Dan Burton (R-IN)
Chairman, Committee on Government Reform
November 22, 2002

The Autism Epidemic and Its Possible Connection to Vaccines

Mr. Speaker, I am here today to clarify for my fellow legislators why I have objected so vigorously to the inclusion of certain provisions in the Homeland Security Act.

There is no one in Congress who more strongly supports the need to protect the United States and its people from terrorist attacks.

The fact remains that we weren't prepared to prevent what happened on September 11, 2001. And we weren't prepared to recover from a terrorist attack of that magnitude. We need to have these agencies working together in a coordinated way to prevent the next terrorist attack. By creating this new department, we're going to improve that coordination.

I am a strong supporter of the President, our men and women in uniform, and our law enforcement, first responder, and intelligence communities.

I also am a strong supporter of the legislative process. It is important to have a bipartisan process where every issue is handled in a fair and open way.

Last week, the legislative process was hijacked and we ended up with a fiasco of extreme proportions. That is what I am here to talk about today.

At the eleventh hour, several sections were added to the final version of the Homeland Security Act, which many members of Congress, including myself, were not aware of.

My remarks today will focus on Sections 1714 through 1717. These four sections were thrown in at the last minute-obviously so as they are the last four paragraphs of the 484 page document.

My Family's Experience

Mr. Speaker, I have only two grandchildren-Alex and Christian.

While the so-called experts tell us that vaccines are safe except in rare instances, both of my grandchildren suffered serious adverse events from vaccines.

My granddaughter stopped breathing the day she received her Hepatitis B vaccine and was hospitalized for three weeks. We thought she was fine for years, however, this year she was diagnosed with a seizure disorder and her doctor's tell us that she likely was suffering small seizures for years that went unnoticed.

My grandson Christian was absolutely normal as a baby. He developed on time and healthy. He talked, walked, he was outgoing. He made eye contact. He enjoyed being with people. We joked that because he was expected to be very tall, that be would take care of us in our retirement by being a professional basketball player.

My daughter took Christian to receive the vaccinations that our Centers for Disease Control and Prevention say children are supposed to receive. And he got them all in one day-at least six shots for nine different diseases…all in one office visit. And in many of those shots was the mercury-containing preservative, thimerosal.

We totaled up the amount of mercury he may have been exposed to and it was over 40 times more than a safe exposure according to Environmental Protection Agency's guidelines for methyl mercury. (Which the Institute of Medicine validated as accurate)

Within days he lost all speech, he began banging his head, ran around flapping his hands…he withdrew into himself, and very soon after that was diagnosed with autism.

I want to specifically thank Dr. Cathy Pratt from the Indiana Autism Resource Center at Indiana University for helping us in those early days.

Autism

And Christian is not an isolated case. We have heard from thousands of families across the country that this same thing happened to their child.

What Is Autism? Autism is a complex neurobiological disorder, resulting in developmental disability. It typically appears in the first three years of life.

Autism is a spectrum disorder. The symptoms and characteristics of autism can present themselves in a wide variety of combinations, from mild to severe.

Although autism is defined by a certain set of behaviors, children and adults can exhibit any combination of the behaviors in any degree of severity. Two children, both with the same diagnosis, can act very differently from one another and have varying skills.

• People with autism process and respond to information in unique ways. In some cases, aggressive and/or self-injurious behavior may be present.
• Forty Percent of individuals with autism do not have speech.
• Persons with autism may be resistant to change. They may have difficulty expressing their needs, using gestures or pointing instead of words. They may laugh or cry, showing distress for no reason apparent to others.
• Persons with autism often prefer to be alone. They may throw tantrums.
• They often have difficulty interacting with others.
• Children with autism may not want to cuddle or be cuddled. Imagine having a child who does not want you to hug him. Imagine a child who never spontaneously tells you that he loves you.
• Persons with autism frequently make little or no eye contact.
• They will not respond to normal teaching methods, they may have odd play habits, and frequently spin objects.
• Many have sensory integration issues-over or under sensitivity to pain. They may not understand the need to fear danger. Imagine your child wandering away from school and walking out on a highway-this happened just last year in the Washington areas.
• Children with autism may often first appear to be deaf because they do not respond to verbal cues. In fact, the first diagnosis a child with autism first receives is a speech or language delay.

