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Congressman questions officials at thimerosal hearings 


06/20/2002

By VALERI WILLIAMS / WFAA-TV
http://www.wfaa.com/latestnews/stories/wfaa020619_am_thimerosalhearings.547d2350.html

A United States congressman is calling for criminal penalties for any government agency that knew about the dangers of thimerosal in vaccines, and did nothing to protect American children. Last month, a News 8 Investigation disclosed allegations that some government officials may have suppressed documentation about the risks. Some of those officials testified at Wednesday's congressional hearing. News 8 research showed that the FDA began asking questions about the dangers of thimerosal back in 1972. By 1992, the preservative had been pulled out of dog vaccines and contact lens solutions because of the risks.

However, it remained in vaccines for children until last year. Government health officials squirmed uncomfortably in their seats Wednesday as more evidence emerged suggesting that they misled the public. "You mean to tell me that since 1929, we've been using thimerosal," Congressman Dan Burton (R-Indiana) said to the officials, "and the only test that you know of is from 1929, and every one of those people had meningitis, and they all died?"

For nearly an hour, Burton repeatedly asked FDA and CDC officials what they knew and when they knew it. And when memories seemed to be a bit fuzzy, the congressman produced old memos as a refresher. One memo, from 1999, states that the FDA had an "interim plan ... already in place for many years" to get rid of thimerosal. The same e-mail also addresses the FDA's fear that it will be accused by the public of being "asleep at the switch for decades, by allowing a dangerous compound to remain in childhood vaccines".

Burton has proposed bringing criminal charges if it's proven the government agencies were involved in a cover-up. "Look, I don't think it makes any difference whether it's a private company or a government agency," Burton said. "If they know they're harming somebody and they continue to let it happen, then they should be held accountable."

Government accountability is something that parents of autistic children have been asking for for years. Cooper Earp, 7, had lost his ability to talk by age three, and his mercury levels were off the charts. His parents said Cooper's only exposure to mercury was through his vaccines. Today, he has all the classic signs of autism, such as repeatedly hitting himself, and fixating on such things as a spinning chair. Cooper's mother Kristi Earp has a dream that one day Cooper will call her "mommy" in a sentence.

"I probably have that dream once a week that he's speaking to me. It would be wonderful," Earp said. Parents like Earp would like to ask the panel of government officials why, in eighty years, they never ordered one clinical test on the effects of thimerosal in vaccines. Burton asked the question several times Wednesday, but never got a direct answer. After the hearing, News 8 asked the same question of an official, walking briskly down a corridor. "You have to call the press office," an assistant replied.

Burton has a personal stake in the growing scandal: he said his grandson became autistic a few days after receiving nine inoculations. Thus far, within the government, Burton has been a minority voice, but he has subpoena power, and he keeps threatening to use it. "So what you do is keep making the case, and keep trying to get the message out to a broader and broader audience so that people start saying 'Why?'," Burton said. "When enough people say 'Why?', change starts to take place."

 

June 19, 2002

In April the Committee conducted a hearing reviewing the epidemic of autism and the Department of Health and Human Service’s (HHS) response. Ten years ago, autism was thought to affect 1 in 10,000 individuals in the United States. When the Committee began its oversight investigation in 1999, autism was thought to affect 1 in 500 children. Today, the National Institutes of Health (NIH) estimates that autism affects 1 in 250 children.

In April we looked at the investment our Government has made into autism as compared to other epidemics. We showed in that hearing that the CDC and NIH have not provided adequate funding to address the issues in the manner that our Public Health Service agencies have used to address other epidemics.

After our hearing, I joined with my colleagues on the Coalition on Autism Research and Education to request from our appropriators that at least 120 million dollars be made available in FY 2003 for autism research across the NIH and at that an additional $8 million be added to the CDC’s budget for autism research.

Giving more money to research is not the only answer though. Oversight is needed to make sure that research that is funded will sufficiently answer the questions regarding the epidemic, how to treat autism, and how to prevent the next ten years from seeing the statistic of 1 in 250 from becoming 1 in 25 children.

High quality clinical and laboratory research is needed now, not five or ten years from now. Independent analysis of previous epidemiological and case control studies is needed as well. We have learned that a majority of parents whose children have late-onset or acquired autism believe it is vaccine-related. They deserve answers. We have also learned that the parents have been our best investigators in looking for both causes of autism and for treatments.

It has been parents who have formed non-profit organizations to raise research dollars to conduct the research that the CDC, the FDA, and the NIH have neglected to do. We have heard from many of these parents in the past, Elizabeth Birt, Rick Rollens, Shelley Reynolds, and Jeanna Smith, to name just a few. Each of these parents had healthy babies who became autistic after vaccination.

I might have been like many of the officials within the public health community – denying a connection - had I not witnessed this tragedy in my own family. I might not have believed the reports from parents like Scott and Laura Bono, Jeff Sell, Jeff and Shelly Segal, and Ginger Brown, who came to me with pictures, videos and medical records. I might have been like so many pediatricians who discounted the correlation between vaccination and the onset of fever, crying, and behavioral changes. Because both of my grandchildren suffered adverse reactions to vaccines, I could not ignore the parent’s plea for help. I could not ignore their evidence.

My only grandson became autistic right before my eyes – shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing healthy grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism.

As part of our investigation, the Committee has reviewed ongoing concerns about vaccine safety, vaccine adverse events tracking, the Vaccine Safety Datalink (VSD) Project, and the National Vaccine Injury Compensation Program. I have joined with Congressman Weldon, Congressman Waxman and 32 other members of Congress in introducing HR 3741, the National Vaccine Injury Compensation Program Improvement Act of 2002 to realign the compensation program with Congressional Intent.

In today’s hearing, we will receive a research update from several previous witnesses as well as new research findings that further support a connection between autism and vaccine adverse events. We will learn more about both the possible link between the use of the mercury-containing preservative thimerosal in vaccines and autism, as well as autistic entercolitis resulting from the Measles-Mumps-Rubella (MMR) vaccine.

