107th Congress

Autism -- Why the Increased Rate? -- A One Year Update (Part II of a Two Part Hearing) -- House Committee on Government Reform and Oversight -- April 26, 2001

Rep. Burton, Chairman:

Being present, the committee on government reform will come to order. The minority ranking member will be here shortly as will some of the other panelists. I ask unanimous consent that all members' and witnesses' written opening statements be included in the record, without objection, so ordered. I ask unanimous consent that all articles exhibited and extraneous or tabulor material be included in the record, and without objection, so ordered. We're going to be hearing today from the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. Autism is a neurobiological disorder. It locks a person inside himself or herself. This disorder, which leaves children, like my grandson Christian, unable to express themselves or interact with others, is now at epidemic levels in this country. And I mean epidemic. 1 in 400 children in Indiana, 1 in 190 children in Oregon, 1 in 150 children in Brick Township, NJ. How has the Department of Health and Human Services responded to this epidemic? Have our health agencies recognized this dramatic rise and acted accORDingly? If we generously estimate that NIH has focused $60 million on autism, and that is generous, autism research out of a $20 billion budget, that would mean that their investment is .003 -- 3 thousandths of one percent. Does that adequately address an epidemic that affects between 1 in 190 children in Oregon and 1 in 500 children nationwide? I'm including in the record a document taken from the NIH Web site this morning that shows research initiatives at the NIH in their funding for a three-year period. And we will give you all copies of this. We would like you to take that back with you. AccORDing to this document, NIH estimates they will spend $45 million this year on autism (technical difficulty) sleep disorders and $434 million on vaccine development, which could be part of the problem, especially if it's got mercury in it. Two of the issues that were discussed at length yesterday were the concerns that the dramatic rise in autism may be related to the MMR vaccine and mercury exposure through childhood vaccines. We do not yet have enough research evidence to make a conclusion one way or the other. Our health agencies need to fund clinical and laboratory research that will get the answers. As we learned yesterday, epidemiological studies cannot answer these questions. Epidemiology is important for looking at incidence and prevalence, but not in answering questions about causality. I have a short video showing the effects of mercury on the brain. I think that simply saying we're moving to get new vaccines on the market that have little or no mercury is a step in the right direction, but I continue to be concerned on behalf of the 8,000 children a day who may be exposed to mercury through their childhood vaccines until the current supply is used up. And why that isn't being recalled by the health agencies in this country, the FDA, I cannot fathom. As we speak, kids are having mercury shot into their arms, and we know it is a toxic substance. We had toxicology experts here yesterday talking about what it does to the brain, and we're going to show a video on what it does to the brain. And yet the people in the health agencies continue to allow that to be done. And I cannot figure out why. Yesterday we also heard about research at the NIH's funding at the University of Rochester regarding mercury in autistic children. We'll hear today how research is to evaluate the level of mercury in the serum, the hair and the urine of children receiving the currently recommended childhood immunization schedule. I hope the reports will include the hair and urine data as Dr. Haley, a leading mercury expert, suggested. Simply reporting the blood data will be misleading. To only report the blood data and not analyze and report the hair and urine samples would be an injustice. We need to look at it all. And I want to tell you something. We have 113 members of Congress who have signed up for the autism caucus. We are going to end up with about 270 to 280. And we're probably going to have over half of the United States Senate in the caucus. And if you think this is going to go away, you guys are blowing smoke. Because I am telling you, I am going to make sure that everybody in the Congress knows the problems and knows what is facing us. And if the health agencies don't deal with this and deal with it quickly, you're going to have a big problem over there. And I have also talked to Tommy Thompson, the new head of the health department, and he is going to continue to be talked to on a regular basis if we don't do something about this. It is unconscionable that we have thousands and thousands of children being inoculated and vaccinated with vaccines that have toxic substances in them, and we see a horrible increase in the number of people that are autistic, and we continue down the same path. I just don't understand it. Last year the Centers for Disease Control and Prevention reported that they did not know why so many children in Brick Township, New Jersey had autism. They conducted a thorough evaluation of environmental toxins and numerous other potential factors, but chose not to include vaccine history as a part of their valuation and report. Why is this? I believe vaccines are so important, but why they put 3 and 4 and 5 and 6 and 7 and 8 and 9 together at one time with mercury and other toxic chemicals in them into our kids, I just don't understand. We have an epidemic on our hands that we cannot ignore any potential path that may lead to any the epidemic. And with that we have this brief video that we would like for you to see, that shows the effects of mercury on the brain. And I hope you will pay particular attention to this. (video) How mercury causes brain neuron degeneration. Mercury has long been known to be a potent neurotoxic substance, whether it is inhaled or consumed in the diet as a food contaminant. Over the past fifteen years medical research laboratories have established that dental amalgam (phonetic) tooth fillings are a major contributor to mercury body burden. In 1997, a team of research scientists demonstrated that mercury vapor inhalation by animals produced a molecular lesion in brain protein metabolism which was similar to a lesion seen in 80 percent of Alzheimer diseased brains. Recently completed experiments by scientists at the University of Calgary's faculty of medicine now reveal with direct visual evidence from brain nuron tissue cultures how mercury ions actually alter the cell membrane structure of developing neurons. To better understand mercury's effect on the brain, let us first illustrate what brain neurons look like an how they grow. In this animation we see three brain neurons growing in a tissue culture, each with a central cell body and numerous nurite processes. At the end of each nurite is a growth cone where structural proteins are assembled to form the cell membrane. Two principal proteins involved in growth cone function are actin (phonetic), which is responsible for the pulsating motion seen here, and tubulon (phonetic), a major structural component of the nurite membrane. During normal cell growth, tubulin molecules link together end to end to form micro tubules, which surround neuro fibroles (phonetic), another structural protein component of the neuronal axon (phonetic). Shown here is the nurite of the live neuron isolated from snail brain tissue, displaying linear growth due to growth cone activity. It is important to note that growth cones in all animal species, ranging from snails to humans, have identical structural and behavioral characteristics and use proteins of virtually identical composition. In this experiment, neurons also isolated from snail brain tissue were grown in culture for several days. After which, very low concentrations of mercury were added to the culture medium for 20 minutes. Over the next 30 minutes, the nurite membrane underwent rapid degeneration, leaving behind a denuded neurofibrole seen here. In contrast other heavy metals added to this same concentration, such as aluminum, lead, cadmium and manganese, did not produce this effect. To understand how mercury causes this degeneration, let us return to our illustration. As mentioned, (technical difficulty) during normal cell growth to form the microtubules which support the nurite structure. When mercury ions are introduced into the culture medium, they infiltrate the cell and bind themselves to newly synthesized tubulin molecules. More specifically, the mercury ions attach themselves to the binding site reserved for guanicine (phonetic) tryphosphate (phonetic), or GTP, on the beta subunit of the affected tubulin molecules. Since bound GTP normally provides the energy which allows tubulin molecules to attach to one another, mercury ions bound to these sites prevent tubulin proteins from linking together. Consequently, the nurites microtubules begin to dissasemble into free molecules leaving the nurite stripped of its supporting structure. Ultimately, both the developing nurite and its growth cone collapse, and some denuded neurofibroles form aggregates, or tangles, as depicted here. Shown here is a nurite growth stain specifically for tubulin and actin before and after mercury exposure. Note that the mercury has caused disintegration of tubulin microtubule structure. These new findings reveal important visual evidence as to how mercury causes neurodegeneration. More importantly, this study provides the first direct evidence that low-level mercury exposure is indeed a precipitating factor that can initiate this neurodegenerative process within the brain. That was made -- I think that test was done in June of 1999, almost two years ago. And I don't know if our health agencies are aware it, but in your comments today I hope you will address whether or not you are familiar with that study and whether or not (technical difficulty) taken an interest in that and can respond to it. Do you have an opening statement, Mr. Gilman? Okay.

Rep. Gilman:

I want to commend the Chairman and our committee for looking into this problem, one that's long overdue, and I thank you for the opportunity to be here with you.

Rep. Burton, Chairman:

Thank you, Mr. Gilman. I don't know if you're familiar, but Congressman Chris Smith and Congressman Doyle have formed what's known as the autism caucus. And I don't know if you are a member yet, but I hope you will join so we can make sure that every member is aware of all the problems with it. Let's start with Dr. Rennert. Do you have an opening statement?

