[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
VACCINES AND THE AUTISM EPIDEMIC: REVIEWING THE FEDERAL GOVERNMENT'S
TRACK RECORD AND CHARTING A COURSE FOR THE FUTURE
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
DECEMBER 10, 2002
__________
Serial No. 107-153
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
________
U. S. GOVERNMENT PRINTING OFFICE
84-605 WASHINGTON : 2003
____________________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California CAROLYN B. MALONEY, New York
JOHN L. MICA, Florida ELEANOR HOLMES NORTON, Washington,
THOMAS M. DAVIS, Virginia DC
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida DANNY K. DAVIS, Illinois
DOUG OSE, California JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky JIM TURNER, Texas
JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
C.L. ``BUTCH'' OTTER, Idaho ------ ------
EDWARD L. SCHROCK, Virginia ------
JOHN J. DUNCAN, Jr., Tennessee BERNARD SANDERS, Vermont
JOHN SULLIVAN, Oklahoma (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on December 10, 2002................................ 1
Statement of:
Baskin, David, M.D., professor of neurological surgery,
Baylor College of Medicine, Houston, TX; Mark Geier, M.D.,
Ph.D., Genetic Consultants of Maryland, Bethesda, MD; and
Walter Spitzer, M.D., M.P.H., F.R.C.P.C., emeritus
professor of epidemiology, McGill University, Montreal,
Canada..................................................... 30
Midthun, Karen, M.D., Director, Office of Vaccines Research
and Review, Food and Drug Administration, Rockville, MD;
Stephen Foote, Ph.D., Director, Division of Neuroscience
and Basic Behavioral Science, National Institute of Mental
Health, Bethesda, MD, accompanied by Christopher Portier,
Ph.D., Director, Environmental Toxicology Program, National
Institute of Environmental Health Sciences, Bethesda, MD... 122
Letters, statements, etc., submitted for the record by:
Baskin, David, M.D., professor of neurological surgery,
Baylor College of Medicine, Houston, TX, Lancet article.... 34
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, exhibit 3...................................... 150
Clay, Hon. Wm. Lacy, a Representative in Congress from the
State of Missouri, prepared statement of................... 172
Foote, Stephen, Ph.D., Director, Division of Neuroscience and
Basic Behavioral Science, National Institute of Mental
Health, Bethesda, MD, prepared statement of................ 143
Geier, Mark, M.D., Ph.D., Genetic Consultants of Maryland,
Bethesda, MD, prepared statement of........................ 51
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 10
Maloney, Hon. Carolyn B., a Representative in Congress from
the State of New York:
Washington Post article.................................. 16
Prepared statement of.................................... 20
New York Times editorial................................. 14
Midthun, Karen, M.D., Director, Office of Vaccines Research
and Review, Food and Drug Administration, Rockville, MD,
prepared statement of...................................... 125
Spitzer, Walter, M.D., M.P.H., F.R.C.P.C., emeritus professor
of epidemiology, McGill University, Montreal, Canada,
prepared statement of...................................... 109
VACCINES AND THE AUTISM EPIDEMIC: REVIEWING THE FEDERAL GOVERNMENT'S
TRACK RECORD AND CHARTING A COURSE FOR THE FUTURE
----------
TUESDAY, DECEMBER 10, 2002
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 1:30 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Weldon, Waxman, Maloney,
Kucinich, Tierney, and Green.
Staff present: Kevin Binger, staff director; Pablo
Carrillo, counsel; S. Elizabeth Clay and John Rowe,
professional staff members; Blain Rethmeier, communications
director; Allyson Blandford, assistant to chief counsel; Robert
A. Briggs, chief clerk; Robin Butler, officer manager; Joshua
E. Gillespie, deputy chief clerk; Michael Layman, Susie
Schulte, legislative assistants; Nicholis Mutton, deputy
communications director; Leneal Scott, computer systems
manager; Mindi Walker, staff assistant; Corinne Zaccagnini,
systems administrator; T.J. Lightle, systems administrator
assistant; Sarah Despres, minority counsel; Ellen Rayner,
minority chief clerk; and Jean Gosa and Earley Green, minority
assistant clerks.
Mr. Burton. Good afternoon. A quorum being present, the
Committee on Government Reform will come to order. I ask
unanimous consent that all Members and witnesses' written and
opening statements be included in the record. And without
objection so ordered. I ask unanimous consent that all
articles, exhibits and extraneous or tabular material referred
to be included in the record. And without objection so ordered.
Because my good friend Mr. Waxman has to leave at 2 and
because my opening statement is going to include a couple of
clips on video, I've asked him if he'd like to go ahead and
make his opening statement first, and he'd like to do that. So
we'll let him start off and then I'll go into the details I
want to go into in my opening statement.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman, for the courtesy of
allowing me to go first in the opening statements. There is a
Democratic Caucus meeting at the same time as this committee
hearing and it's unfortunate the scheduling conflict exists. So
I wanted to make my opening statement. I unfortunately won't be
able to be here for the testimony of many of the witnesses.
Mr. Chairman, in my lifetime polio has gone from every
parents' fear to being a distant memory. Measles epidemics are
few and far between. Congenital rubella, which can cause
blindness, deafness, and autism, is increasingly rare. In just
the last decade the most common causes of bacterial meningitis
in young children have been controlled. We have vaccines to
thank for these incredible accomplishments.
While millions of American children have been protected by
immunization, no vaccine is 100 percent safe. The government
must ensure that these vaccines are as safe as they can be,
insist that vaccines are only administered when the benefit
greatly outweighs the risk, and provide those who are injured
with quick and fair compensation.
Today's hearing will focus on the allegation that routine
childhood immunizations cause autism. Too often in this debate,
though, solid public health information gets lost among
sensational allegations or in recent days disgraceful political
acts that are intended to protect special interests. This
committee, unfortunately, has played a role in sowing
confusion.
Mr. Chairman, I think you've been well intentioned in your
efforts and genuine in your convictions, but often your
theories have just been wrong. Two years ago, for instance,
this committee publicized allegations that the measles-mumps-
rubella, MMR, vaccine causes autism. This allegation frightened
many parents. But the allegation has been disproven by
scientific evidence. Studies in Europe and here in the United
States by the Institute of Medicine have concluded that the MMR
vaccine is not associated with autism and there should be no
confusion about that.
Mr. Chairman, you've repeatedly, and rightly in my view,
asked for more scientific studies so that we can know as much
as possible about any adverse health consequences from
vaccines. But it's important for our committee to pay attention
to those studies once they are completed. In fact, it's
important that parents know about two recently concluded peer-
reviewed research reports. The first, which appeared in a
recent issue of New England Journal of Medicine, examined the
theory that the measles-mumps-rubella vaccine causes autism.
Concerns about a potential link have terrified British parents
and have resulted in measles outbreaks in the United Kingdom
because of the children who are not getting vaccinated.
At previous committee hearings some Members and witnesses
have called for a comparison between vaccinated and
unvaccinated children in testing the safety of this vaccine.
Well, this comparison is exactly what the New England Journal
of Medicine study provides. It found no increase in autism
among those children who were vaccinated compared to those who
were not. The commentary that accompanied the study said that
this study should put to rest parents' concerns over the safety
of the MMR vaccine.
A second peer-reviewed research report was published in the
Lancet 2 weeks ago. This study addressed the theory that
thimerosal, a mercury based vaccine preservative, causes
children to suffer neurological damage, including autism. In
this study researchers measured the amount of mercury in the
bloodstream of recently vaccinated infants. They found that
this level does not exceed safe values in any child. The
commentary that accompanied this study said it provided,
``comforting reassurance.'' It should be reassuring to parents
that thimerosal has been removed from all routine vaccine
immunizations except for the recently recommended flu vaccine
and that additional studies on thimerosal are under way. These
two research reports, with more research under way, are good
news for public health. And I ask that these studies and the
commentaries be included in the record.
Mr. Chairman, if I----
Mr. Burton. Without objection.
Mr. Waxman. Thank you. The vaccines are an essential part
of child health and parents should know that leading experts
such as the CDC and the American Academy of Pediatrics continue
to recommend that children receive all vaccines currently
approved for routine use.
Now, I know that we have witnesses today who are going to
include--the list of witnesses are going to include some
scientists that dispute these findings. Now, that's appropriate
for them to dispute the findings. And in fact many of them
dispute the findings at the peer-reviewed meetings that
resulted in these two studies. If scientists have scientific
arguments, they should take it up with their scientific peer
members. That's how scientific evaluation proceeds: Theories,
evidence, contradictions, discussions, and then a consensus and
then a challenge to that consensus. But this committee and
politicians in the Congress are not the ones to make scientific
decisions. And those who are in the minority and disagree with
the scientific conclusions of their peers should challenge
their peers by additional scientific arguments in evidence. I
want to make that point very, very clearly, because what we
have in this hearing is one of a series of hearings where we
had a political argument that's being made which seems to be
refuted by the scientific evidence, and the answer to that is
more political arguments and hearings, and I fear that these
hearings only scare people without scientific arguments to back
them up.
Now, the bad news for vaccine safety--the good news is
these two studies reassure us about the vaccines, but the bad
news for vaccine safety, however, has come on the political
front. During the recent passage of the homeland security bill
the Republican leadership snuck in two vaccine-related
provisions that help industry and do nothing to help people who
are injured by vaccines. The first of these provisions gave
manufactures of the smallpox vaccine and hospitals that
administer the vaccine virtually complete immunity from
lawsuits but does nothing to compensate people who suffer
vaccine-related injuries or death. The net result is that
Republicans have managed to protect everyone but those who need
the protection the most. Imagine an emergency room worker who
is vaccinated against smallpox in order to protect the rest of
us in case of a bioterrorist attack. If this hero or heroine on
the front lines become incapacitated by the vaccine, he or she
has no guarantee of compensation for his or her sacrifice. This
is completely unacceptable.
Republicans also snuck in another vaccine-related provision
into the homeland security bill that has no bearing on homeland
security whatsoever. It provides liability protection for Eli
Lilly, a manufacture and distributor of thimerosal. The
provision was cherry picked from a list of recommendations made
by an expert panel that overseas the Vaccine Injury
Compensation Program. Not included in the homeland security
bill were those recommendations made by this same expert panel
that helped families and children, including increasing the
death benefit, doubling the statute of limitations for the
program, and allowing the program to pay for family counseling.
Here's a telling fact: The Republican leadership is so
embarrassed by what they did that they won't even admit about
what they've done. After the thimerosal provision was put in
the bill, House Majority Leader Dick Armey said the provision
was put in at the request of the White House. But when I wrote
to the White House about this the White House claimed the idea
originated in Congress. But to this day, not a single Member of
the Republican leadership will admit responsibility for this
provision.
I don't know what kind of values these actions represent,
but they are not the values that I want to have any part of.
They put the interests of powerful and wealthy special interest
ahead of families with children suffering from debilitating
illnesses. This is an embarrassment to the Congress and to our
great country.
As we revisit these issues in the next Congress I hope that
Republicans when considering changes to the Vaccine Injury
Compensation Program do not forget that the purpose of the
program is to help families not just to reduce the liability
for industry; I also hope that the politics of vaccine safety
reinforce rather than undermine the success of immunization.
The lesson from the homeland security bill is not that people
should fear that the smallpox vaccine is always dangerous or
believe the allegations that thimerosal causes autism; the
lesson is that protecting industry alone is unacceptable, both
as public policy and principle.
I thank the witnesses that are going to be here today--I
know this is a hearing where they've been asked to testify. I'm
going to have a chance to review the record of the testimony.
And I'll look forward to reviewing the record but I want to
underscore again scientific issues should be decided by
scientific principles and evidence, not by politics and not by
presenting discredited minority views that have not yet been
able to prevail in scientific evaluation as if they were fact
and as a result scare a lot of people to do something that
would be more harmful than helpful.
Thank you very much, Mr. Chairman, for your courtesy in
allowing me to make this statement, and I'll look forward to
reviewing the record.
Mr. Burton. Let me just say before Mr. Waxman leaves he's
been a big help in trying to change the vaccine injury
compensation fund to be more responsive, and I do appreciate
that. The one thing that I would like to say though is that Mr.
Waxman does have a lot of other responsibilities and as such he
has had to leave a number of times before we go into the
details about scientific research that shows conflicting
information. And I know that he reads these documents but I
think sitting here and hearing the scientists from around the
world that we've had come before us might give you a little
different perspective, and I'm very sorry that you're not going
to be able to be here today and have not been here for some of
the witnesses that I think might have piqued your interest,
maybe dissuaded you from some of the positions you've taken.
Nevertheless, you're my buddy. I'm glad you work with me.
Mr. Waxman. Will you yield to me? Thank you very much for
your comments. I have had a chance to review the testimony of
witnesses. I've had my staff very much involved in this issue.
I've been involved in vaccine issues for at least 20 years in
the Congress of the United States. And if you come in with a
preconceived idea and hear witnesses say what you believe to be
the case, I'm sure it reaffirms your views. But I think still
these issues of science ought to be decided by the scientific
method. That's the thing that's going to protect us.
I thank you for letting me make the statement.
Mr. Burton. I will send to your office, it will only take
you about 20 minutes, I have a couple of tapes I would like for
you to take a look at.
I will let Mr. Weldon go next and I'll let my colleagues
speak as well because I am going to take a little bit of time
about my opening statement. I don't want to be discourteous to
them. So Dr. Weldon.
Mr. Weldon. Thank you, Mr. Chairman. And I want to commend
you for calling this hearing and I specifically want to commend
you for your willingness to explore this issue. If scientists
behaved purely like scientists and did purely objective
research all the time, then the comments made by Mr. Waxman
would be valid. The reality is scientists and medical
researchers operate with a system of biases that frankly can be
very, very politicized. And the claims that were made by the
ranking member that these issues essentially have been put to
rest I don't believe are valid. Specifically when you look at
the issue of the MMR, the Danish study, the data from the
Danish study which he was referring to, which I'm sure we're
going to hear more about today from our witnesses, was valuable
but it didn't really get at answering the question of really
looking at kids with regressive autism. I don't think the
opinion of this committee has ever been that mercury per se or
the MMR per se causes autism, and I think the general consensus
of scientific opinion is that this is probably a multifactorial
disease. And while the Danish study provided some valuable
information, really it didn't answer the question, I think, of
regressive autism.
And the other thing that was very disturbing about the
Danish study is they documented a tenfold increase in the
incidence of autism in Denmark. There's absolutely no comment
in the New England Journal about that issue.
And let me just say I share Mr. Waxman's sentiments on
vaccines. Vaccinations and septic systems have probably done
more to save hundreds of millions of lives in the civilized
world than anything else, and we all need to be very, very
grateful to these tremendous breakthroughs in vaccinations. But
there's, I think, some very, very troubling issues that have
not been resolved. The thing that I continue to find extremely
disturbing is the fact that the CDC still does not allow
researchers access to the vaccine safety data. If everything
was so objective and any scientist at all can look at this
stuff, it would be one thing, but they continue to deny people
access to this information. And until we get a free and open
dialog within the scientific community, I don't think, for one,
I will ever be satisfied that there isn't some data suggesting
that some children may have serious side effects from some of
these vaccines that is really going undetected, unnoticed and
they may actually cause autism.
Let me just conclude by saying that the issue with the MMR
that got all this started was a clinical study, and the Danish
study is again another epidemiologic study. And a clinical
study is very, very cheap and easy to do but nobody seems to
want to do it. We had somebody at one of our previous hearings,
a Dr. Kriegsman from New York, who had replicated some of
Wakefield's work showing that these kids are developing
inflammatory bowel disease, and then he wanted to do the next
step, he wanted to actually do the pathologic analysis on these
biopsy specimens, and the institution that he worked at said,
no, they don't want to get into it, this is too controversial.
So if everything was so objective and scientific like Mr.
Waxman is saying, why do you have a major institution in New
York City saying, no, we don't want to get into that?
You know, to a certain extent the problem is we're trying
to investigate a sacred cow. For a lot of people in the medical
community, there's this tremendous fear. If you say anything
negative about vaccines, then parents will stop vaccinating
their kids and then you'll have all these outbreaks of these
diseases. I don't think parents are that stupid. I think
parents will continue to vaccinate their kids. We have a
responsibility to them to really find out if there's truth in
all this. I don't think the answers are in, and I don't think
this mercury study really helps us that much either. It
provides--let my just say it's a great study and we're going to
hear more about the mercury study because it gives us data in
an arena where we had no data, so I'm thankful for that, but
basically studies 40 kids. We don't know if the kids that get
autism in response to mercury are kids who don't handle the
mercury properly. And I don't think the ranking member was
accurate at all to say that this puts this issue to rest.
Frankly, I've been very, very surprised at his attitude in all
this because before I got here I had an image of him as being
somebody who would really go after all these toxin issues and
all these pollution issues, and ethyl mercury, which is what
thimerosal disassociates into, is chemically very, very similar
to methyl mercury in its structure. It's very, very bothersome
when you follow the vaccine--well, it's not in the vaccines
anymore, but a few years ago when you followed the vaccine
schedule you were giving kids doses 10, 20, 30 times the toxic
dosage for these kids. And the recent--I guess it was in the
Lancet study that looked at these kids and looked at
excretions, I think it was a very valuable study but it doesn't
answer the question that the kids that become autistic may be
the kids that don't process the thimerosal properly, and that
study only had 40 kids in it.
So I say to you, Mr. Chairman, keep it up. I would like to
see you get a subcommittee chairmanship in the next Congress
and I'd like you to continue pushing this vaccine safety issue
until we get answers to some these questions, until the CDC
starts opening up that VSD data to independent researchers. You
know, in Florida we have this thing called a sunshine law. What
everybody says is sunshine is the best antiseptic. The best way
to get answers on the vaccine safety data is to open it up and
let objective scientists come in and look at it. If these
vaccines aren't that safe then that will be validated.
I think I've gone more than 5 minutes, Mr. Chairman. I want
to thank you. I yield back.
Mr. Burton. Just to followup on what you said, the Justice
Department filed a motion asking the Special Master to keep all
information secret, and that follows along with what you're
talking about. That's very disconcerting to me.
Mr. Weldon. Mr. Chairman, if I could just interject one
other point. I objected to the language that was put in the
Homeland Security Act on protecting the vaccine producers. And
you know, Mr. Waxman just said that these studies show that
it's safe and then he criticized us for protecting, he
criticized Republican leadership for protecting the
manufacturers. If what he said is true, that they're safe, then
why should he be critical of us protecting the manufacturers?