Through a Congressional mandate to review thimerosal content in medicines, the FDA learned that childhood vaccines, when given according to the CDC’s recommendations exposed over 8,000 children a day in the United States to levels of mercury that exceeded Federal guidelines. Is there a connection between this toxic exposure to mercury and the autism epidemic? We will hear from Dr. James Bradstreet and Dr. Vera Stejskal on this issue.

We have twice received testimony from Dr. Andrew Wakefield regarding his clinical research into autistic entercolitis. We will learn today that not only has he continued to conduct clinical research, but that this research is confirming the presence of vaccine-related measles RNA in the biopsies from autistic children. Dr. Wakefield - like many scientists who blaze new trails - has been attacked by his own profession. He has been forced out of his position at the Royal Free Hospital in England. He and his colleagues have fought an uphill battle to continue the research that has been a lone ray of hope for parents whose children have autistic entercolitis. Dr. Arthur Krigsman is joining us as well today to discuss his clinical findings of inflammatory bowel disorder in autistic children. He will share with us his initial findings as well as discuss his research plans currently with his Institutional Review Board for approval.

Do the epidemiological and case control studies, which the CDC has attempted to use to refute Dr. Wakefield’s laboratory results, answer the autism-vaccine questions honestly? Epidemiologist Dr. Walter Spitzer is back today to answer this question. What else is needed to prove or disprove a connection?

Unfortunately, rather than considering the preliminary clinical findings of Dr. Wakefield as a newly documented adverse reaction to a vaccine, the CDC attempted to refute these clinical findings through an epidemiological review. While epidemiological research is very important, it cannot be used to disprove laboratory and clinical findings. Valuable time was lost in replicating this research and determining whether the hypothesis was accurate.

Officials at HHS have aggressively denied any possible connection between vaccines and autism. They have waged an information campaign endorsing one conclusion on an issue where the science is still out. This has significantly undermined public confidence in the career public service professionals who are charged with balancing the dual roles of assuring the safety of vaccines and increasing immunization rates. Increasingly, parents come to us with concerns that integrity and an honest public health response to a crisis have been left by the wayside in lieu of protecting the public health agenda to fully immunize children. Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well. How will!
HHS restore the public’s trust?

Access to the Vaccine Safety Datalink (VSD)

One of the primary topics to be discussed at this hearing is access to the Vaccine Safety Datalink. (VSD). To help fill scientific gaps, the CDC formed partnerships with eight large health maintenance organizations through an agreement with the American Association of Health Plans to continually evaluate vaccine safety. This project is known as the Vaccine Safety Datalink (VSD) and includes medical records on millions of children and adults. Up until this year, access to data from the VSD has been limited to researchers affiliated with the CDC and a few of their handpicked friends. This ‘good old boy’s network” practice has predictably led to questions about the objectivity of the research and the fairness of the results.

The VSD data should be made available to all legitimate scientific researchers so that independent studies can be conducted and results verified. This database contains a wealth of data involving millions of patients over a ten-year period. If properly utilized, it can help researchers study vitally important questions about the safety of vaccines, the effects of mercury-based preservatives in childhood vaccines, and many other questions.

The Committee first raised this issue with the CDC two years ago. For two years the CDC delayed. Six months ago, we were informed that the CDC was developing a plan to expand access to the database. Finally, in February of this year, after a great deal of prompting from the Committee, Dr. Robert Chen, Chief of Vaccine Safety and Development at the National Immunization Program, informed Committee staff that the CDC had finalized its plan and that it was poised to put it into effect. Under this plan, any legitimate scientist could submit a proposal to the CDC to conduct research using VSD data and access to the data would be provided along with some basic safeguards.

In preparation for today’s hearing, Committee staff asked the CDC why the plan described to us in February had not yet been put into effect. The staff was informed that the plan had been put into effect. However, there had been no public announcement. How are researchers supposed to know about the availability of the data if there is no announcement? It took two years of prodding by this Committee to get the CDC to open up access to the database. For four months it appears that the CDC didn’t inform anybody but this Committee of the data’s availability.

That doesn’t make it appear that the CDC is making a good faith effort to open up this database. It looks to me like the CDC is trying to do the bare minimum that they have to do to get us off their backs. That’s not acceptable. That’s why I insisted that Dr. Chen be here today. I just want to ask him why they didn’t tell anyone about the database being available. I’d like to know how he expects researchers to use this data if nobody tells them it’s available.

Dr. Roger Bernier is here from the CDC to testify about these issues. He is accompanied by both Dr. Chen, the creator of the VSD Project and Dr. Frank DeStefano, the CDC official who is also a co-author of the MMR – IBD study. They are here to address our questions on the VSD project and the vaccine- autism research. The CDC employees are accompanied by Dr. Stephen Foote of the National Institutes of Health and Dr. William Egan of the Food and Drug Administration.

As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury.

I look forward to hearing from our witnesses today. Our hearing record will remain open until July 3.

I now recognize the ranking minority member, Mr. Waxman for his opening statement.


Part 1 - thimerosal Hearings
 Dr. Colleen Boyle:

 I think we've made a 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?

 Unknown 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?

 Unknown 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.

 Unknown 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?

 Unknown 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?

 Unknown Speaker:

 Yes, that is correct.

 Rep. Burton, Chairman:

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

 Unknown Speaker:

 That is correct.

 Rep. Burton, Chairman:

 Then why are you putting thimerosal in it?

 Unknown Speaker:

 At the present time, as Dr. Midthun and Dr. Boyle mentioned, we have a 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 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 an 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 the Chairman, Chairman Burton is  raising I think 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 make, 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 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 product 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 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
 

Part 2 - thimerosal Hearings


 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 concern 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 were 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  (Vaers)  (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 the 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 -- 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 that's going to  come down with autism. A day. 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.


 Unknown 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 over stimulated 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?

 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 like 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, to 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 single shot vials. And with that, thank you  for being here. We stand adjourned.

New York State Petition for HR 3741
July 2002

It is very important to understand this is not an anti-vaccine campaign.  This bill is VERY important, especially for the older children as it would allow a one time chance to file with NVICP even though the statute of limitations has passed. (Only for injuries occurring after 1988).  This bill was introduced on February 13, 2002 and is sponsored by Rep. Dan Burton (Indiana).  As of June 24, 2002, there are only 36 cosponsors.  Many more are needed.  The petition reads as follows...