Dr. Owen Rennert:

Thank you. Can you hear me now? Mr. Chairman and members of the committee, I am Dr. Owen Rennert, scientific director of the National Institutes of Child Health and Human Development at the NIH. I appreciate the opportunity to provide information on behalf of the NIH autism coordinating committee about ongoing and planned research activities at the NIH that are relevant to autism and pervasive developmental disorders. Autism, as you know better than I, is a cruel disorder, not only as a result of the disability it causes, but also because it is an illness that challenges the emotional bond between child and parent. In its most severe forms, it effectively isolates that child socially, cognitively, emotionally and linguistically, denying other family members even the opportunity to console and comfort. In light of these immense human costs, and the significant public health burden that autism brings with it, the NIH (technical difficulty) with ever greater intensity on this terrible disease. And we appreciate the continued involvement that parents have given us in that effort. The Children's Health Act of 2000 called for expansion, intensification and coordination of autism related scientific programs at NIH. I am pleased to report that significant progress is being made, including towards the establishment of a new network of centers of excellence in autism. The Act directed the Secretary of Health and Human Services to establish an interagency autism coordinating committee, which will include NIH, the Centers for Disease Control and Prevention, and other HHS agencies. Yesterday, Secretary Thompson delegated to NIH authority for establishing this coordinating committee. And we can assure you it will have at least three members from the parent community of children with autism. There has been considerable expansion and enhanced coordination of autism research efforts at NIH. The amount of NIH supported autism related research grew from 22 million in fiscal year 1997, to 52 million in FY 2000. This demonstrates the commitment of institute members to the broad intensification of autism research efforts. As you requested, Mr. Chairman, we have supplied for the record the ten-year funding history of NIH sponsored autism related research, the projects funded in FY 2000, and we will also be supplying the abstracts of those funds (technical difficulty) that grants shortly. This week also NIH has released an RFA, a request for applications, containing set-aside funds for research support for the development of autism centers' applications. This is part of an overall plan to support a variety of investigative teams and, wherever possible, to recruit the participation of outstanding investigators who previously have not worked in autism research. These grants could be funded in September 2001 if meritorious applications are submitted. A second RFA will be issued in fiscal year 2002 to solicit applications for the centers of excellence with funding of the first of these centers targeted for early in FY 2003. NIH anticipates a pool (technical difficulty) available for the first five years of the funding of those programs. The Children's Health Act of 2000 calls upon NIMH, the National Institute of Mental Health, to take the lead in providing a program under which samples of tissues and genetic materials are donated, collected, preserved and made available for autism research. NIH presently supports ongoing efforts by Harvard's Brain Tissue Resource Center, UCLA, and the University of Miami's tissue banks, and recently special supplements were awarded to target acquisition of necessary biological materials from individuals with autism for focused study. The network in 1997 through an RFA, the National Institutes of Child Health and Human Development, with cofunding from the National Institute of Deafness and Communicative Disorders established the networks on the neurobiology and genetics of autism, referred to as the Collaborative Programs of Excellence in Autism. Currently, we have enrolled nearly 2,300 patients with well diagnosed autism in the network, and are gathering data from their families. A major ongoing CPEA initiative, a part of this network that is cofunded by NICHD, NIDCD and the CDC is the autism regression vaccine study. A principal goal of this study is to assess temporal association between measles, mumps, rubella vaccine and the onset of autism and attempts to differentiate early and late onset forms of the disorder. Another aim of this study is to try to replicate studies of persistent measles infection in children with autism versus those children who are not affected. Stage one of the project, which got underway in September of 2000, includes 1,600 well diagnosed cases of autism, and 1,250 healthy controls. Individual vaccination records, as well as records of the onset of autism, specifically looking at the age of onset, the age of recognition and the age of the diagnosis will be examined in this study. Stage two of this project will attempt to replicate previously reported findings regarding abnormal measles, antibody tiders (phonetic) and persistent measles infection. In this phase, investigators will examine 250 children with early onset autism, 250 children with the regressive form of autism, 250 healthy controls matched to early onset cases, as well as 250 controls matched to regressive autism cases. Neuroscience research, as you know, requires that we understand the pathogenesis and cause of autism and is the most promising approach to ultimately developing targeted effective treatments. Until the brain mechinisms responsible for the manifestations of autism are understood, it will not be possible to develop truly targeted interventions. Treatment research also is currently focused on studying the efficacy and safety of promising treatment interventions, which are commonly used in the community without adequate testing or are aimed at specific impairing symptoms, and these include both psychosocial and pharmacologic interventions. Last October, neuroscientists, including autism researchers, parents, advocates and NIH program staff participated in a one day brainstorming session on the role of the environment in autism, which was organized by the National Institutes of Environmental Health Sciences. This group identified key priorities. Large-scale epidemiologic studies to determine autism incidence and prevalence strengths, studies to describe the natural history of autism, and to identify meaningful subgroups that may be at increased risk from environmental exposures, and studies specifically to examine the proposed association between regressive autism and thimerosal in vaccines. With regard (technical difficulty)

Rep. Burton, Chairman:

Excuse me, Dr. Rennert, but we would like to get to the questions as quickly as possible.

Mr. Owen Rennert:

Okay, I'll abbreviate it. I would simply indicate to you that there are ongoing studies of several institutes amongst the ones you mentioned, the one at the University of Rochester, which attempt to look at hair, urin, serum levels of children having received thimerosal and mercury derivatives, of children having received immunizations, those who have had thimerosal containing vaccines and those who haven't. Preliminary data, as you were told yesterday, shows no difference in blood levels. I do not have at this point in time the complete analysis because it hasn't been completed. There are also studies at several centers that are looking at the pharmacochenetics (phonetic), the metabolism, the disposition, and the disposition in tissue such as brain of mercury when administered as thimerosal mercurial mercury in monkeys. There are another set of studies that have been funded in November of 2000 that are carrying out somewhat similar experiments in rats. And these again look at the cellular distribution patterns of mercury in tissue, including the brain, and also are attempting to evaluate the role of immune activation in altering brain levels of mercury after exposure to thimerosal. The last comment I'll make in a general way is that, as you know, the children's health act authorized a longitudinal study to investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes. In the context of environment, one is talking about chemical, physical, social behavioral influences on children who have critical windows of vulnerability during development, during which time environmental exposures could have a greater influence, and diseases of increasing prevalence, such as autism and asthma, are two targeted elements of this. Planning for this study, which will follow about 100,000 children across the U.S. from birth into adulthood, is currently underway with pilot studies scheduled to occur in FY 2002. The other comments I was going to make related exclusively to the efforts of the NIH to increase its dialogue with the parents and the public community with regard to what our priorities should be, how we conduct our research as it relates specifically to autism. The only thing to highlight there is as a consequence of those efforts, there is a listserver presently available that provides up-to-date information about autism related research activity at the NIH. There is an NIH web page which also allows you to identify all the research that presently is funded by NIH. It gives you information about advocacy groups, the scientific literature, etc. In closing, we at NIH understand the passion of parents and families of those who have been affected by autism and related disorders, and share your concerns for quickly unraveling the mystery of autism. Thank you, Mr. Chairman.

Rep. Burton, Chairman:

Dr. Midthun.

Dr. Karen Midthun:

Can you hear me?

Rep. Burton, Chairman:

You have a softer voice, you might pull it just a little bit closer. It is kind of stuck there.

