the vaccine war

Interview: Anthony S. Fauci, M.D.

“There'll always be people who are skeptical no matter what you do. ... Let your transparency, honesty, the facts of the science be your best advocate.”
Anthony S. Fauci, M.D.

An immunologist, he is the director of the National Institute of Allergy and Infectious Diseases [NIAID]. This is the edited transcript of an interview conducted on March 22, 2010.

How would you rate vaccines compared with other public health breakthroughs?

I don't think there's any question that vaccines are among the very short list of beneficial health interventions literally in history, if you look at everything from the number of lives that have been saved over decades and decades since we began actively vaccinating people for diseases that sometime ago were devastating and frightening, particularly for children, that are now essentially either completely suppressed, to the point where there are only rare cases, or in many cases actually eliminated.

So when you look at the cost-benefit -- cost both in economic cost as well as cost in suffering and death, and the benefit of the vaccine -- it's an absolutely striking and stunning, in a positive way, beneficial intervention. ...

A child growing up in the '50s would have few vaccines compared to today?

Very few. For example, when I was a child, there were not that many vaccines. I was vaccinated for polio. I actually got measles as a child. I got pertussis, whooping cough. I remember that very well. I actually got it and gave it to my father, who also got very sick. Right now, many of those diseases we take for granted because they're almost historic in nature -- measles, mumps, rubella, pertussis, diphtheria -- things that were frightening for my parents, ... if you look back just measured in several decades, it was frightening in the sense that, for no reason, an otherwise healthy child could actually get seriously ill, which could lead to some residua, be it mental retardation when you get meningitis or difficulties with other health aspects if you get sick, to even death for things that we now know just are historical.

[For example,] measles is a very, very serious disease, and we know now, whenever there are clusters of measles cases, even today, in little pockets of groups of people in this country and in other countries who don't get vaccinated, it is a serious disease that can lead to hospitalization, that can lead to morbidity, and, unfortunately in some cases, mortality. So it's a different scene now in the 21st century, or even the mid- to late 20th century, than it was in the middle of the 20th century and earlier.

It's often said that vaccines are a victim of their own success and that people having babies today have no knowledge of this past burden of infectious disease.

In some respects, vaccines are the victims of their own success, because first of all, they're still, as they were in the beginning, highly effective and very safe, when you look at risk-benefit ratio of a disease versus the very, very, very small risk of any adverse event that you would have with a vaccine. However, the motivation to get vaccinated is crystal clear and sharp when you look around you and you see people getting serious disease.

I think the classic example of that motivation to get vaccinated was when I was a child and the big scare was polio, where you would see your friends playing ball outside with you, baseball and basketball, and all of a sudden get sick and be in bed, be in an iron lung, and then come out with a deformity, a serious limp or a serious physical disability. That is absolutely frozen in your mind as a very scary scenario, so that when the [Jonas] Salk and then the [Albert] Sabin vaccine became available, people absolutely flocked to get vaccinated because they saw what the consequence was. When you get to a situation where the vaccines have been so successful as they have, it's a major success story, [and] the looking around for people who are getting sick, you don't see it, so the idea of the frightening nature of the threat of the disease is no longer there. ...

Tell me about pertussis. Whooping cough sounds like a mild disease.

Whooping cough is not a mild disease. Whooping cough, before the vaccination, could make you very, very sick. First of all, there was a chance you could die from it -- small chance, not a big chance. You would be coughing and coughing. It wouldn't last for a few days, like a cold. It would last for weeks, and there would be vomiting and fever and difficulty breathing. And sometimes you'd wind up with some residua, like brain damage from anoxia and things like that. So it could be a really serious disease. ...

Tell me about pneumococcal disease.

Pneumococcal disease is a real threat. Pneumococcal disease is a bacterial infection that causes anything from middle ear infection to pneumonia to meningitis. Children are particularly vulnerable to it, but adults can get pneumococcal disease themselves. We have a highly effective pneumococcal conjugate vaccine right now that has really turned around the situation vis-à-vis that type of infection in children. So that's a serious disease that can really kill you. ... Luckily we have good treatments for pneumococcal disease, but sometimes you get to people a little bit too late when they have advanced disease, even pneumonia or meningitis.

