well, it felt horrible. It felt horrible. Ultimately, right around that time, I started looking for other positions within the public health service. I had just gotten remarried to somebody at CDC, who was very interested in getting a lab position somewhere, and there were no lab positions at CDC, but there were at FDA. Bingo. Where’s my train ticket? I’ll see you later. Bob Keegan had a party for me, and he gave me, which I still have, a baseball, because I’m a baseball fan, with signatures of—everybody who cared about me signed that ball, and I still have it.

CRAWFORD: Who’s on that ball?

PATRIARCA: Well, Keegan was the ringleader. Everybody who respected me, and who I respected in turn. I mean, I have a vivid memory of my going-away party, and it was one of the saddest days of my life because I was not going to be able to work with these people on a day-to-day basis anymore. They insisted on having a party for me. I didn’t want one. I ended up telling them that I was going to refuse to go, so it was actually partly a surprise party. It was a sad day because of that.

After that, guess what? I’m an R&D guy through and through, so I go to FDA, and guess what? Guess what I do? I learn about the front end of vaccine development.

CRAWFORD: How’s that different from what you’ve been doing?

PATRIARCA: Up until then? Well, I was on the back end. My career at CDC was devoted to vaccines that already existed: they were already approved, they were already used, so the focus is on, how do you use them? How do you use them better? Which is a lot of the things I was most interested in. If there is a vaccine that’s on the near-term horizon that’s going to be approved for the first time, how are you going to use that? Do you have the systems in place to make sure that it’s continually going to be effective when it’s actually used in the field under real-world conditions? Do you have an immunization system in place to make sure that people know how to use it, when to use it, who should they give it to, who shouldn’t they? All that stuff, all the operational stuff. I switch from that to the front end, which is vaccine development from square one. Products that have never been tested in people yet, only in animals. How do you get those from there to licensure?

That’s what I’ve done for the last—well, since the early 1990s. That’s all I’ve done ever since.

CRAWFORD: Have you had any contact with the Bill & Melinda Gates Foundation?

PATRIARCA: Yes. In fact, I’ve been a reviewer. As you can imagine, somebody with my background has been a reviewer for some of their programs. One of the programs that I was involved with is a program which, in my opinion, should have started in 1990. That has to do with literally new-generation, never-tried-before ways of making an oral polio vaccine that will work after one, maybe, dose, or two or three, and not ten or twenty. I was involved with that. I’ve been involved as essentially a scientific reviewer for some of their other programs, including—we talked about this a little bit before—the use of what are known as microneedle delivery devices, to deliver a vaccine intradermally, using these needles that are so tiny that you can’t see them. This literally, this thing that I’m talking about, literally looks like a Band-Aid. It can be administered under essentially room temperature, or even tropical conditions. You walk up, you hold your hand out, you get this thing that’s about the size of my fingertip and looks like a Band-Aid, literally looks like a Band-Aid on top of your skin. You let it sit for ten minutes, or sometimes five. You take it off, and you’re vaccinated.

CRAWFORD: That’s in development now?

PATRIARCA: That is in development now. One of the developers of that is right down the street from here at Georgia Tech. Georgia Tech Department of Engineering. You should go talk to them.

CRAWFORD: That would be interesting.

PATRIARCA: There are other companies besides them, but yes. Any of the things I just mentioned, none of them are rocket science. They could have been, had somebody been interested and had financial backing or a grant mechanism—all of these things could have been invented twenty years ago. They could have, but nobody was interested.

CRAWFORD: I’ve heard it said that the program has been shaped very much by the timing of funding, and when funding has come in.

PATRIARCA: Oh, sure. Yes.

CRAWFORD: Well, in December of 1988, there wasn’t a lot in place.

PATRIARCA: Right.

CRAWFORD: I mean, the Rotarians had raised $247 million, and that was in place, but it sounds as though it would have taken a lot more than that to launch some of these technologies.

PATRIARCA: Oh, sure.

CRAWFORD: But it also sounds like that was not being discussed.

PATRIARCA: No. No. Once there was a plan, once the plan said OPV, once the plan said, “Give as many doses as you can,” once the plan said, “Give it routine, give it National Immunization Days, give it,” quote-unquote, “‘mop-up.’” Boy, I hated that term. The PAHO term for “mop-up,” where they would essentially have missed whatever neighborhoods or cities or whatever, so you’d have to go back in and vaccinate them again—

CRAWFORD: What makes you hate the term “mop-up”?