We, the undersigned, are requesting your support and assistance to insure the passage of bill HR3741. ince 1988, the National Vaccine Injury Compensation Program (NVICP) has been the principal source of compensation for families whose children have suffered vaccine-related injuries. The NVICP was intended by Congress to compensate families generously through a non-adversarial process. However, during hearings before the Government Reform Committee, the program has been criticized for becoming overly litigious and less compassionate than intended by Congress.

The National Vaccine Injury Compensation Program Improvement Act of 2002 (H.R. 3741) is bipartisan legislation that builds on a set of recommendations to improve the program put forward by the Advisory Committee on Childhood Vaccines. The bill would:. Extend the statute of limitations for seeking compensation from three years to six years.

. Provide 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. (Only for vaccine injuries incurred after 1988.) . 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 1986.

. Allow 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 during the sometimes lengthy adjudication process. Please support families of vaccine-injured children by cosponsoring HR 3741 today. 
 

Jeff Bradstreet At Burton Hearing on MMR Vaccine, Monkey Virus in Spinal Fluid Jeff Bradstreet, M.D., F.A.A.F.P. Medical Director and Founder, The International Child Development Resource Center and an autism parent, Palm Bay, Florida

Last week we presented the testimonies of Congressman Dan Burton and Dr. Andrew Wakefield from the U.S. House Of Representatives, Government Reform Committee On The Status Of Research Into Vaccine Safety And Autism on June 19, 2002.  Thanks to Jeff Sell, here is the transcript of Dr. Jeff Bradstreet's remarks.  Bradstreet has treated over 2000 children with autism and does clinical research.  Dr. Bradstreet's complete presentation and extensive references can be found at the website URL below.
  http://www.house.gov/reform/hearings/healthcare/02.06.19/bradstreet.pdf

Unfortunately, the nature of autism is so complex that to do it in five minutes will be challenging.  So I have submitted, under tab five, a more complete review of the nature of our research.  I will try and get through my slides quickly, Mr. Chairman. Thank you very much for the hearing and for an opportunity to present this.  Dr. Weldon and I previously met two weeks ago in your office with the deputy secretary of health and human services, Claude Allen, to present this data to him.  So he has been made aware of it. And it was a very encouraging and very positive meeting.  I look forward to the outcome of that over time.

 With that, the next slide. The prevalence may be both misunderstood and underestimated.  Two recent studies, one from England and one that was a CDC study with Brick Township, indicated between 57 per 10,000 and 67 per 10,000 children. However, autism is primarily a boy-related disorder; four to eight times as many boys suffer with this disorder.  That means that the prevalence is therefore in the order of one percent for boys.
      Next slide.
The economic impact.  We estimate that there are approximately 420,000 children with autism in this country at this time, based on those studies, greatly less than what the "Time Magazine" article set at one million. However, that puts a price tag, over the next 50 years to take care of these children, in excess of $1 trillion. That was a lot of zeroes.  I had to go through that a couple times on my calculator to make sure that that was correct.  But that is the real number.  The lifetime costs could be $3 trillion to $4 trillion for the families and for society, with the lost wages and other factors.
      Next slide.
The biological evidence for causality is growing significantly. And for those members of the committee who may not be familiar with me, I am a physician.  I am also a parent of a child with autism.  And I am a clinical researcher associated with studies currently ongoing at 14 medical schools around the world. The growing evidence is substantial that measles virus is still the front runner with the viral etiology aspects of things.  And not all children suffer from measles virus-related disorders.  But we'll show you today some examples that are quite, I think, impacting. Additionally, autoimmunity continues to be published by a variety of researchers at multiple medical schools that there is a unique disorder affecting the autoimmunity in these children where they become immune to their gut and their brain.  And that is a disaster for them. Mercury -- and, to a lesser extent, lead -- remain significant toxic burdens.  And we presented that data to the Institute of Medicine in July of last year.
      Next slide.
The first case -- I'm going to present two cases today.  I'll try and go through them briefly. Matthew (ph), who was born in 1984 from an uncomplicated pregnancy and an easy delivery, had a normal early development, except he did develop some gait abnormalities that are very consistent with what you might expect from Mercury.  We'll see that data later on.  He had a rapid decline after each of two MMRs.  He did receive those in combination with other vaccines, however. He developed autoimmunity to myelin basic protein, a critical insulator of the brain.  He suffered seizures shortly after the second MMR. And he has consistent immune deficiency with protracted low mythecide (ph) counts.
      Next slide.
He has inflammatory bowel disease that has been documented on an endoscopy and biopsy.  He has persistent measles virus genome in that inflammatory disease.  He has persistent measles virus in circulating white blood cells.  He has persistent measles virus "F" gene in his cerebral spinal fluid, which is the fluid that surrounds the brain, implying it is present in the brain as well. He has auto-antibodies to measles virus in his spinal fluid.  He has auto-antibodies to myelin basic protein in his spinal fluid, elevated a million, a very low serum sulfur level and cysteine level and very high Mercury as a result of that. 

Next slide.
 And next.  That is my son, who is also the, I think, inspiration for our research and the work that we do. He was a very happy, well- connected child prior to his MMR.  That's about approximately at 12 months of age. And that is Matthew (ph), completely lost, about two months after his MMR vaccine.  Next slide.  That is a copy of the laboratory result documenting the presence of measles virus in his terminal ileum.  Next.  Copy of the laboratory result from Utah State University where Matthew (ph) had spinal fluid analyzed that showed antibodies to myelin basic protein and to measles virus in his spinal fluid.

 Next slide.  This shows the presence of antibodies in his RBCs. Excuse me, the presence of virus in his red blood cells.  It is also present in his cerebral spinal fluid.   Next slide.  And this is his first mercury titer, showing marked elevations of mercury.  And if you can see for all those, essentially the only thing that is truly abnormal is a significant increase in Mercury.
 Next slide. 