Haemophilus influenzae type b?

Haemophilus influenzae type b is a very interesting story. It's called Hib for Haemophilus influenzae type b. It was formerly the leading microbial cause of mental retardation and deafness in children until just recently. It's a serious disease. It can kill you, and it can lead you to have residual morbidities such as mental retardation, secondary to serious meningitis, deafness due to middle ear disease that causes a serious problem in kids.

The Haemophilus influenzae vaccine that was relatively recently developed -- a matter of a couple of decades -- if you look now in the United States and even in some developing countries at the curve of the incidence of Haemophilus influenzae b, it is striking and dramatic, the decrease that's been associated with the wide administration and availability of the Hib vaccine. In many respects it has eliminated in many developed-world countries the threat of what was the leading cause of bacterial-related meningitis with mental retardation and deafness due to middle ear disease. ... And now in certain developing-world countries, such as in South America and in Africa and Asia, the more we get that vaccine available to people, the same thing. So it's a really classic example of a highly successful, safe vaccine.

How many vaccines are we up to for children up to age 6?

It is between 12 and 14 vaccinations that children get.

Are they all safe, necessary and effective?

The track record proves that when you talk about safe, they clearly are safe. Whenever you talk about safety in anything, in any intervention, there's never zero risk, ever. But when you do an intervention, particularly an intervention in a well person, which is what vaccines are mostly given to, you weigh the risk-benefit. So if you're talking about safety in the context of risk-benefit, the risk of the disease, the risk of getting into a difficulty is far greater than the risk of any deleterious effect, which, if you look at the many people that have been followed, millions and millions of people that have been followed, the safety record of these vaccines is very clear. Also the efficacy in preventing infection is very, very clear. ...

If I'm a healthy person and I take a vaccine, the safety trials have to be more rigorous than for a drug to treat a sick person, right?

... When you're dealing with a very sick person and you're doing something to them, an intervention, be it a procedure or a medication, safety is critical. But sometimes some of the interventions have a significant risk that you wouldn't tolerate in a well person but you have to tolerate, because if you don't intervene, there's no doubt that the person will get into more serious trouble, if not die. That's when you have a sick person.

When you're dealing with an intervention, namely a vaccine, in an otherwise well population, safety concerns are ratcheted up even more. That's the reason why, when you have vaccine trials, it involves thousands and thousands of people.

More than for drugs?

Much more than the drugs, no doubt. All you need to do is to just show that [the drug] is effective. ... But when you're going to widely use a vaccine in large numbers of well people, particularly well children, you've got to be very, very careful and make sure that you're sure about the safety and that the safety profile clearly outweighs any risk.

That's the reason why you have vaccine trials. There are multiple aspects of safety of vaccine trials. There's the gradual phasing in of clinical trials before a vaccine is approved. You do a Phase I in very few people, determine the right dose, make sure it's safe. You do a Phase II in a larger number of people, make sure you get the right immune response, make sure it's still safe. Then you do a Phase III to nail down the efficacy and show in a large number of people that it really is effective and safe.

But it doesn't stop there, because after the vaccine is licensed, there's the post-licensing observation of adverse events, both by the FDA [Food and Drug Administration] and by a combination of the FDA and the CDC [Centers for Disease Control and Prevention] and a number of other monitoring groups. So there's a constant monitoring to make sure that something that looked pretty clearly like it was safe in the beginning, even if you follow it for several years, it still is safe. And if it turns out that something unexpected comes up, then you could act accordingly by yanking it off the market or what have you.

Some people think we have too many vaccines. Babies are given hepatitis B very soon after birth. What's the justification?

Hepatitis is a serious disease, number one. You can get chronic hepatitis. Chronic hepatitis can lead to hepatic carcinoma -- cancer of the liver. So the real question is, when is the best time to get someone vaccinated? The safety profile for hepatitis B vaccine is very, very clear. It's a highly effective vaccine, and the thought is that the best time to get people vaccinated is when you are a child, and you come in and you have a regimented situation where you go to see your physicians; you have a well-timed-out regimen of getting vaccinations.

