Media Briefing

FOR IMMEDIATE RELEASE Tuesday, July 19, 2005

Contact: HHS Press Office (202) 690-6343

Press Briefing with Dr. Julie Gerberding,
Director, CDC

MS. Christina Pearson: [In progress] --Dr. Murray Lumpkin who is the Acting Deputy Commissioner for International and Special Programs at the Food and Drug Administration, Dr. Eileen Ouellette who is President Elect of the American Academy of Pediatrics, Dr. Robert Wah who is a member of the Board of Trustees of the American Medical Association, and Dr. Peter Hotez who is a father of a child with autism as well as a medical researcher.

So from here I'd like to introduce Dr. Gerberding and hear the statements and we'll open it up for questions afterwards. Dr. Gerberding?

DR. GERBERDING: Good afternoon. Thank you for joining us today.

We're really all here today for one purpose, and that is to affirm our commitment to protecting the health of children around our country and really around the world. We're going to be covering some of the issues around vaccine safety, some of the steps that we're taking to assure the safety of our vaccines, and also some mention of the research that we think needs to be done so that we can continue to protect our children.

We know the issue of the safety and well-being of our children is near and dear to the hearts of everyone, and especially the parents in our country. There has been a renewed interest in the issue of vaccine safety, particularly focusing on whether or not some of the preservatives or the preservative thimerosal was used in vaccines up until the early part of this century may be linked to causing autism in some children. So that controversy has stimulated a lot of focus on vaccine safety and a lot of concern on the part of parents. So what we want to try to do is present some perspectives on that and really help people feel confident in the immunization programs that we are recommending.

This isn't a new debate, but it is one that has been in the media's attention and we feel we have a responsibility to speak out on the issue.

What I'll try to do is say a few words about what do we know about this issue today, what don't we know, and, again, what are some of the steps that we're taking at CDC and at other parts of the Health and Human Services agencies to really improve our knowledge base and get answers to some of the questions.

We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that certainly we would want to prevent and do anything we could to avoid.

Parents want answers. They want answers about autism and they want answers about the safety of their vaccines that we're recommending, and they deserve answers. We really want to emphasize how important it is that we as government agencies and as clinicians and as parents all address collectively our shared responsibility to protect the health and safety of our children.

We don't know, unfortunately, for most kids with autism what causes it. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.

You may have heard some statistics about 1 in 166 children having autism. I can emphasize that those statistics were drawn from a relatively small sample, but there are studies in progress now going on in an increasing number of states and locations to try to help us get a better and more reliable handle on the true incidence and prevalence of this disease in our communities.

We don't have the information to report today, but we expect beginning next year that we'll begin to see this trend data emerge, and I think that will help all of us have a more epidemiologic orientation to the problem.

Some have suggested that the thimerosal used in vaccines as a preservative is a cause of autism in at least some children. What we know today is based on many studies that have looked at children in various populations around the world including the United States and have involved thousands of children that the preponderance of evidence consistently does not reveal an association between thimerosal and autism. These studies have been looked at by some of the best and brightest scientists across the world and in the United States through our Institutes of Medicine and the National Academy of Sciences.

But I can't sit here today and tell you with 100 percent certainty that there is absolutely never going to be any association of thimerosal and autism in one or more children. Science doesn't say that and it will be very difficult for science to ever prove a negative. What is we can say is the predominance of evidence does not associate a link, and we've certainly been looking hard to find such a link.

Science is an evolving process, however, and there are more studies underway and we hope there will be even more studies underway. One of the things I like to emphasize is the importance of keeping an open mind. When you're dealing with a problem as complicated as this one and as important to so many children and so many families across the United States, we have a responsibility to be open to any and all hypotheses. But as we're looking for answers to the problem, we have to also be careful not to base our decisions as scientists or policy makers or parents on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and I think that's a very, very important message for all of us to remember.

I know for certain that children today live longer and healthier because of the vaccines they receive in childhood. Just to put this in context, before the Childhood Immunization Program was present in the United States, 13- to 20,000 kids developed paralytic polio every year. Before measles vaccines, almost everyone in the country got measles when they were child, and about 450 children died every year from measles. Before rubella, epidemics of rubella occurred and sometimes up to 20,000 children were born with congenital rubella syndrome with 2,000 deaths and more than 1,000 miscarriages. We also know that rubella is a cause of autism, and during the most recent epidemic in the 1960s, 7 percent of children with congenital rubella syndrome developed autism.