Dr. Karen Midthun:

I will try to speak up. Mr. Chairman and members of the committee, I am Dr. Karen Midthun. I am the director, office of vaccines research and review of the center for biologics evaluation and research, FDA. With me today are Dr. Susan Ellenberg and Dr. Norman Baylor (phonetic). Dr. Susan Ellenberg is director of the office of biostatistics and epidemiology, and Dr. Norman Baylor is the associate director for regulatory policy in the office of vaccines. Mr. Chairman, as a physician and a parent, I want to express to you, the members of this committee, and to parents that I am aware of the devastating effects of autism on children and their families. I am here to assure you that we are working diligently to ensure that the vaccines we license for use in the United States are shown to be safe, pure and potent. I appreciate the opportunity to participate in this hearing on autism and to respond to the committee's concerns regarding a potential (technical difficulty) regulates the investigation and licensure of vaccines. FDA's regulatory process for licensing vaccines has for decades served as a model for other countries. To date, the existing data do not demonstrate a causal relationship between vaccines and autism. However, I want to assure this committee, the public and especially parents that FDA takes these concerns seriously. One concern that has been raised relates to the use of thimerosal, a mercury compound as a preservative in some vaccines. FDA recognizes and supports the goal of reducing exposure to mercury from all sources. Consistent with this goal, for several years FDA has encouraged manufacturers to develop new vaccines without thimerosal as a preservative. And to remove or reduce the thimerosal content of existing licensed vaccines. Initial results of this effort were realized at least a year prior to the enactment of the FDA modernization act of 1997, with the licensure of new thimerosal free vaccines. As required by section 413 of FDAMA, FDA conducted a review of the use of thimerosal in childhood vaccines. Our review revealed no evidence of harm caused by thimerosal used as a preservative in vaccines except for local hypersensitivity reactions. Under the U.S. recommended child immunization schedule, the maximum cumulative exposure to mercury from thimerosal at the time of this review in 1999 was within acceptable limits for the methyl mercury exposure set by FDA, the Agency for Toxic Substances and Disease Registry, and the World Health Organization. Of note, all these guidelines contain a safety margin and are meant as a starting point for evaluation of mercury exposure, not absolute levels above which toxicity can be expected to occur. However, during the first six-months of life, cumulative exposure to mercury in some cases could've exceeded the more conservative limits of the EPA, depending on the specific vaccine formulations used and weight of the infant. The clinical significance of exceeding EPA's limits is not currently known. Nevertheless, reducing exposure to mercury from vaccines is warranted and achievable in part because in the U.S. it is possible to replace multi dose vials with singled dose vials, which do not require a preservative. I am pleased to be able to report substantial progress in the efforts to reduce thimerosal exposure from vaccines. At this time, all routinely recommended licensed pediatric vaccines being manufactured for the United States market contain no thimerosal, or contain only trace amounts in the final formulation. Prior to the recent initiatives to reduce or eliminate thimerosal from childhood vaccines, the maximum cumulative exposure to mercury by routine childhood immunizations during the first six-month of life was 187.5 micrograms. With the newly formulated vaccines, the maximum cumulative exposure during the first six-months of life will now be less than three micrograms of mercury, more than a 98 percent reduction. In an effort to better characterize any toxicity that could have accompanied an exposure to thimerosal from vaccines, FDA is in the process of nominating thimerosal to the national toxicology program for further study. Reports of developmental delay following vaccination have been submitted to the vaccine adverse event reporting system, commonly referred to as VAERS. Although VAERS reports by themselves usually cannot establish a causal relationship between a vaccine and an adverse outcome occurring after vaccination. Further study of these reports can sometimes provide important clues and suggest directions for further research. FDA takes these reports seriously and has begun a followup study of VAERS reports of autism. In addition, FDA is pursuing research involving the characterization and development of an animal model for autism. While looking at ways to improve the safety of vaccines, we must keep in mind that childhood vaccines have contributed to a great reduction in vaccine preventable diseases including polio, measles and whooping cough. Today it is rare for American children to experience the devastating effects of vaccine preventable illness. However, vaccines, like all medical products, are not risk-free and FDA is committed to continuing its efforts to reduce these risks whenever possible. In conclusion, FDA continues to work diligently with manufacturers to eliminate or reduce exposure to mercury from thimerosal in vaccines. As stated previously, at this time all routinely recommended licensed pediatric vaccines being manufactured for the U.S. market contain no thimerosal or contain only trace amounts in the final formulation. Although no causal relationship between vaccines and autism has been established, FDA, along with other Health and Human Services agencies, continues to pursue -- excuse me -- continues to pursue research activities to increase our understanding of any potential relationship between vaccines and neurodevelopmental disorders. Although the prevention of disease through the use of vaccines is a tremendous public health accomplishment, there's more work to be done. I assure you that the office of vaccines and FDA will continue to make regulatory decisions and recommendations regarding vaccines based on the best scientific evidence to protect the public health. Mr. Chairman, I appreciate the committee's interest in this area and look forward to continuing to work with you on this in the future.

Rep. Burton, Chairman:

Thank you. Dr. Boyle.

Dr. Colleen Boyle:

Good morning, Mr. Chairman, and members of the committee. I'm Dr. Coleen Boyle, acting associate director for science and public health in the newly established center on birth defects in developmental disabilities at the centers for disease control and prevention. I have with me today Dr. Roger Bernier, an epidemiologist and the associate director of science (technical difficulty) opportunity to update you on CDC's activities related to autism. One major change since last year is that CDC has established, at the direction of Congress, a new center, the national center for birth defects and developmental disabilities. This center will increase CDC's efforts to discover causes and develop preventive strategies for birth defects and developmental disabilities, including autism. First, Mr. Chairman, I want to stress that CDC is committed to understanding the prevalence of autism, identifying its preventable causes, and establishing and evaluating prevention programs. And we have made considerable progress over the last year toward fulfilling this commitment. Last year we mentioned that CDC and the Agency for Toxic Substances and Disease Registry were about to report on an investigation, the prevalence of autism in Brick Township, NJ. The investigation found a rate in birth that is high compared to many previous studies. However, there are few very recent studies, none in the U.S., that have reported rates in the range which suggests the rate of autism may be considerably higher than previously thought. To increase our ability to monitor autism prevalence in the U.S., in September of 2000 CDC competitively funded health departments in Arizona, South Carolina, Maryland and New Jersey to establish monitoring programs for autism in their states. CDC is also completing the analysis of the first year of autism monitoring data, gathered from its own metropolitan Atlanta developmental disabilities surveillance program. And their report should be complete later this year. This September, as directed by Congress, CDC will competitively fund up to four centers of excellence in autism epidemiology to conduct collaborative epidemiologic studies. The research objectives of these studies will be determined by an independent oversight committee, and representatives from parent and consumer groups will be invited to provide input to the oversight committee in planning the epidemiologic study. CDC has also developed a wide range of activities that are responsive to the needs of parents of children with autism and health-care professionals working with these children. For example, CDC funds a program at Marshall University in West Virginia of an intensive community support program for families with young children with autism. And as part of the centers for excellence in autism and epidemiology, we expect to fund projects of model intervention programs for children with autism, of the economic and social costs of autism, and of studies to look at the natural history of autism. Some parents have expressed concerns about the potential link between autism and vaccines. Although the weight of the scientific ethnist (phonetic) does not support such a link, CDC is committed strongly to assuring vaccine safety. The concerns raised regarding autism and vaccines have focused primarily on thimerosal, a preservative in some vaccines, and on the measles, mumps and rubella vaccine. Today all manufacturers are producing for infant immunization only vaccines that are free of thimerosal, or have only trace elements of thimerosal. As shown in figure 1 of my testimony, the Merisel content of pediatric vaccines purchased by states through CDC's contract has dramatically decreased since 1998. CDC is actively investigating whether there have been any adverse effects related to thimerosal in vaccines. Preliminary analyses of vaccine safety datalink have not supported a link between thimerosal containing vaccines and autism. It has been suggested that vaccination, particularly with the MMR vaccine, may be related to the development of autism. Substantial scientific review does not support this suggestion. First the American academy of pediatric executive committee, dated in March of 2001 (technical difficulty) does not support a causal relationship between MMR vaccine and autism or inflammatory bowel disease. Second, the IOM stated just this week that existing evidence does not favor a causal relationship between the MMR vaccine and autism. In addition, Dale Thetall (phonetic) recently reviewed changes over time in the MMR coverage and autism diagnosed in California. There was a 373 percent increase -- relative increase in the prevalence rate of autism between 1980 in 1994 while the MMR immunization coverage was relatively flat over that same period. To date, the weight of the scientific evidence does not support a causal relationship between vaccines and autism. Nevertheless, because of the continuing concern of parents, we are committed to conducting research to evaluate this matter. At present, we are conducting a study in Atlanta with their centers and programs of excellence in autism to further examine the relationship between vaccines and autism. While we must remain vigilant to assure the safety of vaccines, we must also remember that vaccines benefit the individual child and the public by protecting persons from the consequences of infectious diseases. While we have made great progress to reduce the number of cases of vaccine preventable diseases, threats posed by vaccine preventable diseases are known and are real. We want to assure you that CDC knows how important it is to find the causes of autism and prevent these disorders. We are committed to conducting this research that will lead to these answers. With the support of Congress, we have made a good beginning by funding autism monitoring programs in several states, and the centers for excellence in autism epidemiology to look at the causes of autism. CDC's efforts will continue until we have found the answers that will enable us to prevent this serious condition that effects so many American children. Thank you, Mr. Chairman, and members of the committee for the opportunity to testify before you today. Dr. Byrne and I would be happy to answer any questions that you have.