We know historically that it's much more difficult to get adults vaccinated for a variety of sociological and other reasons, whereas when you have the children, you can get it out of the way so you know that child is safe from this particular disease. A lot of advisory councils have gone into this, a lot of input from pediatric societies, to make the decision that if you look at it, that even though that child has a very small chance of getting hepatitis B, when that child gets older, the chances become greater, depending upon their conduct, their activity or the circumstances they find themselves in. But overall, the decision is made, get it over with. Get the child safe so the child will be safe for the rest of their lives.

Some people say chicken pox is an unnecessary vaccine. What's wrong with getting the chicken pox?

Chicken pox most of the time is a very benign disease. However, there is a percentage of children who, when they get these lesions all over them, they can get infected. And we've seen children who get into serious trouble with infection from the lesions, streptococcal infection, staphylococcal infection, particularly even some kids who have some immunodeficiency of mild degree that they don't really recognize. The other thing is passing it on to other people who might be immunosuppressed.

So if you can get the chicken pox level in the country down to a very low level, you accomplish two things: benefit to the individual, because even though most of the time it's mild, it isn't mild all the time; secondly, it's a benefit to society, because you can prevent it being spread to people who might be immunosuppressed and quite vulnerable to much more serious consequences.

Talk about rotavirus. Is this a serious disease?

Yes, it is. It's a serious disease in the United States. It's much more serious in the developing world. Rotavirus is one of the most serious infectious diseases, [a] cause of diarrhea morbidity, and in some cases, particularly in the developing world, morbidity and mortality in countries where the sanitation really predisposes to having outbreaks of rotavirus.

In the U.S., people get sick but don't tend to die?

You have several thousands of hospitalizations and anywhere between 50 or 60 or so deaths per year. It's unusual to have a death, but any death of a child from a diarrheal disease is a tragedy. Any death of any child is a tragedy, but [from] a disease that you could prevent is even more of a tragedy.

Some parents support vaccines but fear their babies are overexposed to pathogens.

That conclusion is understandable but factually not based in scientific reality, because if you look at antigen exposure, antigen is a component of a microbe or any other environmental compound of some sort, something you can eat, something that you get through the respiratory tract, something that gets into the gut.

A bit of a germ.

It could be a microbe, a germ, but there are other things that you get exposed to: environmental antigens, allergens, etc. The body is continually exposed to a lot of different antigens.

So the people who understandably might say, ''Well, gee, we're putting all of these vaccines into the children, into a little baby; we are overloading their immune system,'' as I said, that's an understandable conclusion but not factually correct, because if you compare that with the enormous bombardment that that little infant gets from the moment that they're born -- their GI [gastrointestinal] tract gets colonized with millions of antigens from bacteria, bacteria that may not make them sick but that their immune response is seeing and may be making an immune response to, by antigens that they get from the mother from breast milk or what have you -- that the bombardment of the infant with these foreign antigens naturally, excluding vaccination, is enormous and evolutionary and doesn't seem to do them any harm. In fact, it's good, because they gear up their immune system to be able to respond.

So the thought that if you look at the number of antigens that are given in a vaccine and compare it to the natural exposure that an infant gets to hundreds, thousands and millions of antigens, there's no comparison. It's like a drop in the bucket. You're not overwhelming anything, because nature itself is continually bombarding the infant with a lot of antigens. ...

What about components and additives -- aluminum, phenol, monkey cells?

The monkey cells are not in the vaccine. The monkey cells grow some of the vaccines. If you look at some of the components that are in the vaccine, the safety record for those is enormous. There is no scientific evidence at all that there are any safety issues. ...

Is it OK to make up an alternative vaccination schedule like that proposed by [pediatrician] Dr. Bob Sears?

The schedules that have been put forth in the guidances from the Centers for Disease Control and Prevention weren't just random. It wasn't just people sat down and said, ''Hey, let's do this and that.'' It was a group of experienced pediatricians who were trying to balance getting the maximum protection as quickly as you can, in as safe a manner as you can. And the schedule of how you put them together and cluster them together was well thought out. The idea that by spreading this out by months or what have you, doing your own random type of scheduling is going to make something that is already very safe even safer, is not based on any scientific data. It's random. It's just a conclusion in your mind that by clustering them together, that's unsafe, where there's actually no scientific data at all to even suggest that it's unsafe. To then say I'm going to spread it out by whatever factor you want to spread it out is going to make it safer has no scientific basis.