It's also I think very important to remember that we don't see these diseases very often in the United States anymore. I'm an internist, but I did some training in pediatrics and it would be a novelty to see a case of measles. We would call people in to see the patient because it was so unusual. And that's really a wonderful thing, but it's something that we forget, and when we're trying to think about the benefits of vaccines, it's very difficult when we don't remember the terrifying diseases that vaccines really can prevent.

Unfortunately, the vast majority of these viruses haven't gone away. They exist in many other parts of the world, and we periodically learn the hard way that we are just one traveler away from reintroducing measles or polio or rubella into our population. Just this year we were dealing with a measles outbreak in the Midwest among people who were underimmunized for measles virus.

So in order to protect our children, we have to continue to vaccinate them until we achieve some state in the future where these childhood diseases are not present anywhere in the world, and we are a very long way away from that for almost all of the conditions that we're concerned about.

Thankfully, the technology of our vaccine production has evolved and we can manufacture vaccines today that do not contain thimerosal as a preservative. I think it's very important for people to recognize that with the exception of some kinds of flu vaccines, the immunizations that we're recommending for children today do not contain thimerosal as a preservative. And let me just emphasize that concept of as a preservative because in order for thimerosal to keep bacteria from contaminating a vaccine, it needs to be present in a significant concentration. As we have moved away from thimerosal, we now are packaging vaccines as single doses. That can be a little bit more expensive, but it's worth it if it helps parents have an easier mind when it comes to making their decision.

I think the Department of Health and Services, our expert advisory committees and the vaccine manufacturers have all worked together with the Food and Drug Administration to get thimerosal as a preservative out of vaccines. Some of the manufacturers still use thimerosal in the manufacturing process to clean and sterilize the equipment or for other steps in manufacturing so that by the time they end up with the vaccine product, there may be traces of thimerosal in it, but this is well below the amount of thimerosal used as a preservative and it is a concentration of thimerosal that I think from anyone with common sense you would recognize that this would not be a focus for a health issue.

So I think what we're looking at today is a state where we know the benefits of vaccines, we're very committed to understanding vaccine safety. The CDC has made some changes itself to try to increase our ability to monitor and understand the complications of vaccines, but the predominance of evidence today does not indicate that thimerosal is a risk for parents who are considering vaccination of their children.

My colleagues and I have spent a long time this past year listening to parents of children with autism and others who advocate for better science and better policies around kids with autism. I think we've heard some very strong voices and some very powerful voices, some very caring voices, from people who are rightfully upset and dismayed and wanting to do everything possible to protect their children, to help treat their children, and to prevent other children from having this important disease.

As we listen and we learn, one of the key messages that we've taken home is that we need to be doing more as a government, and I know Secretary Leavitt shares this commitment and that's why he's--

[Tape change.]

--the various agencies. We've been working with our colleagues at NIH, with FDA, and with the other organizations to really put our heads together and say what are the most important research steps that need to be taken to get to the bottom of this condition?

Parents want to know not only what causes autism but they do want to know how you can detect it, how you can screen for it, and I think very importantly, how it can be treated.

We also need to know where is it, where is it going, is it increasing, it is staying the same, who's got it. There are many other factors about the condition, that if we learn more, we might be able to generate even more robust hypotheses and make effective decisions.

So we are committed to getting answers to this question. It's not going to happen overnight and it's going to take time.

And I think in the meantime, we have to rely on the science that we do have, and that science tells us very clearly that vaccines save lives and protect our children. Ultimately this conversation is not really about autism, it's not really about thimerosal, and it's not really about vaccines.

It's about the health and safety of our children, and that I think is something that we all share an interest in, and if we work together, I think we can make a stronger position for solving some of these problems.

Thank you.

MR. Duane Alexander: Good afternoon. The National Institutes of Health is pleased to have been asked to participate in this event. Our nation's health depends, in large part, on the health of our children and I want to echo the sentiments that Dr. Gerberding expressed, that vaccines protect our children.