There are certainly children who are born with autism.

• They have what can be called "classical autism.''
• There is, however, a growing number of children who are growing normally and then acquire autism. It is sometimes called "atypical autism'' or "late-onset" autism.

There most probably is a genetic component to autism. But genetics is not the only issue.

• Many children seem to have severe food sensitivities, particularly to gluten and casein, ingredients in the most common foods, dairy and wheat.
• Many of these children show signs of autism shortly after receiving their immunizations.
• Some of these children suffer from heavy metal toxicities. When tested they have abnormally high amounts of aluminum and in particular mercury. How did they get this overload of mercury in their body, except through their vaccines?

How Many People Are Affected?

In California the rates of the most serious form of autism have tripled in the last decade. And as the researcher who evaluated the California data stated, it is not because of a broadening of the definition of autism.

What is being seen in California is being seen across the country.

Once a rare condition, the National Institutes stated earlier this year that autism is now seen in 1 in 250 children in this country. It affects boys four times more often than girls. This means that one in 156 boys in this country have autism.

And in some places the rate is higher. For instance, in Brick Township, New Jersey the CDC determined that 1 in 150 children is autistic.

And these are cases of the most severe forms of autism, not the entire spectrum that would incorporate the less severely affected often called "high functioning" autism.

The Autism Society of America estimates that autism is increasing at a rate of 10 to 17 percent each year. This is faster than any other disease or disability.

What is the Potential Burden to Society and to the Taxpayer? A study published in California several years ago indicated that it would cost the state at least $ 2 million for each child with autism for the first 18 years of life.

The Autism Society of America estimates that the total cost of autism is between $20 and 60 billion annually.

School districts are struggling to meet the needs of the huge number of new cases.

While many individuals with autism, especially high functioning autism, may grow up and be able to work, a vast majority of those with the most severe forms of autism will not. Their families are faced with finding long-term care solutions. Much of the financial burden for the long-term care will fall to the Government.

What we can't measure in dollars is the cost to families. The divorce rate in autism is said to be about 85%. Siblings in families with an autistic child must make do with less attention from their parents. Many of the medical treatments for autism are not covered by insurance. Children often need one on one intensive speech and behavioral therapies. It is often a constant struggle for families to help their child and to stay financially solvent. Research In the sixty years since autism was first described, we have not yet figured out what causes it. We do not know if classical autism and late-onset autism are the same conditions or two different conditions with similar symptoms. We have come a long way in sixty years. Doctors no longer blame the condition on bad mothering. But we have a lot more work to do before we can pat ourselves on the back for our accomplishments. In the Committee, we looked at our investment in research on autism on a comparable level with other epidemics?

We asked these questions:

• Are the CDC and NIH funding studies that will help prevent or cure autism?
• Is their research adequately addressing the medical issues associated with autism such as food allergies, chemical sensitivities, and autistic entercolitis?
• Is the information about autism provided by our Government adequate and useful to families?

The CDC:

• The CDC will told us they plan on spending 11.3 million dollars on autism this year and 10.2 million dollars next year.
• We compared that to two other conditions that have been declared epidemics-diabetes and AIDS.
• Both of these conditions can be devastating. Both deserve sufficient research dollars to develop treatments and look for cures.
• The CDC is spending over 932 million dollars on the AIDS epidemic this fiscal year. AIDS deserves attention-don't get me wrong. And so does diabetes, which both Secretary Thompson and the former Surgeon General declared an epidemic.
• CDC this year will spend just over 62 million dollars on diabetes.
• The autism epidemic just like the diabetes and AIDS epidemics, is no less deserving.
• Yet, CDC's spending for autism is almost 80 times less than that for AIDS.
• And CDC's spending for autism is 5 times less than that of diabetes. CDC should be committing more research money to autism.