Rep. Burton, Chairman:

I neglected to have you sworn. Would you all please stand so I can avoid those -- Do you swear to tell the whole truth and nothing but the truth, so help you God? Dr. Boyle, why is it that there is a reduction in thimerosal in vaccines that are being produced today? Did not our health agency's request that thimerosal be removed from vaccines as the newly produced vaccines?

Dr. Colleen Boyle:

I think we've made considerable progress in reducing the thimerosal content in vaccines.

Rep. Burton, Chairman:

No, so you've asked that thimerosal be reduced in vaccines, have you not?

Dr. Owen Rennert:

I think the answer is that this was done as a precautionary measure.

Rep. Burton, Chairman:

Why?

Uknnown Speaker:

Because it was feasible to do, and there are sources of exposure to mercury that we cannot control, such as that from food. And so --

Rep. Burton, Chairman:

I'm talking about the vaccine. Why is it that you have started at our health agencies to reduce the amount of thimerosal in vaccines? As a precautionary measure?

Uknnown Speaker:

As a precautionary measure.

Rep. Burton, Chairman:

As a precautionary measure. That would lead one to believe that you're not really sure whether or not thimerosal causes some problems. Otherwise why wouldn't you just leave it in there and say, hey, we've run all these tests, there's no causal link whatsoever.

Uknnown Speaker:

There is a theoretical risk.

Rep. Burton, Chairman:

Okay. So there is a theoretical risk. Then why have we not recalled the vaccines that have thimerosal in them right now while you're testing this? If there's any question whatsoever about what we're putting into our kids arms, and their bodies, and if you're reducing thimerosal because you think there may be a causal link as a precautionary measure, why don't you recall the thimerosal that is in doctor's offices that are being injected into kids as we speak until you are sure? Because obviously you are not sure or you wouldn't be taking it out in anyway. Why don't you recall it?

Uknnown Speaker:

I can give you my comments, the FDA may wish to weigh in on this issue of recall. But as succinctly as I can put it, Mr. Chairman, being safe means being safe from disease as well (technical difficulty).

Rep. Burton, Chairman:

Let me ask you this question then. Can you create a measles vaccine, and do we have a measles vaccine, does it not have thimerosal in it?

Uknnown Speaker:

Yes, that is correct.

Rep. Burton, Chairman:

Can we create a mumps vaccine that does not have thimerosal in it?

Uknnown Speaker:

That is correct.

Rep. Burton, Chairman:

Then why are you putting thimerosal in it?

Uknnown Speaker:

At the present time, as Dr. Midthun and Dr. Boyle mentioned, we have made very good progress. And I can say to you that we are not putting in thimerosal any longer in the vaccines that are being produced.

Rep. Burton, Chairman:

So, if you are not, if you're not as a precautionary measure, then why are you leaving vaccines on doctor's shelves and in drugstores around this country that are being used in facilities where they supply them, are being used if you are not putting them in new vaccines? If you have, as a precautionary measure, why don't you recall the supply you have out there until you are absolutely sure beyond any doubt that thimerosal has a causal link to autism? Why don't you recall it? Dr. Midthun.

Dr. Karen Midthun:

(indiscernible) public health service act, in order to make a mandatory recall of vaccine, there has to be an imminent and substantial hazard to the public health. And as the weight of the evidence does not support a causal link between thimerosal --

Rep. Burton, Chairman:

Then why are you taking it out of the new ones?

Dr. Karen Midthun:

As Dr. Bernier said, it is as a precautionary measure. It's recognized that mercury, in large doses, is toxic. And any way we have of reducing the exposure to mercury over which we have control is something that is desirable to do.

Rep. Burton, Chairman:

Let me tell you, my grandson was very healthy, and very normal, and spoke, and ran around like every other child. He got (technical difficulty) the allowable amount of mercury through thimerosal in one day, and 10 days later we lost him. We're trying to get him back. Now there's a lot of parents out there that are getting all these shots when their children's immune systems are depressed, they've got colds and they're getting these shots with several of them at a time with thimerosal in them. And as a precautionary measure, if you think there may be a causal link, don't you have any latitude whatsoever to recall those and say, we are not going to destroy this, but we are going to hold these supplies in advance until we know for sure, until all the tests have been done?

Dr. Karen Midthun:

Not under the public health service act, that is not what would allow us to make a mandatory recall.

Rep. Burton, Chairman:

But you are taking thimerosal out of vaccines as a precautionary measure?

Dr. Karen Midthun:

That is correct.

Rep. Burton, Chairman:

How long are these studies going to take, Dr. Rennert?

Mr. Owen Rennert:

We hope to have answers of various phases within the next two to three years.

Rep. Burton, Chairman:

Do you know how many kids are going to be vaccinated today? Do you know that in California there used to be one child every six hours who was becoming autistic? It is now one every three hours. In the United States 1 out of 400 to 500 kids are autistic, and in some parts of the country that is under 200, and that boys have a four times more prevalence of getting autism than girls. So if you go to Oregon, 1 out of 190 kids are autistic, that means 1 out of 50 boys being born are going to be autistic. And you are telling me these studies are going to take two to three years, and at the same time the studies are going to take two to three years you are going to keep mercury in vaccines, and you just saw from that Calgary, Canada study what mercury does to brain cells? I mean, come on. If there is any doubt whatsoever, and you say it's a precautionary measure you are taking, then why in the heck don't you get that stuff off the market until you've tested it thoroughly? And if it is going to take three years, put it someplace for three years in a storage box. And if the tests don't prove out, you've still got it. And the pharmaceutical companies can still get their money. Now, on these tests that you are doing, you said you are testing the blood for mercury. Are you testing hair and urine samples?

Mr. Owen Rennert:

Yes. In the studies that were done by Navy and the University of Rochester, there are samples that have been obtained for studies of hair and urine concentrations as well.

Rep. Burton, Chairman:

Have you had any results from that yet?

Mr. Owen Rennert:

No, sir. The study, as far as I know, has just been completed and the analysis is occurring. I don't have the data.

Rep. Burton, Chairman:

How long will it take to get that analysis?

Mr. Owen Rennert:

I would imagine -- to be honest, sir, I don't know. I don't think it will be long, but I will attempt to find out and give you that answer.

Rep. Burton, Chairman:

We would like to have copies of the analysis as quickly as you get them. We would like to have any records you have whatsoever about the analyzing of blood, hair, urine, whatever it is regarding mercury and thimerosal in these kids. You know, you were talking about how vaccines have reduced measles, mumps, rubella, diphtheria, all these other things and that is great. And we really appreciate what vaccines and pharmaceutical companies have done for this country. Because they have saved a lot of lives. And what you have done has been very laudable. But when you have a child who is autistic, from the time he becomes autistic until he dies, they estimate that the cost to our society is $5 million for each child. Now, if we have 1 in 400, and the cases are rising at a very rapid rate, do you have any idea what that is going to do to our economy? Not now, but 5, 10, 15, 20 years from now. And so, every precaution that should be taken, must be taken, and must be taken now, because this is not only a health issue, it's an economic issue that is not going to go away. I mean we are talking about trillions and trillions of dollars if we don't find an answer. And if you have got substances, aluminum, formaldehyde, mercury, in these vaccines, and you have this huge rise and you are not absolutely sure that mercury is not causing it, you ought to get it out of there. You ought to recall this stuff, because a doctor just said. Dr. Bernier just said that they are producing and can produce vaccines without mercury in them, without thimerosal. Now, granted, you might not be able to put three or four different vaccines in one vial, because as I understand it you put the mercury in there to keep everything pure so that they can be used and it won't be tainted. But if you can go to single vials with single vaccines, sure the parents would have to have more shots, but if it is going to be safer then why not do it? And why wait three years for studies? If you think that there may, even the most remote possibility be a causal link. And if you look at some of these studies like we've seen, and I am not a scientist, I am not a doctor. I am just a grandfather who has an autistic kid, and I didn't even know what autism was until a couple years ago. But when you see the huge number of people that are contacting us through e-mail and through conferences, there is one going on right here, you have got to take the proper precautions. You can't say, let's wait three years and let this go on. So, as I said earlier, and I am going to yield to my colleagues here, as I said earlier, we have 113 members in the autism caucus. They will be supplied with every bit of information we get, not only from you folks, but from Calgary, Canada and around the world and from the experts we have here. And I will be taking special orders on the floor of the House. I will be going down there on a regular basis, reading into the record and talking to the American people about the problems that we have. And so, the pressure that you are feeling if any now, I don't know if you are or not, but the pressure you are feeling right now is going to be magnified as many times as I can make it until our health agencies either come to some conclusion that's scientifically provable, or they get that stuff out of there, in particular thimerosal. And I don't know why if you are coming up with vaccines that don't have these toxic substances in them as I believe they are, I don't understand why you don't recall that stuff, get it off the market -- and FDA, can you do a voluntary recall for manufacturers the same as the rotavirus recall?