 The first challenge to us to get Mercury out of his body resulted in an extremely high titer.  That number of dots actually represents 24 micrograms for gram of creatne (ph).  It would take it well off the slide, perhaps into the next room. Next?  This is an interesting correlation.  Mark Blacksill (ph)presented this to the Institute of Medicine last year.  And that shows the rising titer of cumulative Mercury in the vaccine program in California, compared to the prevalence of autism in California.  Next?  And I want to superimpose on that a very interesting graphic derived from the government website on the use of methylphenidate, also known as Ritalin or Concerta.  And look at the time relationship between the rise in that. Next?  It's identical.  In 1990, the rise in the mercury titer started to go up.  And in 1990, there is a striking and continuous rise in the use of Ritalin in this country, which I think is rather telling.       Next slide, please.  This is the thimerosal versus autism relative risk that was produced in the CDC confidential study that was acquired under the Freedom of Information Act, showing that by the time approximately 37 micrograms of Mercury is administered, there is more than a doubling of the relative risk of autism.


 Next.  This is a copy of a transcript from the Simpson-Wood (ph) meetings.  It is page 229, where Dr. Brent (ph) -- who is not employed by the CDC; he is a public health official from one of the states -- said that the medical-legal findings in the study, causal or not, are horrendous.  If an allegation was made of a child's -- the behavioral findings were caused by thimerosal-containing vaccines, you will not find a scientist with any integrity who would say the reverse of the data that is available.  So we are in a bad position, from the standpoint of defending any lawsuits if they were initiated.  And I am concerned.  I think that may set part of the tone for what we have seen happen in the last several years.

 Next slide.  Additionally, there was a very good documentary on this. Parents are aware.  And I think it's very important for Congress to be aware that the parents are receiving information from a variety of outlets.  This is not just your doing or undoing a vaccine policy.  Parents are well educated.  They are hungry for information.  And they currently don't believe many of the reassurances that are being provided by CDC.   Next slide.  Case two is very similar to my son.  And I present it so that you
will realize that this is not -- my son was not an isolated case.   He had, again, normal developmental milestones.  He arrests shortly after his first MMR at 15 months.  He again has antibodies to many things in his brain and persistent measles virus in places that it doesn't belong, including his cerebral spinal fluid.


 Next. Lab slide.  This indicates that, in fact, he has antibodies to myelin basic protein and to measles virus in his spinal fluid. Next.  He has this unique antibody.  And this is the presence of MMR antibody, which is actually the "H" protein or the hemogluten (ph) protein from the measles virus of a special antibody titer that was derived using MMR vaccine.  And this was done in Dr. Singh's laboratory at Utah State University.  Also positive in spinal fluid.   Next.  We presented this data, Dr. Singh and myself, at the American Society of Microbiology last month, which indicates that 50 percent of children in our society had antibodies to this special measles, mumps, rubella-derived protein in their cerebral spinal fluid.  Also, 86 percent have antibodies to myelin basic protein in their spinal fluid.  And again, a very high percentage, up to 100 percent, had antibodies to myelin basic protein in their blood. This is not present in normal controls.  This is a controlled study. We now have significant controls.  And we do not see these present.  This is not an antibody leakage phenomenon.  This is real disease in these children.


 Next.  Again, Scott (ph) has documented measles virus in his terminal ileum in his blood, as well as the spinal fluid.  These are laboratory data. Next.  And I want to include from Dr. Menkes (ph), his comments, where he concludes that, in fact -- this is related to the MMR vaccine in this particular child.  Dr. Menkes (ph) wrote the textbook, "Child Neurology." He is considered to be one of the foremost experts, both on child neurology and on vaccine safety and has concluded that measles, mumps, rubella vaccine is causing this syndrome.
Next.  That's the child.  I think it's always important to put a face. This is impacting human lives.
Next slide.  I would leave you with some questions.  I think we have some important things that we need to ask.  These are in the handout.  But as we work through this, I think we need to know that what if Dr. Wakefield,myself, Dr. Singh, Dr. O'Leary and Dr. Menkes (ph) and others are right. What then?  What would be the reaction to public health officials if, in fact, this data is -- as we believe it is -- verifiable? In addition to that, what is the response to treating these kids? How are we going to get this virus out of these kids and restore them to good health?  And have we traded a very rare occurrence of severe side effects to natural measles infection for a very common occurrence of autism?

Dan Burton speech before Congress on 11/22/2002
This was sent to me in document form so I do not have a URL

Special Order
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. 

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

2    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.

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

4    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. 

5    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.

6    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. 

7    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. 

1    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. 

2    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.

3    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. 

4    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. 

5    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)

6    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. 

7    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?
1    Autism is a complex neurobiological disorder, resulting in developmental disability.  It typically appears in the first three years of life.

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

3    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.

o    People with autism process and respond to information in unique ways. In some cases, aggressive and/or self-injurious behavior may be present.
o    Forty Percent of individuals with autism do not have speech.
o    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.
o    Persons with autism often prefer to be alone.  They may throw tantrums. 
o    They often have difficulty interacting with others.
o    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.
o    Persons with autism frequently make little or no eye contact.  
o    They will not respond to normal teaching methods, they may have odd play habits, and frequently spin objects. 
o    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. 
o    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.

1    There are certainly children who are born with autism.
o    They have what can be called ``classical autism.''
o    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.

2    There most probably is a genetic component to autism.  But genetics is not the only issue.
o    Many children seem to have severe food sensitivities, particularly to gluten and casein, ingredients in the most common foods, dairy and wheat. 
o    Many of these children show signs of autism shortly after receiving their immunizations.
o    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?
1    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. 

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

3    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. 

4    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. 

5    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.

6    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?
1    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.

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

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

4    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. 