The truth is that language shouldn't have been in there. I
objected to it and I think you objected to it as well, and it
was a Member of the Senate who put that language in there. And
I'm ready to work with Mr. Waxman and all the other Members on
the minority side when we try to move that vaccine safety bill
in the next Congress. I know Senator Snowe is very, very
interested in doing something about this, and I think we can
fix this issue.
And the one thing that Mr. Waxman said which is correct is
that we need to make sure the kids are protected. But I might
say that if mercury isn't a problem and if MMR isn't a problem,
then, you know, why should he be concerned that language was in
there? I think the language should be changed. I'm ready to
work with you, Mr. Chairman and Mr. Waxman, to try to fix it.
Mr. Burton. Very good. Mr. Kucinich.
Mr. Kucinich. As I listen to the debate and have listened
to it over this past year between two individuals who I respect
most highly in this Congress, Chairman Burton and Mr. Waxman,
it causes me to reflect on how is it possible that you can get
two people who care so much about this country and whose
dedication to the people is unquestioned and revered, how Mr.
Waxman, for example, who's been the champion in Congress in
challenging the tobacco companies, long before anyone thought
about it, understood the health questions that were involved,
and built a national reputation around that. And on the other
hand you have Chairman Burton, who I happen to believe has been
far ahead of the rest of the country in raising issues about
the safety of vaccines, and rightly so, how is it you can get
this kind of conflict.
Here's how I think it happens: There are really profoundly
different philosophical views on how knowledge is organized and
I think it is reflected here, and I think it's worth thinking
about when we think about the debate that goes on here. One
approach deals in allopathic medicine, another one respected
holistic medicine. One approach is linear, the other one is
nonlinear in its thinking. One is rational, the other one is
intuitive. The one approach is deductive, the other one is
inductive. Neither is wrong. They're just simply different ways
of looking at the world. They often can lead to the discovery
of matters that are urgent to the public interest, which is why
I'm here to state my support for the efforts of Chairman
Burton. He's been courageous and he has gone forward with
dedication and persistence, and his commitment to the search
for a cause for autism has provided leadership toward a goal
that will eventually help not only his own family but also
thousands of individuals with autism throughout the world.
I want to thank the witnesses who have researched studies
and experienced firsthand the effects of autism. As you know,
autism spectrum disorders present a significant problem to our
youth. The Centers for Disease Control estimates almost 400,000
children are affected by autism. Equally disturbing are
estimates by the International Child Development Resource
Center that autism-related costs will exceed 1 trillion in the
next 50 years. $1 trillion. As the rates of autism appear to be
increasing in many States, autism presents a problem of
profound significance to all of us. It is essential that we
continue to address this issue.
The NIH has taken significant steps to find answers with an
international effort that brought together researchers from
Canada, Britain, France and Germany to study causes and
mechanisms of autism. From this research theories about the
connection between autism and vaccines are being developed,
providing possible clues that bring us closer to the answers we
seek. The NIH should be applauded for these efforts. At the
same time we must recognize the research is ongoing. It is by
no means complete.
The Institute of Medicine reports that the report that was
published last year concluded, ``the evidence is inadequate to
accept or reject a causal relationship between exposure to
thimerosal from vaccines and neurological development,
disorders of autism, ADHD, speech and language delays.'' It
also called for more research. From this report and other
recent research it could be possible that thimerosal is a
contributing factor in autism. And unless we have forums like
this, there is no way to move that discussion and that effort
forward.
With these conclusions in mind, it's unjust that an
exemption has been provided to vaccine manufacturers in the
homeland security bill in sections 1714 to 1717. This exemption
will effectively shield vaccine manufacturers from lawsuits
from claimants that allege injury from thimerosal containing
vaccines. Even those claimants involved in pending litigation
will be forced to drop their lawsuits and begin a new process
through the Vaccine Injury Compensation Program. While I
believe that the Vaccine Injury Compensation Program is largely
a good program, it is in need of reform and I support the
chairman's legislation to make needed reform, H.R. 3741.
The exemption that slipped into the homeland security bill
will deny many thimerosal injury claimants redress because the
current law governing the Vaccine Injury Compensation Program
imposes a 3-year statute of limitations. This will restrict the
number of claimants that can seek redress for their injuries.
The overall effect of the sections 1714 to 1717 will be that
many claimants will be prevented from seeking recourse through
the judicial system and some claimants are prevented from any
sort of redress. Meanwhile, manufacturers that are ultimately
responsible will be shielded from that responsibility. Both the
substance of these provisions and the process in which they
were added were wrong.
I know, Mr. Chairman, you share my concerns. You addressed
these passionately on the floor of the House and addressed to
the House on the day that the House passed the homeland
security legislation and emphasized over and over these same
points. This committee has investigated this issue in depth
over the past 3 years. Should this committee have introduced
legislation to repeal sections 1714 to 1717? And I hope the
committee takes the lead on this issue.
Well, sections 1714 to 1717 may be just one issue of the
many that this committee has investigated relating to autism. I
look forward to reading the testimony of the witnesses as it
relates to several vaccines and the work of a number of
government agencies.
I thank the witnesses for their work, hope to continue to
improve the way our government addresses autism and want to say
that I am proud to be on a committee that is chaired by Dan
Burton and I'm proud to be brought to this committee by my dear
friend Henry Waxman. Thank you very much.
[The prepared statement of Hon. Dennis J. Kucinich
follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. Thank you very much. Mrs. Maloney.
Mrs. Maloney. Thank you, Mr. Chairman. I'd like to thank
you and Ranking Member Waxman for focusing on this important
issue. I would especially like to thank you, Chairman Burton,
for your determination, courage and long time commitment to
investigating an issue that I know is very personal to him,
autism. May I also say that I have often been on the other side
of issues with Chairman Burton. We don't always agree, but I
have seen his dogged determination firsthand and if anyone can
get to the truth on this issue, he can, and I applaud your
effort, Chairman Burton.
I have understood from the Republican staff that in his
opening statement the chairman will detail a chronology of
events surrounding autism research and the role of the Federal
Government. But I do not believe that his presentation will
include what I think was an outrageous abuse of legislative
power, the Majority Leader Dick Armey's gift to Eli Lilly that
added last minute provisions in the Department of Homeland
Security bill. These provisions that were added in the dark of
night deny families of autistic children the right to file
suits seeking compensation from manufacturers of thimerosal.
Let me be very clear the new law blocks pending litigation
against the manufacturers of this mercury based preservative,
thimerosal, being brought by the families of autistic children.
The new law forces families to seek relief from the Vaccine
Injury Compensation Program. The New York times called the
leadership's late addition, ``an abuse of congressional
process.'' And I believe this is an understatement and I
request unanimous permission to place in the record the
editorial from the Times.
Mr. Burton. Without objection, we'll do that.
[The information referred to follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mrs. Maloney. Another quote was included in yesterday's
Washington Post. Donna Brinker, the mother of an autistic son
named Thomas, said, ``I believe in protecting our homeland but
it petrifies me to think that our nation would protect any
industry at the expense of our children.'' And, Mr. Chairman, I
would like to add yesterday's Post story likewise to the
record.
[The information referred to follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mrs. Maloney. The Homeland Security bill was not the right
place to change existing law governing vaccines and certainly
not vaccines that have absolutely nothing, absolutely nothing
to do with homeland security, and it certainly isn't the way to
change existing law. Rewriting public policy in the middle of
the night without proper notice, without regular order, without
hearings, real legislative policy should not be made this way.
It is inexcusable and flies in the face of the principles of
open and just government.
Another part of the scandal, and I considered it a scandal,
is for days we couldn't find out how this happened. At least
and finally Mr. Armey finally came forward days later and
claimed credit for the inclusion of the language at the request
of the White House. I would not want to claim credit for what
one editorial called, ``sneaky, backhanded and anonymous.'' But
what I would really like to know and to learn from these
hearings is what is Eli Lilly, this pharmaceutical company, so
worried about? Why do they need this new protection? Hopefully
we will learn some of what they are worried about today from
our distinguished panelists and scientists.
Autism and the growing rates of autism among our children
is a serious issue that deserves sincere deliberation and
attention from this Congress. I am proud to have been part of a
bipartisan commitment and coalition that has worked for the
past 5 years to double the funding for the National Institutes
of Health, the research arm for health. We worked to double it
from $13.6 billion in fiscal year 1998 and when we finally get
a budget in 2003, if it goes forward as planned, it will have
climbed to $27.3. The hope is that these strong investments in
biomedical research will spur scientific advances that will
ultimately translate into better health care for the American
people, including a better understanding of autism and vaccine
safety. We do not have a consensus in the scientific community
as to the cause of autism. More research and funding is needed
to investigate this troubling health issue.
I wholeheartedly support Chairman Burton's quality call for
a White House conference on autism. We need continued robust
research for the sake of our children. We need to know more.
And I congratulate your efforts on focusing on this important
health issue. Thank you, Mr. Chairman. I yield back the balance
of my time.
[The prepared statement of Hon. Carolyn B. Maloney
follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. Thank you, Mrs. Maloney. My good friend down
there at the other end, Mr. Tierney.
Mr. Tierney. Thank you, Mr. Chairman. Once again I thank
you for holding hearings that are both relevant and important
to our country.
Mr. Burton. Before you start I want to thank you and your
colleagues from Massachusetts for being so hospitable to us
when we were up there recently.
Mr. Tierney. We were happy to do it. That is just one of
the topics that we dealt with recently under your leadership in
dealing with the FBI and its culture and conduct and the
importance of making sure that agency is in fact protecting the
interest of the American people and not working against them.
Similarly here you've shown some great leadership in
bringing this issue to the forefront of the American public's
consciousness. Everywhere we've seen an increase in the number
of incidents of autism, and my community is no different than
any others. We've seen a tremendous increase, oftentimes
concentrated in very particular areas, inexplicably so. While
that awareness has led to a great community response, and we
have many people that have been working on this issue trying to
support the families that have to care for people with autism,
making sure that centers are established and facilities are
available and people are there to work with the families and
with the children, and the children, in particular as the
children get older, in dealing with the situation of what
happens with their future, that's not enough. Obviously we have
an obligation to try and find out as a government, encourage
and support the scientific research and try to find out what is
the cause, must determine that, to educate families so that the
research is available to deal with autism within their family
and to find either a cure or some way to prevent autism from
impacting us in the extent that it has. The resources to do
this have to match the proportion of the situation. I'm not
sure at all that they do.
And I think, Mr. Chairman, that you're right to raise that
question, where have we been on this issue, are we projecting
forward enough so that we give it the attention that it needs?
Are we doing the right kinds of studies and has our government
been doing historically what it needs to do to address these
situations and will it be equipped to move forward as we look
into the future? I think these are all important questions.
This is obviously a growing concern to many communities.
For those of us that won't be able to stay for the whole
hearing I want to thank our witnesses for their written
testimony, which will be reviewed and which will inform us, I'm
sure, in the direction we take.
I want to close just again, Mr. Chairman, by thanking you
for your hard work in this area. I know it's a great personal
concern to you. I think that you've moved beyond your own
personal concern to embrace the concern that it has for many
people across this county, and I thank you for that.
Mr. Burton. Thank you, Mr. Tierney. Before you leave, at
the end of my opening statement I was going to show two clips,
but I'd like for you to see them before you leave. It will just
take a few minutes.
I'd like for you to start off by showing the clip of what
happens to brain tissue when it comes in contact with just a
minute amount of mercury. Can you start with that one? Then I
want you to show a brief tape showing what happens to a child
who becomes autistic.
[Tape played.]
Mr. Burton. Now that was a very low level of mercury that
was introduced into that study. And we continue to inject or we
have been continuing to inject our children with thimerosal,
which does contain mercury. I don't know how anybody who could
watch that and know that has validity could doubt that there's
a very strong possibility that has had a debilitating impact
not only on children but on senior citizens. Scientists
believe, as was stated in that show, that it's a contributing
factor to Alzheimer's, which has grown dramatically in recent
years.
With that I want to show you, because a lot of people don't
know before I make my opening statement, I want you to see what
happens to a child who becomes autistic. I want you to bear in
mind why I feel so strongly about this, because my grandson was
a normal child and 2 days after he got nine shots in 1 day,
several of which contained thimerosal, mercury, 40 some times
the amount that was tolerable in an adult, he started exactly
like this child. This is what parents are going through all
across this country and they have no recourse. The Vaccine
Injury Compensation Fund has a 3-year statute of limitations.
If they don't know within that 3-year period that their child
may have been affected by these vaccines, they're out of luck,
and they have no place to go but the courts. And the language
that my colleagues talked about that was put in the homeland
security bill blocks them from ever getting restitution. And
those people, some are selling their homes, they're spending
their life savings, working day and night trying to take care
of their kids, and it's just wrong, and our government has to
'fess up to this. And if the pharmaceutical companies are
responsible, then some way they have to aid in the compensation
of these people, either through additional moneys going into
the victims' Vaccine Injury Compensation Fund or some other
way. And the Vaccine Injury Compensation Fund needs to be
revisited very soon so that these people have access to it. To
leave them high and dry is criminal, in my opinion.
Now I want you to see what these parents are going through
with these kids.
[Tape played.]
Mr. Burton. I could let you watch more of that but I think
you get the general idea. Now my grandson and thousands of
children across this country were normal kids and they got
vaccinated with multiple vaccines. And mercury in the brain has
a cumulative effect; all scientists will tell you that it
doesn't wash out easily. It gets in the fatty tissues and it
stays there so it has a cumulative effect. And yet we continue
to get reports that say there's no scientific evidence that
mercury causes autism. They don't say it doesn't, they say we
can't conclusively prove that mercury causes autism. They don't
say it doesn't.
I was on television today, on CNN, and they had a scientist
who incidentally has a 9-year-old child who's autistic. She
said that there's no scientific evidence that mercury in
vaccines cause autism. And I said, can you categorically say
that mercury does not in any way cause autism? And she jumped
all over the table trying to say, well, you know there's no
studies that show it and everything, but she would not say and
I have yet to find any scientist who will say that there's no
doubt, no doubt, that the mercury in vaccines does not
contribute to autism. Now, they'll say there's no scientific
evidence, there's no studies or anything that proves that yet.
But turn that around, there are no studies that disprove it
either. And so they're skirting the issue.
Now, the pharmaceutical companies are involved in a great
deal of research, and I think that's good, and vaccines are
important. They've given us the highest quality of health of
any country in the history of mankind. And I am for vaccines,
but they need to be properly tested. We had the Rotoshield
virus that affected children in their stomachs. And we had an
advisory committee that tested the Rotoshield vaccine and they
said that it was ready to go on the market. There were several
people who dissented in that even in that advisory committee.
But they put the Rotoshield vaccine on the market and a couple
of children died, several were injured, several had to have
surgery. So they took it off the market in about 11 months.
The guy who headed that advisory committee had a stock in a
company that was making the Rotoshield virus vaccine. Shouldn't
have done it. He had a tainted point of view. But nevertheless
he did. Now, I asked the FDA how many times they do not agree
with the findings and accept the findings of the advisory
committees, because that's all they are, are advisory
committees. Do you know how many times? 100 percent. 100
percent of the time they accept those findings and go ahead
with it. So we may have some conflicts of interest here that
need to be explored.
Now you may say, well, that's subjective. You're not really
sure about that. What about the homeland security bill? We have
a class action suit, and I'm no friend of the trial attorneys,
but we have a class action lawsuit with hundreds of families
that are suing because they think their children are being
damaged by mercury in vaccines and our committee wrote most of
that bill. We were the committee of jurisdiction, primary
jurisdiction. We should have been notified of any change in the
bill because we wrote most of it, but what happened? The
leadership stuck in at the last minute under the cover of
darkness the amendment that we've talked about today. I support
my leadership, I think they're great. I think they've done an
outstanding job. But that should never have happened because it
cuts off the access of a lot of families who have had damaged
children from any source of compensation for their child's
injury, and it's just wrong and it was designed to protect the
pharmaceutical industry, and that's not right.
Now, you say, well, if it was designed to protect the
pharmaceutical industry and it was stuck in there, nobody
really knows who did it, you can't find anybody in that gang
that got it done that's going to own up to that, then there
must be some concern that the suit might be successful. And so
they're throwing those kids out in the cold and their parents
who are mortgaging their homes and losing their life savings
trying to take care of a child like that so they can protect
their company. Now, I want to tell you, I want to protect the
pharmaceutical companies. I voted for the Vaccine Injury
Compensation Fund, which was to put money out of each shot that
was given to people into the fund so that if there was damage
they could go to that fund and get restitution, get some help
for their kids or whoever was damaged by the vaccine. But it's
not a nonadversarial program. We've got people who have waited
10 years. And then they've been threatened by the Justice
Department in some cases if they say anything about the
problems and the roadblocks they've run into. They'll extend
that time before they get compensation for another year or two
or three, and they need the money desperately for their kids.
Is that the way government should operate?
I think not.
Now, if we have to say to the pharmaceutical companies, OK,
we are going to extend the Vaccine Injury Compensation Fund for
a longer period of time so that the fund parents have access to
it, who missed the boat, then so be it. If we have to say to
the pharmaceutical companies that you're going to have to put a
little bit more money out of each vaccination that's given into
the Vaccine Injury Compensation Fund so these kids are
protected, then so be it.
If they would do that, I'd get off their back and our
committee would get off their back and the Congress would get
off their back.
But, no, what do they do under the cover of darkness? They
try to block every attempt for these parents to get
restitution, and that is wrong. It's wrong for our government
to participate in that, and it's wrong for the pharmaceutical
companies to participate in that. It's wrong to throw those
people out in the cold who have been damaged. And it's not just
a few; it used to be one in 10,000, and now it's one in more
than 250 kids that are being damaged in this country that are
autistic.
Now, those kids are going to grow up. They aren't going to
die. It's not like a lot of diseases where they get infected
and they drop dead. They're going to live to be 50, 60 years
old. Now, who do you think's going to take care of them? It's
going to be us, all of us, the taxpayers, and it's going to
cost, I think, as you said, Mrs. Maloney, trillions of dollars.