From what we know, the greatest risk would be to forego vaccination, placing children in danger of a variety of life-threatening and debilitating diseases. But above all, we want the parents of children with autism to know that we are listening to them and we hear their concerns.

We are investigating all possible risk factors and biological markers of autism, to better understand the genetic and environmental factors that are involved in autism.

We are committed to research that will enable us to understand, treat and prevent autism and autism spectrum disorders.

In 2004, the Institute of Medicine conducted a thorough review of clinical and epidemiological studies, to examine whether or not thimerosal-containing vaccines can cause autism.

The IOM identified five studies that contributed to the evaluation of causality, studies conducted in Sweden, Denmark, the United States, and United Kingdom.

Based on these studies, they concluded that there was no evidence that thimerosal causes autism. As was suggested in IOM reports, scientists at NIH and elsewhere continue to conduct studies to identify risk factors and biological markers of autism, in order to better understand genetic or environmental causes or their interaction as inducing autism.

Autism includes a range of disorders and is complex. Our research agenda, reflected in an autism matrix, has defined the genetic and environmental factors, improved diagnosis in terms of accuracy and earliness, and develop potential treatments and preventions for autism.

We have created teams of scientists and networks and centers to continue to work with families, to pursue answers to these challenges. Autism is an important public health issue. It has a high priority at the NIH.

The NIH's investment in autism research has grown steadily, from $22 million per year in fiscal year 1997, to $102 million in fiscal year 2005, and we continue to make progress.

Early on, back in 1997, the NIH established the collaborative programs of excellence in autism that linked together 129 researchers at 23 universities, and more than 2200 families of people with autism.

This network conducts research on the possible genetic, neurological, immunological, and environmental causes of autism. The network also investigates the development of brain structures and their functions as they relate to autism, as well as the developmental course of autism.

There are also eight research centers across the country known as the studies to advance autism research and treatment network.

Each center is conducting studies on the neurobiology, genetics, characterization and treatment of autism.

Treatment studies include research on pharmacologic interventions, diet changes, and behavioral strategies. There are plans to maximize these resources by combining these Start centers and the CPEA network.

The NIH also sponsors the research units on psychopharmacology and psychosocial interventions, which has conducted several studies on treatment of children and adolescents with autism.

We also support two centers of children's environmental health and disease prevention, that focus on possible environmental causes or contributions to autism.

The NIH is in the process of creating a national online database for autism research. Such a database would allow researchers to share the raw materials of research and make disparate databases available through a single resource.

The database will foster academic collaborations, facilitate public/private partnerships and enhance communication between researchers and the public, to ensure rapid dissemination of research findings into clinical practice.

We never forget the children with autism or their families. The special nature of the autism spectrum disorders demand that government agencies, private foundations, scientists and families work together to solve this problem, and we will. Thank you.

DR. LUMPKIN: Good afternoon. My name's Murray Lumpkin. I'm the acting deputy commissioner at the U.S. Food and Drug Administration. I'm also extremely glad to be here with you this afternoon as a parent, as a pediatrician, and as a member of the largest scientific community that is looking at this issue of vaccines, vaccine safety, vaccine efficacy.

I think as you heard from Dr. Gerberding, vaccination has been one of the mainstays of the therapies that we've had made available to us over the past decades to try and improve the human condition, and I think you've heard from her the lists of diseases and the kinds of devastating effects those diseases had in this country and still do have in many parts of the world where vaccination is not available.

I think we also feel, as we look to the future, and we look both at some of the infectious diseases that are still devastating our populations, when we look at some of the noninfectious diseases, vaccination and the theories behind vaccination and the practice of vaccination, really provides a tremendous amount of hope for the future as much as it has shown us progress and benefit in the past.

But any kind of therapy is only as good as those who are willing to take it, and I think as Dr. Gerberding pointed out, one of our major concerns and one of our major goals is for parents to have confidence in the vaccines that their health care practitioners are recommending that their children have, and this confidence is extremely important, if we, not only for the individual child, but for the community at large, are going to benefit from the vaccination programs that we have.

I think we at FDA are particularly keen that parents and that health care practitioners, when they look at the benefits of vaccination, realize that looking at the data as Dr. Gerberding pointed out, at the very stringent scientific data, that the benefits of vaccination outweigh the risks of vaccination when looking at our populations, and that is an extremely important point.

