Kevin Malone



TORGHELE: It is March 28th, 2018, I am Karen Torghele, and today I'll be talking with Kevin Malone for the Global Health Chronicles Oral History of Polio Project. Mr. Malone is a Senior Attorney in the Office of General Counsel at the Centers for Disease Control and Prevention [CDC]. He has been the legal counsel for CDC's Immunization Program and the Advisory Committee on Immunization Practices for 30 years and is the Office of General Counsel's Team Leader for CDC's Global Health Programs. He is also the first attorney we have interviewed for this segment of the Global Health Chronicles. Welcome, Mr. Malone and thank you for being here.

MALONE: Hello Karen, it's nice to be here.

TORGHELE: So, to start, would you tell us a little bit about your background and how you came to be working at CDC all these years?

MALONE: Sure. I grew up in Kansas, in the heart of the country and wanted to see 00:01:00what the coast was like and went to college then out on the west coast. And my dad said okay, well you can go out there, but you need to get residency and so I ended up working at the UCLA [University of California, Los Angeles] Medical Center on the Pediatrics ward for a year and became very interested in medical ethics during that time. There were a lot of new procedures, CAT [computerized axial tomography] scans were new, bone marrow transplants were still in the experimental phase and so it was very fascinating, particularly in the context of children--to see how those were implemented and it just really got me very interested in health care in general. My college major then at the University of California, Santa Barbara was in Environmental Studies, which is kind of a similar thing to public health.

Later I went to law school at the University of Kansas and upon graduation moved to Atlanta where I became legal counsel for the Georgia Department of Human Resources where I worked on licensing of medical facilities. Later, I went to 00:02:00grad school at the University of Michigan School of Public Health where I received a master's degree and came back to Atlanta. At the time, I had done only government work so I was really looking to be out in a private law firm or potentially in-house counsel at a hospital and so I actually didn't apply for a job at CDC. However, I answered the phone one day, and the General Counsel's Office from CDC was on the phone, offering my wife a job interview. She had a lab background, had graduated from law school recently herself, had applied for a job at CDC, but by that point, already had a job. And so, quick on my feet, I turned that into a job interview for me, which I later was told that the ability to turn the offer for her to interview into a job interview for me probably 00:03:00helped my standing a little bit. I ended up getting a job at this incredible place that is CDC, and I've been here 30 years now.

TORGHELE: And at the time--what year was that?

MALONE: That was in 1987.

TORGHELE: How many other lawyers had worked at CDC around that time?

MALONE: CDC first got lawyers around the late 1970s, I believe. And we were kind of continuing to grow. By 1987, I was the seventh lawyer hired-- another lawyer had been hired earlier that year. Effectively I was actually the lawyer for most of CDC. It was a much sleepier place, if you will, back then. We had people who specialized-- AIDS [acquired immunodeficiency syndrome], of course, was very big by then so we had an AIDS specialist lawyer. We had a NIOSH [National Institute 00:04:00for Occupational Safety and Health] lawyer, we had environmental lawyers with the development of ATSDR [Agency for Toxic Substances and Disease Registry] and other environmental things, and then, basically, everything else, infectious diseases, immunization, quarantine, I ended up taking on. And it wasn't 00:05:00overwhelming, though, because at the time, people didn't naturally think to reach out to the lawyer for things and CDC was not big in the news. And so--

TORGHELE: So, there were seven--seven lawyers when you first started in 1987?

MALONE: Correct.

TORGHELE: You were the seventh.

MALONE: I was the seventh, and most of the other folks then were basically specialists. Then I became the general lawyer for the agency. As I said, it was a sleepier time then, and there weren't a lot of controversial legal issues. But I quickly picked up the Immunization Program, and it became truly the focus of my career over the last 30 years. And also--so I gradually ratcheted back my portfolio, but always kept immunization and then in the last decade have picked up global health law work as CDC's international presence has changed, and I've become the Team Leader for the Global Health Law Team.

TORGHELE: So how would you describe an everyday work experience for you? Like, what kinds of things would you do? What were you tasked to do?

MALONE: Well, a lot of it has had to do with statutory interpretation. Over the last 20 years, in particular, the Vaccines for Children Program came along in 00:06:001994-- our office helped to draft the statute for that. It's the largest--makes CDC the largest purchaser of childhood vaccines in the United States, purchasing over half the childhood vaccines used in the country. And so, as that program came into existence and then has matured over the years, there has been any number of questions dealing with immunizing many, many children around the country through that program.

TORGHELE: Before you started working at CDC, what did you know about it as an organization?

MALONE: I think I first heard of CDC during the Legionnaire's disease outbreak. I was in law school during that outbreak, and I later attended a conference in New York City. Within a year or two after that where there was also an outbreak of Legionnaire's disease and it kind of heightened everybody's interest in well, what's going on? What do they know about that? And so, it kind of grew from there-- I started paying more and more attention over the years then. And then, of course, moving to Atlanta in the early '80s, it was already a prominent institution here. Although, it's funny how you think that it's better known than 00:07:00it perhaps is, a lot of people probably to this day, have no idea that CDC is a federal agency, for example, part of the Department of Health and Human Services. I remember going to parties and introducing myself with the acronym that I work at CDC and folks a lot of times would say oh, Control Data Corporation? So, it kind of gave us our comeuppance, I guess around here. But of course, in recent years, particularly after 9/11, the CDC's prominence in our society and people's awareness of it, in general, has certainly expanded.