The National Institutes of Health has a total this year of 27 billion dollars.

The NIH told us their to researching autism has grown dramatically in the last few years. In fiscal year 1997, the NIH investment in autism research was only 22 million dollars. Last year that number had grown to 56 million-in large part because of Congress. Let's put that into perspective. At the same time the NIH is spending 56 million dollars on autism-a condition that affects 1 in 250 children in this country-they are investing over 2.2 billion dollars in AIDs research. The rates of diabetes increased by 49 percent between 1990 and 2000. Diabetes is a devastating condition in the Native American community and of increasing concern in the African American and pediatric populations. This year, the NIH investment for diabetes is 688 million. I believe the numbers speak for themselves. Funding into basic and clinical research into autism needs to grow. We have an epidemic on our hands and we in Congress need to make sure that the NIH and the CDC treat this condition like an epidemic and put their efforts into doing several things:

• Find out the cause(s) of the epidemic
• Determine how to stop the epidemic in its tracks
• Evaluate treatment options
• Look for a cure

Thimerosal: What is it?

• Thimerosal is a preservative that has been used in some vaccines since the 1930's.
• Thimerosal is about 50 percent mercury and 50 percent thiosalicylic acid.
• In 1999, the FDA recognized that some children could be exposed to a cumulative level of mercury over the first 6 months of life that exceed the federal guidelines on methyl mercury.
• Methyl mercury is associated with neurotoxicity in high doses.
• According to the FDA, a 6-month old baby that received all the vaccines on schedule would receive 75 micrograms of mercury from three doses of DTaP, 75 micrograms of mercury from three doses of Hib and 37.5 micrograms from three doses of hepatitis B vaccine. The total of 187.5 micrograms exceeds the suggested safe limits published by the EPA.
• Some of you may say that the Federal Guidelines are for methyl mercury not ethyl mercury, however, there is no Federal Guideline on safe dosing of ethyl mercury.
• In fact, what we learned when we investigated was that the Food and Drug Administration appeared to be asleep at the switch on making sure that all the ingredients being injected into our babies is safe. There appear never to have required a safe human exposure of thimerosal to be established.
• In 1999, and after much debate they decided to ask the manufacturers to start switching to thimerosal-free vaccines for children.

Many of my colleagues have reported that thimerosal is no longer being used. This is not true.

• The flu vaccine given to children and to members of Congress has thimerosal.
• Many clinics and doctor's offices still have vaccines on the shelves that contain thimerosal. Parents need to ask their doctors for the package insert and look at the ingredient list to assure that there is no thimerosal. We have received reports where doctors were told by the pharmaceutical salesman that the vaccine was thimerosal free, and yet, when the parent looked at the package insert, they had been sold vaccine with thimerosal.
• Many adult vaccines still contain thimerosal. This could be problematic especially to new recruits in the military who get a large number of vaccines all at one time.
• Many of the vaccines that we ship to Third World Countries to be given to babies and young children still contain thimerosal.

An internal HHS document produced to the House Government Reform Committee during its investigation into vaccine safety described what it referred to as a "weak signal" in its data linking thimerosal to neurological disorders:

"Preliminary screening of ICD-9 codes for possible neurologic and renal conditions following exposures to vaccines containing thimerosal before 3 months of age showed a statistical association for the overall category of neurological developmental disorders and for two conditions within the category, speech delay and attention deficit disorder."

If there were no concerns that scientific research would demonstrate a connection between thimerosal and autism in court, Sections 1714-1717 would not have been tacked onto the Homeland Security Act in the eleventh hour with no debate.

The Institute of Medicine

Much has been said about the Institute of Medicine's review of thimerosal in vaccines. Many have said that the IOM concluded that there was no connection between thimerosal and autism. This is not exactly accurate.

In 2001, the Institute of Medicine concluded that a connection between thimerosal and autism, while unproven, is "biologically plausible."

The IOM called for further research, stating, "the evidence is inadequate to accept or reject a causal relationship between exposure to thimerosal from vaccines and neurological developmental disorders of autism, ADHD, and speech and language delays."