To be practical, if you say, ''Well, instead of giving it here, I want to give half of it here and half of it a week later,'' now, that probably, in the big picture of life, is not going to make any difference. But for the convenience of people, particularly working mothers and others who have to bring their children to the doctor to get these regimens executed or to get these vaccinations, in the big picture of things, it may make it so inconvenient that the mothers maybe will not bring the babies in, or [they will] miss some of the shots, ... because if you take something that should have been given over a period of a few weeks to a few months, and you spread it out over many months to a year, you're leaving a gap of not being protected. So there are several reasons to believe that these ad hoc type of refashioning your own schedule for vaccination doesn't really make a lot of scientific sense, and could have some deleterious effects.

Is this a little bit disturbing to public health people?

I wouldn't say it's disturbing. It's just that when you start getting random about schedules, then things drop off the radar screen. You may have some children who don't get vaccinated. You may have a gap of lack of protection. And then you ask yourself, as a scientist, for what reason? Is there a scientific, justifiable, validated reason to do this? And there's not. ...

There are vaccine-hesitant communities where parents undervaccinate or avoid vaccination, and these pockets build up. Is that more of a public health concern?

... We have some good examples, for example, in Sweden and in the U.K., where pertussis or other vaccines have been withheld for the thought that maybe they're dangerous. And things go along very well, and then all of a sudden an imported case from somewhere comes in, and the general population is protected, but this cluster of children who have not been vaccinated, they get into serious trouble. So what worries me as a physician is that you can probably go for a significant period of time in some communities not vaccinating kids, but there is a risk that sooner or later there will be the importation into that community, likely by accident, of someone who has measles or someone who has pertussis or someone who has one of those diseases, and then you have vulnerable pockets of people who are not protected.

Explain herd immunity.

Herd immunity is a concept where, if you have the vaccination and the protection of a certain proportion of the population, you can statistically lessen the probability of a virus spreading to the point of infecting someone who is unvaccinated. If you have a highly transmissible virus, to get herd immunity, you've got to have a large, large percentage, 90-some-odd percentage of the population, that are immune through vaccination or infection, to protect the smaller 10 percent. ...

Explain why herd immunity is important.

Herd immunity is important for a number of reasons. It is good just in general in society. ... You can prevent a spread of a highly communicable disease by having good herd immunity. Typical example of that is that when you have an influenza outbreak and you get a lot of people who are vaccinated: When influenza sees a naive society, it just rampages through it, whereas if you have a substantial proportion of the population vaccinated, it has trouble gaining momentum.

Another issue of herd immunity that's important is that there are some people, because of the fact that you have live vaccines and some people have serious immune-compromise -- they are congenitally or, because they're on certain medications, immunosuppressed -- so it would be dangerous for them to get vaccinated. If they are living in a society where the vast proportion of people are vaccinated and are protected, they can indirectly be protected because the virus or the microbe doesn't have a chance to freely circulate in society and has less of a chance of getting to them. So even though they can't get vaccinated, they're shielded, as it were, by the herd immunity.

Who else might herd immunity protect?

There are a couple of other people or groups of people who would benefit from herd immunity. One is a baby in that window while they're waiting to get protected. Usually, during the very early months, they get passive immunity from the antibodies that they get from their mother through the placenta and then particularly in breastfeeding.

But then there's another group. Because it is very unlikely that a vaccine would be 100 percent effective -- a really good vaccine is 90-plus percent effective, which means that even if people get vaccinated, there's a small percentage of people who, despite the fact that they were vaccinated, are not protected. Good herd immunity, or broader blocking of the spread of infection by an immunoprotected population, would indirectly protect those people also.

Is vaccination an individual choice or a communal responsibility?

Certainly you need to think of it as an individual choice. I don't think it should be thought of as something that's purely altruistic: I'm getting vaccinated only because I want to play my role in making society a safer society. There are two aspects that go hand in hand. One is protection of yourself, and the other is really being part of a program that keeps society safe, because as an individual, if you don't get vaccinated and you're the only one that doesn't get vaccinated, it's unlikely that there's going to be a negative impact on society. But if multiple individuals take that attitude, then you have a weakening of the system which has been historically shown to be so successful in protecting society.