Dr. Karen Midthun:

That was not a voluntary recall. The manufacturer, on their own initiative, withdrew their product from the market.

Rep. Burton, Chairman:

Can you contact the people that manufacture thimerosal? And I know who it is. Can you ask them to recall it temporarily?

Dr. Karen Midthun:

That would be something that would be voluntary on their basis.

Rep. Burton, Chairman:

You can't write them a letter and say that because of the concern of thousands and thousands of parents, and because we are in the process of doing research on this, we think it would be prudent to recall thimerosal products until we run all of our tests, which may take as much as three years?

Dr. Karen Midthun:

I am sure that the companies are well aware also of these concerns over autism.

Rep. Burton, Chairman:

But you guys can't even write them a letter?

Dr. Karen Midthun:

It is their choice to make a voluntary recall and they know that they have that choice, sir.

Rep. Burton, Chairman:

So you are not going to do anything?

Dr. Karen Midthun:

Under the PHS Act we can make a mandatory recall for the reasons that I indicated, and the Company, of course on its own volition can do anything it would like in terms of making the product available or deciding not to distribute it any longer.

Rep. Burton, Chairman:

I will yield to my colleagues in one second. I found out yesterday that there is a lawsuit pending, I believe in Mississippi, regarding mercury toxicity and how it has affected children. And if that lawsuit is successful by the people who are bringing the suit, it will probably involve a great deal of money to the pharmaceutical company that produces this product, and other pharmaceutical companies that use it in their vaccines. And I wonder, I just wonder if perhaps one of the reasons why FDA is not pounding these pharmaceutical companies to get this off of the market, especially when you look at this Calgary study about mercury and the toxicity of it, if maybe there is not pressure being exerted by pharmaceutical companies on our health agencies because they are afraid of what might happen in the lawsuit if they do withdraw it from the market. Is there any validity to that kind of thinking?

Dr. Karen Midthun:

I really couldn't say. I do not know, sir.

Rep. Burton, Chairman:

Okay. Mr. Gilman.

Rep. Gilman:

Thank you, Mr. Chairman. I want to thank you for raising these issues. Permit me to request that my opening statement be made a part of the record.

Rep. Burton, Chairman:

Without objection.

Rep. Gilman:

I do have several questions. I think what Chairman Burton is raising is quite pertinent. And I am surprised to hear, Dr. Midthun, that you are reluctant to issue any letter to the manufacturers if there is some concern. You say there is some mandate in the legislation that permits you to make some of these corrections?

Dr. Karen Midthun:

Under the PHS Act, the FDA can make a mandatory recall if there is an imminent or substantial hazard to the public health. And as I noted before the preponderance of the evidence does not suggest there is a causal relationship between thimerosal containing vaccines and autism. Thus, there is no substantial imminent hazard that would authorize us to make a mandatory recall, sir.

Rep. Gilman:

And yet, you are making a request that thimerosal not be included in the future production of vaccines because of some concern, is that correct?

Dr. Karen Midthun:

As Dr. Bernier noted, wherever it is possible to reduce exposure to mercury, that is a goal we would like to achieve because there are many aspects of exposure that we don't have control over, for example environmental, food intake, and thus it is considered a precautionary (technical difficulty) measure. We can move from multidose vials that require a preservative to single does vials, and that is what we have been doing, and actually have made a substantial achievement toward reaching. As I noted before, currently all vaccines being manufactured for pediatric use under the routine childhood immunization schedule either contain no thimerosal or only trace amounts.

Rep. Gilman:

And that is based on your recommendations?

Dr. Karen Midthun:

That is based on working collaboratively together with the other public health service agencies and also the manufacturers that it was agreed that this would be an achievable goal and it would be good to reduce the exposure to mercury whenever possible.

Rep. Gilman:

So there is a consensus in the thinking in the medical world that it would be preferable to eliminate that possibility in treating -- in providing vaccines for children? Is that correct?

Dr. Karen Midthun:

It is a toxin and thus it is good to be able to reduce exposure, you can never eliminate exposure, but it is good where you can to be able to reduce it.

Rep. Burton, Chairman:

(multiple speakers) Would the gentleman yield? Let me just ask is mercury a cumulative thing in the body?

Dr. Karen Midthun:

I am not a toxicologist.

Rep. Burton, Chairman:

We had one yesterday, and the toxicologist, Mr. Gilman, said that if you get a shot with mercury in it and then you get another one and another one, there is a cumulative effect. And our children are getting 26 shots by the time they go to school. And I might add, did you get a flu shot?

Rep. Gilman:

Yes I did.

Rep. Burton, Chairman:

You got thimerosal. You've got mercury in your body from that shot. And Dr. Isold (phonetic), our admiral, I called him about it and he didn't even know it was in there.

Rep. Gilman:

That raises another good question. You have taken some precautionary measures. What have you done with the public so that they are aware of these problems? What is your educational process -- what have you done in the educational process to the consuming public with regard to these concerns that you have in the medical community?

Dr. Karen Midthun:

Our labeling for our products indicates what is in the product and in the case where there is a preservative it is so stated.

Rep. Gilman:

I am not asking just labeling. I am asking have you undertaken any educational initiatives to the consuming public so they would be aware of these problems?

Dr. Karen Midthun:

We believe that the vaccines are safe and effective including those vaccines that were licensed with thimerosal as a preservative, sir.

Dr. Roger Bernier:

Mr. Gilman, if I might add something, because we've discussed this at CDC in anticipation that we might have this question. And I think one of the things that CDC has done, at least as we generally try to work with the provider community to try to provide information about these matters. And so in the last 22 months, during the time when this episode has been ongoing, there have been repeated publications, for example, in the morbidity and mortality weekly report at CDC, there have been joint statements between the government agencies and the American Academy of Pediatrics, and the American Academy of Family Physicians. So we have worked to put information in the hands of the providers so that they could address the concerns of the parents. Also, we have had on our website information about these matters. We have a hot line where parents can obtain information. So, I wouldn't want to leave the impression that we haven't been proactive, if you will, about putting information out there. Because I think we have been.

Rep. Gilman:

You're saying you are putting it in the hands of the providers. But what about the consuming public? What are you doing -- you are a government agency, what are you doing about educating the public about these dangers? What has been done by your agency or any of the panelists who are here representing our government agencies? What has been done to make the consuming public aware of these mercury problems?

Dr. Roger Bernier:

Like I said, at least speaking for CDC, traditionally we work through the providers to address the concerns of the parents.

Rep. Gilman:

You don't go beyond the provider? If the provider fails to make the information available, are you satisfied?

Dr. Roger Bernier:

Well, we have also the vaccine information statements that parents are given prior to vaccination. And that is one direct connection we have with the parents at the time of vaccination.

Rep. Gilman:

Are these statements that your agency makes for the parents?

Dr. Roger Bernier

Are they what, sir?

Rep. Gilman:

Are these statements that you make available to the parents?

Dr. Roger Bernier:

Yes.

Rep. Gilman:

How is that distributed?

Dr. Roger Bernier:

These are widely available, required by law to be made available, (technical difficulty) children are immunized before every immunization vaccine --

Rep. Burton, Chairman:

If the gentleman would yield. Let me just ask and then we'll get to Dr. Weldon. Mr. Gilman, do you ever use nasal spray?

Rep. Gilman:

No.

Rep. Burton, Chairman:

Does your wife or any of your friends ever use nasal sprays?

Rep. Gilman:

My wife does.

Rep. Burton, Chairman:

Do you know that most nasal sprays have thimerosal in them?

Rep. Gilman:

I didn't know that.

