Dan Burton (my hero)
MUST SEE VIDEO
http://video.c-span.org:8080/ramgen/kdrive/e121002_vaccine.rm
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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