In order to try to help parents have as much confidence as they can in vaccinations, and in order to try to reduce the amount of environmental mercury that children are exposed to as they grow up, the Public Health Service, the manufacturers of vaccines, and we at FDA began working, in 1999, to try to remove as much of the thimerosal and mercury components to vaccines that could possible be removed at that point in time.

Just to give you some facts of what has happened since 1999. Since 2001, all vaccines routinely recommended for children six years of age and younger, that are manufactured for the United States market, as Dr. Gerberding pointed out, contain no thimerosal or only trace amounts of thimerosal, and when we're talking about trace amounts, what we're talking about here are amounts less than one microgram. That's m-i-c-r-o, microgram of mercury per dose.

And as Dr. Gerberding pointed out, those few vaccines still remaining, that have these trace amounts, are vaccines not where the thimerosal is used as a preservative but where it is used as part of the manufacturing process itself and that presents its own issues of supply, were we to go forward at this point and try to even remove those amounts without some kind of a supply on the other side that would be available for us.

Now when we talk about these vaccines, what we're talking about are vaccines that are used to prevent diphtheria, whooping cough, tetanus, Hepatitis B, hemophilus influenza type B, and don't let that word influenza be confusing. It's always confusing. This is not influenza in the idea of the virus, influenza flu. We'll talk about that in a minute.

This is a bacterium that in the past was very common in children, it caused devastating diseases such as meningitis and it is one that has been one of our very successful vaccines that has come around in the last decade.

We're also talking about the vaccines for pneumococcus, for polio, for measles, for mumps, for rubella or what is also known as German measles, and for chickenpox.

So this is a large array of vaccines that now, since 2001, in this country are routinely manufactured and available with no thimerosal or less than one microgram of mercury as part of their manufacturing process.

All new vaccines that have been licensed in this country since 1999 are free of thimerosal as a preservative.

One of the ones that Dr. Gerberding mentioned, that I want to spend just a little time on is to tell you about the influenza. Now we're talking about influenza in the sense of the virus and the flu, the normal kind of influenza that most of us think about.

This is a vaccination that became routinely recommended for children between six and 23 months of age only in 2004.

There are manufacturers, there is now a thimerosal-free version of this. We are working with the manufacturer to increase the supply of the thimerosal-free version and I think as capacity increases and as time goes on, we will indeed be able, even with the influenza virus, to get us to a position of having adequate supply without the thimerosal contamination that we've been talking about.

I hope from this that what people from an FDA perspective will realize is that as Dr. Gerberding was talking, we are very, very concerned that people have confidence in the products that they use, whether they are medicines, whether they're medical devices, whether it's the food they eat or whether it's the vaccines that they give their children, and particularly if it's the vaccines they give their children.

Here we are in a very special situation dealing with an otherwise healthy child and we're trying to do something that we know from the history that Dr. Gerberding was talking about has shown us over the past century that we can create a more healthy life for our children by looking at our vaccines, by using our vaccines, and by working as hard as we can not only to create new vaccines to help us deal with diseases that at this point still continue to haunt us, but also to look at science and the new science that comes in to make the vaccines we have even safer than they are now. Thank you.

DR. OUELLETTE: Good afternoon. My name is Eileen Ouellette, and I am the President Elect of the American Academy of Pediatrics. It's a pleasure to be here today on behalf of the Academy of Pediatrics which has more than 60,000 pediatricians as members. Our mission is dedicated to improving the health and well-being of all children. To put it simply, we care very deeply about our patients.

Children make up 23 percent of our population, but they are 100 percent of our future. It is an honor and privilege to take care of them.

This is the seventy-fifth anniversary of the American Academy of Pediatrics. In 1930 when we were founded, pediatricians spent the vast majority of their time taking care of sick children with measles, mumps, chicken pox, whooping cough, German measles, diphtheria, polio and the three bacterial causes of meningitis, H flu or H influenza, pneumococcal meningitis and meningococcal meningitis.

Today there are vaccines to prevent each and every one of these diseases, and as a result, most of them have virtually disappeared from this country. Yet when children are not immunized, these diseases return. We have had outbreaks of whooping cough in parts of this country, and after almost being eradicated, polio has resurfaced in parts of Africa and Indonesia. So it concerns us when parents do not vaccinate their children because of fear about their safety.