Rep. Burton, Chairman:

Yeah. There's mercury in a great many products that we use as adults. And there is a tremendous rise in the number of cases of Alzheimer's. And mercury has a debilitating impact on the brain, as you saw, you probably didn't see it in that Calgary study. And so it is not only the children that are being affected by this, in my opinion, and I am not a scientist, it is all of us. Because we are getting mercury through the environment, but we are getting them in nasal sprays -- and health agencies, not too long ago, took mercury out of all topical dressings because they said it would leach into the skin and cause problems. And yet it is in nasal sprays, it is in a lot of products we use (technical difficulty)

Rep. Gilman:

Mr. Chairman, if I might reclaim my time. It would seem to me there is a responsibility by our agencies, whether it be NIH, whether it be CDC, whatever agency is involved in regulating our vaccines, that we make more information available to the public of the dangers of mercury. And make it available, not only just to a potential user of the vaccine, but to the entire public. So I'm urging those panelists who are here today to address that problem, since it is a problem that can affect millions and millions of our population. Just one other question, Mr. Chairman. Parents are becoming concerned about the vaccines that are already on the market that have not been recalled. But many are unaware of what is being done (technical difficulty) preventative actions are your concerns because you have directed the manufacturers to take some steps to remove this product. But what have you done with the product that is still on the shelves around the country?

Dr. Karen Midthun:

It remains on the shelves, sir.

Rep. Gilman:

And could be used.

Dr. Karen Midthun:

And could be used, that is correct.

Rep. Gilman:

Shouldn't you have some responsibility to remove that if you are concerned about its use?

Dr. Karen Midthun:

Again, as I mentioned, there are certain conditions that allow us to make a mandatory recall, and that is not one of them. You have to have an imminent or substantial hazard to the public health -- (multiple speakers)

Rep. Gilman:

Are you concerned that if some of these products are used they could cause some problems in the health of young people?

Dr. Karen Midthun:

The evidence does not show that there is a causal relationship between thimerosal as used in vaccines (technical difficulty).

Rep. Gilman:

And yet you recommended that -- (technical difficulty)

Dr. Karen Midthun:

That's correct, because if we can decrease exposure to mercury in ways that are available to us --

Rep. Gilman:

But if you are concerned about the increase in exposure, then why not take these products and take them off the shelf, prevent their distribution if you really are sincerely concerned about the use of these products? It would seem to me there is an absence of responsibility here by your agencies.

Dr. Karen Midthun:

Well, we have to follow the regulations as they are written, sir.

Dr. Roger Bernier:

Mr. Gilman, could I add -- I want to, I think, try to correct an impression that I think is being generated here. And that is that if the vaccine is not being recalled, then nothing is happening. And I think nothing could be further from the truth. Please allow me to just take a minute to explain what has changed between (technical difficulty) and I think the impression is getting, well, if we don't accomplish a recall, then somehow this problem is not being addressed. And I think there are two or three things I'd like to point out.

Rep. Gilman:

Doctor, if I might interrupt. When you have faulty tires on vehicles, we demand that they be recalled. If we have a medication that is on the shelf that could create some problem, it would seem to me there is enough evidence, even though it is not fully explored, that there is enough evidence available that these products should not be allowed to go out to the consuming public.

Dr. Roger Bernier:

Mr. Gilman, we have no faulty vaccines on the shelves.

Rep. Gilman:

You already testified before us, at least Dr. Midthune has testified that as a preventive measure you are recommending to the producer not to use this product. It would seem to me that that is enough evidence to take the rest of the product off the shelf.

Dr. Karen Midthun:

We have not recommended that a product not be used. We have worked with manufactures to reduce the use of thimerosal as a preservative in vaccines.

Rep. Gilman:

And you have done that because you have concern about the future health of young people, isn't that correct?

Dr. Karen Midthun:

We have concerns about overall exposure to mercury from all sources in the environment, and this happens to be a source we can control by switching to single dose vials in large part.

Rep. Gilman:

And these other products that are still on the shelf could contribute to their health -- to their poor state of health, is that right?

Dr. Karen Midthun:

We do not believe the products out there -- we believe that they are safe products, sir.

Rep. Gilman:

No further questions.

Rep. Burton, Chairman:

Dr. Weldon.

Rep. Weldon:

Thank you, Mr. Chairman. I want to thank all the witnesses for testifying. I certainly thank your efforts to try to answer and address the issues and concerns we have. Dr. Rennert, you testified, I believe, that the total spending at NIH will be $52 million on autism related research?

Mr. Owen Rennert:

I believe that's right.

Rep. Weldon:

Correct me if I'm wrong, that is including a lot of autism related research, but the actual figure on autism specific research is smaller than that, is that correct?

Mr. Owen Rennert:

I can't tell you that for sure. I will tell you that the list we submitted is correct. We will go back and review and provide you with the information.

Rep. Weldon:

I would like you to personally provide that to me because I have had people come to me and say the net was cast pretty wide to come up with a figure that high, and that the figure for autism specific research is actually about a third or less of that. And the reason I bring that up is, I had my staff pull a congressional research study on AIDS. And the figures that were provided to me from CRS is that there are 300,000 Americans currently suffering with AIDS, and 115,000 living with HIV. Now I realize some people estimate that those figures are quite a bit higher, and that there is a substantial cohort in the population who have exposure to HIV, they are carrying HIV and they don't know it. But if we use those figures, and those figures have appeared in the media, that is about 415,000 people. The federal expenditures on research and treatment and the various (technical difficulty) billion dollars. Now if we just look at the research number, I have a figure of 3.1 billion in the year 2000. I could not get the 2001 figure. Now, I am told we have about a similar number of kids with autism. That is also very debatable. If you look at autism spectrum disorder, you get a much larger number. When I do the math, it comes out to, for research, about $7,000 per person with AIDS and about $140 for each child with autism. Another way to look at that figure is for every $7.00 we spend on AIDS related research we are spending $.14 on autism related research. Do you, and I would ask any of the panelists to comment on this, do you feel that -- and I feel the ultimate responsibility for this rests with the Congress, not with you, okay? So I am not trying to make you feel bad. I think we have a responsibility to make sure that our money is spent, or the public's money, the taxpayer's money is spent appropriately. Do you think this is an appropriate level of funding, a relatively appropriate level of funding?

Mr. Owen Rennert:

You have evoked my bias as a pediatrician. And I believe our future is with our children. What I can tell you is that we will spend more money on autism research, that the numbers that I've presented, regardless for the moment of the magnitude, represent an increase in funding, at least in recent times, for this area. And I certainly subscribe to the notion that this is an area that should be an area of focus and emphasis for us.

Rep. Weldon:

Does anybody else want to comment?

Dr. Colleen Boyle:

I would be happy to.

Rep. Weldon:

Adequate levels of funding for the types of research studies that need to be done on this?

Dr. Colleen Boyle:

We direct money at CDC as directed by Congress, but I can tell you that in the last year we have gotten a substantial increase in our funding for autism. And that has really allowed us to develop the state surveillance, state monitoring programs that I referred to in my testimony. It is allowing us to develop the infrastructure to actually be doing a very large study of the epidemiology of autism. So I feel that we have made substantial progress. But we have a lot further to go.

Rep. Gilman:

Would the gentleman yield?

Rep. Weldon:

I would be happy to yield.

Rep. Gilman:

Have any of you made a request for additional monies that have not been allocated for your autism research? Have any of your agencies made a request for additional sums in the budget that were not allocated to you? Or were you all satisfied with the way the funds were being allocated?

Rep. Weldon:

I could ask it a different way. Were all of your requests granted to you by your superiors within the agencies you work in?

Dr. Karen Midthun:

May I just say that at FDA and office of vaccines we don't have the ability to ask for funding for studying autism per se. Our mission is to regulate vaccines.

Rep. Weldon:

What about CDC and NIH?

Mr. Owen Rennert:

The answer for NIH is no.

Rep. Weldon:

We will make sure your future is secure in the years ahead. Dr. Boyle, I have got to ask you a question related to what you are doing. We had a physician testify yesterday about this increasing incidence issue, and I think you came in my office once and we talked about this and the change in the diagnostic statistical manual. And he made a very good point. We're all the adults, if the prevalence isn't increasing, if the incidence isn't increasing, then where are all the adults? In all of these studies you are looking at prevalence and incidents, are you looking at prevalence in adults to try to make a determination to answer that question? Is the rate increasing?

Dr. Colleen Boyle:

Our studies have been directed at children. We primarily look at school-age children, children age 3 to 10. That is a very good question. And as may have come up yesterday, the prevalence, we call it prevalence only because we think most of it has to do with sort of prenatal etiology, so that someone is either with the condition or with the specific genetic predisposition for the position. So we refer to prevalence.