So we can't let the pharmaceutical companies and our
government cover this mess up today, because it ain't going to
go away, and it's going to cost the taxpayers trillions more if
we wait around on it. And for our FDA and HHS and the health
agencies to continue to hide behind this facade that there have
been studies that conclusively prove otherwise is just wrong,
too, because not one of them is going to tell you that there's
no doubt whatsoever that mercury in vaccine does not cause or
contribute to autism; and the same thing is true with the MMR
vaccine. We need to have conclusive evidence, and that means,
don't say we can't prove that it causes it.
Turn that argument around. We can't prove that it doesn't,
so we're going to study it and we're going to find out. And you
in the health field, you who run our health agencies in this
country who are sitting here today, you have an obligation to
these kids that you just saw there, to make sure that these
studies are complete, thorough, so that everybody knows that we
have all the facts. And you don't have that.
And when you come up to testify today from HHS, I want you
to tell me that you are absolutely sure 1,000 percent that the
mercury in the vaccines has no impact whatsoever on autism. If
any of you will tell me that, I want you to prove it to me, and
if you can't, then, damn it, get on with doing another study.
I have been fighting this battle for 3 years, as has my
committee, and we are tired, but we're not nearly as tired as
all these families that are watching their kids grow up,
banging on the walls and having chronic diarrhea and
constipation and other things. You shouldn't let that happen,
and you should get to the bottom of it.
Now, I know you people over at HHS and CDC don't like me
much, and I really don't care. I care about these kids, and I
care about my grandson; and I'm not going to be chairman
anymore, and a lot of you people think, well, he's not going to
be chairman anymore so we'll have him off us. You will not have
me off your back. I'm going to be a subcommittee chairman and
I'm going to make absolutely sure that I'm going to have under
my control the investigations of our health agencies because of
this very issue. And so I'm not going to go away and neither is
this committee, and we are going to continue. And the new
chairman, I'm going to talk to him when necessary about
subpoenaing you back before the subcommittee to talk about this
issue.
So, please, for the sake of these kids, and for your own
sakes if necessary, study this thing thoroughly. Study the
thiomersal in the vaccines. If you want to protect the
pharmaceutical companies because you have been getting,
indirectly or directly, money for grants and stuff for
scientific research, that's OK. I don't like it, but that's OK.
Just make sure that the Vaccine Injury Compensation Fund works
and that the parents who have had damaged kids will be able to
go to that compensation fund and get restitution without having
to mortgage their homes to pay for legal fees that aren't paid
until the end, because they can't do it. And there's a lot of
lawyers that won't even take those cases because they want to
get their money as they spend their time.
So I think I have said enough. I'm just telling you, I feel
so strongly about this because I've seen these mothers and
these fathers come forward with tears in their eyes, crying,
saying, we've got this terrible problem and we have nowhere to
go, nowhere to turn; and our kids were damaged, and they
changed right after they got these vaccines. And it ain't
right, it's just not right.
So I have said enough. Our first witness, and I'm sorry I
didn't read all of the opening statement today. I know my staff
worked real hard on it.
First panel is Dr. Baskin, Dr. Geier and Dr. Spitzer, and
we'd appreciate it if you'd approach the witness table and
stand to be sworn.
[Witnesses sworn.]
Mr. Burton. Dr. Baskin, would you like to start with an
opening statement?
STATEMENTS OF DAVID BASKIN, M.D., PROFESSOR OF NEUROLOGICAL
SURGERY, BAYLOR COLLEGE OF MEDICINE, HOUSTON, TX; MARK GEIER,
M.D., PH.D., GENETIC CONSULTANTS OF MARYLAND, BETHESDA, MD; AND
WALTER SPITZER, M.D., M.P.H., F.R.C.P.C., EMERITUS PROFESSOR OF
EPIDEMIOLOGY, McGILL UNIVERSITY, MONTREAL, CANADA
Dr. Baskin. Yes, sir.
Mr. Chairman, distinguished members of the committee,
colleagues, ladies and gentlemen, my name is David Baskin. I'm
a professor of neurosurgery and anesthesiology at Baylor
College of Medicine. I'm a neurosurgeon. I do complex spine and
brain surgery, about 350 cases a year.
I have also been involved in research, looking at ways to
protect the nervous system from damage and to reverse damage,
for over 20 years, and have over $1 million in Federal funding,
both from NIH and BIA, as well as State funding and private
funding from foundations, to look at a variety of issues in
terms of brain damage. In fact, our group was involved in the
discovery of the drug that could reverse paralysis in spinal
cord injury, which has now become the standard of care. So I've
been working in this area for over 20 years.
I also serve on scientific advisory boards for NIH, as well
as the Cure Autism Now Foundation, the largest private funder
of autism research in this country, which funds over $7 million
a year.
Now, as you said, Mr. Chairman, autism is exploding. This
is a recent cover of Time magazine talking about the fact that
over--now, it looks like one in 150 children suffer from some
form of autism.
What is autism? It's a lifelong brain disorder with very
severe problems communicating, responding to surroundings and
forming relationships. Most of these children, as you say, will
grow up and will require lifelong care and cannot live
independently. Horrible fact, over one-half will never speak.
Many of them will never be even able to look at their parents
and tell them they love them.
It's worse than Alzheimer's disease. There's been a
tremendous focus on Alzheimer's disease, but these children
never had a chance to enjoy life before they lost it.
Let's look at some medical definitions. What's a
preservative? I looked it up in Stedman's medical dictionary,
and it says a preservative is a substance added to a product
for the purpose of inhibiting or destroying microorganisms.
What's a poison? A poison is a substance that, when
injected in a relatively small amount, causes damage to
structures or disturbance of function.
Now, while there's going to be quite a bit of debate this
afternoon over dosages, make no mistake, there is the intent to
put a preservative in these vaccines to prevent the growth of
microorganisms that has gone awry, because the preservative
that was used ended up being a poison.
There is no debate in the scientific literature that
mercury is a potent neurotoxin. We've known that since the late
1890's. The debate only comes to degree and extent and that
sort of thing. So I don't think in the course of your
deliberations today you should confuse that fact. We are
talking about a known poison, neurotoxin, that's been added to
these vaccines with the initial idea that it would function as
a preservative.
Mercury has a long history of medical misadventures. In
1890, ethyl mercury was synthesized in London, and it soon
became a popular treatment for syphilis. The saying went, ``A
night with Venus and a lifetime with mercury.'' In fact, in
1927, the Nobel prize was awarded because it was felt you could
improve outcome by adding treatment with mercury. Many of these
patients developed serious neurological disorders, but it was
thought initially this was due to the syphilis, when it turns
out that a lot of these cases, retrospectively reviewed, had
evidence of mercury toxicity.
Thimerosal was placed in vaccines in the late 1930's; and
guess what: Three years later Tanner first described the
syndrome of autism--never ever been described before in the
medical literature. The neurotoxicity of mercury has been very
well established in terms of brain injuries since the 1960's,
as you'll see.
In 1956 and 1960, there were massive outbreaks of mercury
poisoning in Iraq, and the reason this happened was that ethyl
mercury was used as a fungicide. The grain was treated with
this fungicide, the idea being that you could plant this grain,
it would grow, the crops would flourish. But I would imagine,
because of poverty, a lot of this grain was just taken and made
right into bread and people ate it. So they ate these doses of
mercury. And there were hundreds of cases, both in Iraq and
then there was a similar outbreak in China.
A number of these cases just had really severe, horrible
brain damage, but what came out of this work, there was a much
more mild syndrome with developmental delays and
neurodevelopmental disorders, problems with language, problems
with communication. Some of the descriptions of these kids
looked just like your videotape. So there was a--pretty early
in the 1960's it was known there was a direct relationship of
the dose of mercury received and the severity of the injury,
and as early as the late 1960's, the scientific literature said
the fetal and infant brain is clearly more sensitive than the
adult brain.
The brain damage in these cases was studied, and it's
interesting that the type of brain damage seen was the loss of
the Purkinje cells, which are cells in the cerebellum, and the
loss of the cortical column, which is the part of our brain
that is involved in complex thought. And guess what: At the
recent meeting for autism research at the Society for
Neuroscience, this exact same histopathology has been described
in autism.
There were other outbreaks elsewhere, so we've known about
this scientifically for a long time. There is no debate that
this is a toxin that causes brain injury.
Now, there was a study trying to look at lower-dose
exposures conducted in the Faroe Islands beginning in 1987, and
what this did was it looked at 1,000 children and it followed
them from birth to age 7. It tested them very specifically for
neurodevelopmental disorders. It measured blood levels of
mercury in the umbilical cord, and it found an association
between very low doses of mercury and neurodevelopmental
disorders just like autism, and found that mercury here
actually wasn't as predictive as the blood levels, which is the
gold standard.
The Environmental Protection Agency established, as a
result of primarily these horrible problems in Iraq, a standard
for what was a maximum safe level of ingestion of mercury,
which was 0.1 microgram per kilogram per day, and they called
this, ``a level of daily exposure that was likely to be without
an appreciable risk.''
They based this on 81 children in Iraq. They looked at
symptoms very much like autism--problems talking, problems with
mental cognition, problems with walking; and as recently as
2000, our National Research Council reviewed this data and
supported these limits, said these are the right limits to use
not only based on the Iraqi experience, but also based on the
Faroe Islands experience.
Let's look at what the children actually received. This can
be a source of debate. There are a lot of different ways to
calculate these numbers, but what I have done here is simply
taken the FDA's numbers as they prevented them published by
Leslie Ball in 2001; and if you look at the various numbers,
you see that a child, by 6 months, receives somewhere between
one-and-a-half to three times the maximum safe EPA dose of
mercury.
If you take into account that mercury is preferentially
taken up into the brain at five times the concentration, these
kids are getting somewhere around 12 to 15 times the maximum
dose, and that is the most conservative estimate.
Making lots of assumptions that many scientists wouldn't
agree with, they're overdosed. Yet the last formal review by
the FDA was in 1976, and they said, ``No dangerous quantity of
mercury is likely to be received from biological products in a
lifetime.'' Mind you, this is 16 years after the experience in
Iraq with all the mercury poisoning, and also the outbreak in
China.
Dr. Ball in 2001 said, ``Reassessment of the risk is
appropriate.'' I think that was a nice thing to say, but I
think that really--consistent with prior testimony before this
committee, I think there is a concern that perhaps the FDA was
asleep at the switch for decades, as was stated in an internal
e-mail, that it really does only take eighth-grade math to see
that they're beyond the maximum safe levels.
The pity about this is thimerosal is not an essential
component for vaccine. The argument with thimerosal is not an
antivaccine argument. Vaccines are wonderful. They're here to
stay. They save lives. The argument is that you don't need to
put a toxic poison in them in order to deliver them.
But it's worse. The incidence of autism is increasing, and
we don't know why. As you said, nobody can explain this.
There are many other sources of mercury exposure in the
environment; so that if we're going to inject our kids with a
neurotoxin, and they're already being exposed to a certain
amount of mercury, this just adds insult to injury.
We clearly know infants' brains are more sensitive. We know
the blood brain barrier, the barrier to drugs between the blood
and the brain, is virtually gone in infants. We know there is
probably at least a five-times preferential uptake into the
brain.
And we know about lead. You know, lead has been around for
a long time. In one of the NIH study sections that I served on,
there was a proposal to study lead and juvenile delinquency
rate, and the consensus was, why do we need another study to
know that lead exposure in infancy can relate to juvenile
delinquency rate in adults; we already know this is the case.
This is accepted science. So the idea that a metal can cause a
very specific brain injury has been around a long time.
I'm going to turn my attention a moment to the article that
was published by Dr. Pichichero and his colleagues in Lancet in
November 2002 since this was just referred to.
[The information referred to follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Dr. Baskin. This was a study of 40 infants, age 6 or
younger, in which they measured blood, urine and stool mercury
levels. The conclusion was that administration of that change
containing mercury did not seem to raise blood concentrations
of mercury above the safe values.
The data are the data, and I think, as you said, Dr.
Weldon, it's good to have some data, but interpretation of data
is paramount. In my residence, we teach residents and we teach
young doctors how to be neurosurgeons. We spend a night a month
pouring over the medical literature and make the important
distinction that while the data in the papers are probably
correct and true, the way you interpret the data, the way you
look at that and come to a medical conclusion is often subject
to interpretation; and I'm going to show you and talk to you
about the fact that while the data are the data, I think the
conclusions are not borne out.
First of all, I was shocked when I read this study that
there was no disclosure of conflict of interest. As an NIH
scientist, anytime anybody funds my research for any reason, I
have to disclose the conflict of interest. Yet these authors
have vaccine patents, have received numerous funding for
studies by drug companies that make vaccines; and I was
surprised that Lancet took it. I'm sure it's not over with.
Whether or not there's a true conflict of interest, they
certainly should have revealed it.
The sample size, as you said, Dr. Weldon, was small. Autism
occurs in one in 150 kids. So if a child had some different
tendency in their blood to absorb more mercury or have it
remain in the blood longer or be more sensitive in their brain,
if they only checked 40 kids, they may well not have found even
one kid with a predisposition to autism. So it's a meaningless
study without a larger sample size.
The sample wasn't random. They didn't take kids from
different portions of the population in different areas. If
there's some metabolic difference based on race or sex or where
you live or other things, they wouldn't have found it. They
didn't even talk about the preferential uptake of mercury into
the brain, which is fivefold.
But they did find a very high stool level of mercury, and
one kid had 81.3 nanograms. If you again go to the very
conservative FDA data, a 50 percentile kid receives 20.7
nanograms per gram. So somehow the mercury went from the
injection, ended up in a much higher level in the stool. And
obviously, the mercury gets to the stool by traveling through
the blood; there's no rectal administration. If you put
gasoline in your car that has lead in it and somebody comes by
and scrapes your tail pipe and says we have a high lead level,
it got there by traveling through the system.
So what happened here is, we know the stool levels were
high, but if you look at when they actually measured the blood
levels, they said it was somewhere between 3 and 27 days later.
The peak mercury levels after injection occur within hours or
at least within the first 24 hours. So if they were drawing
blood later than that, and much later than that, of course the
levels weren't going to be high. But the mercury doesn't jump
from the injection to the stool; it goes through the blood. At
some point it was high because it was high in the stool.
And because they didn't measure the peak levels, they can't
even talk about what they did, which is the pharmacal kinetics,
which basically means the way the drug is metabolized; and they
drew a bunch of fancy curves. You can't do a pharmacal kinetic
study if you don't have the peak level. They clearly didn't
have the peak level because they have high stool mercury, and
they have low blood mercury--doesn't make sense.
So they described this as a descriptive study, and that's
exactly what it was. It provides some interesting information,
it's a start, but the interpretation is inaccurate--as what we
would say in neurosurgery, ``The operation was a success, but
the patient died.''
Let me turn to some studies that we're doing at Baylor
College of Medicine. We have the opportunity to actually grow
human frontal cortex cells in cell culture. So these are cells
from the front part of the brain that grow in culture. We
incubate these cells with thimerosal at various doses, and we
use a number of very sophisticated techniques to detect cell
death and cell damage.
It turns out that every cell has a program inside of it to
commit suicide. The reason we have this in our bodies is, when
we're babies we have webs between our fingers, but when we're
born, we don't have these webs. These cells are eliminated by
activating a genetic program, so there's no inflammation and
there's no scar tissue.
We basically start out with many more cells than we end up
with. We kind of prune ourselves into shape, and this process
is called apoptosis. Well, it turns out that toxic substances,
including mercury, turn on this suicide program in the brain.
Here are some pictures from our cell culture experience,
and you can see the arrows pointing to those little knobs
sticking off the cell. These are the cells committing the
suicide program and breaking themselves into tiny little pieces
with a very low dose of mercury.
Here is a slide where you see a lot of blue cells. This is
a blue dye that normal cells don't take up. In order for
something to turn blue, the cell has to have holes punched in
their membranes. And guess what: At an extraordinarily low dose
of thimerosal, most of the cells are blue. It means that this
stuff grabs ahold of the membrane and punches holes into it, so
that the dye can penetrate, not only into the cytoplasm but
into the very center of the cell, the nucleus, where all the
DNA exists.
This is a fascinating slide. The center of the cells are
blue, which means there have been holes punched into the
membranes so the dye gets to the center of the cell. The rest
of the cell is green which is the release of an enzyme that
only gets released during the suicide program. So these cells
are turned on to commit suicide or go into apoptosis.
We found this to be dose- and time-dependent. We found that
101 nanograms per gram is the lowest dose we've studied, and
it's toxic. And we didn't even expect this to be toxic, yet if
you consider a five-times preferential uptake and you use FDA
numbers, infants receive 380.5 nanograms, three times the dose
that we found to be toxic to brain cells.
Don't forget, we did this in adult brain cells. Remember
that infant brain cells are much more sensitive, so there's a
real cause for concern.
In addition, there was discussion that there's no
scientific data or evidence. I don't agree with that. At the
recent International Meeting for Autism Research at the Society
for Neuroscience, a number of investigators around the world
are finding similar things.
At Columbia University, there's now a model in mice who
were injected with low doses of thimerosal very similar to
what's given in human vaccines. These mice develop neurological
deficits that look like autism, and when you take their brains
out and you analyze them, they have the same type of brain
damage.
There's evidence that thimerosal not only binds to the
proteins you saw in the cartoon, but also binds to sulfur
groups which are pretty essential groups for the membrane. So
this is probably how it punches holes in the membrane.
This is work at Northwestern, and the very important work
that is coming out of a number of NIH-funded centers is that if
you give patients thimerosal, you can take their lymphocytes
and make them killer lymphocytes and trigger the onset of
autoimmune disease, which also may be part of what's happening
in terms of brain damage.
So science has come a long way. We've gone from caveman
clubs, and now we're at ICBM missiles, and I would be very
optimistic that in the next few years, Mr. Chairman, you're
going to see a tremendous amount of scientific data supporting
the fact that this is a horrible toxin that shouldn't ever have
been in these vaccines.
Well, what can you do? What can Members of Congress do to
try to make this better, to do something to improve the
situation?
First of all, as a physician, I probably prescribe a pound
of drugs a week and, you know, I always rely on the FDA. I
don't go through and test the safety data of each drug myself;
I assume it's safe.
Somewhere along the line, the process failed. Mercury is a
known neurotoxin, and you know what: It's still being given
today in flu vaccines, to pregnant mothers and to children.
Why? It's not necessary.
So I think one thing you can do is compel the CDC and the
FDA to do their jobs. Insist on properly managed
accountability. Insist on conflict-of-interest disclosures. I
live in Houston. We sure learned a lot from Enron, and I hope
that we can avoid similar unfortunate circumstances.