TORGHELE: There at the time too in the '80s when you came were there any political--was there any political impact on the work that you did? I know there were some politics involved with AIDS, but was there in the specific work that you did?

MALONE: You know one of the interesting things about working at CDC is it's the only federal agency that is headquartered outside of Washington, D.C. And I 00:08:00think. As a result, there's a lot less politics if you will, that happens here. People can do their public health work without really having any kind of pressure from the political side. And I think that that's led to a lot of the achievements actually at the agency by being able to focus truly in the public health arena.

TORGHELE: I was also curious about what you might have had to do with media relations. Did you have to go over things that people said in interviews before they talked to the media?

MALONE: We did have close contact with the media relations folks, a guy named [Donald A.] Don Berreth, who was one of the great old lions of CDC, was certainly a regular presence in our office, as we were in his. As we basically helped people to respond in a way that made sure then that politics was not 00:09:00involved in their decision and then to the extent that anything of legal significance that came up that it was dealt with.

TORGHELE: Can you now talk a little bit more specifically about polio, when you first started to get involved with that and what that was like for you?

MALONE: Sure. Polio then, certainly by 1987, polio and the vaccines that came about, IPV [Inactivated Polio Vaccine] and OPV [Oral Polio Vaccine], were well 00:10:00established-- people were regularly taking it. And so as often happens with vaccines or with the--well, what happened then with vaccines is that we went from folks, like I'm 62 years old and I stood in line when I was a child around five years old I believe to get my first--or maybe a little bit older, to get my first oral polio vaccine on a little sugar cube at a public school. I remember I think that they called them Sabin Sundays back then.

And you know, I certainly was well aware, I had neighbors who had had polio. Everyone was well aware, even at my age, were well aware of the risk of polio. And so, folks, in general, were pretty amenable to the introduction of 00:11:00vaccination mandates over the years. And then, over time, you find that we reached the point in society where the impacts of the diseases themselves that are vaccine-preventable have been diminished because these diseases. Thankfully because of the creation of vaccines, have been incredibly reduced in their incidence in the United States so that almost any vaccine-preventable disease that exists and for which folks are immunized routinely in the United States, there are almost no cases of that anymore. And so, then what you had come up is that people started to focus more on the adverse events from vaccines. And that's actually where the legal side truly picked up, I would say-- is that with polio, in particular, you had VAPP, Vaccine Associated Paralytic Polio, where the vaccine itself is not totally safe, and it actually ends up causing some amount of polio in both recipients of the vaccine and in some close contacts. At that time, probably by the late '80s, certainly oral polio vaccine was routinely 00:12:00administered for years before that-- there might be a half dozen cases a year of people who got VAPP, were injured, and obviously needed some recourse to take care of their medical condition.

TORGHELE: Okay, so, as an attorney, you probably are familiar, although you weren't here, you're familiar with the Reyes versus Wyeth case that involved polio vaccine.

MALONE: Correct. That's a 1974 case-- was certainly significant in that it potentially was going to change CDC's role in vaccination. What happened, in that case, was a child was immunized in a county public health clinic and then ended up getting polio later and the family sued the corporation that made the oral polio vaccine, Wyeth. And the resulting court decision was relevant in that it established a difference between vaccinating people in what were called mass immunization settings, such as public health clinics, and private doctor's offices. The significant point being that typically in an immunization clinic, 00:13:00you're not seen by a physician where you have an individual determination of whether or not to be vaccinated.

And the significance then of the Reyes v. Wyeth decision was that there are package inserts that vaccine manufacturers write and are approved by the Food and Drug Administration as part of their licensure and those package inserts then are provided with each vial of vaccine. The physician reads that and then makes an individual determination about whether or not to vaccinate the child. In a mass immunization setting, you don't have a so-called learned intermediary, that is, someone like a physician who makes an individual medical determination about whether or not the benefits outweigh the risks for you. And so, what that decision said is that the vaccine manufacturer then, because there was no learned intermediary, a physician who did an individual determination about whether or not to vaccinate that person; the manufacturer has an obligation to directly inform the individual about the risks associated with that product. They are marketing it in a way that balances out the negative and the positive so that you minimize the potential for adverse events. And so, after that decision, the manufacturer said to CDC--which was the primary purchaser of vaccines for use in mass vaccination clinics around the country-- that we're not going to sell you vaccine anymore because we're going to be held liable all the time. Because you are administering them in these clinics, where there's not an individual determination by a learned intermediary. What we want to do is, we want you to take on that obligation and so CDC, as part of our contracting for the purchase of these vaccines, agreed to include a clause -- called a duty to warn clause. CDC takes on the manufacturer's responsibility to make sure that 00:15:00either the child is in fact seen by a learned intermediary who makes that individual determination about using that vaccine or that they are given written information. At the time, they were called Important Information Statements, to let the person know that these are the known risks and you can decide whether or not then you're going to get your child, in this instance, vaccinated knowing those risks. And so, given the inclusion of the duty to warn clause, CDC then was able to continue purchasing vaccines.