5    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
1    In the sixty years since autism was first described, we have not yet figured out what causes it.
2    We do not know if classical autism and late-onset autism are the same conditions or two   different conditions with similar symptoms.
3    We have come a long way in sixty years. Doctors no longer blame the condition on bad mothering.
4    But we have a lot more work to do before we can pat ourselves on the back for our accomplishments.
5    In the Committee, we looked at our investment in research on autism on a comparable level with other epidemics?
6    We asked these questions: 
o    Are the CDC and NIH funding studies that will help prevent or cure autism?
o    Is their research adequately addressing the medical issues associated with autism such as food allergies, chemical sensitivities, and autistic entercolitis?
o    Is the information about autism provided by our Government adequate and useful to families? 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.
o    Both of these conditions can be devastating. Both deserve sufficient research dollars to develop treatments and look for cures.
o    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.
o    CDC this year will spend just over 62 million dollars on diabetes.
o    The autism epidemic just like the diabetes and AIDS epidemics, is no less
deserving.
o    Yet, CDC’s spending for autism is almost 80 times less than that for AIDS.
o    And CDC’s spending for autism is 5 times less than that of diabetes. CDC should be committing more research money to autism. 
NIH

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

2    The NIH told us their to researching autism has grown dramatically in the last few years.
3    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.
4    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.
5    I believe the numbers speak for themselves. Funding into basic and clinical research into autism needs to grow.
6    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?

1    Thimerosal is a preservative that has been used in some vaccines since the 1930’s.
2    Thimerosal is about 50 percent mercury and 50 percent thiosalicylic acid.
3    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.
4    Methyl mercury is associated with neurotoxicity in high doses.
5    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.
6    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. 
7    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.
8    In 1999, and after much debate they decided to ask the manufacturers to start switching to thimerosal-free vaccines for children. 
9    Many of my colleagues have reported that thimerosal is no longer being used.  This is not true.
o    The flu vaccine given to children and to members of Congress has thimerosal.
o    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.
o    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.
o    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.”

1    If there were no concerns that scientific research would demonstrate a connection between thimerosal and autism, 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.

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

2    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:

1    “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 ethylmercury and the more exposures are associated with neurological damage.”

She also stated,

2    “There is also toxicological and epidemiological literature suggesting that methylmercury 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 ethylmercury that exceeded some safe exposure guidelines for methylmercury. In addition, some children could be particularly vulnerable or susceptible to mercury exposures because of genetic or other differences….

3    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. …

4    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
1    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. 
2    We found that all too often the right research questions have not been asked.  In fact, very little research has been done.
3    When Dr. Andrew Wakefield reported that in a small population of late-onset autism cases, in which there was chronic bowel disfunction, 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. 
4    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.
o    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.
o    This study found that there was a five-fold increase in autism over the ten years they looked.
o    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

1    Section 1714-1717 affect the National Vaccine Injury Compensation Act. 

2    They do not protect Americans from a terrorist threat, or affect the Department of Homeland Security. 
3    Rather they protect large domestic pharmaceutical companies who manufacture the components of campaigns.  They protect them from potential civil liability from vaccine injured children. 
4    Amending the Vaccine Act through this legislation is inappropriate.
5    These sections were intentionally insert to protect the manufacturers of thimerosal.
6    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.

1    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 was 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. 
2    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
1    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. 
2    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

1    The Committee on Government Reform, over the last two years has conducted an extensive investigation into the Vaccine Injury Compensation Program. 
2    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. Allow 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. ·    Provide 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.

1    Other bills were also introduced. 
2    However, the other bills also appear to protect industry, while whittling down families opportunities to receive compensation through the program.
3    These provisions include the ones inserted we have talked about here.
4    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 Support, they do not have the support of the vaccine injured.

Conclusion

1    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. 
2    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. 

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

o    I have asked him to begin a national effort to determine why autism has reached epidemic proportions in the United States. 
o    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.
o    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. 

1    The first is an outline of what we know from the published literature about thimerosal’s safety. 
2    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. 
3    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. 
 
 

http://www.cnn.com/2002/HEALTH/parenting/12/10/cnna.autism.vaccines/index.html

Tuesday, December 10, 2002 Posted: 3:22 PM EST (2022 GMT)
  
Burton says the government isn't doing enough to determine if vaccines are linked to autism. 

(CNN) -- A congressional committee is holding hearings Tuesday into the relationship between childhood vaccinations and autism. According to the House Government Reform Committee, as many as 1.5 million Americans suffer some form of autism, and the rate is increasing by 10 percent to 17 percent a year. Many people believe thimerosol, a mercury-based preservative used in some vaccines, may be partly to blame for these statistics, but many scientists dispute that theory.

Rep. Dan Burton, R-Indiana, who chairs the committee, also has a personal stake in the inquiry: He's the grandfather of a 5-year-old who was diagnosed with autism three years ago. Burton joined CNN's Leon Harris and childhood immunization expert Dr. Sharon Humiston, also the mother of an autistic child, to discuss the issue.

HARRIS: Good to see you again, Congressman. How is your grandson doing?

REP. BURTON: He's doing a little bit better. He still has severe speech problems. But he's doing a little better.

HARRIS: Well, that's good to hear. Here's hoping it gets even better down the road. So what is it you hope to accomplish with these hearings this afternoon?

BURTON: Well, first of all, I think that the public needs to know about some of the problems that we have with vaccines. I'm a strong advocate for vaccines. I think they're important for the health of the nation.

But at the same time, some of the vaccines, I think, have not been tested as well as they should have been. Some of the contents in the vaccines should not be in there, like thimerosol, which contains mercury, and mercury has a cumulative effect on the brain, and  causes -- I believe it's a contributing factor to autism. So these [are] things I think that should be looked into by the Food and Drug Administration and Health and Human Services, and I don't believe they've done as good a job as they should have.

HARRIS: There's some, and doctors even, who have come up with distinctly different opinions about that, saying that the science behind all that isn't that strong.

BURTON: Well, we have had scientists from all over the world come in and testify, scientists from the United States. There is no question that mercury is a toxic substance that affects people and causes neurological damage. They've taken it out of topical dressings in 1985, and yet they continue to put it into our children and adults, in flu vaccines, and there's a growing body of evidence that it may be a part of the Alzheimer's problem we have.
  
Humiston says there's no evidence vaccines cause autism. 
 
So mercury, which is a toxic substance, should not be injected into human bodies in any way that's avoidable.