Dr. Marie McCormick, IOM Committee Chair made the following statement:

"Because mercury at high doses is known to pose risks, some parents and researchers are concerned that thimerosal in vaccines puts children at increased risk for developmental disorders such as autism. Preliminary data from a few studies have suggested that thimerosal-containing vaccines could possibly-very minimally-affect some measures of normal child development. But the data are inconclusive….Our committee has reviewed the limited body of toxicological, clinical, and epidemiological literature on ethyl mercury and the more exposures are associated with neurological damage."

She also stated:

"There is also toxicological and epidemiological literature suggesting that methyl mercury is a toxicant to the developing nervous system. Some children who received the maximum number of thimerosal-containing vaccines on the recommended childhood immunization schedule had exposures to ethyl mercury that exceeded some safe exposure guidelines for methyl mercury. In addition, some children could be particularly vulnerable or susceptible to mercury exposures because of genetic or other differences…. It was viewed as feasible as well as consistent with the public health goal of decreasing mercury exposures in general, as much as possible. Mathematical calculations also suggested that some infants received a total amount of mercury from vaccines that exceeded some federal agency guidelines for safe mercury exposure. … Based on information from these sources, our study has come to the following conclusion: The hypothesis that thimerosal exposure through the recommended childhood immunization schedule causes neurodevelopmental disorders is not supported by clinical or experimental evidence. Existing epidemiological evidence is inadequate to either accept or reject a causal relationship between exposure to thimerosal from vaccines and the neurodevelopmental disorders of autism, ADHD, and speech or language delay. However, there are some indirect associations concerning biological plausibility, which refers to a theoretical but unproven possibility. For example, high-dose thimerosal.

Vaccine Injury Research

It is important to remember that the absence of proof of a correlation between vaccines and autism is far different than no proof of a correlation. Each time the Institute of Medicine has evaluated vaccine safety issues, they conclude that there is inadequate research to reach firm conclusions.

We found that all too often the right research questions have not been asked. In fact, very little research has been done.

When Dr. Andrew Wakefield reported that in a small population of late-onset autism cases, in which there was chronic bowel dysfunction, that he found measles in the guts of these children, the CDC's response was to fund epidemiological research to try to disprove his hypothesis. In the four years since this first was made public, our health officials have yet to conduct one clinical study to replicate the Wakefield work. Instead, we get large-scale population based reviews of medical charts, rather than actual clinical research with children looking at their specific medical issues.

This is the case for the Danish Study recently published in the New England Journal of Medicine.

• While the news media reported that the case is now closed on a correlation between MMR and autism, nothing could be further from the truth. Comparing epidemiology with clinical research is like comparing apples and oranges.
• This study found that there was a five-fold increase in autism over the ten years they looked.
• This study in no way can be considered a conclusive study. Much more research needs to be done-and the research we need to do needs to be biomedical research that will result in understanding what is going on with each child and how best we can help them.

The Homeland Security Act: Section 1714-1717 affects the National Vaccine Injury Compensation Act.

They do not protect Americans from a terrorist threat, or affect the Department of Homeland Security. Rather they protect large domestic pharmaceutical companies who manufacture the components of campaigns. They protect them from potential civil liability from vaccine injured children.

Amending the Vaccine Act through this legislation is inappropriate. These sections were intentionally insert to protect the manufacturers of thimerosal.

If, as some Senators were told, the desire was to protect manufacturers of the components of any smallpox vaccine, the date of enactment would not have suspended the currently filed cases. None of the current cases are related to smallpox.

What Will This Mean for Families? These provisions will some families have no legal recourse.

For instance, Scott Bono of Durham, North Carolina testified before our committee a few years ago. His son, Jackson Bono is one of those children who were adversely affected by thimerosal. He has autism; he has documented to have toxic levels of mercury in his body. He is now 13 years old. It is likely that the case his family has filed in the Vaccine Injury Compensation Program will be kicked out because of the short three-year statute of limitations. Unless his family can seek compensation through civil litigation, they will likely never be compensated for their child's vaccine injury.