Rep. Weldon:

I would recommend you look at that issue, looking at the disease prevalence throughout all age groups in the population, because I think that is a very critical question if we are going to try to get --

Dr. Colleen Boyle:

I think Dr. Amerol (phonetic) testified yesterday about efforts in California to address the issues of sort of changes in diagnosis as many researchers have suggested as well as the greater awareness of the condition and the impact that has had on the increase in the number of cases seen in California. And actually I think that is going to be a very interesting study. It is really going to be able to shed some light on what is happening.

Rep. Burton, Chairman:

Can we come back to you, Dr. Weldon? Mr. Waxman is here and he wants to ask a few questions then we'll come right back to you.

Rep. Waxman, Ranking Member:

Thank you, Mr. Chairman. Dr. Bernier, the CDC has explained that it is opposed to recalling thimerosal containing vaccines because it is concerned about shortages. In fact I understand there is a concern about a shortages of DTaP vaccine. But at the hearing yesterday, one of the witnesses suggested that stocks of non thimerosal vaccines are adequate and that there was no need to keep containing vaccines on the shelves. Can you explain your concerns about shortages? For instance, if the DTaP vaccines containing thimerosal were recalled, what possible affect would that have on our children?

Dr. Roger Bernier:

Yes, Mr. Waxman, it is correct that at the present time for DTaP there is a very tight supply situation. We have two additional manufacturers that have left the market (technical difficulty) and are now left with only two manufacturers. And there are backorders at the present time that cannot be filled because the amount of available vaccine is not adequate to fill those backorders. So, if in fact there was to be issued a strong preference for thimerosal free DTaP, or if there were to be a sudden recall of the existing DTaP vaccine with thimerosal, this would produce spot shortages which would create, we think, delays in children being immunized, which could lead to disease very quickly. In 1999 alone, there were 15 deaths from pertussis in the United States, and this year already we have had five deaths from pertussis. So, the need to continue the coverage with DTaP is very real. These are not hypothetical our theoretical risks. We know that creating shortages will produce coverage problems, will increase the risk of children to these diseases.

Rep. Waxman, Ranking Member:

Last year CDC testified that they are actively monitoring possible adverse effects of thimerosal, the mercury containing perservative that's being phased out of vaccines, and that CDC found no link between thimerosal and developmental delays. Have you continued to monitor for any of these effects and what has your surveillance shown?

Dr. Roger Bernier:

Well, we have continued at least to look at the autism question. In the original results from the vaccine safety datalink, there was no evidence of a link between thimerosal exposure and autism. And in the last year an additional number of cases has accumulated. I believe somewhere in the vicinity of an additional 40 cases. And when we add those cases to the ones we looked at before, we reach the same collusion, it has not altered the original conclusion which was that there was no link between exposure to thimerosal and autism.

Rep. Waxman, Ranking Member:

Thank you. Dr. Midthun, at the hearing yesterday, Dr. Haley testified about the toxicity of thimerosal containing vaccines. He suggested that the thimerosal in vaccines was harmful to children. In the prelicensure phrase, is a vaccine tested for toxicity?

Dr. Karen Midthun:

Yes, it is. The vaccines are usually evaluated in a very large number of infants, if that is the target population for whom they are intended. And they are tested with regard to the entire formulation and thus if there were (technical difficulty) trials that are done in support of the license application.

Rep. Waxman, Ranking Member:

Does this mean the entire vaccine including all of its component parts is tested for toxicity?

Dr. Karen Midthun:

That is correct. The vaccine in entirety is tested.

Rep. Waxman, Ranking Member:

So, if a vaccine were toxic, this should be revealed in the prelicensure phase, is that correct?

Dr. Karen Midthun:

That is correct.

Rep. Waxman, Ranking Member:

What did the toxicity testing of vaccine with thimerosal reveal? Did this testing indicate that the thimerosal is likely to pose health dangers for children?

Dr. Karen Midthun:

The preclinical studies did not suggest that, sir.

Rep. Waxman, Ranking Member:

So why did the FDA move quickly to remove thimerosal from vaccines?

Dr. Karen Midthun:

Because we felt it was an achievable goal. It was a way where we could reduce the overall exposure to mercury among children. And it was something that was achievable because we could switch from multidose to single does vials in the United States, that's something that was feasible.

Rep. Waxman, Ranking Member:

Dr. Boyle, Dr. Wakefield testified at yesterday's hearing that we need active surveillance of vaccine adverse events. Can you explain what CDC does to actively monitor potential problems associated with vaccines? Or whichever one of you want to answer that.

Dr. Roger Bernier:

The CDC is actively looking at vaccine safety events through the Baer (phonetic) system. We are monitoring events. And when events occur that create cause for concern, we have the resource represented by the vaccine safety datalink population, which is a way -- it provides us an easier means of testing hypotheses that may arise from adverse events that are detected. So, we have this detection arm, and then we have a testing arm where we can test hypotheses. And for example, this has one of the ways in which it worked recently with rotavirus and interception where both arms of the vaccine safety mechanisms were put into play in order to address that concern.

Rep. Waxman, Ranking Member:

Thank you very much. Thank you, Mr. Chairman.

Rep. Burton, Chairman:

Let me just follow up on what Mr. Waxman says. I know he has to leave and he's probably not going to hear the response. But did you folks test the rotavirus vaccine before you put it on the market?

Dr. Karen Midthun:

I have not been involved with the rotavirus vaccine vials.

Rep. Burton, Chairman:

But it was tested by the FDA, wasn't it?

Dr. Karen Midthun:

It was tested by FEBITDA --

Rep. Burton, Chairman:

And within nine months it was recalled, wasn't it?

Dr. Karen Midthun:

Maybe I could ask Dr. Baylor. I wasn't here at the time.

Rep. Burton, Chairman:

You don't have to ask him. It was recalled because one child died. There were several serious problems with intestinal problems where there was surgery involved, and it was recalled because --

Dr. Karen Midthun:

I just spoke with Dr. Baylor. It wasn't actually a recall, either a mandatory or a voluntary recall. The company decided to withdraw it from the market, sir.

Rep. Burton, Chairman:

Because one child died, and a whole host of them were injured. I mean, you can cut it either way you want to. The fact is they took it off the market, and it had been tested. So you folks are not infallible. Now the DTaP shot, are they still manufacturing that with thimerosal in it?

Dr. Roger Bernier:

No, Mr. Chairman they are not.

Rep. Burton, Chairman:

They are not. But you say they are not producing enough of the single shot vaccines to take care of the needs of the country at the present time?

Dr. Roger Bernier:

At the present time there is a shortage in the supply, correct. They are backordered, and the new vaccine they are producing is not adequate to meet the demand at the present time.

Rep. Burton, Chairman:

How long will it take for that to be adequate?

Dr. Roger Bernier:

I think the FDA could have a better idea of that. My impression is that -- I mean, relatively short -- I'm thinking of a few months, but I don't, I mean, I don't have the information. I think FDA needs to --

Rep. Burton, Chairman:

So, in a few months they could have the supply up. Now let me ask you this --

Dr. Roger Bernier:

Could we just get FDA, because I don't want that to be on the record if that is true or not.

Rep. Burton, Chairman:

How long will it take for them to get the single shot vial doses up to a safe level?

Dr. Karen Midthun:

I can't give you an exact timeline. What I do know is that there are two more lots potentially containing thimerosal that the Company intends to release. But after that, they would then be releasing only the thimerosal reduced versions, sir.

Rep. Burton, Chairman:

How many shots are in a lot?

Dr. Karen Midthun:

That's proprietary information, sir.

Rep. Burton, Chairman:

You want me to subpoena it?

Dr. Karen Midthun:

I would be happy --

Rep. Burton, Chairman:

You will get it for me or I will subpoena it. I want it.

Dr. Karen Midthun:

I would be happy to respond to the Chairman's letter on that.

Rep. Burton, Chairman:

There are thousands and thousands of shots of DTaP that you are going to put into the system, and kids are going to get those shots because of the shortage. Now let me ask you, what is the likelihood -- let's say it takes six months, let's say it takes six months to get the single shots up to snuff to where you have got a supply. Let's say it takes six months. How many kids do you think are going to die in six months because they don't get that shot?

Dr. Roger Bernier:

I can't estimate, Mr. Chairman. I can tell you that, as I mentioned earlier in my testimony, this is not hypothetical. In 1999, there were 15 deaths associated with pertussis. And already there have been five deaths this year. So if we created a situation where we abruptly said, you must use thimerosal free vaccine, that would create shortages which would lead to delays, which would lead to what I'm calling days of lost protection.