Now later in the 1980s, in 1986, there was a law passed called the National Childhood Vaccine Injury Act. That was a law that was pushed, in part, by folks from the public health side and in part by folks who were very skeptical about 00:16:00vaccines and were concerned about the very nature of these products. Vaccines are given to healthy people, unlike most medications that folks get in their life. They are typically getting medication to treat them for some condition. What happens with the vaccine if you're being given a product to prevent you from getting the disease? And, on top of that, there is an interest in our society, given the nature of the way that vaccines operate, to have people as widely vaccinated as possible because of the notion of--

TORGHELE: Herd immunity.

MALONE: Yeah. Herd immunity is the driving force behind the success of vaccines 00:17:00to my knowledge as a layperson again working with vaccines. And what herd immunity does is depending on how infectious a particular vaccine-preventable disease is, if you get enough people in a community vaccinated against that disease, that disease will ultimately die out because there's no way for that disease to spread readily among the folks in the community. And in order to get herd immunity, though, you have to immunize as many people as you can, which again varies depending on the infectiousness of the particular disease.

Measles, for example, is highly infectious, it's one of the reasons we continue to see measles outbreaks in the United States even though there are no domestic routine pockets of measles in the United States. Polio is not quite, but it still has a requirement for herd immunity in order to be able to extinguish it from our society, which the use of vaccines in the United States did accomplish. And herd immunity, though, is accomplished by actual creation of immunity in the individual. Not everybody who gets a vaccine gets immune because of the use of that vaccine for various reasons. So, you have some fall off, but the total 00:18:00number of people immunized have not been--had not created immunity. And then you 00:19:00also have some people for which there is a medical contraindication to use of the vaccine. They might be allergic to one of the components of the vaccine, maybe had an earlier adverse effect with a vaccine and so it's not appropriate for them to get that vaccine. So that's another group of people who cannot be vaccinated.

When you set aside those people then, the unknown folks who were immunized who 00:20:00in fact are not immune to the disease and the folks who don't get the vaccine because it's medically contraindicated or in our system of law--here in the United States, it's the states that determine whether or not people are mandated to receive particular vaccines. And most states, in addition to having the provision for a medical exemption also provide for a religious exemption. There are 47 states in the United States that say if you have a religious opposition to the use of vaccines, that you don't have to be vaccinated. In addition, a number of other states, currently 18, have what are called philosophical exemptions where folks who have reasons other than religious opposition to the use of particular vaccines or vaccines in general under those particular state laws don't have to be vaccinated. And so, you take all those folks, and you end up with a group of people who are not immune from the disease because they either are not immune because the vaccine did not take, or they never received the vaccine, and you still want to create herd immunity. And so, with the notion that I am taking a vaccine partly to protect myself from getting the disease and partly to create herd immunity in my community so that other people don't get the disease. And of course, the fact that herd immunity protects me if that vaccine doesn't take with myself or with my child.

But the legal issues then are--that are significant then is one of the reasons there's been such great success in getting rid of vaccine-preventable diseases 00:21:00in the United States is because people have actually been required to receive those vaccines from way back, back in the smallpox era in the 1700s and 1800s. In the United States, smallpox was still quite a scourge in society, and so laws started being passed to require that people be vaccinated. Later on, as more vaccines were created for infectious diseases that were susceptible to vaccine-preventable vaccines, the focus was on--well we, as a society, to create herd immunity we really need to make sure that folks are immunized.

There was a landmark public health decision called Jacobson v. Massachusetts in 00:22:00the U.S. Supreme Court in 1905, which upheld the right of the government. In that case a city government in Cambridge, Massachusetts to require an individual to be immunized for smallpox, again, with that notion that we want to create 00:23:00herd immunity and we, of course, want to protect the individual. And a fellow there, for no reason other than he simply did not want the vaccine, had challenged the use of vaccine saying that he ought to have the right to not be immunized.

TORGHELE: So, Mr. Malone, would you talk about the basis of the Jacobson decision?

MALONE: Sure. The Jacobson decision then was where a local government had mandated that smallpox vaccination be given to all the citizens. And what the basis of that was under the U.S. Constitution there's something called the "police power." And the police power are powers that are reserved to the states to fulfill the state's obligation to, among other things, care for the public health of the nation. And the states then use that authority to make various 00:24:00laws, among them, vaccination mandates.

So, what the Jacobson decision did then was that it upheld that police power as a legitimate use of the government authority in order to create--in order to minimize the potential public health impact of having these vaccine-preventable diseases if there are in fact vaccines being used in the United States. Over the years then, that's been further elaborated on as we focused more on the nature of where are the pockets of disease that happen, and one of those is schools. That schools are places where children are closely congregated, being young they typically don't have a lot of the same kinds of immunities that older folks would have, and so the law eventually started to focus on schools as the appropriate nexus for determining under the state vaccination mandates that folks should be immunized. And so, these laws were created that, in order to attend school, you had to bring indications from your medical provider that you received whatever the vaccines were that were mandated at that time. Folks have challenged that over time. There has been litigation where people say, for example, in Arizona, there was a case where the state constitution provided a 00:25:00right to education, where people were saying that my right to education then should trump the ability of the state to exclude me because I don't want to get a vaccination.