I think you should consider this a problem very similar to
September 11th--it's interesting, we talk about homeland
security, it's a severe problem--it's chemical poisoning at
home, and it's very similar. I was in a cab today, and the
radio was talking about the FBI, the CIA and lack of
communication that might have avoided the terrible problems of
September 11th. Well, you know, the EPA knew this for a long
time. All of these agencies had pieces of this data, but they
don't seem to talk to each other; there doesn't seem to be any
sort of coordination, very similar to the issues with homeland
security.
I think another thing you can do is support the NIH. The
NIH has done a great job recently trying to catch up. The NIEHS
particularly, but some of the other institutes as well, has
really put together first-rate scientists and first-rate
programs to do this. You could help by proposing specific funds
to be set aside by NIH.
NIH has something called ``request for application,'' which
means we are entertaining applications only on this subject,
and then they pick the very best ones. They don't have the
money to do that too often, but if you can give them a small
extra pot, that would bring the very best research in this
country along very quickly.
Allow science and the press and our legal system unfettered
access to the issue: This is the only way the truth is going to
come out, and particularly in science, if we couldn't read and
critical-review each other's data, we would go nowhere. I think
you have to insist on that, and by doing that, consider
reversing the relevant provisions in the homeland security
bill, as was discussed, and stand up for our Nation's children
and their rights.
In conclusion, Plutarch said, ``The mind is not a vessel to
be filled but a fire to be kindled.'' Please do everything you
can to ensure that our Nation's most valuable resource, our
children, have their rights protected and can grow and flourish
to their full potential. Thank you.
Mr. Burton. Dr. Baskin, I'm going to send your presentation
to everybody I possibly can, because it was so thorough, and
you're to be congratulated for all that hard work. I just think
you summed it up so well, and I'm going to make sure we send
that over to the FDA and CDC to make sure they take a look at
it.
Dr. Geier, you're recognized.
Dr. Geier. Thank you for inviting me, Mr. Chairman and
other members of this committee.
Vaccines are one of the greatest triumphs of the 20th
century, resulting in the virtual eradication of most
infectious diseases. Vaccine producers should be commended for
their efforts, but one must openly acknowledge that, on
occasion, vaccines are indeed responsible for adverse
reactions.
The U.S. Government judiciously established the Vaccine
Compensation Act in 1986 as one of its provisions. The Vaccine
Adverse Events Reporting System data base was created. The
VAERS data base has been maintained by the CDC in Atlanta, GA,
since 1990, and vaccines suspected of adverse reactions are to
be reported to this data base as mandated by U.S. law.
The reporting of serious adverse reactions to VAERS
requires written and telephonic communication by the CDC. The
CDC follows up serious adverse reactions 1 year later to
determine whether the patient has recovered, and the FDA
inquires into deaths reported to the VAERS data base by
contacting the patient's health care provider and physician.
Despite the continuing insistence by the FDA and the CDC
that the VAERS data base is subject to severe limitations, the
FDA, CDC, David Geier, my son, and I analyze and publish from
the VAERS data base. The VAERS data base provides a prospective
about vaccine adverse reactions unobtainable by any other
means, as it contains almost 200,000 adverse events, following
almost 50 different vaccines resulting from more than 1 billion
doses of vaccine administered in the United States.
It is biologically plausible that thimerosal, contained in
vaccines, contributes to childhood neurodevelopmental delays,
but there are few epidemiological analyses that study the
effects of thimerosal contained in vaccines. We analyzed the
incident rates of neurodevelopmental delays reported to the
VAERS data base following thimerosal-containing diptheria,
tetanus and acellular percusses, called DTaP, in comparison to
thimerosal-free DTaP vaccines.
The CDC provided us with a number of doses manufactured and
distributed each year of each type of vaccine, manufactured by
each manufacturer, but in so doing, we had to agree to withhold
the identities of the vaccine manufacturers because the CDC
considers this information proprietary. Thus, we are prohibited
from releasing data on which company makes a safer vaccine,
when two or more companies make the same vaccine. We feel that
it is essential that this information not be denied to doctors
or patients.
The CDC and FDA also knows the number of doses of each lot
manufactured. We feel it is important that this information be
released so that analysis of potential so-called ``hot lots''
can be carried out.
This slide shows that autism and mental retardation were
approximately six times statistically significantly more
likely, and speech disorders were two times statistically
significantly more likely following thimerosal-containing DTaP
vaccines in comparison to thimerosal-free DTaP vaccines.
Further, the details of our study----
Mr. Weldon. Dr. Geier, can I just interrupt you, is that
published data?
Dr. Geier. That's been submitted and accepted with
revision, but it's not finally accepted. So it has not been
published yet, but shortly we hope.
Mr. Burton. I don't want to interrupt you either, but I
think it's very important at this point. We talked to the
health agencies about the VAERS being made public and being
made available to any researchers, completely available; and
you're telling us that you still can't that get information?
Dr. Geier. We can--well, there are a number of problems
with VAERS. First of all, VAERS is maintained by CDC in Atlanta
on a data base that's proprietary. So it's very difficult to
access. We get it accessed, and a computer programmer takes it
off and puts it--makes it available so that Microsoft Access
can work on it. This allows everybody to work on it.
My son has also figured out a system to put their--I think
it's seven different data bases together to make one, however,
so we can get access. But you can't just call up this site and
get useful access; you get some data, but it's not useful.
But in addition to that, in order to interpret VAERS, you
need to know the denominators, you need to know how many doses
were given; and we've been given the information of how many
doses of each type of vaccine were given each year.
Additionally, in order to do these calculations, you need
to know the number of doses produced by each vaccine
manufacturer. We were given that with the provision that we
were not allowed to tell which vaccine companies are which.
So we can do the study we did up there because, you notice,
all we said is we compared the relative risk of one that
contained thimerosal with a similar vaccine that didn't, didn't
tell you which company. But it really hurts us to see--when we
see two or three manufacturers of a particular vaccine where
one is far worse than the other, that we can't publish which
one is worse. And, in fact, CDC has published a paper showing,
I think, a sixfold increase in serious reactions of one
manufacturer versus another, and they call them manufacturer A
and manufacturer B.
I think that the American public are entitled to know which
manufacturer is which, so they can choose the better vaccine
for their children.
Mr. Burton. Well, I don't want to interrupt anymore of your
testimony, but what I'd like to do is have you give us a list
of the problems that you're having in getting this information,
and we'll try to see what we can do to lift the veil of secrecy
so that you can get on with your work.
Dr. Geier. We would appreciate that very much.
The doses of mercury children were receiving from
thimerosal on a given day following vaccination in comparison
to the EPA, AFDR and FDA limits of exposure to mercury are
summarized in the next slide, and this is similar to a slide
that Dr. Baskin showed. This is what's in each one.
This calculates the risks, the amount of the excess the
children received, and the way that Dr. Baskin did it was very,
shall I say, ``charitable'' toward the production. Children
actually receive from a ten- to a hundredfold excess of mercury
from their childhood vaccination on the days of immunization in
comparison to the guidelines. The daily dose of mercury
children received was equal to or exceeded the guideline even
when averaged out for 10 days following vaccination.
Further details are provided in the packet that I submitted
to the committee.
The IOM analyzed the mercury dose children received at 6
months of life and averaged it over every day in a child's
life, that is, 180 days, showing that the dose received by the
child was only in slight excess of the EPA limits. This type of
averaging makes no scientific sense. As an example, if I were
given a lethal dose of mercury and my dose was averaged over my
more than 50 years of life, I would not have received a dose
exceeding the limits, despite the fact that I would be dead.
Realistically, children are receiving large doses of
mercury at intervals that far exceed all the Federal agency
guidelines and not by fivefold but by over a hundredfold.
This slide summarizes the CDC's VSD data regarding the
relative risk of autism versus the mercury dose that the child
received. When we saw this, we were very, very disturbed.
Despite the fact that our study had shown that two populations,
one population had received a vaccine with thimerosal and the
other didn't, were statistically different, this is more
powerful data because this is a plot of the amount of mercury
that a child received versus the amount of autism, and it turns
out that this plot is not linear. In fact, it goes up faster
and faster with increasing mercury doses from childhood
vaccines. And again, the packet I submitted has quite a bit
more on these graphs.
But we did--each point in their analysis was barely
significant, but the graph on the whole is very significant,
and there's an interesting trick used in presenting their data.
Their data had data for each of the first two points. The third
point said greater than 62.5 exposure. It's kind of hard to
plot greater than 62.5, and therefore, you can't do this
analysis, but when we looked at it, greater than 62.5 has to be
75; there's no other possibility.
So we replotted it with 75. I mean, that's just the way the
vaccines are given. And when you replot it with 75, you get a
very, very good curve fit, and it's statistically significant,
and it fits for several different disorders. And it's very
disturbing, because this is a kinetic study. You know, if you
compare two things and one is bigger than the other, well,
maybe even though the statistics show it is unlikely, maybe it
was chance, but when it goes up as you go up with dose, and it
goes up faster and faster as you go up with more and more dose,
this is very disturbing.
Also, the relative risk at the top top is 2.5. That means
that of these children, who belong to the Kaiser plans, a very
large segment of the autistic children were related to the
thimerosal.
I mean, there are two issues. One is, can thimerosal cause
autism; and another is, does it cause a significant part? I
mean, maybe it only causes 1 percent of autism. This tells you
that it causes a very significant part of the autism.
Now, I'd like to go into a little bit of what you asked me
in the question. You asked me about the VAERS data base, and I
wanted to talk to you about the VSD data base.
As described in the packet that I submitted to the
committee, despite correspondence between myself and the CDC,
originally dating prior to the CDC's press release to open the
VSD to the public, I have not been given access to the VSD.
This has been ongoing for more than 4 months, and my last
proposal was more than 150 pages long.
Mr. Burton. Let me interrupt you here just a second.
Now, the VSD, we were told by our health agencies that was
going to be made available to any researcher completely; and
you're telling us you're still not getting it?
Dr. Geier. Let me go through my experience. And I gave Dr.
Weldon the complete documentation of all of our exchanges.
It's available, but it's so difficult to get--I think we're
in a very good position among independent researchers to ask
for it, and we have little hope; and let me go over some of the
barriers they've put in our way.
We've been doing this for 4 months. My last proposal was
more than 150 pages long, and despite the fact that I've
published approximately 30 peer-reviewed scientific studies
analyzing VAERS, I still haven't been able to move beyond the
first hurdle of gaining access to the VSD.
And I had a very simple solution to their question of what
do you want to study. I simply said, well, let's do something
really easy. Let's study whether VSD has the same kind of
results as the VAERS. And you know my studies are valid because
they have been peer-reviewed and published by 30 different
journals, such as the Annals of Internal Medicine and
Rheumatology and various other journals. So rather than going
into a whole big study design, let me see if we can confirm our
results with the VSD.
This didn't please them, and they required that we ask
every single possible question and make various predictions,
and we came up with a 150-page proposal. However, that didn't
satisfy them because, first of all, they seemed to put up
continually additional steps, fees and hindrances and seemed to
make the realistic possibility of ever gaining actual access to
the VSD remote.
Basically my understanding is, after we get them to agree
to our study, which we have to describe every possible thing we
want to test, then we have to go before each of the Kaiser
boards in order to get their permission; and CDC does not even
know what Kaiser boards will require. If we go to each Kaiser
board and ask that we be able to use their Kaiser data and it's
approved, then my understanding is it goes back to the CDC for
approval. After the CDC approves it, then I get limited access
in a little town in Maryland. This happens to be near where I
live, but anybody else would have trouble, because they're
going to give you like 5 minutes of access a week, so you'd
have to fly in here from, say, California.
In addition, when you go there, we've been told that we
can't take cell phones. We can't copy anything. We can't take
any data out. We're going to be searched. All of this in the
name of confidentiality when, in confidentiality, all you have
to do is what VAERS does, just take the names off. And as far
as validity of the studies, if the studies are valid, I'm going
to submit them for peer-reviewed publication. If they're
published, they're valid. I don't need them to review the
validity of the studies.
Mr. Burton. Would you ask excuse me 1 second.I think
Michael Crane is here.
Mr. Crane, would you raise your hand real quickly. I'd like
to talk to you after this hearing is over to find out why these
impediments are put in front of these people. OK?
[Witness sworn.]
Mr. Burton. Thank you.
Dr. Geier. Finally, there's a constant mention of fee, and
we've asked for the amount of the fee on several occasions, and
we're told repeatedly there's a fee and they don't know the
amount of the fee. My suspicion is no one is ever going to get
that far, but we're independent and we don't have any outside
support. We do this because we care about the children. So if
they ask for $1 million fee, we have no granting fund to pay
the fee.
Turning to another subject. I've been asked to comment on
the Lancet article which measured mercury in blood, urine and
stool, which was commented on by Dr. Baskin, in infants 3 to 28
days following thimerosal-containing vaccines in comparison to
infants receiving thimerosal-free vaccines. The findings of
low-level mercury in the blood is only indicative of measuring
too late.
If they wanted to see it, they should measure 3 to 24 hours
after the shot, and it does nothing to assure that these
children were not exposed to potentially damaging levels of
mercury. We know, in fact, these children received by injection
more than 100 times the daily permissible dose of mercury, and
the mercury would be more damaging in the brain than the blood.
It's almost as if they want you to read the study and
think, well, I guess they didn't get any mercury. But we know
they got the mercury. So why is it supposed to be reassuring
that they measured later, and it's not in the blood; that means
it could be in the brain. So that study, to me, has no
validity. It has some interesting data, but no validity on the
question of whether thimerosal causes problems.
I've also been asked to comment on the recent New England
Journal of Medicine study done in Denmark, which failed to find
a correlation between MMR vaccination and autism. This study
attempted to compare children vaccinated with MMR to a
comparable control group of children who were not vaccinated
with MMR.
The author's own analysis showed that the two groups were
statistically different in most respects even before being
vaccinated, making the results dubious. You want to have match
controls. Basically they adjusted them; I have no idea on which
way to adjust. For example, if the control group and the
vaccinated group differ by how their income--what their income
level is, I don't know whether to raise it or lower it. Neither
do they. So they just changed it in such a way that it evened
out the numbers.
Even overlooking the weakness in the study design, the
study would have only shown MMR to be statistically linked to
autism if MMR caused a rather large proportion of all autism in
the population being studied. This already was known not to be
the case. HHS itself has published that there is a causal
relationship between MMR and permanent brain injury.
Our study using VAERS, contained in the submitted package--
this is another study we've submitted for publication--shows
that MMR increases the relative risk of autism, but its
contribution to autism in the whole population is relatively
small since much of the autism seems to be linked to thimerosal
which, of course, is not contained in the MMR vaccine.
So their study doesn't say that MMR didn't cause 10 percent
of the autism. It just said it didn't cause 60 percent of the
autism, and--because you'd have to have a large percentage the
way they looked at it.
In conclusion, these two recent studies do little to
alleviate the fact that the scientific data indicates that
thimerosal in vaccines and from other sources, such as RhoGAM,
a product containing thimerosal, given during pregnancy to RH-
negative women, appears to cause or contribute significantly to
the recent dramatic increase in the rate of autism seen in the
United States.
As far as RhoGAM goes, I practice as an obstetrical
geneticist. I do amniocentesis. I give RhoGAM. I was not aware
that RhoGAM contained thimerosal. It no longer does, but it did
for a number of years. The reason I wasn't aware of it is that
I've never seen a multidose vial of RhoGAM. If it's ever been
made, I have never seen it in my 22 years of practicing, and
yet, they put thimerosal in it as a preservative. What the heck
are they preserving?
And there are studies by clinicians who take care of these
children, who find that a very high proportion of these
children are born to women who are RH-negative, who had RhoGAM
during the pregnancy. I see no reason in the world--if they
have to put thimerosal in single-dose vials, are they afraid
that they don't know how to make things sterile? Are we to
assume that sterility testing is not good?
Ideally, vaccines should be killed, single antigen, highly
purified and checked to determine if any of the epitopes they
contain are cross-reactive with human lymphocytes. They should
come in single-dose, sealed vials, so the preservatives are not
necessary; and they should contain enough antigenic materials
so that adjuvants are not necessary.
History has written that the fall of Rome may well have
been related to lead poisoning from newly invented lead pipes.
Let it not be written that our great society poisons itself
with mercury preservatives. Thank you.
[The prepared statement of Dr. Geier follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. I think Dr. Weldon has a quick question for
you, Dr. Geier.
Mr. Weldon. I think you answered my question. Thimerosal
was in single-dose RhoGAM injections?
Dr. Geier. Yes. That's the only kind of RhoGAM injection
I've ever seen; and I have bought it from several companies,
and they're always single-dose. They come in a syringe,
prefilled, and they contained, up until recently, a year or two
ago, thimerosal.
Mr. Burton. Thank you very much.
Dr. Geier, that was an excellent presentation, as well.
We'll try to make sure, along with Dr. Baskin's, this gets to
everybody. I'm going to send this to Secretary Thompson over at
HHS. I hope I can convince him to watch this whole
presentation.
Dr. Spitzer.
Dr. Spitzer. Thank you, Mr. Chairman.
In the interest of time, I will focus on the Danish study,
as requested. There are somewhat related matters that I will go
over a bit more quickly, but the main focus is on the Danish
study, and the paper was the New England Journal paper
appearing on November 7th, which itself focused primarily on
MMR. And the hypothesis declared in the paper in the New
England Journal was about a relationship and association
between the vaccine and autism, simply expressed as that, by a
Danish group, about which I'll say a bit more in a moment.
So, in evaluating the hypothesis that MMR vaccination and
autism are associated, they came through enlightened policy of
the Danish Government to link data bases of the--data bases I
have on the projection here, which are, from my experience of
the Saskatchewan data base, perhaps one of the best, to look at
relationships between disorders and risk factors, however they
might be exposed, properly done.
I'll emphasize that the linkage was with computerized data
bases. Also, I will mention it again, they were created for
other purposes, and they were well linked.
Madsen has a good reputation in Europe. I worked in Europe
for 4 years on epidemiologic studies and know their work by
reputation. I have not met Madsen or any of the
coinvestigators. I have no interest one way or another in terms
of that team.
It was sponsored and funded by the Centers for Disease
Control and Prevention. I'll have more to say about that.
Let me read the conclusion from the abstract, which is very
similar to the conclusion later in discussion of the paper:
``this study provides strong evidence against the hypothesis
that MMR vaccination causes autism,'' and the emphasis is mine.