Physicians and other health providers are committed to the health and safety of our children. Many pediatricians are parents also, and they vaccinate their children.

AAP recommendations to parents are always based on science. Science is not perfect and it is always evolving. But it has served us well in making tremendous strides in medicine. Science has led us to recommend putting infants on their backs instead of their stomachs to sleep. This simple action has resulted in a 50 percent reduction in the incidence of sudden death syndrome, also known as SDS. Science has led us to call on the federal government to fortify and enrich grains with folic acid to reduce birth defects such as spina bifida. Science has also led us to one of our greatest achievements in child health in the 20th century, vaccines.

The organizations standing here today have reviewed the scientific research about vaccines and autism and universally do not believe in a causation theory. We want to discover the causes of autism as well as how to prevent it and treat it, but the evidence does not point to vaccines as one of those causes.

Pediatricians treat and support many children and families coping with this difficult disorder. We are committed to providing them with appropriate services and offering them the latest information. The American Academy of Pediatrics has offered updated guidelines to pediatricians about the screening and diagnosis if autism. We have published studies in our journal Pediatrics to help further professional understanding of the disorder.

We also support, strongly support, more federal funding for autism research, and we have joined a public awareness campaign with the CDC to help educate parents about the early warning signs of autism. Our website www.aap.org contains educational materials for families and pediatricians not only about autism but about vaccines and the diseases they prevent.

In conclusion, we want parents to know that immunizations are safe and save lives. If parents have questions about vaccines or about autism, they should ask their pediatrician and discuss it with the pediatrician. Pediatricians provide care to children in a family centered environment within a medical home. We understand the importance of listening to our patients and their parents. Working together we can continue to improve child health. Thank you.

DR. Robert WAH: I'm Dr. Robert Wah, obstetrician/gynecologist and reproductive endocrinologist from here in McLean, Virginia. I'm pleased to be here representing the American Medical Association to add our voice to the chorus of public health and other experts assuring the safety of vaccines for America's children.

Since the introduction of vaccines, diseases like polio that once caused thousands of childhood deaths in this country are now rare. Immunization's role in preventing disease and death cannot be overestimated. Vaccines protect us from at least 14 different diseases as you heard earlier that once were common in this country, such as mumps and measles. Without a doubt, immunizations rank among the 10 most significant public health achievements in history.

As an obstetrician, I've met with many parents and soon to be parents to discuss what's best for the health of the new babies. I advise new parents to protect their children by getting them vaccinated.

On the subject of autism, autism is a heart-wrenching disease and the upheaval felt by new parents with such children that have autism is very understandable as is their search for answers. We need more research to investigate the actual causes of autism, yet it would be a shame and a disservice to the health of our children if we let these vaccines take the blame for this tragic and little understood disease.

It is critically important for parents to know that numerous scientific studies show no connection between thimerosal in vaccines and autism. As a further reassurance, all current formulations as you've heard in vaccines administered to children younger than 6 years of age do not contain thimerosal as a preservative.

The AMA urges all parents to get their children vaccinated as protection against diseases. Without these vaccines' protection, our children are at risk for measles, mumps rubella, polio and other diseases that used to stalk the nightmares of parents.

Talk to your doctor if you have questions. We're here to help you make healthy decisions and help take the best possible care of your children. Thank you.

DR. HOTEZ: Good afternoon. My name is Peter Hotez. I'd like to thank the Department of Health and Human Services for allowing me to speak this afternoon. My day job is that I'm chair of the Department of Microbiology and Tropical Medicine at George Washington University here in the District where I lead a multinational effort to develop a vaccine for human hookworm infection, a parasitic disease that affects hundreds of millions of children in developing countries.

In addition to being a pediatrician and a vaccine researcher, however, I am also a husband the father of our children. My 12-year-old daughter Rachel has pervasive developmental disorder, autism, which was first diagnosed at the Yale Child Study Center in New Haven, Connecticut, when she was just a few years old.

I can say authoritatively without question that having a child with autism has been my family's single greatest challenge and my own personal greatest challenge. My own opinion is that autism is one of the cruelest medical conditions that could befall a child of her parents. Although Rachel has some special gifts and unique charms and we love her, there have also been a number of occasions where the grueling and unrelenting care that she requires as well as the incredible financial hardships she creates have caused clinical depression in some members of my family, and on multiple occasions have come close to tearing apart our family.