In that particular case, what the court held is that fundamentally if people are not safe in the classroom from the spread of infectious diseases, there can really be no opportunity for education. And so what the court upheld in that instance was that not only then could you be required to be vaccinated and bring evidence of that to the school, to the extent that either you had a medical contraindication for which you could not be vaccinated or under the state's law you asserted a legally allowed exemption. Such as a religious exemption or a philosophical exemption, that in the case where there was a disease outbreak, 00:26:00typically measles outbreaks, the school district, if they wished, they could actually exclude you from attending the school since you were vulnerable to the disease. And then, given the nature of the burden. Because of the challenge of maintaining herd immunity, the schools then were given the right under these legal decisions to exclude those children from attendance at school while there was the risk that disease might--such as measles. If there is a current measles outbreak or there appears that there's an impending measles outbreak, that children who were not otherwise protected from the vaccine, could be excluded from that.

One other thing I'd like to talk about is religious exemptions. People tend to think well--I just have an inherent right under the U.S. Constitution to assert that my religion prohibits me from having a vaccination and therefore, I should not be vaccinated. In fact, the U.S. Constitution, the courts have held, does 00:27:00not provide an inherent right to a religious exemption from vaccination based again on the notion that the public health requires all of us as a community to do the right thing, if you will, in order to create herd immunity. The courts have held that that overwhelms any religious belief that you may have. On the other hand, under the First Amendment right to their freedom of religion, states have been upheld in passing statutes that do allow people to assert that under their religion a particular vaccine is not allowed.

And so, as I mentioned earlier, 47 states, all but West Virginia, Mississippi 00:28:00and just a few years ago the state of California, allow folks to assert a religious exemption to vaccination. One of the other interesting things with religious exemptions though is, what's the scope of that? Under the First Amendment, you not only have the right to the free exercise of religion, the state itself cannot establish a religion. And so there has been some interesting litigation where folks have asserted that they have a personal religiously held belief that is contrary to vaccination. And the state has said, but you don't belong to an organized religion that we recognize, and the courts have actually struck that down saying that that interferes with the notion of the establishment clause of the First Amendment. The courts then have determined 00:29:00that a state cannot basically decide which religions merit consideration under the religious exemption. And they have held that because under the establishment clause of the First Amendment of the U.S. Constitution, the United States should not be in the job of determining, or their state governments, of determining which religions are favored in any way.

And so, this particular decision held that a sincerely held religious belief 00:30:00should be all that's required-- that is, it is based on a religious belief in God and the way that that person interprets the nature of their religious beliefs that it has to be sincerely held. And as a result, then, typically people who are not necessarily part of organized religions, but hold sincerely--held religious beliefs, can, in fact, qualify for religious exemptions.

TORGHELE: So, what has been the effect of those sincerely held religious beliefs on vaccinations?

MALONE: Well, vaccination exemptions, in general, can be problematic. There are parts of the country where a number of folks claim them. And you can end up where-- herd immunity shows up again--where you create the risk for importation of diseases since many of the diseases aren't naturally occurring in the United States anymore. But when you have these pockets of anti-vaccination folks who don't have their child vaccinated, that can create problems because of the herd 00:31:00immunity not being at quite the adequate level. And so there have been studies in recent years to determine about how that has affected immunizations and how has that affected the possibility of having outbreaks of diseases. And what these studies have found is the complexity of the process for obtaining a vaccination exemption seems to affect whether or not those exemptions are claimed. In some states, it's actually easier to claim an exemption from vaccination than it is to get the form to take to school. You have to go to the doctor, you have to get your child vaccinated, and you have to bring the form that the doctor completes to the school. And in some states, it was as simple as just filling out a form saying that I have a religious or philosophical opposition to vaccination. And I think one of the concerns then was that that's 00:32:00fine if people are educated about the risks of vaccines. And I think the concern is that not everyone was and when it gets easier to claim the exemption and people don't have a lot of experience with vaccine-preventable infectious diseases. Folks of my age are about the last folks around who actually even know people who had polio, for example, or had measles or mumps or any of those diseases. And it's to the point now that not only do most parents not have any personal experience with endemic vaccine-preventable diseases. Frankly, most providers who are active nowadays grew up in an era, and certainly were trained in an era, where there was, at best, outbreaks of disease. And so, because of that, there was a complacency that existed among many people that they don't see these diseases out in their community, they know there are risks associated with 00:33:00the vaccines, and so it makes some sense, logically, to not want to have your child vaccinated. But the concern is, is that you don't know the risks associated with it and that if herd immunity is sufficiently undermined, in fact, these diseases will come back, and we will have outbreaks of these diseases. And many of these diseases not only can have severe adverse events, those can include dying. And so, the determination was made that in those states that had a more complex system for asserting the exemption from vaccination that in fact, you had less people being exempted.