The category of the study, it is a cohort study which was,
as a cohort study, well done, the followup being from January
1991 to December 1998, 8 years, and there were over 500,000
children in the cohort, 440 having received MMR, or 82 percent;
and they translated this to personal years because of the
difference in time of followup of different children. That was
appropriate to do; it was the right thing to do in what was a
dynamic cohort--that is, opposed to fixed. You don't start
with, say, 100,000 children today and follow them together in
the future.
The children were introduced to the cohort as they were
born, we call it a dynamic, and followed forward in time to
determine whether the outcome of interest, in this case,
several subgroups of--several manifestations of autism appeared
or not during that period of time, although the followup went
on for one more year; and then I just show here how--visually
how that happens.
Now, this was a major strategic advance in epidemiology.
You have heard me say here before words to the effect that
most, if not all, of the epidemiology until now has been
clearly shoddy. People think that because the discipline is in
adolescents, maybe infancy, you can afford to be shoddy. In
fact, you should pursue as high a standard as possible. And
it's also the first epidemiological study published to be
adequately controlled, an adequately controlled observational
study.
An important attribute of linked national data bases, or
provincial ones like Saskatchewan, is that there is no
selection bias. This is especially true in Denmark where well
in excess of 97 percent of the people and the children of the
country, however they entered, by immigration or birth and so
on, are there. It's not matter of representivity. They're all
there. So there is no selection bias. That's very hard to
accomplish in epidemiology when you don't have this advantage.
Now, unfortunately, the important strategic advance was not
matched by some important, detailed methodological tactics in
the execution of the study. That vitiates the strength of the
authors' conclusions, which I found unusual considering what
came out in the data, which I'll summarize in a moment, and in
this presentation, I'll review some of the methodological
problems without being exhaustive.
Let me share with you that much of what I have here is as a
result of conversations of colleagues, some seniors, who have
written to the New England Journal. There hasn't been enough
time yet to accept the things, and I need to respect
confidence. I myself have forfeited my letter because I think
it's more important, more socially sensitive that it be
presented here, but I cannot assume that of any colleague; and
on one or two occasions that I have asked permission, it's been
denied and understandably so. They might get promoted. I can't.
Now, the key result to be published here, which leads to
public statements of reassurance from authorities not only in
this country, but in Europe and elsewhere, is a relative risk
of 0.92 with confidence interval there, which shows no
significance, as it wouldn't if there is no difference--that's
for autistic disorders, one of the two major subgroups here;
and for other autistic spectrum disorders, 0.83, again with
that confidence interval.
And unlike the CDC study that I discussed at an earlier
meeting, Mr. Chairman, the power here is high. Remember, it's
only 12 percent in Davis' study. Here, it's 80 percent to
detect an authorization of 1.5, and I remind you that in OR, an
observation of one shows no association, and the key results we
have here with the confidence intervals overlap 1, and there's
the power which is quite adequate. In fact, it's superior. You
don't often see that high a power obtained.
It's curious. They never give it to you. You have to
calculate it yourself, but that's the way it is.
Now, going to some of the more detailed problems--and if I
went into everything I'd be here for 2 hours, Mr. Chairman; I
wouldn't be too popular even with you. But the first thing I'd
like to say and perhaps the most important point, that of the
numerator, the affected cases here, only 13 percent were
reviewed. That is very inadequate, especially if done for
validity purposes, just for validity.
To fail to examine all the records among the 787 children
in the numerators of the cohort, or 738 in Table 2, that are
similar, and without using a clinical and epidemiologic and
large statistical multidisciplinary approach, it leaves the
project wide open to errors and misclassification.
They said that because it was validity and it's a
psychiatric diagnosis in Denmark, they had to use
psychiatrists. Well, that's the last reason I'd use
psychiatrists. I want validation from other health
professionals, appropriately involved clinically and otherwise
in the situation.
If they say it was too much work, in a self-selected group
of affected children in Britain, with which I have been working
with Professor Leary, among others, and so on, we did nearly
500 children, 493 children, looked at their lifetime histories
with seven colleagues, including psychologists and
pediatricians and so on, in about a month.
In later collaboration, also of 62 of the involved, for
reasons they became involved in laboratory study, one-third of
them, 28, or 45 percent, which is artificially high; but
nevertheless, we could clearly show they were regressive; and
with a bias against it, because we forced the situation where
you waited 30 days--not just 3 or 4, as can happen, but we took
30 days to be very conservative--and it was in that little
period we call them ``unconfirmed.''
The probable proportion in general populations--we could
get it in Denmark, but they didn't do it--is between 10 and 15
percent.
Now, my questions are, were clinical psychologists and
other clinicians involved in the Danish exercise? Was
noncaseness validated, the controls? Was there a definition of
zero time for any manifestation? They talk about diagnoses, but
zero time is when you first observe by a competent clinician
the signs or symptoms related to the condition. It may take
years for you to get the diagnosis, especially by a
psychiatrist, and the average in our studies was about 2.2.
Other British studies go up to averages of about 5.2.
Regressive autism, I asked the question, but I don't think
it was demarcated and whether there would be prolonged exposure
to MMR when they were doing the review.
Now, I'm going to make the most important point of the
presentation, in case you need to cut me short a little bit
down the line. Assume hypothetically--and I'm doing everything
conservative--that there is a vulnerability to MMR-induced
disease in a subgroup of 10 percent of the autistic cases.
Mr. Burton. Should this be a new slide?
Dr. Spitzer. Sorry.
So we assumed that there's 10 percent and we assume further
that in the main autism group, 80 percent had been vaccinated,
which is similar to the 82 percent we've seen in the paper and
95 percent vaccinated in the subgroup of autistics, all of it
being plausible. And I stress this is hypothetical.
Now, if you did a nested case control study within these
cohorts, which I'll explain in a minute, and did that design in
those Danish cohorts, the odds ratio for MMR in that subgroup
of 10 percent would be 4.17, which is appreciably high for
preventive or therapeutic medicine in pharmacal epidemiology.
Now, combining all the autistics, the OR becomes 0.97, so
that the 90 percent mask what's happening in that 10 percent.
Here I show briefly--this will be distributed--how the
calculations will be done. And I assume--and I stress it's
hypothetical. That's why we don't give confidence intervals. It
would be contrived.
Now, is 10 percent trivial? Conservatively, very
conservatively, perhaps this is half. Ten percent would
represent approximately 50,000 children in the United States
alone, perhaps a little less, with the yearly burden of one
point--I'm sorry, with a lifetime burden, it would be of 1.25
billion for just that 10 percent. It isn't trivial. And as a
public health doctor, I hope MMR can be ruled out.
There are those that say I am biased, and I will admit it,
but let me tell you that my bias as a public health doctor is a
profound desire that we can exonerate this effective vaccine,
because it is one of the most effective interventions for
important problems we have. But the failure to demonstrate
safety so far means I cannot recommend it, even after the
Danish study, for my own grandchildren.
So there is the--there is the trivial figure for the 10
percent.
Next slide. Two slides--another slide, I'm sorry. Now, next
slide.
At the core of the methods problem is that the workers
described a very important subgroup in the introduction of
their paper but did not examine it specifically. They did not
or could not test the most relevant hypothesis as proposed by
Wakefield. In other words, they were looking for a question to
be appropriate for the question they were putting and ignoring
what Wakefield and others have published over the last few
years from clinical and laboratory and not epidemiology.
Next slide.
Now, there are also analytic issues, and these are the ones
that I am reticent to give too much--you will see it in the
literature within days or, at most, weeks. Now, one strength
here is that Madsen and her colleagues used person years.
That's what you do in a dynamic cohort situation. I've seen it
criticized, and I don't understand it because that's a
strength. However, they had allocation of cases to subcohorts
of exposed and nonexposed which are difficult to understand.
That's one of the two examples that I gave. There is an unusual
distribution of ages in the cohorts to which you alluded to,
Dr. Geier, and they have problems with measurement of clinical
phenomena, and their censoring rules are surprising or are
inappropriate.
These are just five or six of the statistical issues over
and above that main issue of failing to protect against hiding
a phenomenon in a subgroup by looking at the 90 percent, if you
wish.
Next slide.
So the questions I have first is, why did Madsen and IOM do
an adjustment to the subcohort that removed six autistic and a
total of 13 cases of progressive developmental disorder cases
from the vaccinated subcohort and then place them in the
unvaccinated one? This single adjustment reduces relative risks
of autism due to MMR vaccination by 17 percent, from 1.26 to
1.09.
Next slide.
Why did Madsen not simply exclude all cases involving
earlier, that is, nonregressive, diagnosis of autism? If they
had removed all cases diagnosed before 2 years of age from both
subcohorts, the relative risk would have risen from 1.26 to
1.28.
Next slide.
Now, another problem is difficult to understand. I'm not
saying they are wrong, but I still haven't quite figured out
what they did and why and how they adjust it. To age cohorts
coming close to the end of the study or the end of followup, we
have an average inception of the disease. It's about 3 years.
If you only follow them for a year and a half, you are going to
miss an awful lot of autistic cases among those exposed. So the
censoring is difficult to understand, how they adjusted for it.
I'm still in the process of figuring out and may well write an
article on that with colleagues in the relatively near future.
Next slide.
Now, the classical problem of computerized data bases as
they had, as we had in Saskatchewan, and I did a big study on
beta agonists in Saskatchewan in--almost exactly 10 years ago,
published in the New England Journal, the most cited paper in
the literature that year. These data bases can and are useful,
but there the data are gathered for other purposes, and when
you go into those data bases, sometimes you just cannot get the
data you need because it was never gathered or it was never
archived. That may almost certainly be the case here, and
certainly variables could not be considered.
There has been very, I would say, wise discussion of
mercury and the implications a few moments ago. There was
nothing about mercury in all of this and nothing mentioned.
Next slide.
I think we will skip this. This has to do with what I have
from Wakefield in the literature, the fact that this is
multifactorial. It involves interactions between potentially
enabling factors, triggering factors such as mercury and MMR
working in concert, subgroups genetically. You know, I don't
know much about genetics, and I don't know--I don't--can't
appreciate well how far we have gotten there, but I really hope
we never discourage the pursuit of genetic information because
it's likely to be an interactive, multifactorial profile which
we don't understand yet.
Next slide.
Now, the fourth issue is research management tactics, which
refers to some of the issues that you directly or indirectly
mentioned earlier, Mr. Chairman, you and some of the
colleagues. The concerns are about the process of funding, the
interaction of sponsors with protocol formulation and approval,
compliance with protocol, the role of the investigators vis-a-
vis sponsors in the actual conduct of search and the input of
the CDC epidemiologist in the preparation of the report with
its conclusions. Now, sponsors should stay out of it except
through clear, ethical accountability patterns. Sponsors should
not be involved in the research.
Was there a protocol?
Next slide. Next slide, please.
Was there a protocol? Who approved it? Were there any
changes in the protocol? Who approved the changes? Who
monitored the work in progress? Who approved the final report?
Was there a scientific advisory board? What exactly was the
role of the CD and its professionals? That I don't know, and
it's not in published literature, and it's not been the
appropriate thing, for now, for me to approach Dr. Madsen.
Next slide.
Now, I would like to point very quickly to epidemiologic
research priorities based on computerized data bases. The
Danish one is excellent, it really is, for that kind of data
source. And we don't have it in the United States. We only have
it in Saskatchewan in Canada, maybe to a lesser extent in
Quebec, a few other places, perhaps Sweden. But in Sweden the
confidentiality is so high that they destroy your letters
before they read them.
As I said, heavy metals and the developing immune system,
all those issues, were not touched on for reasons I said.
Forgive me for going on ahead. Next slide. Next slide.
Likewise, we have heard here, and earlier testimony which I
heard, synergistic adverse effects upon the immune system of
susceptible children could not be studied here. The triggering
phenomenon couldn't be studied in any manifestation of autism.
Next slide.
There is no mention of heavy metal as a likely
multifactorial causal association. And it's not the fault of
the investigators. I don't want us to go away and thinking
badly of Dr. Madsen and her colleagues. They are good
scientists. We don't know the pressures they had upon them,
whether yes or no, from outside agencies. But this cannot be
done with the Danish link data bases, as good as they are. It
just can't be done.
Mr. Burton. Doctor, sir, are you near----
Dr. Spitzer. I'm almost--2 minutes or so.
Mr. Burton. Thank you, sir.
Dr. Spitzer. Next slide.
Now, it's my view and that of others that the Madsen group
should replicate, extend, and perform complementary designs of
the recent work. One should also explore whether it is feasible
to do the same in Saskatchewan, Canada.
Next slide.
The hallmark of science is replication, verification, and
corroboration. One study proves nothing. In any of these
national preventional data bases, one can do cohort studies
that are extensions and corroborations and--but the methods
must be declared for analysis in advance. And unless the case
control study goes into this representative two subcohorts,
takes all the cases as cases and takes the probability
representative sample of the controls as the controls, and then
you have all the advantages of both cohort and case control in
one study and at about a tenth of the cost, for that matter.
Next slide.
Now, there must be total transparency, considering the
things that I've heard from distinguished members from both
parties of the committee. There must be a scientific advisory
board monitoring all phases, especially protocol changes in
progress, proposed publications. The majority should be
epidemiologists and biostatisticians. Ethics and conflicts of
interest for reasons that are self-evident and may ultimately--
should be under surveillance, perhaps by a community advisory
board as we did in Alberta.
And the main protocol should be published in advance. We
should be able to critique that protocol in the peer-reviewed
literature. In major studies, that's what my group at McGill do
and what many groups in Europe are doing as well, even in North
America.
Next slide.
A significant first step has been taken in epidemiology. It
is imperative that the whole feasible road of research be
taken. One study proves or disproves nothing in any field, or
two, if you take the lines, that one that you described.
Thank you for your attention.
Mr. Burton. Thank you, Dr. Spitzer. We appreciate your
comments as well.
[The prepared statement of Dr. Spitzer follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. I think I will let Dr. Weldon start off.
Doctor, would you have any questions?
Mr. Weldon. Yes, Mr. Chairman. I have a question for Dr.
Geier.
You said the CDC or the FDA has the data as to which
manufacturers produce which vaccines that contain thimerosal
and which ones don't. And the VAERS data shows that some of
them have a higher incidence of these neurodevelopmental
disorders, and--but you just can't disclose that? Is that
correct?
Dr. Geier. Yeah. There are three levels of denominators.
One level is, how many doses of each type of vaccine were made
per year? Which we have and can disclose, although that seems
to be not generally available, but we have managed to get it.
The second one is broken down by company, which we have
under agreement that we not disclose which company. So we can
do a study like the one I presented and compare one with and
one without, but I couldn't say such and such a company makes a
vaccine and another company makes a vaccine, and the first
company is five times worse than the second company.
And then the third level that they also have--and this is
all published by them if they have it, is that they have the
number of doses per lot number. So with that information you
could investigate the possibility of a bad lot. I looked in my
VAERS data, and I find some lots that have far more reported
reactions than others, but I don't know how big the lots were.
If I knew how big the lots were, I could tell you, yes, there
was a bad lot of particular vaccine made in such and such a
year or, no, there wasn't. And that information I've been
unable to get with or without any agreements.
Mr. Weldon. So what you are saying is if it is an average-
sized lot but there's a higher incidence of side effects----
Dr. Geier. Well, I don't know. I mean, let's say I look at
two lots, and one of them has 100,000 reactions and one of them
has 10,000 reactions. It could be that the 100,000 was a 10
times bigger lot. If I average them, that's not valid. I have
to know. And they know exactly how many doses were in each lot.
And if they release that, we could look lot by lot through the
VAERS data and say, well, there was a bad lot. Boy, it had 20
times--and we could do statistics to see whether it was just by
random choice or chance or whether it was real that a
particularly bad lot was made.
There has been a lot of literature on bad lots. In fact, in
the 1980's the FDA used to keep a list called the ``hot lot''
list, and they also had trouble getting the numbers. But they
have the numbers now to do it, and they won't release these to
any scientists, and they won't allow people to discuss which
vaccine company makes a worst vaccine when they're two of the
same vaccine made by the same company, and I think consumers
are entitled to that kind of information. It's sort of like,
you know, we get an automobile crash test and you find, gee,
one car is a lot safer than the other when it runs into a wall,
but we are not going to tell you which kind of car. Well, they
tell us which kind of car, but they won't tell us which vaccine
producer. They won't allow it to be released which vaccine
producer makes a safer vaccine. And I think with our children
and our lives it's critical that we have that information.
Mr. Weldon. Dr. Spitzer, I always find it very interesting
to hear you speak. It's frequently a little hard to follow,
though, not being a biostatistician or an epidemiologist, so I
just want to make sure I understand you correctly. You said the
Danish study, the Madsen study, is a good study. But is what I
said in my introductory remarks accurate, that it did not--is
it the case that if MMR was causing the majority cases of
autism, that the study is good, but if it's causing a
percentage less than 50 percent, then the study is not valid?
Is that what you were basically saying?
Dr. Spitzer. Well, what I would like to stress is that the
Madsen study in a sense broke a barrier in being the first
properly controlled epidemiological study ever done and new
avenues which can be followed and also had the advantage of an
extraordinarily good data base with the disadvantages----
Mr. Weldon. And I understood all that.
Dr. Spitzer. Now, what I'm saying is, they just didn't go
far enough, first of all, with inadequate evaluation of the
cases, both in terms of a small sample and in terms of how much
within each case was looked at. We don't have the details of
that.
And, second, I'm just saying they cannot rule out with the
decisiveness that they imply, they cannot rule out an
association. They can for the totality, but they can't say
there is no subgroup that conceivably could be affected.
Mr. Weldon. So is it correct----
Dr. Spitzer. And so that's--it just didn't go far enough,
even though it's a major advance in the study of autism
epidemiologically in the last decade.
Mr. Weldon. Is it correct to read it and interpret that MMR
does not cause the bulk of autism in Denmark, but it may
cause--it could cause----
Dr. Spitzer. You can infer that if you take them as a
totality and look at them that way. It's not detectable should
it be happening in a subgroup.
Mr. Weldon. But if MMR is causing a percentage--let's say a
percentage well below 50 percent, then that study didn't answer
that question----
Dr. Spitzer. No.
Mr. Weldon [continuing]. Correct? OK.
Mr. Burton. Can I followup on that, please? Would the
gentleman yield?
Mr. Weldon. I would be happy to yield.