The good news is that so far we have made it and we've remained together. So my wife and I often as each other what did we do to become so unlucky as to have a child with a condition that occurs with the frequency of only 3 to 6 per 1,000 births? One thing that we're totally confident about is that Rachel's autism had absolutely nothing to do with the vaccines that she received. Even if we could turn back the clock and do it all over again, I can honestly say that we would still give Rachel her fill complement of pediatric vaccines.

Our confidence about this is based on what we know to date about autism. Autism has a huge genetic component and it's more or less a genetic disorder associated with structural changes in the brain that occur prior to birth. We know that autistic children have a reduced head size at birth and then experience and sudden and excessive increase in head size at about 1 month of age, even before they receive their first set of pediatric vaccines.

We know heredity is the single most important risk factor for autism. At least five major studies that examined the health records of hundreds of thousands of children in the U.S., Britain, Denmark and Sweden, have conclusively shown no link between autism and vaccines or the thimerosal previously contained in vaccines. Indeed, these studies which are published in some of the best medical journals show that rates of autism either remain the same or may have even increased after mercury containing thimerosal was removed.

As a scientist this makes sense to me, that autism does not cause vaccines, thimerosal does not cause autism. Instead, we know that mercury exposure in infancy produces a unique syndrome that bears no resemblance to pervasive developmental disorder. We know this because of the unfortunate children living in Minamata City, Japan, who were exposed to toxic levels of mercury from environmental pollution during the 1950s. These children exhibited stunted growth, limb deformities, and a unique type of brain atrophy that looks nothing like the enlarged brains of children with autism.

There are two important messages I want to convey today. First, as a pediatrician and child advocate, I want to remind the audience today of the consequences we face by not vaccinating our nation's children. Because of my interest in parasitic and tropical diseases, I work extensively in developing countries such as Brazil, Honduras, Guatemala, Panama, China and Indonesia where because vaccines were missed or were not available, children suffered devastating consequences. My colleagues and I have witnessed infants and children die excruciating deaths from measles, from tetanus, from H flu meningitis, as well as from cancer caused by hepatitis B.

We have seen children gasping for air because of whooping cough, and we have seen children permanently disabled from polio. There is nothing intrinsicly different about these children compared to children in the United States. The only difference was that the children living over there did not get vaccinated and ours did.

Second, as a parent of an autistic child, I want to focus our national attention away from these unfounded claims about vaccines and shift it to what we really need to make our lives and our children's lives bearable, we need access to child services and respite care that can help us get us through our day especially when our autistic children are not in school.

Even the very best public school systems provide education and care Monday through Friday, 9:00 a.m to 3:00 p.m., 5 days a week, not including summers and school holidays. Rachel is only in school and has a structured environment only 20 percent of her waking hours. We need venues that provide stimulating games and fun activities when our children are not in school. We need pediatricians, we need neurologists, we need child psychiatrists, to understand the complex and diverse needs of autistic children and who have access to the latest psychiatric medicines and have the training on how to use them.

We need insurance companies that are willing to step up and to again reimburse families for visits to the child psychiatrist. We need research to better understand the causes of autism and to develop genetic screening tests for this devastating condition.

We need a war on autism, not a war on childhood vaccines. Thanks.

MS. Christina Pearson: Thank you very much to everyone up here who spoke before us today, and we have time for a couple of media questions, questions from the media. Jessica has the microphone. If you would please just identify yourself, your name and media outlet, because we do have people listening on the phone. First question?

MS. Reporter: [inaudible] here in Washington, D.C. I have two questions. First of all, can you address the virus in the California study that basically showed that there was an increase in autism in direct relation to the 1990's when the series of vaccines were increased, and now since thimerosal has been taken out there is a slight decrease in autistic cases. That's my first question.

My second question is I'm wondering why we're here today. I'm not hearing any new information and I'm wondering if this was a press conference held to address the rally that the parents are having tomorrow on Capitol Hill?

MS. PEARSON: Dr. Gerberding.