What do I mean then by a more complex system? Typically what that constitutes is 00:34:00a requirement that an individual be informed by a physician about the pros and cons of vaccination - of the possibility of getting the disease, the negatives, the potential adverse effects of vaccination of the vaccinations themselves, and then you will make an informed decision about whether or not to assert the exemption that you otherwise were thinking of having exerted, including actually even religious exemptions. We find that as folks get more educated about it that they sometimes find that they're convinced that, in fact, it's in the interest of their own child to be vaccinated. And so, that's an example of the way that the law has been modified to assist in creating a vaccine-preventable disease--an infectious disease-free society by making sure that people are immunized to the best extent possible.

TORGHELE: I would think too that some of the susceptible people would be children on chemotherapy, for instance, or people who are immune compromised for some other reason. Are there ever--

MALONE: In fact, that's an interesting thing that you brought up because the reason that California in 2015 repealed their religious exemption and in fact, their philosophic exemption, was that there had been a big measles outbreak at Disneyland that year. Another gathering of a lot of people closely together and folks from other countries and there were cases that were imported and people at the park were vulnerable to it-- it's a very infectious disease and a number of people got sick and it even spread a little bit around the United States as those folks went home. And, partially in response to that, the state of California, where there are a number of these pockets of many people who have 00:36:00asserted a philosophic exemption to immunization. Which in my view, in some instances is frankly not being adequately educated about the risks of the disease creating an outbreak in a community and at the same time balancing in their mind, well, I only know about the adverse events about the vaccine rather than the adverse events of the disease. And so, logically, people are choosing, in some cases, to not get immunized because they think, well, this is a good bet for me, this is not really a risk for my child. But the problem is that because you need herd immunity, in fact, and this Disneyland outbreak showed, that you 00:37:00just never know when there might be an outbreak, that the more people who can be immunized the better. And you mentioned about people having immune problems. In fact, there are folks for which vaccines are contraindicated. And in the California case there was an example of a young child in the Bay area, I believe, where the father was concerned that his child was attending a school where he believed that there were large numbers of children who were unimmunized.

As just a side note, I might note right now that one of the other things that they accomplished was getting a law passed that allowed people to find out how many people, in fact, are claiming an exemption at your school so that you can have some sense about the vulnerability that your individual child has given, again, the herd immunity impact of vaccines. And in this particular instance where the child was very immune-compromised, therefore, could not get the 00:38:00measles vaccine, but could have an incredibly severe reaction if he did get measles--the disease. The father went and lobbied the legislature to change these laws. To take away the ability to have the philosophic exemption where people based on whatever reason, whether they're educated or not, are deciding that they are not going to immunize their child and his child and other vulnerable people who would like to be immunized are put at risk. And so that was one of the reasons behind that change in the California law.

TORGHELE: Interesting. I wanted to go back for just a minute-- you mentioned something called Important Information Statements. Those were intended to help people understand what the risks were for vaccines, is that right?

MALONE: Correct.

TORGHELE: So, can you give us an example of, for instance, maybe what the polio vaccine statement would say?

MALONE: Sure. Okay, and those have evolved a little bit over the years. The Important Information Statements were created by CDC in response to the legal obligation that we took on through the addition to our purchase contracts for vaccine of the duty to warn clause where we said that we would notify people about the risks associated with vaccines.

And over the years, later that got codified in that there was a statute passed in 1986 called the National Childhood Vaccine Injury Act. Congress requires CDC to write what are now called Vaccine Information Statements that are provided to everyone then who receives these particular vaccines that are covered by that program, whether or not they receive vaccine that's been purchased by CDC. In 00:40:00the past, CDC would've purchased vaccine that was used in public health clinics, with the creation of the Vaccines for Children Program in 1994 also in many private doctors' offices. But initially, our requirement under the duty to warn clause was only to inform folks who were getting vaccine purchased by the federal government through CDC's contracts. And that 1986 law, the National Childhood Vaccine Injury Act, required CDC to write those materials for use by every provider in the United States who administers any routinely administered childhood vaccine.

And what those do is--it's interesting the way that, I mentioned that those things have evolved over time. The initial law required CDC to write those through a rule-making process, which is a legal, statutory process under the 00:41:00Administrative Procedure Act, which is a fairly convoluted process through which you publish a proposed regulation in the Federal Register seeking public comment, you analyze the comments and you come out with a final version of that. We found that with those particular materials that it was a years-long process to develop those materials, and we ended up because of the detail through which that law required us to list the types of things to be covered by the Vaccine Information Statements at that time, that we ended up with vaccine information materials that were often ten pages long. And we started thinking that given the context of where you get a Vaccine Information Statement. You're typically getting it at the doctor's appointment, the well child appointment, where you 00:42:00don't have a lot of time, you're out there in the waiting room with your child, maybe some other children, might be a little bit unruly. You're sometimes given these materials there, or other times you're given the materials actually in the exam room where you're going to see the physician. And we found that it wasn't very practical, the idea that for each vaccine, you would read a ten-page document. So, there was an argument that you could actually, by providing people too much information, you were actually under-informing them because, realistically, you knew that there was no way that they could read, much less understand, the content of those lengthy materials during that short period of time. So, we sought a change in that law and a few years later, it changed it from having to go through a formal rule-making process, which is a bureaucratic process that itself requires a long period of time, to more of a process that's comparable to that focused on developing any kind of public health education 00:43:00materials. And that's where the law requires CDC to develop materials in consult with both medical providers and parents of children so that we get understanding not only of where the physician is coming from, but where a parent (is coming from).