PATRIARCA: Well, a lot of reasons, but maybe the main ones—I just don’t like the term. It almost has the term of, like, an afterthought. Like, it’s somebody who sweeps the floor after some big event, and what they’re doing is not really that important. I don’t like it because of that. It’s derogatory. That’s number one. Number two, to mop up—I mean, the intent was to go back to places that were kind of hard to get immunized in the first place. In other words, people would have a campaign, and some places would do great and some wouldn’t, and some of those areas would then go back and have polio. The occurrence of polio certainly was a red flag, so the mop-up places would involve things like that. But that was a term that was developed mainly by Ciro [C.A.] de Quadros [MD, MPH]. He invented that, he called it that, and it just continued onwards.

I just never liked it, because it never got to the heart of the matter. The heart of the matter is—to me, it was so simple. If you use OPV, you have to give ten, fifteen, twenty doses, period. Is there a better way, an easier way, to do that? What is it? How much would it cost? How does that cost compare to giving every kid in the world ten or fifteen or twenty doses? Is there anything about the product that you could change that would reduce costs in other areas? Maybe it could be thermostable, so you don’t have to have a cold chain, which, by the way, exists. Maybe it could be having Elon [R.] Musk develop all these drones that could go in and do—I mean, you can think of all these crazy things, but my point is, nobody talked about it except me and a few other people, and nobody cared about it, and nobody thought that it was worth making those investments. “We have everything we need. Go away.”

CRAWFORD: Let’s not talk about technology.

PATRIARCA: Right.

CRAWFORD: Looking at my list here, I wanted to get some more description from you of your role in the funding request in the early ’90s, and really go back to the beginning of the story.

PATRIARCA: Right. Yes. The people who worked on polio in the early days, in the mid-1980s—and I’m only talking now about Walt Orenstein’s group, the National Immunization Program [NIP] or whatever it was called at the time. I’m not talking about the lab guys. We obviously interacted with them, but we were under a different support structure and all that.

CRAWFORD: It was fairly fragmented, is the way Bob Keegan described it.

PATRIARCA: Yes, and it was. Uh oh, I lost my train of thought. The theme was—?

CRAWFORD: The beginning of—the story leading up to the funding request.

PATRIARCA: Oh, right. We were a ragtag group. We were all part of the NIP—

CRAWFORD: National Immunization Program?

PATRIARCA: National Immunization Program. Most of the guys I worked with were part of my—it was called a section. It was actually a subdivision. My section was called the Epidemiologic Research Section [NIP, CDC]. We had, like, five or six people, and we had the best job of anybody in the whole NIP, because we were doing research. Everybody else was doing program. We got to investigate outbreaks; we got to go out in the field; we got to go travel—we got to do all the fun stuff.

The polio group did not exist. There was no money for polio. Basically, what I did is I begged, borrowed, and stole from every place I could to create the equivalent of a polio unit. What do I mean by that? Well, there was a guy named Robb Linkins. Robb is basically a statistician, is what he is. He’s a computer guy. In those days, nobody knew how to use a computer or to do statistical programming or S.A.S. [Statistical Analysis System, S.A.S. Institute, North Carolina, USA] or any of that stuff, but he did. We grabbed him, pulled him over, talked to him real nice: “Robb, in your free time, do you think you could do this, that, and the other?” “Sure.” There was Robb, there was a guy named Robin [J.] Biellik [DrPH]. Robin Biellik was the world’s greatest field investigator. What do I mean by that? A guy who will go out and collect epidemiological information and analyze it in the most beautiful way you can imagine. He did that entirely on his own. “Robin, there’s an outbreak of X.” It wasn’t necessarily polio. In one case, I sent him to Wisconsin to investigate an outbreak of pertussis. He did the world’s greatest field investigation of an outbreak of pertussis.

We had him. We had Mary [R.] Reichler [MD], who was probably the most technical and most sort of epidemiologically-oriented person in the group, who thought of different ways of analyzing information that nobody else had thought of. Well, that was before Keegan. We had Mac Otten. Mac Otten, his claim to fame is that he is the first guy in the United States government in any agency who was allowed to buy a Macintosh computer.

CRAWFORD: Tell me about that. Computerized surveillance—are those connected?