DR. GERBERDING: I'll take your first question. The California study, as you know, is an ongoing study and they are addressing the estimates of autism prevalence on a quarterly basis, sort of like the stock market bounces around a little bit.

The most recent reading from that study is in fact that the rates are increasing, they have not shown a decline, but we would refer you to the investigator in California who is aware that these questions may be coming up and would be available to take your question and give you more detail of the latest results. So just contact the press office and we can put you in touch with them.

QUESTION: [inaudible] reaction to tomorrow's rally.

MS. PEARSON: [inaudible] anyone else wants to jump up too. But we are here to talk about an issue that we received questions on and doctors have been out and talking about this for a while and we want to make sure to speak clearly and talk about the issues of vaccines and child health.

So it's more today as an educational thing, to step forward and to make these resources available to you all. Who's the next [inaudible] questions and so we want to make sure to speak clearly to people. Thank you.

Next question. Todd.

QUESTION: Todd Zwolicki [ph] [inaudible] and UPI. Dr. Gerberding, the benefits of vaccination on a population level are clear but parents make decisions on an individual level for their own kids.

For a parent making a decision about whether or not to get vaccinated, they're going to weigh whatever they think the risks of thimerosal exposure are with the risks of disease like polio, which on an individual level are rare, even if your child is not vaccinated, the chances of your child getting polio in the United States is effectively remote, or effectively nil at this point.

So how do individual parents--most everything you said is on a population level. The polio has been eradicated, rubella, these diseases are now rare. But that doesn't tell individual parents anything.

How do they make decisions?

DR. GERBERDING: I think you're really speaking to the heart of the parent who's looking at their child and wants to do the very best thing they can to protect that child. Yes, it's true that at a population level, there's absolutely no question that vaccines are appropriate and helpful to our society.

But they are also very helpful on an individual level. As I said, we are just one traveler away. I mean, it doesn't take very many parents in a community to decide not to vaccinate their children for us to see those kinds of outbreaks.

We see them periodically here in this country, certainly in Britain they're having problem with even a slight reduction in immunization coverage can result in community outbreaks, and that's a problem for the individual child and parent as much as it is for the community.

It is more difficult now, parents have a bigger dilemma because they're not as familiar with these virus infections, and, you know, that's a good thing, that we don't have that kind of parental experience with these diseases, and most parents are young enough now where they don't remember them, although some of us older folks do.

But I think that what we're here to do is to really try to put forward what we know about the importance of immunization, the science as we see it today, with a very humble recognition that there is more science to come and really reassure parents that the vaccines we're using right now to protect their children do not contain thimerosal as a preservative, so that issue is off the able.

And secondly--and they have a very fine track record of safety. We have been using many of these vaccines now for several decades and we can see their safety record, over time, and we have a lot of confidence that this really is the right thing for parents to do.

QUESTION: Thank you very much. A question for Dr. Gerberding. Just on the question of future research efforts, are you putting any money into clinical studies rather than epidemiological studies, to verify or disprove the parents' claim about a particular channel, a particular mechanism by which a minority of genetically suspectable kids are supposed damaged by [inaudible].

DR. GERBERDING: Thank you. There is a concerted effort on the part of the relevant parts of Health and Human Services, including NIH, CDC and FDA, to develop a broader research agenda about autism, as well as to expand our ability to do effective vaccine safety monitoring.

Some of those studies are epidemiologic but some of those studies are clinical.

To do the study that you're suggesting, looking for an association between thimerosal and autism in a prospective sense is just about impossible to do right now because we don't have those vaccines in use in this country so we're not in a position where we can compare the children who have received them directly to the children who don't, since right now none of our children are being vaccinated with vaccines containing thimerosal as a preservative, with that one exception that Dr. Lumpkin mentioned, with some of the doses of the influenza vaccine that are available for children.

DR.ALEXANDER: It's really not possible, as Dr. Gerberding said, in this country to do a prospective study now of thimerosal and vaccines in relationship to autism. Only a retrospective study which would be very difficult to do under the circumstances could be mounted with regard to the thimerosal question.

However, many other studies are underway looking at trying to find etiological aspects of autism. We're looking at brain development, we're looking at different kinds of imaging studies of the brain of autistic kids compared to other kids.

We're looking at children who have an aggressive form of autism compared to those children who have exhibited abnormalities like autism from the start.