Often it is a brand-new parent, first child, where they are scared about many things, scared about changing the kid's diaper, much less about the potential risk that a vaccine may come from that -- what are the kinds of things that they needed to know? And we determined that basically there were a few categories of information that would be good then and we came up with documents that we thought would accomplish that, which are two pages long, the Vaccine Information 00:44:00Statements. And each vaccine has them, many of the vaccines are multiple antigen vaccines, so you have measles, mumps, rubella given as a single vaccine and the Vaccine Information Statements themselves cover all those things.

The first thing we do is we talk about the history of the disease, why is it that we needed to develop a vaccine for a particular illness, such as polio? Polio was a scourge for many, many, many years up into the 1950s before the creation of the inactivated polio vaccine by Salk. Then later in the early '60s, the creation of the oral polio vaccine by Sabin where--if nothing else, people's summer lives were disrupted, that there was apparently a seasonality to polio, and typically then, it was during the summer that people were getting it a lot and so a lot of communities closed down their pools.

Once again, it's that whole thing of people congregating close together-- that's where the risk is created. And so, the ability for people to congregate together was at risk, with the risk of polio developing. And so, the incredible development of these two vaccines allowed folks to be vaccinated and then for these diseases to eventually go away in the United States. And we're on the cusp of actually polio being eradicated from the entire planet Earth with only a couple of countries left where there is any endemic polio, and that's because of the success of these vaccines. And so, we wanted to provide some historical context because, as I mentioned earlier, folks don't have, generally speaking, most people in the United States, both parent, and provider, have no personal 00:46:00experience with most vaccine-preventable diseases, and certainly with polio. And so, we wanted to give them the historical context. That these are the numbers of people who each year came down with polio in the past, prior to the development of these vaccines and this is what happened after the creation of the vaccines-- that the numbers of cases plummeted to the point that the United States has not had any endemic polio disease actually for decades now. But there's, again, this risk that if not enough people are vaccinated, that it will be imported by folks who are not immune and have the disease when they come to visit the United States.

And so, the next thing that the Vaccine Information Statement does is it tells you about the creation of the vaccine and then it tells you the way that the vaccine is used. For example, it's given at two, four and six months of age or 00:47:00it's given at a later time. Some of the other vaccines are not given until even the teenage years. And beyond telling people what the schedule is, you want to tell them, well, what are the risks of the vaccine itself? What are the adverse events that we know about with this vaccine? So that's the truly important aspect of these Vaccine Information Statements and the original Important Information Statements, is to inform people to the extent that they know then that their child or themselves have a particular risk for an adverse event. For example, some folks are allergic to components of vaccines and by letting them know that - one of the classic things is folks who have an egg allergy for the way that most current influenza vaccines are made, in eggs, and that if you have an egg allergy it's not advisable to get the flu vaccine. So, by being informed 00:48:00of that, you know upfront to say hey, I can't get this vaccine.

And so, by informing people about the adverse event risks and what the numbers are, it allows them to make an educated decision. And then you piggyback that on my earlier discussion about the way that the process works for claiming exemptions from vaccination. To make sure that people, not just at the doctor, receive the Vaccine Information Statement because they are there to get the vaccine. But they may find that it's in fact, not indicated for them to get the vaccine, but that folks who have decided that they're not going to get the vaccine at all are educated so that they make an informed decision about whether or not to get the vaccine.

The other reason that these Vaccine Information Statements are created is they 00:49:00also provide people with information about a program that was created as another result of the 1986 National Childhood Vaccine Injury Act, and that's the creation of the National Vaccine Injury Compensation Program. What the Vaccine Information Statements let people know is that in some rare instances, particular people, in fact, will be injured by these vaccines.

In the past, there was the tort provision under which folks could sue vaccine manufacturers. Vaccine manufacturers started dropping out of the production of vaccines because there was a fair amount of litigation with that but given the nature of tort law where they are not, in fact, warrantying the quality of these products, they're not warrantying that you will never get sick or have an adverse event from a vaccination. In fact, under the tort provisions that talk 00:50:00about the utility to society of having vaccines that are imperfect, that as long as you inform people about the risks associated with that you, the vaccine manufacturer, will not be held accountable for that so that people can make an informed decision about that. And so, in general, people aren't going--in the tort realm, people are not going to actually frequently prevail in this kind of tort litigation because they will, in fact, have been informed about the risks associated with that vaccine.

But given the very nature of vaccines, that they are administered to healthy people, that they are good for the individual by preventing the potential of a 00:51:00disease that frankly is quite rare and which in some instances there may be some fairly measurable instance of adverse events, that by encouraging people to do that when there's little actual disease in the United States and that they're doing it on behalf of their community at large in order to create herd immunity, the idea was that perhaps what we ought to do, is recognize the benefit that people are giving to society and the fact that why should an individual whose child or themselves is injured by a vaccine have to totally carry that burden themselves when in fact they are doing work on behalf of society too by helping create herd immunity.