HARRIS: We've heard that said about mercury quite a bit over the years. Pediatrician Sharon Humiston has a different perspective. She is an expert on childhood immunization, and she's the author of "Vaccinating Your Child: Questions and Answers for Concerned Parents." She's also the mother of a 9-year-old autistic son.

Doctor Humiston joins us now from Rochester, New York, where she is on the faculty of the University of Rochester Medical School.

Thank you for taking time with us this morning.

How is your child doing?

DR. HUMISTON: My son at 9 still doesn't have language, but he's a wonderful boy.

HARRIS: We're glad to hear that. And again, as well with you, we hope that this gets better down the road.

Now, can you respond to these statements that we've just heard from Congressman Burton about the signs being so clear that these vaccines have some sort of a link to autism. What do you think about that?

HUMISTON: I think quite the opposite. The overwhelming evidence is that vaccines don't cause autism.

Most recently a study from Denmark showed in hundreds of thousands of children that there was no link between autism and MMR [the measles- mumps-rubella vaccine]. What I'm concerned about is that hammering away at this theory is going to do two things: take away resources from furthering the science of autism and second, plant the fear in  the hearts of parents so that we're going to see a decrease in immunization rates and an increase in disease.

BURTON: May I comment on that? Yes, in 1992, they took thimerosol out of vaccines in Denmark, and that is a flawed study, number one. And I would like to ask the doctor if she categorically says that there is no doubt whatsoever that mercury in vaccine causes -- is a contributing factor of autism. No doubt whatsoever in her mind, not at all?

HUMISTON: We know that thimerosol has been out of vaccines for years in the United States, and there's no appreciable decrease in autism.

BURTON: That is not the question.

HUMISTON: So we have strong evidence, even from the United States,that thimerosol doesn't cause autism. There is a confusion here, too, between MMR and thimerosol. MMR has not now and never had thimerosol in it. The parents shouldn't be confused about those two issues.

BURTON: Well, there is a concern. ... What I asked you is, can you categorically say without any doubt whatsoever that the mercury in vaccine does not contribute to neurological problems?

HUMISTON: Of course I'm a scientist. And scientists...

BURTON: That is not an answer. You will not answer, will you?

HUMISTON: Scientists can't say things in a way that a politician can say them, because scientists can only prove things that are so. We can build evidence. So that's what I'm saying is, that for my child, science will help him more than emotion.

BURTON: Let me say this about emotion... about science. We have had scientists from all over the world, including here in the United States, that say that the mercury in vaccine really causes neurological problems. We have had a scientist in Canada sent us a video showing that a very minute amount of mercury in the brain destroys the sleeve that controls the nerve in the brain.

So there's no question that mercury in our bodies does cause neurological problems. And for the doctor to evade the question about knowing for sure that mercury doesn't cause neurological problems in these vaccines shows very clearly that she simply doesn't know. She's an educated lady, no question about it, but she's not going to give you a straightforward answer.

HARRIS: All right, we'll have to leave it there. We can see why this is such an interesting and controversial topic.

 


CNN: Burton, ASA Speak Out on Mercury Controversy

      [This transcript is from CNN "Newsnight Aaron Brown", which ran
December 10, 2003.]