It's the same thing, for example, if people say: ''Well, there's millions and millions of people who vote. so if I don't vote, it doesn't make any difference. Who cares?'' But if you have a million people who say the same thing, then you have a weakening of the political system, about getting the voice of the people into who gets elected.

Are vaccines completely safe, or do they come with risks?

I think this is one of the delicate issues that sometimes people misinterpret or even misrepresent. Anytime you intervene with anybody -- a sick person and even, importantly, a well person -- there is always the risk that there will be something deleterious, usually extremely minor.

Let me give you an [example of] extremely minor. What is the risk of injecting something into someone's arm? The risk is that a certain proportion of people will get swelling and a little bit of pain, lasting from an hour to a day or so. Most people won't. You can get vaccinated, you get a little pinch, you walk away, and you don't even know you've been vaccinated. Some people get a little discomfort there for a day or so. That is a very acceptable risk. A very, very, very small percentage of people will get an allergic reaction to the vaccine; namely, there's a component of the vaccine that they didn't realize that they were allergic to. Most of the time it's an allergic reaction that can be taken care of by a pill -- an antihistamine or what have you. And then there's a subset of a very, very, very, very small percentage of those who actually can get a serious reaction. But if you look at that, the risk of that is so minusculely small as to be completely outweighed by the benefit.

But to say that there is no risk in any vaccine would not be truthful. ... There's always a risk. But getting out of your house and getting into your car to go to the office to get your vaccination has a risk to it. Can you say there's no risk of your getting into an automobile and driving someplace? There's a risk, but it's a very, very small risk, and it's completely outweighed by the benefit of getting out and performing your duties in society, going to your job, raising your family, getting a livelihood, etc. ...

When you have a vaccine that's gone through the entire safety process, and a vaccine that for years has been followed in follow-up, the risk of those are almost nonmeasurable.

When you give vaccines to so many people, and there's a background rate of rare things happening, how do you tell if something is caused by the vaccine or just coincidence?

That's an excellent question, and that's the reason why you need to know the background rates. What people don't appreciate is, for example, when we were giving the influenza vaccine during the H1N1 season, there was a concern, because way back in 1976, when they gave it, there was an association of a greater pre-incidence of Guillain-Barré syndrome, a neurological disorder that appeared to be related to this particular vaccine. And it was picked up, and the vaccine was stopped [being given]. So this year, when we gave the vaccine, we made sure that we had a very good feel for what the natural occurrence of things that you might relate to the vaccine [was] that occur anyway, even if you don't give a vaccine. And it was striking, the number of things that you might attribute to a vaccine that occur even when you don't give a vaccine.

For example, there was concern that if you give it to pregnant women, they'd have miscarriages. Well, there's about 1,000 or more miscarriages every day in this country, so the chances of a woman going and getting vaccinated and having a miscarriage that has nothing to do with the vaccine, it's pretty good. But when you look at the number of miscarriages and the number of people who are vaccinated, and look at vaccinated versus unvaccinated, it became very clear that there was absolutely no relationship between giving the influenza vaccine and having miscarriages, and no relationship between giving the vaccine and having Guillain-Barré. But if you don't know the background incidence of a particular complication, you could be scratching your head and saying, ''Gee, is this caused by the vaccine?'' So when you finish the vaccination and you look at the data, then you really know if there are any deleterious effects. And that's the reason why you do a clinical trial.

A third group of parents argues that as the number of vaccines increases, it seems to correlate with the rise of chronic diseases like ADHD [Attention Deficit Hyperactivity Disorder] and autism.

... This issue has been looked into very carefully, about any scientific indication whatsoever that autism is caused -- or any of the other chronic diseases -- are caused by vaccine. And independent bodies have looked at this every which way and have come to the conclusion that there's no relationship at all between [them and] vaccination. Those diseases occur; they're tragic diseases, but they're not related to vaccinations.

Why are vaccines proposed as the cause of disorders like autism?