PATRIARCA: Yes, they are. Mac Otten, which, maybe that’s why you like Macs [Macintosh computers] was one of the first sort of natural computer aficionados who I ever worked with. This was, again, back in the ’80s, when personal computers were a new thing. Mac Otten was really the only guy in the group of—within whatever it was called, the National Immunization Program, who was a computer whiz. This was back in the day when PCs were rare. You had to beg, borrow, and steal one to be able to use it. Mac was the first guy, I’m told, the first guy in the U.S. federal government who was able to procure, legally, apparently, a Macintosh computer. Not an IBM [International Business Machines]. Back in those days, they were only IBM. The reason why is that Mac eventually, shortly thereafter, would actually end up being CDC’s representative in the field in China. Mac wanted a Mac computer, because he was also a graphics guy. He actually figured out—he did it himself, he did not use software—but he created graphics software to map China. Every province, every district. He went out in the field, or he got people to bring it back, surveillance data for polio that went back to recorded time. He created maps of incidence rates for polio throughout China for the last, whatever it was—thirty, forty, fifty years. He did that.

CRAWFORD: This is the first I’ve heard about it.

PATRIARCA: Yes. There was him. Who else? I’ve talked about the major actors, other than Keegan, but Keegan—my recollection, maybe I’m wrong—he was actually on the polio payroll. I think he was. I did hire him. It’s possible that I hired him when I was still the head of what was known at that time as the Epidemiologic Research Section. That’s possible. But now that you mention it, I’m not sure.

But Keegan was basically the guy who made everything happen, under any circumstances, at any time, for anything. He was incredible. [Emotion]

CRAWFORD: Could you give some examples?

PATRIARCA: I’m tearing up now because—because he—he was also my friend. [Emotion] He died from cancer prematurely, a few years ago. [Emotion] I’m sorry, I can’t help myself.

CRAWFORD: Not at all.

PATRIARCA: OK. I’m sorry. What did you want me to talk about with Bob?

CRAWFORD: Some Bob Keegan stories.

PATRIARCA: Yes.

CRAWFORD: That’s OK.

PATRIARCA: Keegan. I taught Keegan a few things that he actually took to heart. The main thing that I taught him was that Rotary mattered. This was before some of the huge—I mean, by that time, they had a lot of money in the game, but it ended up being sort of the early days of that. But what I could recognize is that they, Rotary, were really getting behind in a big way the whole idea of the polio eradication program, and that we, CDC, better do everything possible to make sure that we acknowledge them: we know their importance; we want to bring them to the table; we want to keep them in the loop. I was the one who recognized that, so I made it a priority to go anywhere they wanted me to go. I actually gave seminars for—not only at the corporate level, which is in either Evanston [Illinois] or Chicago [Illinois] or someplace, but also these little itty-bitty chapters. I used to go on the road and do these little—essentially dog and pony shows on polio for Rotary.

CRAWFORD: Could you tell me about one of them?

PATRIARCA: The one I remember most, because it was local, was in—somewhere around Atlanta, Kennesaw [Georgia], or something. There was this little bitty, almost like a lodge that I went to. I came in, and I had my slides with me, and they didn’t have a slide projector, so there wasn’t a way for me to make the presentation, so I had to wing it, and I had to—I hate to say this, but it’s true—I had to dumb it down. [Laughs] I had to explain in lay terms, “This is polio. This is what it’s all about. These are the vaccines. This is what we hope to do. This is why your help is so important to us,” blah-blah-blah. I remember that one more than any other. I only did, I’m going to say—I mean, I’m making it sound like I did this all the time; I didn’t. I probably did it like five or six times. But I did convince Keegan, and he always took it to heart, that Rotary was on his side, and if he ever wanted to do anything for any reason related to polio, he should bring those guys on board. Make them a part of this. They’re not just a wallet full of money; they’re interested in this, and they want a stake, and we knew it at the time: they’re going to be in it for a long time, and they’re going to be spending a ton of money. A ton. The initial stake, which they thought was huge—and it was huge—but it was nothing. Drop in a bucket.

CRAWFORD: What was your first contact with Rotary?