There are hundreds of Jackson's out there who need Congress to keep their legal options available to them.

The Vaccine Injury Compensation Program: History of the Program

The National Vaccine Injury Compensation Program was created in the late 1980's as a no-fault compensation program. The trust fund comes from an excise tax from the sale of vaccines.

The companies who make thimerosal and who will now be protected under the new law make no financial contribution to the trust fund. They are being given a free ride.

Sections 1714-1717 will have a devastating effect on the families of children who were injured from their thimerosal-containing vaccines and suffered damage to their central nervous system, resulting in diagnosis of autism spectrum disorder, speech and language delays, or neurodevelopmental delays. Vaccine Injury Compensation Program Investigation and Proposed Legislation

The Committee on Government Reform, over the last two years has conducted an extensive investigation into the Vaccine Injury Compensation Program. After six months of negotiations, on February 13, Chairman Dan Burton and Ranking Minority Member Henry Waxman in collaboration with Congressman (and physician) Dave Weldon, and broad bipartisan group of Congressmen introduced, HR 3471, the National Vaccine Injury Compensation Program Improvement Act of 2002.

This Bill would:

• Increase compensation for future lost earnings for injured children. Under current law, compensation is based o the average weekly earnings of full and part-time workers as determined by the Bureau of Labor Statistics. This bill would specify that only full-time workers should be used in the calculation.
• Increase the level of compensation to a family after a vaccine-related death from $250,000 to $300,000. The death benefit has remained unchanged since the program's inception in 1986.
  oAllow families of vaccine-injured children to be compensated for the costs of family counseling and creating and maintaining a guardianship to administer the funds.
• Allow for the payment of interim attorneys fees and legal costs while a petition is being adjudicated. The costs of assembling the necessary medical records and obtaining expert witnesses are substantial. Under current law, these costs, as will as attorney's fees, are not reimbursed until a case is fully resolved, which oftentimes takes years..
• Extend the statute of limitations for seeking compensation to six years from the date of injury. Under current law, families must file within two years of a child's death or three years of a child's injury.
  oProvide a one-time, two-year period for families to file a petition if they were previously excluded from doing so because they missed the statute of limitations.

Other bills were also introduced.

However, the other bills also appear to protect industry, while whittling down families opportunities to receive compensation through the program. These provisions include the ones inserted we have talked about here. These bills also included a provision to Federalize a state ruling, which found individuals who missed the statue of limitations in the Federal program would loose their ability to file in the state courts of New Jersey. This in essence prevents tolling for minors, and prevents cases from being filed for individuals who did not know about the program in time to file in the Federal program. While these Bills appear to have the Administration's support, they do not have the support of the vaccine injured.

Conclusion

We have a promise from both the Senate and House leadership that Sections 1714 through 1717 will be modified to allow for the existing thimerosal cases that would not fit within the vaccine program's statute of limitation to go forward in the civil court system. This means that as soon as we come back in the 108th Congress, we must make this our first course of action. We owe this much to the families of the 1 in 250 children who are now autistic. And we especially owe this to those families whose children may be autistic as a result of thimerosal in their vaccines.

Yesterday, I sent a letter to the President urging him to host a White House conference on autism.

• I have asked him to begin a national effort to determine why autism has reached epidemic proportions in the United States.
• I believe we must try to determine what is causing this outbreak and how it can be stopped. President Bush is in a unique position to provide the leadership that this issue needs.
• He could bring together parents of autistic children and the best minds from the scientific community to chart a course of scientific research to uncover the underlying causes of this alarming epidemic.

Mr. Speaker I have provided three documents I would like put into the Congressional Record.

The first is an outline of what we know from the published literature about thimerosal's safety. The second is a report submitted to the Committee that outlines through the scientific literature the similarities between mercury poisoning and the symptoms of autism. And the third is testimony submitted to the Committee last April by the Autism Society of America, which outlines the economic implications of autism, and the research needs.

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