... The one common denominator of childhood is that you get vaccinated. That's not cause and effect. So what you need to do is to see if there is any cause-effect relationship, and a lot of groups have looked very carefully at that, and there isn't. There's just no scientific data to indicate that that's the case.

Now a methodological question: Specific hypotheses -- e.g., thimerosal, MMR [measles, mumps and rubella vaccine] as the cause of autism -- have been settled scientifically. But autism groups say the cause could be any one of the 14 vaccines or any one of the components. Does that put pressure on you to keep testing?

You obviously need to always be alert and vigilant and look around, follow the situation. Every time you look, you find out even more information to argue that it's not the case. There was this issue about thimerosal and autism, so thimerosal was taken out of virtually all of the childhood vaccines over a period of time, and children were vaccinated with thimerosal-free vaccines, and the incidence of autism was going up. It's exactly the opposite of what you would be expecting if you were making a causal relationship between thimerosal and autism.

Some anti-vaccine groups say the only trial they'll accept is a randomized control study that compares vaccinated children with unvaccinated ones. What are the issues with a study like that?

Methodologically, that is very difficult if not impossible to do, because there are real ethical concerns about withholding a potentially lifesaving intervention from a group of people where it would be a large enough group to have a statistically significant conclusion of unvaccinated cohort and vaccinated cohort. It's logistically difficult and ethically quite questionable. ...

Then they say, why not just go to communities where people don't vaccinate and study them?

Again, I think that those groups are probably so small, you're not going to get any kind of a meaningful information from small groups of people who are not vaccinated, because the incidence of the diseases you're looking for are so rare that you're going to have to have very large groups of people.

So what can you do when they claim, "Why don't they study it?"

... You want to do two things. You want to take the scientific high ground, don't pooh-pooh anybody; be respectful of people's concerns, but let the science be your guide. Continue to accumulate data so that you continue to show that vaccines are actually safe and not causing these diseases at the same time as you focus on what is the real cause of these diseases. As opposed to saying, "No, it's not that," then maybe try and find out what it is. So it's a two-pronged approach. ...

Do you think the turf has got harder in the Internet age?

The turf has gotten extraordinarily more difficult in the Internet age, because just as factual and important and constructive information can get virally spread rapidly, inaccurate, misleading and destructive information can get equally as widely spread. ...

Can the NIH [National Institutes of Health] and CDC keep up in a YouTube era?

I think so. Particularly the CDC is doing a great job on their Web sites and on their ability to disseminate information, to keep the public informed. They're very clear. You go onto their Web sites, they give you the facts; they give you the basis and the reference for the facts; they explain it in a clear, articulate way. I think that they're doing a great job.

Comment on the Redskins cheerleader [Desiree Jennings] who claimed she had a reaction to a seasonal flu shot. That was seen more than 2 million times. Does that alarm you?

Well, you know, it's a fact of life. It certainly is alarming, because people who just turned it on and see it immediately believe it. That's just the way society is. That's the arena in which we are operating.

So rather than run away from it and throw up your hands in frustration, what you've got to do is continue getting back to what I say all the time: Stick with the science. Science, by definition, is knowledge and truth. And I'm a firm believer that sooner or later -- there may be obstacles in the way, and those obstacles may be magnified by the age of the Internet -- but sooner or later, the truth will prevail, and people will realize what is correct and what is real and what is right. It may be more difficult when you're getting bombarded by completely unfiltered statements that have no scientific basis, but unfortunately there's nothing you can do about it.

The Internet has democratized knowledge. It makes it easier for people to appear to do science. Do you think the processes like the ACIP [Advisory Committee on Immunization Practices] are a little elitist?

In fact, I was the first one to call in the activists who were objecting to the elitism of the scientific community and how we conducted clinical trials and how we made getting into a clinical trial very difficult, not fully realizing that when you have no other drug available, you've got to be a little bit more flexible in your clinical trial process and in your approval of drugs. That's history, an important part of our history. I was one of the first, if not the first person, to actually embrace them, to bring them in and say: "Well, maybe there is a degree of elitism. Let's listen to what you have to say." And many of the things that they had to say, even though they were off base on a lot, had some real fundamental basis in reality, namely the rigidity in which clinical trials were conducted, because of the fear that if you weren't rigid, you wouldn't get the correct scientific answer. It became clear that you can be more flexible and still get the good scientific answer. So I'm all for the democracy of listening to what people have to say, but I'm not for the use of the democratization of this to propagate things that have no basis in reality. ...