Mr. Burton. In layman's terms, so that everybody
understands, you are saying that it could cause 10 percent, 20
percent of the autism cases, 30 percent. Is that right?
Dr. Spitzer. When you get up to 30 percent, it's--but 20
percent or below is a concern.
Mr. Burton. Well, see, that's something that a lot of us--
you went right over our heads with all those statistics. But
you are saying that it's possible that 20 percent of the
autistic cases could be as a result of the MMR vaccine?
Dr. Spitzer. Yes, and cannot be ruled out by this study.
Mr. Burton. Thank you.
Dr. Spitzer. I'd use the figure 10 percent to be
conservative rather than 20, although it could be 20. But 10
percent is what we tested hypothetically and I'd like to speak
to.
Mr. Burton. Well, 10 percent is still a considerable number
of children.
Mr. Weldon. Dr. Baskin, you are a clinician, I understand.
Have you looked at the research data done by a Dr. Wakefield
from England on the issue of MMR and autism? Are you familiar
with that at all?
Dr. Baskin. Yes, I'm familiar with that. I've actually met
Dr. Wakefield and conversed with him.
Mr. Weldon. OK. One of the things that I have been very
concerned about since I've been working with the chairman on
this issue, and it's about 3 years now, I think this is now the
third epidemiologic study. There were two out of England and
then there was this--maybe it's the fourth one. I think there
was a U.S. study, if I'm not mistaken.
Dr. Spitzer. There is the Finnish study as well.
Mr. Weldon. OK. But nobody has made an attempt to duplicate
a clinical study like the original Wakefield research. And can
you honestly refute Dr. Wakefield's clinical data with all
these epidemiologic studies, particularly in light of the
conversation I just had with Dr. Spitzer, that the study only--
the best study we've had so far can only be used to say that
MMR does not cause all autism cases in Denmark and that the
study does not exclude the possibility that MMR is causing a
percentage of them?
Dr. Baskin. The answer is, no, I can't refute that. While
thimerosal is my major research base as a clinician, and after
conversations with Dr. Wakefield, one of his great concerns is
regressive autism, the fact the child starts out normal and
then gets worse, and another one of his great concerns is the
second shot, none of these studies have actually looked at
these subgroups in any detail.
Mr. Weldon. I have some more questions, but I would like to
yield back to the chairman for the moment.
Mr. Burton. Thank you.
Let me start with you, Dr. Baskin, and you, Dr. Geier.
Because thimerosal--although MMR is a very important issue as
well and important to me, I am interested in the thimerosal
issue because it has been given to literally millions of people
since the 1930's, and it's been given in more and more greater
quantities in recent years because of the number of
vaccinations involved. Do you personally believe from your
studies that the mercury is a contributing factor to the cases
of autism we have in this country?
Dr. Baskin. Yes.
Mr. Burton. Do you think it's a large contributing factor,
or do you have any percentages? I mean, I know this is a tough
question and everything, but you have done a lot of research.
Dr. Baskin. I think it's hard to look at a percentage. I
think that, as NIH is focusing on, there is probably an
environment gene interaction. In other words, a lot of children
get the injection and don't become autistic, and so there must
be something specific or different about the way a certain
subgroup of children are able to handle toxins which, as I
alluded to earlier, is known for other toxins. I mean, that is
not a foreign concept. I don't think we yet know the answer to
that.
I think that one of the striking things is over the years
at NIH and NICHD the idea of regressive autism was not well
accepted. It was sort of originally preached that you were sort
of autistic from birth and actually there weren't that many
children who have regressive autism. But the NIH with good data
and with good science has actually reversed its position quite
a bit on that, and this group seems to be increasing. So up to
somewhere between 30 and 40 percent of children in very
conservative studies seem to have this regressive autism. In
other words, it doesn't seem like they are starting out
abnormal. Something happens to them, and they backslide.
So I think if you want to take a conservative estimate and
you want to take those conservative numbers, because there are
other studies that say 60, 70 percent of autism is regressive,
I think that it's a very good chance it's more likely than not
that it contributes or causes autism in about 40 percent of
children who are autistic.
Mr. Burton. Would you say that a child like my grandson who
got nine shots in 1 day, seven of which contained thimerosal,
would you say that they had a greater risk of getting a
neurologic--creating a neurological problem like autism than--
--
Dr. Baskin. Yeah, absolutely. I didn't touch on that. I
tried to be very conservative with my analysis. But, as you
pointed out, these EPA guidelines are a small amount per day.
These kids are getting an enormous amount all at once. And you
say--you could say you could average the amount of a lethal
injection over your lifetime and say, well, you never in any 1
day got a lethal dose. The only trouble, you'd be dead and 6
feet under the ground. So, yes. I mean, those are the most
concerning cases, children who were OK, who got worse, and
whose parents can link this to a single or a set of--a serial
set of exposures to mercury. And that sounds like the absolute
typical case that we would be most concerned about.
Mr. Burton. Dr. Geier, I think you indicated that in some
cases kids are getting 100 times the amount of mercury that
would be tolerable at one time.
Dr. Geier. Yes. In fact, some of those calculations are
over 100 times.
Mr. Burton. So a child that got multiple vaccines in 1 day
could conceivably be getting more than 100 times the amount,
according to EPA, that's a tolerable level of mercury in one
fell swoop?
Dr. Geier. Yes. And their levels are actually conservative,
because they meant by ingestion, not by injection. So their
studies were not usually by injection.
Mr. Burton. So the injection would be actually----
Dr. Geier. It's worse.
Mr. Burton [continuing]. Worse, much more lethal, so to
speak.
Dr. Geier. Yeah. I mean, there is no question that these
children are overdosed.
Mr. Burton. Would either one of you take nine shots in 1
day, knowing that seven of them contained mercury, at the same
time? And--or would you allow that to happen to your kids or
grandkids, whether they are healthy or not?
Dr. Baskin. You know, a mercury thermometer broke in my
house, and I cleared everybody out of the house and went to my
lab and got these really bioresistant gloves, and cleared it up
like a toxic spill.
No, of course not. It's a really bad toxin.
Dr. Geier. I wouldn't. And I had a different situation. I
run a laboratory that does chromosome analysis, and we had a
mercury vapor bulb break. And we were located near the NIH, and
we cleared the building and had the NIH guys come in with full
body suits to clean out the area.
Dr. Baskin. And I think we've dramatically underestimated
what's been in the literature for the entire last century, that
this is a highly toxic compound. The more we look into it, the
worse it gets.
Mr. Burton. And it shouldn't be injected into human beings.
Dr. Baskin. Absolutely not.
Mr. Burton. But one of the things--one other thing I want
to talk about, and this is not related to my personal problems,
I hope. And that is that older people are coming down with
Alzheimer's at a more rapid rate than in the past. Do you
attribute that in any way to the levels of mercury that they
are ingesting, either through their amalgams in their mouth or
the vaccinations that they are getting or the food that they
are eating that contain mercury?
Dr. Baskin. I think that's a less well-studied area. But
this work that you described, which I was aware of, of the fact
that as these cells die from mercury they form these kind of
plaques and tangles like we see in Alzheimer's disease is very
intriguing and certainly suggests this may well be a
contributing factor.
Mr. Burton. And should be studied.
Dr. Baskin. Absolutely should be studied.
Mr. Burton. Dr. Geier.
Dr. Geier. I agree. I think it's well-studied, could be
studied, but is very plausible.
Mr. Burton. I don't want to alarm everybody in the United
States, but the Members of Congress have been getting flu
vaccines that contain thimerosal for several years. And I want
you to know that I don't think that's one of the reasons we
have made bad decisions up here, although somebody might ask
that question.
Dr. Weldon, do you have any more questions of this panel?
Mr. Weldon. Yeah. I have a couple of questions for Dr.
Baskin about ethyl mercury versus methyl mercury. I have had
some people say that data on methyl mercury is fairly good, but
we don't have good data on ethyl mercury. I take it from your
testimony there is actually quite a bit of data on ethyl
mercury and that it's as toxic as methyl mercury.
Dr. Baskin. There is more data, more and more data on ethyl
mercury. The cells that I showed you dying in cell culture are
dying from ethyl mercury. Those are human frontal brain cells.
You know, there has been a debate about, well, ethyl versus
methyl. But from a chemical point of view, most chemical
compounds that are ethyl penetrate into cells better than
methyl. Cells have a membrane on them, and the membrane is made
of lipids, fats. And ethyl as a chemical compound pierces fat
and penetrates fat much better than methyl. And so, you know,
when I've began to work with some of the Ph.D.s in my
laboratory and discuss this, everyone said, oh, gosh, you know,
we've got to adjust for ethyl because it's going to be worse;
the levels are going to be much higher in the cells. So, I
mean, I think at best they're equal, but it's probably highly
likely that they are worse. And some of the results that we are
seeing in cell culture would support that.
Mr. Weldon. Now, you said several times in your testimony
that uptake in the brain is probably much higher than in other
tissues. What do you base that statement on?
Dr. Baskin. Well, the literature on methyl mercury is much
better than ethyl on this issue. And if you look at the
studies, the brain is 2 percent of the body weight but took 10
percent of the exposure. So that's a fivefold preferential
update.
Mr. Weldon. This was based on people who died?
Dr. Baskin. Right. And also on animal studies, both.
Mr. Weldon. Animal studies? So the brain--what did they
do----
Dr. Baskin. The brain seems to take five times more the
exposure than it should. In other words, if you assume that you
give methyl mercury and it goes everywhere in the body
equally----
Mr. Weldon. You should get the same level.
Dr. Baskin [continuing]. You should get the same level
everywhere. But the brain takes five times as much as it should
have.
Mr. Weldon. And that was based on methyl mercury?
Dr. Baskin. Methyl mercury. Correct.
Mr. Weldon. The Lancet study, only 40 infants. You agree
that's much too small a sample size to really make any
conclusions?
Dr. Baskin. Right. I mean, there are a number of problems
with the Lancet studies as I mentioned. But certainly, if the
disease occurs in one in 150 children and you only test 40, you
may miss that child, very easily miss the child who had the
problem, or at best maybe only catch one. Not to mention the
other things that have been discussed by several of the panel,
the most significant one being they drew the blood much too
late. They drew the blood days to weeks later, whereas we know
the peak level of methyl mercury----
Mr. Weldon. Three to 28 days.
Dr. Baskin [continuing]. Occur within hours, within 24
hours; yet they drew the blood up to 27 days later. As a matter
of fact, to me it's very worrisome. They are still finding some
mercury in the blood that far out. It should--you know, you
would think it might be gone.
Mr. Weldon. Is there any----
Mr. Burton. Would the gentleman yield? Would that be the
reason that some families see a very, very rapid change in
their children shortly after these vaccinations are given in
large numbers? For instance, in our family it was just a matter
of a couple days and--boom.
Dr. Baskin. Correct. All of the data on both methyl and
ethyl mercury suggests that the peak level--in other words, the
highest level in the blood--is either achieved within hours or
at least within 24 hours. So that's--and, again, if it gets in
the blood, the blood goes to the brain. We know it has a
preferential tendency to be sucked into the brain or to cross
into the brain in excess, and so you would expect to see
something fairly quickly. As a matter of fact, if somebody said
3 months later something happened, I would say that's probably
not related.
Mr. Burton. Can I followup with one question here?
Mr. Weldon. Sure.
Mr. Burton. In animal studies, as I understand it, the
animals evidently didn't become ill for 14 days after the
injection of the mercury. Are you familiar with that study?
Dr. Baskin. It depends on which study you are talking
about. There's a variety of different studies.
Mr. Burton. Well, it's a rat study that was done in the
1950's by the Eli Lilly company. Are you familiar with that?
Dr. Baskin. I'm not familiar with that particular study.
But, you know, in general, remember that if you are doing
studies on rats and mice, you have to have very sensitive
behavioral screens. As long as they are getting up and eating,
I mean, they might be acting weirdly and you wouldn't know it.
So I--without knowing what study you're referring to, it would
be hard for me to comment on it.
Mr. Burton. Thank you.
Mr. Weldon. Is there any kinetic studies on the clearance
of ethyl mercury that are available that could allow you to
make conjectures as to what the peak levels might have been
based on the blood levels that are available in the Lancet
study? Or is that information not known?
Dr. Baskin. It's known to a limited extent.
There's a study in pre-term infants that received
vaccinations. So they--you know, by kind of people not thinking
about it, their weight is very small and they receive the same
dose, and so it was a very high level. And they looked at some
of that data. But, frankly, there is not enough.
I think one of the points in the Lancet study is they drew
all these complicated curves saying that they knew what the
pharmacokinetics were, which refers that they knew how the drug
was taken up, how it was absorbed, how it was distributed, but
they never caught a peak level. And, of course, you can't even
make a comment about pharmacokinetics unless you know the peak
level.
So, I mean, I think the short answer is there is some--some
data available but not enough.
Mr. Weldon. Dr. Geier, when this issue was first brought to
my attention 3 years ago, I was very disturbed about the
mercury issue. Then the CDC study that you referred to where
you drew those curves came out; and, frankly, I was somewhat
relieved with that data. Not being a scientist or an
epidemiologist, I accepted it at face value. There was some
initial data suggesting that some of the kids had language and
speech development problems, and then they added more numbers
and said that association went away. I'm very disturbed by
these curves that you drew, though.
So you're saying that--I just want to make sure I
understand you correctly--that when you plot out the data like
that, you can actually do a calculation and it is statistically
significant?
Dr. Geier. Yes. When you--if you allow us to remove that
greater than 62 point----
Mr. Weldon. Well, I want to ask you about that. You say
it's got to be 75. Is that based on the immunization tables and
the known amount of----
Dr. Geier. Yes.
Mr. Weldon [continuing]. Thimerosal in there? So they
couldn't have gotten 150 or 200. It had to be 75.
Dr. Geier. Right. It had to be 75. And when you allow that
point, then you have a curve-fitting program that tries to fit
the best curve. And it tells you how well the curve fits to
that, and it fits in greater than 95 percent to a logarithmic
curve.
Mr. Weldon. Not being a scientist, I can't honestly--but I
just know what it's like. You know, I'm going to get the CDC
people in my office after all this is over, and I'm going to
say, OK, how do you respond to all of this? And I don't think
they are here today, right? They are not in the second panel,
Mr. Chairman? Which I'm very disappointed by. But I would
assume they are going to say that's not kosher, so to speak,
what you did; that's not a valid scientific technique.
Dr. Geier. No, I think they're going to be upset that we
used their intermediate data before they added all these young
children to dilute it out. And even when they diluted it out,
by the way, it's still there. It just became more dilute. As
far as, you know, doing the curve, I think they'd have to agree
that, you know, if you analyze a single point and then you
compare that to analysis of several points as they go up, you
add more likelihood that it's significant. I mean, just
intuitively, what's the odds that three go up in a row? I mean,
just supposing something is random, forget about even how much
they go up or even what shape they go up, the odds of three
going up in a row are not so good if they were from a random
subject.
So it's obvious that to intuitively that--but--and as well
as mathematically that when you go to a kinetic curve like
that, the curve can be significant even if each individual
point is only, as I think they said, marginally significant.
You get three marginally significant curves that fit like that,
it becomes very significant.
But maybe Dr. Spitzer, who is our epidemiologist and
mathematician, can comment on that.
Dr. Spitzer. Well, it's--trying to say it in nontechnical
terms--but it is a finding that's being observed by appropriate
rules of handling the data in the main. It's usually preferable
that it be declared in advance, and that 75 that he said, not
in the course of analysis and so on, but that this is not
likely to happen by chance, at least at the 95 percent level,
or chance alone. That's the basic principle. It's a finding
where the role of chance has been excluded to the extent of 95
percent.
Mr. Weldon. I believe I understand. I could really go on
much further, but I was just reminded we actually have a second
panel, and we have been at it for 2\1/2\ hours, so I will yield
back. I'm sorry, Mr. Burton.
Mr. Burton. No, that's fine, Dr. Weldon. You ask more
poignant questions than I, because you have that experience and
background.
Before I recognize Congressman Green, who I believe is Dr.
Baskin's Congressman--is that correct?
Dr. Baskin. Yes.
Mr. Burton. Is he a good one?
Dr. Baskin. He is very good.
Mr. Burton. OK. Well, I just thought I'd ask.
Dr. Baskin. He is a good patient, too.
Mr. Burton. That's unsolicited testimony.
Before I recognize him, let me just ask you one quick
question here. Do you, all three of you, think that our health
agencies have done enough in the research of this very, very
important issue of the epidemic of autism?
Dr. Baskin. My opinion is this: I think that the NIH now is
galvanized and is doing more. And if, as I said earlier, if
more funds could be set aside for this specific issue, they
have the capability and the interest to do it.
Mr. Burton. Have they in the past?
Dr. Baskin. Not in the past, no, but I think they are now.
Mr. Burton. So we have an epidemic, and up to this point
they haven't been doing enough.
Dr. Baskin. Right. I think so. I think so. But I think, to
be fair to NIH, a lot of this information wasn't really made
available; like I talked about agencies not talking to each
other.
Mr. Burton. What about CDC?
Dr. Baskin. I think the CDC is not. The CDC, in my opinion,
has been obstructionist.
Mr. Burton. OK. How about the FDA?
Dr. Baskin. The FDA, as they said in their own e-mails, I
think have been asleep at the switch for decades.
Mr. Burton. Asleep at the switch. OK. Dr. Geier.
Dr. Geier. I think--it's Geier.
Mr. Burton. Geier.
Dr. Geier. I think that they've been asleep, and I think
that we found that out when we did a midline search on
thimerosal. There are over 1,500 articles listing problems with
thimerosal. And that doesn't go back--the midline search goes
back to 1967. Actually, the problem goes back farther than
that. If there are 1,500 articles that are implying problems
with thimerosal and the FDA and CDC knew that it was in the
vaccines, something should have been done, more than just
ignoring it.
Mr. Burton. Thank you, Dr. Geier.
Dr. Spitzer.
Dr. Spitzer. Well, as I mentioned before, on this whole
matter, particularly as it concerns MMR, I call myself a
worried agnostic. If I, from the FDA or some of the sister
major agencies around the world, could get assurances that we
have the same quality information on safety of this product as
we have on efficacy or effectiveness--and that is good--my
worry would go down a bit, or go down quite a bit. It's gone a
little bit down with the Danish studies. But that's what I have
not been able to find, Mr. Chairman, is adequate,
scientifically admissible evidence on the safety of the
products as opposed to efficacy.