And so by creating the National Vaccine Injury Compensation Program, what Congress did is it set up a separate program outside of the tort system of 00:52:00products liability law in the states that puts an excise tax on each childhood vaccine used in the United States to create a fund for paying compensation for people then who go through this program that's administered by the Department of Health and Human Services through HRSA [Human Resources and Services Administration] and through the Court of Federal Claims-- where the way it's set up is that if you have a particular adverse event that's known and has then been either placed by Congress through the passage of the initial law, or by HRSA in an amendment, in this vaccine injury table. If there are known adverse events with particular vaccines and you can show that your timing of post-vaccination. You had this particular adverse event happen to you. You are then able to get compensation under this program through this no-fault system that was set up 00:53:00that's administered through HRSA as I mentioned and the U.S. Court of Federal Claims, so that people can be compensated for doing good for our society and yet not having to take the full burden of those risks.

Unfortunately, one of the reasons that there's a lot of anti-vaccine sentiment, I think, in the United States is that children get vaccinated typically at a very vulnerable time of their lives--in infancy when they are actually vulnerable to many kinds of risks. They don't have well-developed immune systems. They may have any number of things that will happen to them during their first year of life that could just coincidentally happen following a vaccination that are temporally associated, we say, with the vaccination-- that is, they happen in some time frame after the child is vaccinated.

So, while the Vaccine Injury Compensation Program will compensate people for adverse events that are shown to be associated with vaccines and there is a process through which you can prove that ones that are not otherwise previously known, in fact, have been caused by vaccines. In fact, certain things happen, certain adverse events happen that are temporally associated with a vaccination, but in fact, were not caused by the vaccine. This is a not a program that will compensate you in that instance. So, some folks are frankly frustrated by that. There are people who believe that vaccines cause any number of adverse events that they've witnessed in their child. As tragic as this particular event is in that child's life, the vaccines are not the reason for that particular outcome. 00:55:00And in fact, many people are then protected by receiving vaccines by preventing the very well-known adverse events from the diseases themselves that often can lead to severe problems from encephalitis to death to other less severe outcomes.

TORGHELE: So, the Vaccine Injury Act would give people money, commensurate with their injury from vaccine?

MALONE: Correct. The Vaccine Injury Compensation Program is not kind of a tort-light version. It's not meant--because it's an easier process--it's not meant to just give you a discounted amount of money for what you have--your proven damages. In fact, it's meant to give people a fair amount of compensation for the nature of the adverse event that they suffered.

TORGHELE: And you had some part in that act, in the wording of that, is that right?

MALONE: No, it actually was passed a year before I came to work at CDC. I have had some experience with some modifications to that law and also with a number of other laws that have been passed in the vaccine realm over the years, including the statute that passed the Vaccines for Children Program, which was a program that was passed by Congress in 1993 and then implemented in 1994. And what that did is that prior to that time, CDC through a grant program called Section 317, which references section 317 of the Public Health Service Act, in which Congress gives CDC money to fund states in preventing diseases. And one of 00:57:00those ways is to buy vaccine. And so, CDC, for many, many years since the creation of Section 317 grants has funded the purchase of vaccines for use in public health clinics. The value in the passage of the Vaccines for Children Program is that it expanded the availability of federally purchased vaccines. And in part, they passed that statute because there was an interest in keeping people in their medical home. One of the things they found is that by--because vaccines were also more expensive and more vaccines were being created, and it was becoming a financial burden on people to get vaccinated; so, more and more physicians were referring folks to go to public health clinics to get vaccinated. But the problem with that is if you send someone who already is burdened with a lot of well-child visits with their newborn and of course all the other challenges of having an infant in your life, that if you require them 00:58:00to go to one more appointment, that may never happen. And so, a lot of people were not ending up at that appointment or if they did get there, that the information wasn't necessarily getting back to the individual's primary care provider that in fact the person was vaccinated.

And so, by creation of the VFC [Vaccines For Children] Program, Congress authorized CDC to purchase additional vaccine to then give to a group of children who are uninsured, are Medicaid eligible, are Indians, or in some instances at particular clinics called Federally Qualified Health Centers or Rural Health Clinics, are underinsured. That is where they actually do have 00:59:00insurance, but their insurance doesn't cover a particular vaccination. And what that did is that then allowed CDC to purchase more vaccine. In fact, CDC purchases over 50% of the childhood vaccine used in the United States and distributes it then, not only to public health clinics, but also to individual private providers who register to become VFC providers, and they can provide these vaccinations to the child in their medical home so that the child is more likely to get the vaccine, will be seen by the physician who can help determine that it's appropriate given their medical condition in that moment to be immunized at that time, in addition to simply relying on the Vaccine Information Statements, and that there is follow-up so that future vaccines are, in fact, administered on a timely basis. Related to that in kind of a similar time frame, Congress started funding the development of Immunization Information Systems, 01:00:00which have typically been implemented at the state and local level where there are systems through which providers can both insert information that they've immunized a particular child and can get information out to find out whether or not the child has been vaccinated.