Rep. Burton, Chairman:

I understand. You've made your point. Let me just say this. I want the names of the producers of the DTaP shot, and I am going to subpoena records from them to find out how much is in a lot. They have two more lots that they have to use, they have two more lots. And I want to find out how long it would take for them to produce the diphtheria, tetanus and the pertussis vaccines individually. And I am going to find out how long it is going to take. Because I suspect that those lots have a lot of shots in them and there is a lot of money involved, a lot of money involved. And as a result, they want to sell those before they go ahead and get their lots of individual shots up to snuff. And I think it is money. I really believe that. And I think there is mercury in those vaccines. And during the time that you say 2, or 3, or 4, or 5, or 6, or 7 children are going to possibly die, and we don't want any child to die, accORDing to my figures there are 16 children a day who are going to come down with autism. That is 17,520 children are going to be at risk for autism in the next three years while studies are going on, if mercury has something to do with it as many, many people believe. Scientists, toxicologists, it is not just me. We had a whole litany of doctors from all over the world talking about this yesterday. And what you are saying is one thing, but what scientists and doctors and studies have already shown is that mercury does have a debilitating impact on the brain and so, you are talking about children at risk. In the three years it is going to take to go through the studies, 17,520 children are likely to become autistic and if you folks are wrong, how are you going to live with yourselves? The gentle lady is recognized.

Uknnown Speaker:

Thank you, Mr. Chairman. I regret that I have not been able to be here for the entire hearing due to an overbooked schedule, but I have the testimony and I look forward to reading it tonight. As I had said before, we have two good friends of our family, Charles and Patience Flick, who have -- two of their two children are afflicted with autism. And I know what a terrible toll autism can take on a family. Everything that the Flick family does is related and surrounded by Bonnie and Willis and their care and what will happen to them, and any steps they take Bonnie and Willis are foremost at their thoughts. Bonnie is a little more high functioning and is able to go to Disney World with us. Willis is unfortunately so overstimulated by the environment that he can barely leave his house. Everything is too much sight and sound for him. And so I look forward to bearing -- to seeing the fruits of the pressure that Chairman Burton is bringing to bear on this issue so that we can improve the research dollars, so that we can have more research going into the causes of autism and then that will lead us to the cure for autism because I know how devastating that affliction is, not just on the children that have it, but on their families. We look forward to getting more evidence about the relationship between vaccinations and the rise, dramatic rise in autism rates. And I know that many are not in agreement with that, but I congratulate Chairman Burton for his steadfast devotion and his bravery in spite of all (technical difficulty) trying to make this seem like there's no tie-in whatsoever. I don't think that we should leave any stone unturned. And if mercury is a factor, we should give serious consideration to revamping our vaccination program and looking at other possible factors involved in the dramatic rates in autism across the country. So, I thank you, Chairman Burton, on behalf of the many Flick families throughout the United States. Thank you, Dan.

Rep. Burton, Chairman:

Thank the Gentle lady. Ms. Morella, do you have any comments or questions?

Rep. Morella:

Actually, I commend you for the ongoing series of hearings you have had on autism. We all care about it. I'm really here to listen, to learn and then to do what I can to lead, and I know you have medical experts before you, many of whom are involved in laboratories in my district, NIH, and of course FDA; I value CDC. And I am also interested in the kind of funding that you do have, and really we work very hard just an example to double the funding for NIH for that five-year plan we have, so that by 2003 we will realize it, and we are well on our way. This is our fourth year. And I'm curious with regard to autism, and I must say a lot of the leadership on looking into autism obviously has come from the Chairman, although I do wear sometimes my little jigsaw puzzle ribbon which is autism, the puzzle pieces, right, which we are trying to put together. And I understand from your testimony and I guess this would be Dr. Rennert that $1 million is being set aside to fund innovative treatment proposals and that you have 30 applications. How do you work with that? I mean are you kind of a magician?

Mr. Owen Rennert:

No. I think one works with it by trying to fund as many grants as one can, and that the limit is the number of dollars.

Rep. Morella:

So how many do you think you can fund?

Mr. Owen Rennert:

Well, I think again the response I would make is that the amount of funding we could use is equivalent to the number of meritorious proposals that there are, and it depends on where you set the bar.

Rep. Morella:

Sounds like a political answer to me.

Mr. Owen Rennert:

No, I can't give you a precise number, but the point is quite clearly we could use more funding to fund more proposals and more research on autism.

Rep. Morella:

It just seems to me that of the 30 applications, obviously probably not all would meet the qualifications, the peer review or what it goes through, but certainly $1 million isn't going to fund more than a couple of them probably.

Mr. Owen Rennert:

Three to four is what one would fund.

Rep. Morella:

So it does say something about the need for us to look more into that in terms of the adequate funding. And then I note also looking at Dr. Boyle's testimony, and I wasn't here to hear you synopsize it for the committee, but you mention that CDC, NIH and 10 NIH funded centers and programs of excellence in autism are collaborating on a case control study of developmental regression. Each of these centers was awarded funds through the NIH competitive process. Can you give us a timeline on it, how that is going?

Dr. Colleen Boyle:

Actually, I may let my colleague at NIH address that since that is actually being organized.

Mr. Owen Rennert:

Again, the program was initiated in 1997. And at this point in time, as we mentioned in our testimony, there are approximately 2300 patients with well-defined autism that are part of the network and the study. The second part is with regard specifically to the question of the temporal association between vaccination and the onset of autism, as well as a study of the potential effects of mercurials in vaccines as preservatives. There are at the present time 1600 cases that are being used for the study. And the phase one part of the study will look at 250 cases or patients with early onset autism, 250 patients (technical difficulty) responding number of controls for each group, and that work now is in the second phase where the analysis will begin and the study of the biological specimens that were obtained. A third part because you mentioned it in regard to funding, I forgot to point out though that it was in my written testimony, that in fact we will release in the coming year an RFA or request for applications for the competitive renewal and the commitment to renew these centers for another five years. Clearly, our hope would be that over time that we could add more centers to this. But specifically, the element of study that ought to be completed as I was asked by Chairman Burton in the next two years or so is that these studies linking or attempting to establish whether there is some association or what the association is between vaccination and vial mercurials will be completed.

Rep. Morella:

Within two years then.

Mr. Owen Rennert:

Two to three years.

Rep. Morella:

Thank you, Mr. Chairman.

Rep. Burton, Chairman:

Let me just say to the gentle lady that in three years is what we thought was going to be the study, but if we waited three years to have a conclusion drawn and we continue to use these kinds of vaccines -- we are all for vaccinations, but not with some of these things like mercury in them -- there would be 17,520 new children that would probably be autistic. That is if mercury did have something to do with it. I think we are about to wrap this up. We have a number of questions we would like to submit to you for the record. I don't want to keep you here all day. Do we have any parents that have autistic children in the room? Would you raise your hands. How many of you believe that your children were adversely affected by something in the vaccines? Would you raise your hands? Is that everybody or almost everybody? About 80 percent? Eight out of twelve -- maybe nine out of twelve. And that is what we are getting in e-mails by the hundreds and the thousands. Now maybe you folks are right, maybe mercury doesn't have anything to do with it, maybe the thimerosal doesn't, but they think it does, and there is a growing body of these people and they are getting organized all across the country and so is the Congress of the United States. And so I really hope you will take a hard look at this, because it isn't going to go away. As I said before, it is going to cost this country trillions of dollars. In any event, do you have any other questions?

Rep. Morella:

No, I don't. But of course, I hope that on the basis of all of this that if you can expedite so that we can come to some conclusions, because I can recognize the passion but also the desire for patience it is so difficult for the Chairman. And I would agree with him if it has been going on since 1997, we should have some results. Thank you very much.

Rep. Burton, Chairman:

Thank you, Congressman Morella. We will submit then these for the record. There are documents we are going to request. Did you have any questions? There are documents that we will be requesting. If there is a problem with you giving those because of confidentiality of any kind, if you would let us know and we will be happy to legally send a subpoena to get that information because we want to make sure we have as much research material as possible. We'd also like to know who are the manufacturers of the DPAT shot.

Dr. Karen Midthun:

I believe Miss Clay has that.

Rep. Burton, Chairman:

Okay, we'll be contacting them to get records on the supply that they have and how long it will take to go to singleshot vials. And with that, thank you for being here. We stand adjourned.