Mr. Burton. And at this point you wouldn't give your
grandkids the MMR vaccine?
Dr. Spitzer. Not yet. No. Not in the foreseeable future, I
don't think.
Mr. Burton. Thank you. Well, let me just end my comment
here by saying that the FDA and CDC and our health agencies
have an awful lot of questions that need to be answered. But
the one thing they could do to make the situation a lot better
is if they get on--get on with admitting there is a problem if
there were 1,500 articles--and start really getting down to the
business of studying this thing and devoting the amount of
resources that are necessary to get the job done. And I want to
thank you guys very much for your help.
And, with that, Congressman Green, it's good to have you
with us.
Mr. Green. Mr. Chairman, I did serve on this committee
three terms ago and I moved to the Energy and Commerce to deal
with health care. It's interesting; I walked back in the office
from a meeting and saw Dr. Baskin, who, one, is a great friend
and great neurosurgeon, and I'm going to ask him to sign an
affidavit that, yes, a Member of Congress does have a brain.
But----
Mr. Burton. Did you get a flu shot this year?
Mr. Green. I did get a flu shot in.
Mr. Burton. Well, it has mercury in it.
Mr. Green. OK.
Mr. Weldon. You know, he has brain cells he's growing in
his lab. I was wondering if he would sell some to Members of
Congress.
Mr. Green. You know, we could use them. We could use them.
But the issue--because we were just responding in our office to
a letter of a family with a child with autism. And on my
Subcommittee on Health Care, that our good doctor is also on,
this is an issue. And I want to thank you for holding these
hearings to help us as Members of Congress go further. But
again, I just came in to say hello to my good friend Dr.
Baskin.
Dr. Baskin. Thank you.
Mr. Burton. Before you leave, let me just say that----
Mr. Green. Thank you.
Mr. Burton. Thank you. Before you leave, I just want to say
that we have a bill that I've talked to Congressman Bilirakis,
the chairman of your subcommittee about, that would go a long
way toward helping solve the problem with the vaccine injury
compensation fund, and I really would appreciate if you'd talk
to him and take a look at that bill.
Mr. Green. OK. Glad to.
Mr. Burton. Thank you very much.
Well, gentlemen, thank you very much. We have gone way
beyond what we normally would, but I thought it was very
important to let you really lay out the whole story. And with
that, we will go to the next panel. And thank you for your
service.
Mr. Burton. The next panel is, we have the FDA and the NIH,
Dr. Midthun, Dr. Foote, and Dr. Portier. Would you please come
to the witness table?
Please stand up so I can swear you in, please.
[Witnesses sworn.]
Mr. Burton. Dr. Midthun, do you have an opening statement?
Dr. Midthun. Yes, I do.
Mr. Burton. OK. You are recognized.
STATEMENTS OF KAREN MIDTHUN, M.D., DIRECTOR, OFFICE OF VACCINES
RESEARCH AND REVIEW, FOOD AND DRUG ADMINISTRATION, ROCKVILLE,
MD; STEPHEN FOOTE, PH.D., DIRECTOR, DIVISION OF NEUROSCIENCE
AND BASIC BEHAVIORAL SCIENCE, NATIONAL INSTITUTE OF MENTAL
HEALTH, BETHESDA, MD, ACCOMPANIED BY CHRISTOPHER PORTIER,
PH.D., DIRECTOR, ENVIRONMENTAL TOXICOLOGY PROGRAM, NATIONAL
INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, BETHESDA, MD
Dr. Midthun. Thank you.
Mr. Chairman and members of the committee, I am Dr. Karen
Midthun, Director, Office of Vaccine Research and Review of the
Center for Biologics Evaluation and Research at FDA.
Mr. Chairman, as a physician and a parent, I want to
express to you, the members of this committee, and to parents
and physicians that I appreciate the devastating effects of
autism on children and their families. I am here to assure you
that we are working diligently to help ensure that the vaccines
we license for use in the United States are shown to be safe,
pure, and potent. I appreciate the opportunity to participate
in this hearing on autism and to respond to the committee's
concerns regarding a potential link between vaccines and
autism.
The Office of Vaccines regulates the investigation and
licensure of vaccines. FDA's regulatory process for licensing
vaccines has for decades served as a model for other countries.
To date, the existing data do not demonstrate a causal
relationship between vaccines and autism. Nonetheless, I want
to assure this committee, the public, and especially parents,
that FDA continues to take these issues seriously.
One concern that has been raised relates to the use of
thimerosal, a mercury compound, as a preservative in some
vaccines. FDA recognizes and supports the goal of reducing
exposure to mercury from all sources. Consistent with this
goal, FDA has encouraged manufacturers to develop new vaccines
without thimerosal as a preservative and to remove or reduce
the thimerosal content of existing licensed vaccines.
As required by section 413 of the FDA Modernization Act,
FDA conducted a review of the use of thimerosal in childhood
vaccines. Our review showed no evidence of harm caused by
thimerosal used as a preservative in vaccines except for local
hypersensitivity reactions. Of the U.S.-recommended childhood
immunization schedule, the maximum cumulative exposure to
mercury from thimerosal at the time of this review in 1999 was
within acceptable limits for methyl mercury exposure set by
FDA, the Agency for Toxic Substances and Disease Registry, and
the World Health Organization. However, during the first 6
months of life, cumulative exposure to mercury could have
exceeded the more conservative limits of the EPA in some cases,
depending on the specific vaccine formulations used and the
weight of the infant. Of note, all of these guidelines contain
a safety margin and are meant as starting points for evaluation
of mercury exposure, not absolute levels above which toxicity
can be expected to occur.
The clinical significance of exceeding EPA's limits is not
currently known. Nevertheless, reducing exposure to mercury
from vaccines is warranted and achievable in principle in the
United States because it is possible to replace multi-dose
vials with single-dose vials which do not require preservative.
I am pleased to be able to report substantial progress in
the effort to reduce thimerosal exposure from vaccines. Since
early last year, all routinely recommended licensed pediatric
vaccines manufactured for the U.S. market contain no thimerosal
or contain only trace amounts of thimerosal in the final
formulation. With the newly formulated vaccines, the maximum
cumulative exposure from vaccines during the first 6 months of
life is now less than 3 micrograms of mercury. This represents
more than a 98 percent reduction from the previous maximum
cumulative exposure of 187.5 micrograms of mercury from
vaccines.
In addition to the initiatives taken with regard to
routinely recommended childhood vaccines, FDA has also worked
with manufacturers to facilitate the removal or reduction of
thimerosal from other vaccines. Two of the three influenza
virus vaccines are now available in a formulation that contains
only trace thimerosal. The manufacturer of the third influenza
virus vaccine has announced that it will not manufacture this
vaccine after this year.
In 2001, the Institute of Medicine's Immunizations Safety
Review Committee focused on a potential relationship between
thimerosal use in vaccines and neurodevelopmental disorders.
The Institute of Medicine concluded that the evidence is
inadequate to either accept or reject a causal relationship
between thimerosal exposure from childhood vaccines and the
neurodevelopmental disorders of autism, attention deficit,
hyperactivity disorder, and speech or language delay.
Additional studies are needed to establish or reject a
causal relationship, and we concur with that.
The committee believes that the effort to remove thimerosal
from vaccines was a prudent measure in support of the public
health goal to reduce mercury exposure of infants and children
as much as possible. In an effort to better characterize the
potential toxicity that could have accompanied an exposure to
thimerosal from vaccines, FDA nominated thimerosal to the
National Toxicology Program for further study. The nomination
was accepted by the review committee earlier this year.
Reports of developmental delay following vaccination have
been submitted to the Vaccine Adverse Event Reporting System,
commonly referred to as VAERS. Although VAERS reports usually
cannot establish a causal relationship between a vaccine and an
adverse outcome, further study of these reports can sometimes
provide important clues and suggest directions for further
research. FDA takes these reports seriously and is conducting a
followup study of VAERS reports of autism. Also, FDA is
pursuing promising research involving the characterization and
development of an animal model to study general biological
principles for autism.
By looking at ways to improve the safety of vaccines, we
must keep in mind that childhood vaccines have contributed to a
significant reduction of vaccine-preventable diseases,
including polio, measles, and whooping cough. It is rare for
American children to experience the devastating effects of
vaccine-preventable illness. Although they provide a great
public health benefit, vaccines, like all medical products, are
not risk free, and FDA is committed to continuing its efforts
to reduce these risks whenever possible.
In conclusion, FDA continues to work diligently with
manufacturers to eliminate or reduce exposure to mercury from
thimerosal and vaccines. Since early last year, all routinely
recommended licensed pediatric vaccines manufactured for the
U.S. market contain no thimerosal or contain only trace amounts
of thimerosal in the final formulation. Although no causal
relationship between vaccines and autism has been established,
FDA, along with other health and human services agencies,
continues to pursue and support research activities to increase
our understanding of any potential relationship between
vaccines and neurodevelopment disorders.
Although the prevention of disease through the use of
vaccines is a tremendous public health accomplishment, there is
more work to be done. I assure you that the Office of Vaccines
and FDA will continue to make regulatory decisions and
recommendations regarding vaccines based on the best scientific
evidence to protect the public health.
Mr. Chairman, I appreciate the committee's interest in this
area, and look forward to continuing to work with you in the
future. Thank you.
[The prepared statement of Dr. Midthun follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. Dr. Foote.
Mr. Foote. Mr. Chairman, members of the committee, I am Dr.
Steve Foote, Director of the Division of Neuroscience and Basic
Behavioral Science of the National Institute of Mental Health.
I am accompanied by Dr. Christopher Portier, Director of the
Environmental Toxicology Program at the National Institute of
Environmental Health Sciences.
I am the witness representing the National Institutes of
Health today because I play several roles in the coordination,
planning, and oversight of autism research at NIH. For example,
I serve as a scientific program staff member of the NIH
Internal Autism Coordinating Committee, a longstanding body
that serves to coordinate autism research NIH-wide. Also, I
have played a major role in organizing and implementing the NIH
centers program called for in the Children's Health Act of
2000, which we have named the Studies to Advance Autism
Research and Treatment, or STAART, Centers Program. Finally, I
have served a leadership role in the establishment and
operation of the Department of Health and Human Services'
Interagency Autism Coordinating Committee that was created
under a provision of the Children's Health Act of 2000.
I appreciate the opportunity to talk with you about NIH's
support of research on autism. I am a neuroscientist who has
been interested in the brain and its disorders throughout my
career, and, like others, I have found autism to be a
particularly challenging mystery.
My view of this disorder has been broadened and deepened by
my continuing interactions with members of the families with
autistic children and adults. I feel their urgency. An affected
child cannot wait for research before growing up. Any potential
improvement is crucial.
I would like to acknowledge the important role of families
and advocacy groups in our efforts. They have not only raised
the visibility of autism and challenged assumptions; they have
pushed for and often funded I might say, accelerated and
expanded research activities.
I testified before this committee earlier this year, but
now there is even more recent progress to report. The basic
research on autism that is sorely needed is moving forward at
an ever-accelerating pace, as is continued genetic research and
studies of the etiology of various autism spectrum symptoms,
including communication disorders and interpersonal
difficulties. Autism biomedical research is rapidly expanding
as the scope and level of detail of scientific topics under
active investigation is aggressively broadened.
Several weeks ago, I attended the Second Annual
International Meeting for Autism Research. This meeting was an
exciting forum for this rapidly growing field. It was a meeting
that just could not have even been imagined just a few years
ago in terms of its scope and quality.
Extremely important funding programs from voluntary
organizations and other Federal agencies, along with very
substantial increases in NIH funding that have occurred over
the past several years, have provided financial support
underlying this growth in volume and quality of research. Other
driving forces have been the advances of closely related
biomedical research fields such as genomics and neuroscience
that have provided the necessary knowledge and tools for more
powerful and promising insights into the biological nature of
autism.
In summary, biomedical research into autism is advancing
rapidly and NIH is playing a major role in this progress.
I am also pleased to report that as part of the enhanced
activities in this area, NIH has made much progress in
implementing the provisions of the Children's Health Act of
2000 that focused on NIH research activities related to autism.
In terms of the requirement for a new centers of excellence
program, NIH has issued a total of three requests for
applications, RFAs, to implement on a fast track, the STAART
Centers program. An RFA, as you know, is a clear statement to
the scientific field, setting aside funds that NIH invites
research in a particular area. The first RFA was for
developmental grants. Those were reviewed. We funded six of
those. The second RFA was for an initial round of competition
for full center support. A number of applications were
received, reviewed in March 2002, and two centers were funded.
A second round of competition for full center support is in
mid-cycle and the applications are being reviewed yesterday and
today. And I was at those reviews all day yesterday and I was
able to attend most of the reviews today, and they are going
very well.
When these successful applications from this round of
competition are funded during fiscal year 2003, the full
network of at least five centers stipulated by the law will be
in place. The five participating NIH Institutes--NIMH, the
National Institute of Neurological Disorders and Stroke, the
National Institute of Child Health and Human Development, the
National Institute on Deafness and Other Communication
Disorders, and the National Institute of Environmental Health
Sciences--have committed up to $12 million a year, including $8
million from NIH, to fund this network at that level for over 5
years--for up to 5 years. This is a commitment of $60 million
minimum.
Another component of the Children's Health Act was the
establishment of an Interagency Autism Coordinating Committee,
the IA CC as we call it. The Secretary of the Department of
Health and Human Services delegated to NIH the authority to
organize the IACC, and NIMH was asked to lead this effort. The
IACC has been organized and has now had its first three
semiannual meetings. It is actively pursuing its mandate to
enhance communication and effective interaction among the
several agencies that support or conduct autism-related
research, service, or educational activities, and it has
engaged family and advocacy groups largely through the public
members that were appointed by the Secretary.
In addition to these activities, NICHD and NIDCD have
competitively renewed their longstanding collaborative programs
of excellence in autism. The NIH is fully committed to this
important program, and will continue its support for both CPEA
and STAART programs for several years into the future. And yet
another recent enhancement of the NIH autism research
portfolio, NIEHS, has funded two centers focused on autism
research.
We at the NIH are at a heightened state of awareness
concerning the need for more research on autism due to the
clear magnitude of this major public health problem and due to
the work of many people within and outside this room. We have
been making progress. In fiscal year 1998, NIH support for
autism research totaled about $26 million; by fiscal year 2001,
which is the latest year for which we have official numbers,
the total was about $55 million.
To put this in perspective, the NIH commitment to autism
research has more than doubled in these few years.
In terms of the specific questions in your letter of
invitation, there are a number of active and planned projects
that address the concerns you raise. NIH recently furnished you
with a summary of the research activities sponsored by the
National Institute of Allergy and Infectious Diseases and by
NIEHS designed to address questions about thimerosal, ethyl and
methyl mercury, and the search for other environmental risk
factors for autism.
Another question you raised was about treatments, and
several institutes are sponsoring numerous projects dealing
with treatment interventions for autism, and the STAART Centers
Program includes a primary emphasis on such studies.
So to summarize and finish, NIH is on schedule in terms of
implementing the letter and the spirit of all aspects of Title
I of the Children's Health Act, including a broadly based
increase in autism research support, the initiation of a new
centers of excellence program, and enhancement of genetic and
other research resources, and the establishment of the
Interagency Autism Coordinating Committee.
That concludes my testimony. And Dr. Portier and I would be
glad to answer any questions.
[The prepared statement of Mr. Foote follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burton. Thank you. I just have a few questions here,
and then I'm going to let Dr. Weldon ask some questions. But I
will have a number of other ones that I think are relevant and
important after he concludes.
I believe Dr. Geier indicated that since the 1980's, there
have been 1,500-plus articles written in scientific journals
about the problems with mercury and thimerosal. Why haven't the
health agencies of our government done something about it
before now; 1,500 articles. Dr. Midthun.
Dr. Midthun. The review that we did in response to FDAMA
went over the literature that existed, and it was our
assessment that certainly, as Dr. Baskin was saying, we all
know that mercury itself in larger amounts is clearly a
toxicant. But our assessment was that the amounts that were
present in the vaccines, that there did not--there was--that
those were safe and effective, and that certainly though our
assessment was that whenever possible it's good as a
precautionary measure to limit the exposure to mercury from any
sources, and in the United States, since we do have the ability
and principal to use to single-dose presentations that don't
require a preservative, that would be the appropriate
precautionary step to take.
Mr. Burton. Why haven't we done that before now? I mean, in
1998, the FDA showed it was concerned about the neurotoxic
effect of mercury from cumulative dosing. And if you look at
exhibit No. 3--do you have that in front of you?
[Exhibit 3 follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Dr. Midthun. No, I don't. Could I please see those?
Mr. Burton. Give that to them, would you please.
I want to read you what--this is a memo from Dr. Marianne
Gruber to Dr. Carolyn Hardegree and Dr. Norman Baylor of the
FDA. It's dated September 17, 1998, and it's entitled ``Point
Paper, Preclinical Reproductive Toxicity Studies for
Vaccines.''
And on No. C there, if you are looking at it, it says--Dr.
Gruber says, for investigational vaccines indicated for
material immunization, the use of single-dose files should be
required to avoid the need of preservatives in multi-dose vials
as are required by the Code of Federal Regulations. Of concern
here is the potential neurotoxic effect of mercury, especially
when considering cumulative doses of this component early in
infancy. All mercury-containing vaccine formulations should be
evaluated in appropriate preclinical reproductive toxicology
studies that include the assessment of postnatal, behavioral,
and developmental end points.
Read that?
Dr. Midthun. I am sorry, I don't see point C on here. I am
looking at exhibit 3, and I see A and B.
Mr. Burton. It's on page 4.
Dr. Midthun. Page 2--3.
Mr. Burton. And these are some of your----
Dr. Midthun. I still--I'm sorry, don't see point C on page
4. I see the heading, the first bold heading.
Mr. Burton. The last paragraph down at the bottom.
Dr. Midthun. For investigational vaccines indicated for
maternal immunization. That paragraph?
Mr. Burton. Yeah.
Dr. Midthun. OK. Let me take a look at that, please.
Mr. Burton. All right.
Dr. Midthun. This is a specific reference to maternal
immunizations, specifically evaluating investigational vaccines
to administer to pregnant women.
Mr. Burton. Right.