Another thing you don't want to do is you don't want to over-immunize because there are risks associated with receiving too many doses of particular vaccines. And so, by being able to refer to this system, you can make sure you know whether or not the person's already fully immunized, is missing particular doses or is needing the full range of doses. And so those systems have also been a very good instance of the way that the law has assisted in making sure that people are immunized, that parents don't have to remember all this or keep that little card that you may get that I remember as a parent, ending up getting 01:01:00repeatedly because I could never keep track of that card after we took it home. And that these systems exist to help inform your provider and, in some instances, then, it also provides information then, reminders are sent to parents to let them know that it's time to take their child to the doctor to be immunized. Also, some of those in some states are used by the school systems. I mentioned that schools have become kind of the nexus of finding out, in fact, are kids fully immunized by the time they hit school when they are going to be in these closely congregated settings. And by having access to these Immunization Information Systems, a number of schools are in the position that they can get this information directly without having to burden the parent to go to the provider to get a copy of that particular immunization card.

TORGHELE: Those are digitized records?

MALONE: They are typically digitized, correct.

TORGHELE: Must save a lot of work for a lot of people.

MALONE: I think it does. And I think they continue to grow, and CDC plays a strong role, both in funding those and in assisting in their further development.

TORGHELE: I guess what we have left is maybe talking about your international work a little bit. You wanted to mention some of that and what it was like.

MALONE: Sure, okay, yeah, I've said I worked at CDC for 30 years. I started out where most of my colleagues were specialists, and I was kind of the generalist for much of CDC, and as the agency has grown, we've gone from seven lawyers in 1987 to over 24 now. And the world has become a more sophisticated, complicated 01:03:00place and people have realized the value of law-- there's public health law. CDC has a separate program beyond our in-house legal counsel called the Public Health Law Program that is a resource to folks out there in the community, to states, and others. Helping them develop laws at the state level that can help with public health in creating ways for the law to assist in achieving the objectives of public health.

And I know then, as I became more specialized, I was peeling off more and more layers of the parts of CDC that I was the legal advisor for while always keeping immunization because partly, I was having kids at that--throughout most of that time so I had a personal interest in it and certainly brought that perspective 01:04:00to my work here. And CDC at the same time was starting to expand a lot internationally, and it was becoming obvious that we needed to gear up from the legal side to provide knowledgeable legal advice for working abroad.

And so, I thought well, that's something I'd like to pick up. I knew that there was this program called STOP, Stop Transmission of Polio program, that's implemented primarily through the World Health Organization through a number of entities including CDC where the goal is to eradicate polio from the planet as smallpox had been eradicated over 40 years ago. And I thought well, you know, I would like to be one of the people. They basically have people go out on these STOP fellowships, if you will, around the world where they help with National 01:05:00Immunization Days where every child in a country is immunized with oral polio vaccine on a particular day-- working on the logistics of setting up those sorts of things as surveillance, other sorts of things. I spoke to my colleagues in the Immunization Program about my interest in that-- I don't think they could ever quite see the role of the lawyer in such work abroad and so I didn't end up getting that opportunity. However, it did whet my appetite for the international world, and certainly, a lot of my work was involved in advising our international program, not only through the STOP program but also with measles and a number of other programs beyond vaccines abroad. And so, I was able to participate in another CDC program called IETA. IETA is the International 01:06:00Experience and Technical Assistance fellowship program that CDC has for training cohorts of individuals to work abroad in CDC's ever-growing offices around the world. And I applied for that program and was accepted and ended up working as the acting Deputy Director for the Tanzania office of CDC in the early part of the 21st century for a few months. And it was very helpful for me, not only in being able to provide assistance to CDC and its incredible work that it does abroad but being able to see the context of how CDC does its work in other cultures and within the diplomatic framework of working with other governments. 01:07:00And so, that I believe, has helped me as I came back here and am now the Team Leader for what we call our Global Health Law Team of several lawyers who provide legal advice to CDC on the full range of its international activities, including global polio eradication.

TORGHELE: So, when you were working in the other countries, you worked with other lawyers as well as coordinators of vaccine programs and can you describe more of your work?

MALONE: Sure. A lot of it was working more with diplomats than with lawyers. The federal government doesn't station a lot of lawyers abroad. We often work through the auspices of the U.S. Embassy in country. The State Department itself typically has their lawyers based back in Washington, D.C. and not abroad. That 01:08:00was another interesting thing I picked up from my experience abroad is people don't have ready access then to lawyers. And just given time zone differences alone, it can be problematic in the moment that some legal issue comes up to get legal advice for some problem that may exist. And so, part of that was just understanding that challenge that people have in the field. So that helped in developing materials that folks can use in the field for dealing with certain legal issues without having to talk directly to a lawyer at the time.

Certainly, we had a lot of contact with the diplomats in these other countries, with the ministries of health in particular and with our U.S. diplomats in working on the various legal--the various public health problems that almost always dovetail into having some kind of legal significance that requires legal input.

TORGHELE: You must have been so useful for them to have you there.

MALONE: Frankly, I think it was more a benefit to me to be able to just learn, learn these things. But I hope that I provided some value from my law degree too.

TORGHELE: That's a good place for us to wrap up.

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