We have other studies in the planning phase. The largest of these is a study that's trying to get at what we really are talking about in terms of environmental and genetic and other related causes of autism.

The National Children's study that the Congress has asked us to plan is one study that offers this opportunity.

It's a study planned to involve a 100,000 children and families from around the country, recruited over a five year period of time, followed to age 21, with information gathered before pregnancy, during pregnancy, during the time of labor and delivery, early childhood development and following the children to young adulthood.

By age three to five, we would have probably 500 children with autism in this study.

QUESTION: [inaudible] public reaction to various claims from the parents about thimerosal. A good way to build public confidence, I would have thought, is to direct [inaudible] have no idea. But I hear nothing from you about we will spend the money to verify, improve or [inaudible] so much difficulty.

DR.ALEXANDER : Like I said, thimerosal is not the only issue. There are many other factors. For example, a combination of genetic factors and environmental influences. But thimerosal could be looked at, and in fact one of our investigators at one of the Start centers, in collaboration with the Mind [ph] Institute in California, is mounting just such a study, looking at mercury levels in children combined with some environmental contaminants, combined with a number of other observational and physical measurements in the children and trying to get at this kind of a question.

The question is can we recruit a large enough sample of children in order to answer that question. We're going to try and that effort is underway.

QUESTION: [inaudible].

DR. ??? : Dr. Kathy Lord in California at the Mind, in collaboration with the Mind Institute. She's not there but the Mind Institute investigators are working with her.

QUESTION: Dan Olmstead [ph] from UPI. Have you looked at autism in a never-vaccinated population in the U.S. and if not, why not?

DR. GERBERDING: In this country we have very high levels of vaccination as you probably know and I think this year we have record immunization levels among all of our children, so to select out on a population basis that would be representative and look at the incidence in that population and compare it to the other population, is something that could be done, but as we're learning, just trying to look at autism in a community the size of Atlanta, it's very difficult to get effective numerator and denominator and to get a reliable diagnosis.

I think those kinds of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to get immunized, also have genetic connectivity that would make them different from populations that are in other sectors of the United States.

So drawing conclusions from them would be very difficult.

I think with reference to the timing of all of this, good science does take time and it's part of one of the messages I feel like I've learned from the feedback we've gotten from parents groups this summer struggling with developing a more robust and a faster research agenda, is let's speed this up, and let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can. So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population, some pretty big steps have been taken and we're careful not to jump ahead of our data but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point.

I know that is our responsibility and we've also benefited from some increased investments in these areas that have allowed us to do this and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.

QUESTION: Lauren Neergard [ph] with AP. Since the flu vaccine is the last remaining childhood one with significant thimerosal, can you all address the numbers of thimerosal-free doses that will be available this season and what you're actually doing to speed up an increase in those and how that impacts your plans to try and get more children vaccinated.

DR. : Lauren, I think the answer to that is that the major element in dealing with this particular vaccine for children is trying to get the capacity to manufacture it as single dose units and that is what we--it's a little bit different than the other kinds of flu availability issues that people throughout the country and I know you have been very interested in. I just don't want people mixing the two up.

Clearly I think what we have, as we've looked at this, and as those who have made the recommendations both at CDC and at the American Academy of Pediatrics, have said that they don't think just limiting it to this one particular kind of vaccine, that is thimerosal-free, and then not having the other children vaccinated is the right way to go.

That still, as we've been talking about here, the benefit of having all of them vaccinated outweighs just using the supply of thimerosal-free that we have at this point.

Clearly, trying to get the manufacturing up to speed to manufacture in the capacity that we need for thimerosal-free is a very high priority obviously for the companies that are involved and one that we are working with them on and as soon as they are ready to go, to be inspected to do this, we will be there and work with them to make sure that gets done.

But I can't give you any idea as to it will happen here or here or here. It's an ongoing manufacturing improvement that they are working on.

QUESTION: [inaudible].

DR. : As far as for the children? I think at this point--and I can't give you the exact numbers but I'll be happy to try to get them for you afterwards. But I think as far as I'm aware at this point it would be very similar to what we have seen. But let me get you the exact numbers for the children on the thimerosal. Okay?

MS. PEARSON : That concludes today's event. We appreciate everyone coming. Thank you and have a good day.

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