      BROWN: This is a story we need to approach with a strong dose of caution. It's about a disorder that hits the very young and can devastate entire families. The number of kids getting it is growing fast and there are suspicions among many  about what may be behind it.    It's autism and the suspicion is that childhood vaccines may be part of the problem. Now, childhood vaccines had been one of the true wonders of modern medicine, saving literally countless lives. And the suggestion that parents may begin viewing somehow them as dangerous is alarming to the medical community, especially since the consensus at this point is that the research doesn't support the suspicions.
      We'll talk with a congressman in a moment who has his own autism story and believes the vaccines need closer scrutiny. First, the science of what we know from CNN medical correspondent Rea Blakey.       (BEGIN VIDEOTAPE)
      REA BLAKEY, CNN MEDICAL CORRESPONDENT (voice-over): The controversy centers around a preservative once widely used in vaccines. Called Thimerosal, it contains nearly 50 percent ethyl mercury. Exposures to high levels of mercury can permanently damage the brain and kidneys, causing tremors, attention deficits, and problems with language development and
memory.
      Can mercury exposure in vaccines also cause autism?
      DR. MARK BATSHAW, AUTISM EXPERT: It is known that autism is increasing and everyone wants to know why. And certainly it was not inappropriate to consider immunization as a cause. But it's been considered now and ruled out.
      BLAKEY: A Food and Drug Administration review of Thimerosal found no evidence of harm caused by doses in vaccines, except for minor reactions like redness and swelling at the injection site. Yet autism activists remain concerned.
      ROBERT BECK, EXECUTIVE DIRECTOR, AUTISM SOCIETY OF AMERICA: But there
is no scientific evidence that shows that it's not. So it's a question that still needs to be answered.
      BLAKEY: In 2001, the esteemed Institute of Medicine issued the most exhaustive study ever on Thimerosal. The research concluded it's biologically plausible that Thimerosal might cause developmental disorders like autism.
      Meanwhile, the IOM report recommended Thimerosal be removed from all vaccines for infants, children and pregnant women.  Except for the flu vaccine, and the one for tetanus diptheria, most vaccines have only trace amounts or none at all.    (on camera): As a result, ethyl mercury levels in routine childhood vaccines have been reduced by 60 percent. So what's the government's recommendation for worried parents? Well, the Centers For Disease Control says there's plenty of preservative-free vaccines. But in cases where those don't exist, vaccines should be given according to the schedule.
      BATSHAW: If you compare the risks of autism to the risks of not having immunization, it is much better for you to be immunized.
      BLAKEY (voice-over): Each year, millions of American children receive childhood vaccinations. Given that fact, autism activists want more studies on role on Thimerosal might be playing.
      Rea Blakey, CNN, Washington.
      (END VIDEOTAPE)
      BROWN: One Congressman has been pushing hard to look more closely at autism and vaccines. He knows the damage autism can do firsthand. He has an autistic grandchild.
      Indiana Republican Dan Burton reopened hearings in the House today and Congressman Burton joins us tonight from Washington. Congressman, it's always good to see you. Thank you.
      REP. DAN BURTON (R), INDIANA: Nice seeing you, Aaron.
      BROWN: Is your gut telling you anything here, one way or another? I mean, science at this point seems to suggest there is no connection.
      BURTON: Well, that's not accurate, Aaron. We have had scientists from around the world and here in the United States who come with very strong evidence that the mercury in some of these vaccines does contribute to the autism in children.   My grandson, whom you mentioned a moment ago, got nine shots in one day, seven of which contained Thimerosal, mercury. And he got about 45 times the amount of mercury in one day that's tolerable in an adult. And he became
autistic in just a matter of a couple of days and he hasn't been right since. And he was a perfectly normal child before that.   My granddaughter got a hepatitis B shot that had mercury in it and quit breathing within a matter of hours. We had to rush her to the hospital and fortunately she recovered. And she's been doing well. But she now has grand mal seizures that we believe may have been related to the Thimerosal, the mercury in that vaccine. So, a lot more -- as you said, a lot more needs to be studied. And that's why we've called on president to have a White House conference on this, bringing in all sides of the issue.
      BROWN: Well, we hope we do.
      Let me ask you -- of a-- this is -- I'll acknowledge a bit tangential to the basic question, but for reasons that are not easily explained to me at least, in the homeland security bill, Lily, who makes some of the vaccines and has some legal issues here, is given essentially a pass in the homeland security bill they're an given immunity to legal action, mostly.
How did that happen?
      BURTON: Well, that was put in the bill in the dark of night and many pharmaceutical companies that use Thimerosal in their vaccines I think were supportive of that, although they won't publicly say it.  The problem, is there's a three-year limit of -- statute of limitations on people who have damaged children as a result of vaccines. There's what's called a vaccine injury compensation fund. And with that three-year statute of limitations, if their child is believed to have been damaged by vaccines after that three-year period, they have no recourse but to go to the courts.
      The language that was put in under the cover of darkness in the homeland security bill, stops even existing lawsuits from going forward, thus taking the ability of these people to get compensation for their damaged children from vaccines ever getting it. And that's a tragic thing
because many of these people had to sell their homes. They have to live with these kids. It's just tragic. And they have nowhere to go.
      BROWN: Who put that in -- in the bill?
      BURTON: I talked to Dick Armey, who was the head of the subcommittee or the leadership committee that finalized the homeland security bill. He said it was put in at the request of the White House.  He also said the committee of jurisdiction was contacted about this amendment, which is not the case because my committee was the primary committee of jurisdiction and we knew nothing about it.
      BROWN: White house, as you know -- I know you know this -- denies it had anything to do with it. White House says it didn't have anything to do with it. The committee apparently didn't have anything to do with it. No one's taking responsibility for this. Did members, particularly in the
House -- did members in the house know this was in that bill when they voted on homeland security?
      BURTON: Nobody knew about it except the people that put it in. And it didn't just fall from the sky. It wasn't an accident that it was put in that bill. It was done deliberately to protect pharmaceutical companies from lawsuits that might originate from these vaccines. Now, the fact of the matter is, I don't mind if we have a vaccination compensation fund that's fair and equitable to these people and gives them compensation without a lot of legal maneuvering. If we can come to that -- get that resolved.  But the fact is, these parents don't have any place to go except to the legal system, many of them, thousands of them. And it's wrong, if they've been damaged by vaccines, not to give them any avenue of hope.       BROWN: I'm going to bring us back in our last half minute to the central question. Where do your hearings go next?
      BURTON: Well, we intend to continue to press for information concerning this issue from the pharmaceutical companies. I have subpoenaed documents that go all the way back to the '30s to find out if this stuff has ever been tested.  Thimerosal, to my knowledge and through our research, has never been tested by the FDA or the pharmaceutical companies. The only time it was ever tested, it was tested in 1929 on 27 people who were dying from meningitis. All of them died but they said it was not as a result of the Thimerosal given to them, so they've been putting it in vaccines ever since. That's just wrong.
      BROWN: Congressman, we look forward to -- thank you. We look forward to the hearings. And you're updating us on them. Thank you very much. Congressman Dan Burton tonight.
      BURTON: Thank you, Aaron.
* *
 

FROM THE HILL NEWS
http://www.hillnews.com/news/012903/burton.aspx
JANUARY 29, 2003

Lobbyists target Burton
By Jonathan E. Kaplan

Rep. Tom Davis (R-Va.), chairman of the House Government Reform Committee, has ended a dispute over what to do with his predecessor, Rep. Dan Burton (R-Ind.), and has decided to give him a subcommittee chairmanship.

Davis told The Hill that he would do so despite criticism from some drug companies who believe Burton has a personal vendetta against them. "Dan ought to have a subcommittee," Davis said. "I have full confidence in Dan Burton. If anybody feels shafted, we'll sit down with them."

Under criticism from some GOP lawmakers, Davis has also rehired committee staffers whom he had fired.

He says the realignment of jurisdictions between Burton and Rep. Mark Souder (R-Ind.), who is giving up oversight of public health policy, is "completely amicable." Davis expects to finish sorting out the subcommittee assignments within a few days, he says.

But lobbyists for the pharmaceutical companies that make vaccines for children do not want Burton, who has an autistic grandson, to be given a platform to pursue more investigations into claims that children's vaccines can cause autism.

The lobbyists spoke on the condition of anonymity. John Cardarelli, Burton's press secretary, did not return repeated calls requesting comment.

"[Burton] has set back immunization efforts in this country 10 years," said a lobbyist for a drug company. "We're now seeing parents scared to get kids immunized. Everybody has expressed their concern about Burton running these anti-vaccine hearings. The feedback we've got is that nobody in leadership is excited."

He added: "My gut feeling is that it does not matter what the name of the subcommittee is. It is a broad enough forum. I don't see Dan Burton going away."

Another lobbyist for a vaccine-manufacturing drug company said they were unhappy to see Burton further undermine the benefits of vaccines, but that the industry had no organized strategy to oppose him or ability to effect committee assignments.