PATRIARCA: It was with [Edward] Ted Trainer [DrPH, MSPH]. Yes. I like Ted. I mean, he was a smart guy. I could talk to him. He and I, I mean, we drank beer together. He was somebody that I could really relate to, and he was—he took his job seriously. I mean, he was the polio—whatever his title was, coordinator or whatever it was called. He took it seriously, I took my job seriously, and we kind of made a good pair.

We developed a rapport, and what I knew he knew, and what he knew I knew. If I had, shall we say, logistical questions for him, like, “Gee, Ted, we’re thinking of maybe doing x in China. What do you think about that? Do you have any advice?” I may have even talked to him about some of the things that Mac Otten wanted to do with surveillance, essentially, computerizing all this incredible information that was available throughout China that ultimately became this gigantic surveillance system. That’s kind of what I remember. I don't know if that’s very helpful, or if you want me to elaborate on anything.

CRAWFORD: I’m interested in the opportunities that were available for Rotary and CDC to really work together at that early moment.

PATRIARCA: Yes, so that was mostly informal, I would say. During my time, at least—and that was really before—my time was before the quote-unquote “big” operation, with hundreds and maybe even thousands, I don't know. This was back in the early days.

CRAWFORD: How did you meet Ted Trainer or know that Rotary was involved?

PATRIARCA: Even though a separate polio activity didn’t exist at the time, beginning in 1985 or ’86, I was the polio guy. That means even though what I really wanted to do was research, like we already talked about, guess what? I had other responsibilities as assigned. I was assigned—and I didn’t mind; I enjoyed it. I did all kinds of different things. I had all kinds of different hats on. I was the field epidemiologist; I was the guy who went out and did training courses in WPRO [Western Pacific Regional Office of the WHO]. I went to Geneva and represented CDC at these polio meetings. Whatever you want me to do, I’ll do it. That’s what I did. I did the work of like ten different people until I could hire ten people to do all this other stuff. By that time, by the time we got ten people, we also had money, and when we had money, we had the—what we already talked about before, the momentum to implement—vaccinate every kid as many times as you can everywhere with OPV. Once you had that system, it didn’t matter what I thought anymore. I left.

CRAWFORD: Later, worked on polio as a reviewer.

PATRIARCA: Right. That’s right.

CRAWFORD: Things that we have not talked about—what have we not talked about that you think is important? Because we’re a bit over time. I want to be respectful of that.

PATRIARCA: Yes. Let’s see.

CRAWFORD: You mentioned the Gambia. I was wondering if there was anything there to talk about.

PATRIARCA: Not really. I mean, I’ve been there. The Gambia was one of the sites we had for the OPV trial, field trial, that we did with the different formulations that we talked about earlier. They were one of the sites. The Gambia also had an outbreak in—I’m pretty sure it was in the mid-’80s. That outbreak was not handled by NIP. It was handled by the Office of International Health [CDC], and it was handled by Mac Otten and Michael [S.] Deming [MD]. There was kind of a weird thing—you should maybe look into this. There was a weird thing, which I never understood, where it was almost competition between two different places at CDC. One was NIP—that was me; I was the polio guy—but there was also the International Health Program Office, IHPO. I can’t remember who was the head of it, but Orenstein would know. There were epidemiologists there, including Michael Deming, Mac Otten, whose name I mentioned before, Steve [T. Stephen] Jones [MD, MPH]—that’s another name. Steve Jones was actually the first guy to go to Brazil to investigate the type 3 outbreak that we already talked about, but—and I’m not knocking him at all, because he’s not a vaccine guy—but he actually was the first one that PAHO called, because of the International Health Program Office. The reason why I got involved was because Steve Jones waved a white flag and said, “Sorry, I’m not a vaccine guy. You should get somebody else.” That’s how I got involved.

CRAWFORD: That redirected it?

PATRIARCA: Yes.

CRAWFORD: The story of writing the request—is there a story?

PATRIARCA: The story is pretty simple. I wish it was a really good story. It really isn’t. The story is there was a guy named Phil [Philip R.] Horne. I don’t remember what his title was, but he was basically—I call him the “head honcho” of all the financial stuff that goes on in NIP. In a private company, he would be the chief financial officer, the guy who manages the books. As I remember this, there was—and I don't know the details, I don't know who asked for this, but somebody in [the United States] Congress asked for a proposal from CDC to support the eradication program, and so Phil Horne, the guy I just mentioned, as he always did, wrote the first draft, which basically said, in so many words, “Hi, we need—” whatever the number was; it was three million bucks for polio, and “this is what we’re going to do with it.”