Now a question about vaccine ethics. Why is it OK to mandate vaccination if it's not 100 percent safe?

When you say mandate, it isn't absolute mandating. You're talking about getting into school. I mean, if a parent really feels strongly against that, that parent can get an exemption. So there's never a situation where someone is going to tie you down and vaccinate you or say you can't go to any schools at all if you're not vaccinated.

So it's a soft mandate.

It's a soft mandate. And I think that the mandate is because it is such an important consequence to society and to the health of the overwhelming vast majority -- 99.9 percent of the children who are functioning in society -- that to have strict guidelines that are a soft mandate is OK. But nowhere should you force someone to do anything.

Are our loopholes too easy to get through?

No, I think we have it right. You want to respect autonomy of people. I do think you need to respect autonomy, but you don't want the respect for autonomy of people to get in the way of a public health mandate.

If more communities followed the Vashon Island, [Wash.,] and Ashland, [Ore.,] model, would we be in trouble?

I think we would be approaching getting into trouble. You have to look at the principle. ... You merely need to go to those places, little pockets in this country, but more dramatically in other countries -- Europe, the U.K., Sweden, Italy to some respect -- where they actually pulled back on vaccinations because of an unrealistic fear that the adverse event would outweigh the benefit. And then what you see inevitably are outbreaks of serious diseases that have been essentially eliminated by the vaccine. And when you go to the hospital and you see kids with measles, who have serious disease, pneumonias and meningitis and CNS [central nervous system] problems, [I] say to myself, ''Oh, my goodness, what have we done?'' So it isn't only a theoretical issue; it's a real issue.

Are we at the end of a vaccine era, or do we have a great future to look forward to?

I think we have a future to look for, particularly since we are now living in a global community. Things have changed over the last couple of decades. We no longer think in a very provincial way. We think about global health. There are many diseases for which we don't have vaccines that it would have a major impact on global health if we did: tuberculosis, malaria. Tuberculosis kills 1.8 million people a year. Malaria kills about a million people a year, mostly African babies. Neglected tropical diseases -- a great source of morbidity, economic problems, even some mortality in the developing world. And then you have vaccines for diseases here in the United States where you might want to make better, more effective vaccines. So I think that the future of vaccinology as a major preventive modality for disease is alive and well, and should be.

Pediatricians are on the front lines. It's a form of benign coercion. Do you have any thoughts on this complicated conversation?

It is a complicated conversation, but I think most of the pediatricians are aware, as physicians, of the importance of preventing serious diseases in their patients. And their patients are mostly well babies. If you look at a pediatric practice, 90-plus percent of their patients are actually well patients. That's why they call it ''well-baby clinic.'' There aren't very many well-adult clinics, but there's a lot of well-baby clinics, and they feel a responsibility to protect those children.

And although they sometimes run into obstacles, particularly the recalcitrance sometimes of parents and their concern, they need to take the time to explain the rationale. And I think for the most part they're doing a very good job of it. ...

There's a lot of distrust of the NIH, CDC and the scientific community. What do you feel when you hear: ''These guys are all corrupt. They've got conflicts of interest with industry, and they won't do the research"?

That's par for the course. That's just not true. If you look at the kinds of questions that are asked, they are asked on a scientific basis. I don't know of any important study that really does need to be done that researchers at the NIH, the CDC or the FDA would shy away from at all. But you just don't do a study because you want to satisfy somebody's concern when there's no scientific reason to actually do the study.

How can the scientific community maintain trust? Trust levels are still pretty high, but a lot of nasty things are said in the media. Has that always been true?

I think that's always been true. If you live by the standards of science, science is knowledge; knowledge is truth. I think transparency is extremely important so that people know what you're doing and why you're doing it, and you try and take the time to explain the rationale for what you do.

There will always be people who are skeptical no matter what you do. ... You try your best to be open, honest, transparent, and let your transparency, your honesty and the facts of the science be your best advocate.


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posted april 27, 2010

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