Public health groups are concerned, too. "If he does not have a subcommittee chair, he'll do something else," said a lobbyist for an advocacy organization. "The bigger question is: When is enough enough? Some of us would say it's been enough."

While the leadership is not happy with the situation, it is staying silent. John Feehery, a spokesman for Speaker J. Dennis Hastert (R-Ill.), declined to comment on the matter.

For its part, the Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying group for the industry, denied it is opposed to Burton 's chairmanship.

"In three weeks of legislative strategy meetings, I did not hear one person say one thing about Mr. Burton," said Mike Tuffin, the group's spokesman. "That's an internal House matter. We're not concerned at all who might chair the subcommittee."

In the 2002 election cycle, drug companies raised $17,481,391 for the Republicans, according to Opensecrets.org. The United Seniors Assn., an advocacy group largely funded by PhRMA, ran a reported $12 million in political advertisements supporting GOP candidates.

The few companies that make vaccines, which are expensive to produce and heavily regulated by the Federal Drug Administration, are concerned mainly because Burton's tactics could subject them to lawsuits over products that generate only 5 percent of their revenues, experts in the industry said.

But Davis, who was chosen over more-senior lawmakers to lead the panel several weeks ago, has the power to rein in Burton: To prevent so-called fishing expeditions, all subpoenas will have to be approved by the full panel's chairman.

Burton, as committee chairman, held extensive hearings into allegations that children's vaccines have caused an alarming rise in autism, and vaccine safety generally. He has a strong following among a small, but politically potent, group of parents with autistic children.

Since April 2001, Burton has held five hearings on the subject, according to the committee's website. He has written letters asking President Bush to host a White House conference on autism and to others advocating increases in research funding.

"It's been pretty clear that there is some connection between vaccinations and autism," said Craig Snyder, a lobbyist with IKON Public Affairs. "I'm sure he would continue to explore this."

Meanwhile, Souder, who currently chairs the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, said he was more than willing to relinquish oversight of public health policy.

"It's more a practical matter," said Souder, adding that his panel had oversight of too many issues. "My primary goal is to keep oversight of narcotics policy, faith-based initiatives, social issues and, hopefully, national parks."

Davis also has announced he would abolish the District of Columbia Subcommittee. "The subcommittees will look very different than the last Congress'," said David Marin, Davis' spokesman. "It will be based on members' areas of expertise and interest."
 

What Dan Burton said to the House Members:

 

Mr. Burton: Madam speaker, as we approach the flu season, many of my colleagues will visit the doctor's office here on Capitol Hill and receive a flu shot. Before they go, I think all of my colleagues ought to know that the flu shot contains mercury, which is a substance that's toxic to the human brain. Now, that's not to say that you shouldn't get your flu shot if you want to, but there are a lot of neurological disorders that have been caused by mercury and I think everybody ought to know that there is mercury in that vaccine. Now, that's not the only vaccine that contains thimerosal. From anthrax to hepatitis to dtap, which is given to infants to protect them, numerous vaccines exist that contain mercury, a harmful preservative. Parents around this country I am sure would be very upset if they knew that. Scientific evidence continues to accumulate regarding the biologically plausible connection between mercury and thimerosal, autism and other neurological, developmental disorders. Yet several well-known and firmly established pharmaceutical companies continue to put mercury into vaccines as a preservative, and it's never been tested. That's very interesting. Although the U.S. Food and Drug Administration asked vaccine manufacturers to begin removing the mercury-laden preservative from vaccines in 1999, they didn't order them to do it, and so the pharmaceutical companies continue to put that in our vaccines. During my tenure as chairman of the house government reform committee, a myriad of scientists testified at a series of hearings before the Committee that mercury in vaccines is a contributing factor to developing neurological disorders, including Alzheimer’s disease and autism in children. 15 years ago, one out of every 10,000 children were autistic. Now it's one out of 150 and many scientists believe that's because of the mercury in vaccines. In May of this year, the California department of developmental services released a report entitled "autistic spectrum disorders, changes in California and the caseload," 1999 to 2002. The findings are very alarming. California's autistic population has nearly doubled in four years, from 10,360 cases in 1968 to over 20,000 cases in 2002. This growth rate represents a 97% increase in just four years and nearly 100% increase in California's caseload since 1999. And they're not alone. The rate of growth in the population of persons with autism across this country is really horrible. It's very bad in states such as Georgia, Minnesota, and Massachusetts. We have an absolute epidemic on our hands, and if this trend is allowed to continue at a constant rate, we could have as many as four million autistic children in America in the next 10 years. Despite a growing body of science linking autism to mercury and thimerosal, the protests of hundreds of thousands of concerned parents across the country, the pharmaceutical industry continues to put mercury into vaccines for both children and adults even though they know mercury is toxic to the human brain. Pharmaceutical caps are concerned they may be held liable for brain damage caused by the mercury-based preservative which is still found in childhood vaccines, diphtheria, hepatitis b, and the flu shots. Because of these liability concerns, language was inserted at the last minute in the homeland security bill to protect the pharmaceutical industry from class-action lawsuits. However, because we caught it, we were able to get it out of there because a lot of members of the House and Senate thought it was terrible what they did. But numerous scientists have testified that there is a simple way to prevent this and that's to go to single shot vials, those little glass containers. You wouldn't have to put thimerosal or any preservative in you -- preservative in if you did that. This could have a positive impact in helping to minimize and perhaps eliminate some of the cases of Alzheimer’s and autism and other neurological disorders linked to mercury. This is something that the pharmaceutical companies must address and our food and drug administration and our health agencies are asleep at the switch, and they're letting children and adults be damaged day after day after day by allowing mercury to continue to be put into vaccines for adults and children. We have a growing number of people who are becoming Alzheimer’s patients, a dramatically growing number. We have one in 10,000 children 10 years ago that were autistic. Now it's one in 150 and scientists before my committee say it's because in large part of the mercury in the vaccines. We have to get the FDA on the stick. They have to demand that pharmaceutical products have mercury taken out of them very, very quickly. If not we will continue to have an epidemic on our hands that America doesn't need and shouldn't tolerate.


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