The reason why it came to me is that there are two—and it sounds like I’m bragging, but you’ll have to trust me that I’m not—there were two people in NIP who were phenomenal writers. The most phenomenal is Alan Hinman. The second most is me. Alan Hinman was not there, I remember that part of it. He was not there to rescue Phil Horne. Like every other request, “This is due by 3:00 P.M. today,” or whatever the number was. I remember Phil Horne coming into my office and saying, “I’m sorry to bother you, but we need you to write this.” I did. Next thing I knew it was approved.

CRAWFORD: What did you add to it?

PATRIARCA: I mostly added technical stuff, like, basically in so many words, WHO wants to eradicate polio. CDC was in fact part of the technical support for the eventual WHA [World Health Assembly] announcement, and whereas CDC, NIP has the expertise to do this, that and the other, and whereas—I mean, I’m saying “whereas” as though it were a legal document. But it was all the reasons why: “number one, polio eradication is important; the United States needs to participate. It will benefit the U.S. in the following ways; plus, guess what, we know what we’re doing; plus, guess what, we want to do this. Therefore, please give us money. Thank you very much.” Essentially, that’s what it said. I was good at writing. I’m not going to say that it was malarkey, but it was kind of, sort of malarkey is what it was. I wrote it. I don’t even remember what it says.

CRAWFORD: Where did it go from you?

PATRIARCA: It went to Phil Horne. It went to—and I should know this, but I forgot who the head of CDC was at the time.

CRAWFORD: [James O.] Mason [MD, MPH, PhD]?

PATRIARCA: Yes.

CRAWFORD: Jim Mason.

PATRIARCA: Jim Mason. It went to Mason’s office. I was told that they made no comments. It went to HHS [U.S. Department of Health and Human Services], and the next thing I heard is—be careful what you wish for—we got it. That’s when polio became official. We had our own little group. [Stephen L.] Cochi [MD, MPH] eventually—Steve Cochi ended up joining us, and then he took over for me. When I left, he essentially took over for me. Everybody was happy, because Steve Cochi is most interested and does the greatest job with the two things that I don’t really like. One is surveillance, and the other—I like the mechanics, or designing a surveillance system, but I don’t like the actual carrying it out and looking at the data and all that stuff. I don’t really care about that, but Cochi does. He’s great at it, too. The other is the program. How and where do you get your vaccine from point A to point B? The actual deployment and all the program stuff. How do you motivate people in different countries, different ethnic groups—how do you motivate them to seek vaccination out? How do you get them to participate in national immunization days or “mop-ups?” Cochi is great at that stuff. He was definitely, definitely the guy to take over from me, and he has done a wonderful job. Wonderful. I’m glad that he took over, because I don’t really—I’m selfish. I don’t like to do that stuff.

CRAWFORD: Any final thoughts, or anything we’ve left out? Anything you would include in a second interview?

PATRIARCA: The only thing I would include, but it’s just me, and I don't know if it would work, is “Where are they now?” To me this interview, in a way, was “Where is Peter now?” because nobody talked to me for twenty years, or whatever it is, after all I did. I mean, I was only brought back to CDC once before I left. That really disappoints me. I thought I did enough to where people would value what I had to say, and I was brought back for a couple of things, but they weren’t really CDC things. They were more Task Force [for Global Health] things, because of my relationship with Bill Foege and Alan Hinman and all that. It’s disappointing. I’m really disappointed by that. I’m sure there were other people besides me who were part of, quote, “the early days,” in other countries, who aren’t part of it now.

That’s all. That’s what I would do, bring back—but it wouldn’t just be CDC-focused. There are other people like me who sort of came and went who were big players at one time in polio that kind of dropped out.

CRAWFORD: Be interesting to find out what happened there and where they went.

PATRIARCA: Yes.

CRAWFORD: I’m so grateful to you for coming down to Atlanta.

PATRIARCA: Yes.

CRAWFORD: Thank you so much.

PATRIARCA: Yes.

CRAWFORD: If it would be OK, is it OK to follow up with questions via email?

PATRIARCA: Yes, sure.

CRAWFORD: OK, great. We’ll close for now, but I might request a second one. We’ll see.

PATRIARCA: OK. All right.

CRAWFORD: Thank you.

[END OF SESSION]