Dr. Midthun. And there, you know, the--obviously, again, as
a precautionary measure to limit the exposure to mercury and
also to evaluate any vaccine that is investigational that you
are trying to evaluate for that particular use that these kinds
of studies should be done. So this is a specific reference to
vaccination of pregnant women, for vaccines indicated for them.
Mr. Burton. So let me get this straight. There are 1,500
articles written about the problems with thimerosal and
vaccines, we have had a 40fold increase in the number of
children that are autistic, You had this statement regarding
pregnant women, and yet you didn't think that there was any
concern about children, infants, getting these vaccines that
had thimerosal in them at that time?
Dr. Midthun. Again, I haven't had an opportunity to look at
this whole--this whole memorandum, but I think that clearly
this relates to a time pursuant to the FDAMA--FDA Modernization
Act of 1997--when a process was initiated to review mercury in
general in all drugs and biologics, including, of course,
vaccines.
Mr. Burton. Do you think mercury is a bad thing to be
putting in your body?
Dr. Midthun. I think we recognize that mercury in large
amounts clearly is harmful.
Mr. Burton. How much is a large amount?
Dr. Midthun. You know, there are different studies that
have been done to look at that. And I think that some of the
studies that came out of the Faroe Islands indicated that
perhaps lower amounts could cause problems based on subtle year
developmental observations that were seen in that study.
Although my understanding was that some of the interpretations
of that study were also somewhat confounded by the probable
exposure to PCBs.
Mr. Burton. Enough. Enough. That's enough. I just don't
want to hear any more of that. Take a look at this slide that's
up here, would you please. That shows the amount of money that
is spent on diabetes at the top, AIDS next, and autism at the
bottom. And autism is one of the fastest growing epidemics in
the country. Why is it we're spending such a small amount on
research? I know Dr. Foote says we're spending more. But even
if we were spending the $55 million you're talking about we're
spending $2,770,000 on AIDS and $845,000 on diabetes, not to
diminish those, they're very important.
But one of the fastest growing, if not the fastest growing
epidemic in the country is autism. And we're spending just a
minute amount on that when we're going to have these kids with
us for life and they're damaged. Why is it more research hasn't
been done before now?
Mr. Foote. Well, as you know, these budget figures are the
bottom line of a very complex set of processes. Certainly we
are doing--we are engaged in a lot of activities designed to
increase the number of investigators who are capable of
constructively utilizing research funding to study questions
about autism. And that's one of the major hopes we have for the
autism centers program is that these will create sites at which
young people can get intensive training in autism-related
issues. And it is our full expectation that then they will
become qualified and highly competitive investigators for NIH
funds.
Mr. Burton. How many studies are currently going on?
Mr. Foote. How many autism-related research grants----
Mr. Burton. Studies, that the Federal Government is
funding, how many are going on right now that are started?
Mr. Foote. I don't think I can speak for the entire Federal
Government, but there are five NIH institutes that fund autism
research and it runs up into probably a few hundred grants.
Mr. Burton. When does all this start, do you know?
Mr. Foote. Well, as I indicated in my opening remarks,
autism research has been going on in some substantial degree
for at least a decade at NIH, but the exponential curves that
we've been discussing certainly apply to the amount of money
going into autism research, which has increased very
dramatically over the past few years.
Mr. Burton. Are there still vaccines in doctors' offices
right now today that contain thimerosal that are being given to
children?
Dr. Midthun. I don't believe so, no. As I mentioned, all
vaccines for the routine recommended childhood immunization
series started 2001 have been manufactured either thimerosal
free or with markedly reduced amounts of that thimerosal. Now,
that's just the vaccines that are in the routinely recommended
immunization schedule. As I mentioned, influenza vaccines which
are not part of that recommended schedule but were encouraged
to be administered by the ACIP, although they're not yet part
of the routine schedule, those are now available in a
thimerosal trace formulation for both of Evans vaccines and
Aventis Pasteur vaccines.
As I mentioned, Wyeth announced its intentions not to
manufacture an influenza vaccine after this year. But the other
two do offer this trace thimerosal presentation. However----
Mr. Burton. But they still have that thimerosal in them.
Dr. Midthun. Yes, they still also have multi-dose vials
that do contain----
Mr. Burton. Why don't they go to single-dose vials?
Dr. Midthun. I know that they are considering the
feasibility of----
Mr. Burton. Why don't you tell them to do that?
Dr. Midthun. We consider these vaccines, which also contain
thimerosal as a preservative to be safe and effective. However,
we do consider that it's important to have vaccines----
Mr. Burton. Did you hear any of the testimony earlier from
those people that were testifying, those scientists and
doctors?
Dr. Midthun. Yes, I did.
Mr. Burton. Did you see the study from Canada there that
showed the damage that's done when a very minute amount of
mercury is given, put in proximity to brain cells.
Dr. Midthun. I think it's hard to extrapolate that data to
what actually happens in a clinical situation.
Mr. Burton. You know, every study that's been done, Doctor,
that you guys put forth showing that there's no correlation
between thimerosal and autism doesn't say categorically that
thimerosal doesn't cause autism. They never say that. Can you
are tell me right now categorically without any doubt
whatsoever that mercury in vaccines does not cause autism?
Dr. Midthun. I think what I'd have to say is what the
Institute of Medicine concluded is that the body of evidence
neither----
Mr. Burton. I want you to give me a yes or no. Can you tell
me, can you say right now just flat out, just say can you tell
me without any doubt whatsoever that the mercury in vaccines
does not cause neurological problems or autism?
Dr. Midthun. We can neither accept nor reject a causal
relationship.
Mr. Burton. So what you're saying is you cannot tell me
that, you cannot say categorically, can you?
Dr. Midthun. We don't know one way or the other.
Mr. Burton. So why are you keeping something in there if
you don't know one way or the other when you know that there's
an epidemic of autism? If there's an epidemic of something, why
do you keep it in there when you're not sure? Because every
study I've seen flatly says you're not sure. You say there's--
you can't say yea or nay.
Dr. Midthun. I think you have to consider the benefit that
vaccines confer. And there's a definite benefit from influenza
vaccine and having an adequate supply of vaccine is very
important.
Mr. Burton. Let me followup on that then. Single-shot
vials, does that need thimerosal?
Dr. Midthun. No, they don't, but----
Mr. Burton. Why do we have single shot vials?
Dr. Midthun. There are a lot of manufacturing issues
associated with switching over. You need much more filling
capacity for the lines. You need a lot more other kinds of
things that need to be introduced, so although it can be done
and both Evans and Aventis Pasteur have started to introduce
that, it is not something that at present they have the
capacity to do in entirety.
Mr. Burton. Let me ask you this: Do these pharmaceutical
companies that produce these vaccines had, in the past, the
ability to produce, and have they produced single-shot vials?
Dr. Midthun. Yes, they do. Because that's how Evans and
Aventis Pasteur is doing it to right now.
Mr. Burton. How about all of the pharmaceutical companies?
Do all of the pharmaceutical companies pretty much have the
ability to produce single-shot vials?
Dr. Midthun. You know, I couldn't speak to that
categorically. I don't know. But I do know certainly in the
case of Adventis Pasteur and Evans they do have the ability
because they are doing that.
Mr. Burton. Then why hasn't the FDA, to be on the safe
side, knowing that we're having one in over 250, and in some
cases, one in 150 children becoming autistic, and there's a
growing body of evidence that thimerosal and mercury is causing
that, why wouldn't you go down the cautious road instead of
coming up with these additional studies that say well, we're
not sure, we can't say yea or nay, why not go to single-shot
vials?
Dr. Midthun. Because we believe that the multi-dose vials
continue to be safe and effective and that they speak to having
enough supply of influenza vaccine, which serves a very
important public----
Mr. Burton. Let me end up by saying this. I'm a student. I
studied at the Cincinnati Bible Seminary. I don't like to quote
scripture very often, but there's none so blind as those that
will not see. You just sit there and you keep saying over and
over and over again that you think that there's not a real
danger for having this mercury in these vaccines. There's been
1,500-plus articles written saying that there is a problem.
We've got scientists from all over the world coming in here.
You saw a demonstration from a Canadian tape showing the
impact of a minute amount of mercury in brain cells. And yet
you continue to say well, we don't think that a very small
amount of mercury--but you don't know because there's no study
that you've put out, not one that says categorically that
mercury in vaccines does not cause neurological problems. You
can't tell me that today. You've hedged all over that issue.
You guys continue to keep coming up here and making excuses.
And I don't know why. Why not just get it out of there?
Dr. Weldon.
Mr. Weldon. Thank you, Mr. Chairman. I want to thank all of
our witnesses in this panel for being here, and I didn't get an
opportunity to thank the previous panel. Dr. Midthun, as I
understand it, according to what you've said, thimerosal is in
multi-dose vials of the influenza vaccine for a variety of
reasons. We do currently recommend that children at risk
receive the flu vaccine injection, is that correct?
Dr. Midthun. That's correct.
Mr. Weldon. So though it is the case that thimerosal has
been removed from all of the standard pediatric inoculations
like MMR and DTPA, that some children may be getting thimerosal
from the multi-dose vials that are still out there on the
market, is that correct?
Dr. Midthun. That's possible although I know that Aventis
Pasteur, in speaking with them, they've tried very hard to
target the trace thimerosal to the pediatric population, yes.
Mr. Weldon. Well, I would recommend to the FDA that you
issue a recommendation that the single dose thimerosal free
influenza vaccine be the vaccine used in the pediatric
population.
Mr. Burton. Would the gentleman yield?
Mr. Weldon. Yes.
Mr. Burton. Because of the huge rise in Alzheimers and
because they're putting thimerosal in the vaccines for flu for
adults as well, and all the Members of Congress that get those
shots are getting them, I wish you would amend that to take it
out of all flu vaccines.
Mr. Weldon. Well, Mr. Chairman I was going to get to that
issue.
What exactly is the problem, could you just explain it a
little more detail, you know, if I were to offer an amendment
on the Labor HHS appropriation bill, mandating that all
thimerosal be removed from the market in the United States by a
date certain, let's say July 2003 or December 31st, what is the
problem with getting rid of this substance?
Dr. Midthun. That is something that you know the
manufacturers, you know, one would you have to say to them
exactly----
Mr. Weldon. Manufacturing process?
Dr. Midthun. It is that one has to remove the thimerosal
from the product but then an even bigger issue is that you then
have to fill multi-dose vials. And to fill multi-dose vials
takes a lot more filling lung capacity than to fill multi-dose
vials. So you have to have an infrastructure in place to be
able to set that up. And I mean----
Mr. Weldon. So your concern is that such a mandate would
result, if I understand your testimony correctly, in a possible
shortage of available vaccine on the market.
Dr. Midthun. That's correct. I believe that is the case.
Mr. Weldon. OK.
Dr. Midthun. I don't believe that a transition can be made
that quickly without creating quite a shortage. Let me just
mention one other issue, and we've all been aware of vaccine
shortages over these last couple of years is that Wyeth did
announce that they are leaving the influenza vaccine market. So
the market which previously had four manufacturers back in
2000, Parke Davis left that year, that had us down to three
manufacturers and that was the first year where we experienced
the influenza shortage.
Then last year we had somewhat of a delay there.
Availability of the three remaining manufacturers worked very
hard to make up for the shortfall of the fourth one who left.
This year we'll be down to two. So I have concerns that taking
that kind of a step, I don't believe it could be accomplished
in that kind of a timeframe without leaving a vaccine shortage.
I think one must consider the benefit that the vaccine conveys
in terms of disease prevention against these other issues.
Mr. Burton. Would the gentleman yield again? I'm sorry. The
implication of your answer is that because of the problems with
thimerosal and so forth, that's why they're not producing the
flu vaccine, influenza vaccine again.
Dr. Midthun. No. No. I do not know that. All I know----
Mr. Burton. Isn't it true they are going to single-shot
vials for measles; is that right? They're going to a nasal flu
vaccine instead, is that not correct?
Dr. Midthun. There is a license application in for a live
attenuated nasally administered influenza vaccine. That
vaccine--and I can disclose that because that is public
knowledge--that vaccine is being developed by Metamune.
Mr. Burton. Will that contain thimerosal?
Dr. Midthun. No, that's a live, attenuated vaccine. That
does not contain thimerosal.
Mr. Burton. Thank you.
Mr. Weldon. I understand there is, under development, a
nasal measles vaccine as well, is that correct?
Dr. Midthun. You know, I don't know exactly what's been
publicly disclosed here in open session. I can neither
acknowledge or deny the existence of an IND. So I don't know
what's been publicly disclosed in terms of any measles vaccines
that might be under investigation or new drug application
development.
Mr. Weldon. OK.
Mr. Foote, you know, I often wish I was Bill Gates and
could just fund some research, I was originally made aware of
Dr. Wakefield's work about 3 years ago when one of my
constituents came in my office and contended that his child was
well, developing normally with appropriate speech and eye
contact, and then got the MMR and then proceeded to go down the
tubes and got a second MMR years later and got even worse. And,
you know, Dr. Wakefield's research was not expensive. You know,
we throw billions of dollars around this town. What's the delay
in getting this research done? And you know, we had a hearing
back I think in July this fellow Kreigsman came in and on his
own he has scoped all these kids and he's seen all the same
exact findings that Dr. Wakefield has and he was real excited
I've been talking to this guy, he's been biopsying all of these
he's got all these little specimens and the IRP, Atlantic
center hospital doesn't want to do the pathology on these
things. They're just--I don't know if they're afraid or what,
but you know, can't you find some way to just answer the
doggone question so I don't to keep asking the same question
year in year out. Am I going to be here in the 112th Congress
asking NIH to answer me the question is Dr. Wake field a crack
pot or is he on to something with the MMR?
Mr. Foote. So, after that hearing which I was either a
witness or I was accompanying, I've already been up here a
couple of times this year so I can't remember exactly which one
that was I initiated a conversation with Dr. Kriegsman. I gave
Dr. Kriegsman my business card, I told him to contact me
because NIH would be interested in receiving a grant
application in this area, especially from someone who it seemed
had pilot data, and in his case, I believe a group of control
subjects, material from control subjects which was--which would
be critical to a well-designed study of the Wakefield kind of
phenomenon.
So I did indeed have some phone conversations with him. We
discussed this IRB issue. He was just at the point of
interacting further with, I think--I think there was--there's
some question in my mind about where exactly the IRB was
located. I think this was part of the problem. But he explained
some of these problems to me. I gave him whatever advice I
could. I made clear that should he be able to resolve those
difficulties, we would be very interested in receiving an
application.
When I attended, the meeting annual meeting of the Autism
Society of America----
Mr. Weldon. Go ahead, I'm sorry.
Mr. Foote. I was going to make one more quick point which
is, when I attended the meeting of the annual meeting of the
Autism Society of America in Indianapolis, I had a meeting with
Dr. Wakefield and with some of his colleagues and so on. I made
clear to them that I was willing to be a contact point within
NIH for Dr. Wakefield or anybody else who was interested in
submitting a grant application to----
Mr. Weldon. You know I'm not really interested in a grant
to Dr. Wakefield. I would like somebody else to try to
duplicate his work. And I think you could duplicate his work
for $250,000 or less. And why can't we get that done?
Mr. Foote. All I'm telling you is when I meet somebody
who--there were others----
Mr. Weldon. You're saying if somebody applies, you'll look
very favorably.
Mr. Foote. I'll go further than that. I will help them
figure out what the most effective--that is my job, I do it
every day--what the most effective way is to approach NIH for
getting funding for that research.
Mr. Burton. Let me just ask a question. Dr. Kriegsman, now
you've talked to him several times you said.
Mr. Foote. I talked to him, I think, twice on the phone
about these.
Mr. Burton. You told him what now?
Mr. Foote. I told him NIH, I would help him interface with
NIH in terms of what kind of grant application to prepare, what
kinds of review committees to institute----
Mr. Burton. What else did he have to do before you could
help him?
Mr. Foote. He told me that his problem was very similar to
what Dr. Weldon indicated, it sounds like Dr. Weldon had some
contact with him afterwards, also that he was having trouble
with his institutional review for human subject studies.
Mr. Burton. Down there at his hospital or his----
Mr. Foote. At his hospital or whatever IRP was responsible.
Mr. Burton. Assuming that's the case and you realized the
gravity of this situation, why doesn't our health agencies try
to assist him in getting past that barrier? I mean, you know,
it seems to me you say OK, if you can get past this barrier,
and you know full well that there's a recalcitrance on the part
of the Board of Governors of a hospital or health institution,
it seems to me you would say, hey, this is significant enough
that we really ought to help this guy instead of just saying
when you get past that, give us a call. Can't you do something
like that? Can't you guys initiate some help for some of these
people?
Mr. Foote. We have in terms of human subjects, animal
subjects, ethical issues and so on, the model that is in place
is that the grantee institutions assume responsibility for
those issues. And NIH tries not to mandate or micromanage those
issues at grantee institutions.
Mr. Burton. So if a person----
Mr. Foote. There is a limit on me intruding or anybody else
intruding into those types of considerations.
Mr. Burton. Let me give you a hypothetical. Let's say we
were going to have, in some part of the country, let's say
major outbreak of smallpox. And let's say that we had an
institution where a doctor or scientist had some kind of an
answer to the problem. And he said he was running into because
of insurance purposes or some other legal reason his board of
directors from being able to get their support for this IRB. So
you would say what let the epidemic spread or what would you
do?
Mr. Foote. Well, I would offer an alternative.
Mr. Burton. What's the alternative you're offering him?
Mr. Foote. He never called me back?
Mr. Burton. Well, I'm telling you he's going to call you
back, and I hope.
Mr. Foote. That's just fine. This is what program staff at
NIH do is help investigators in face with our organization.
Mr. Burton. Does he know that you would help him find an
alternative?
Mr. Foote. I think I had, including at the hearing here, I
think I had three or four very cordial conversations with him
and encouraged him.
Mr. Weldon. I just want to clarify with Dr. Foote exactly
what's going on. He's done the endoscopies, he's biopsied the
kids, he's got the specimens, he wanted to do duplicate the
work that Dr. O'Leary did looking for the presence of measles
virus RNA in the lymph follicles of these kids, and that's the
nature of the patho physiologic conjecture that they're engaged
in, and the IRB Atlantic cell said no, we don't want to go
there, we don't want to mess with this.
I just want to make it very, very clear. My area of concern
is this: Is when you leave all these questions out there
unanswered, it creates a lot of uncertainty. And the British
have not handled this very well and they still continue not to
handle it very well. And that we just have an open dialog and
just absolutely pursue the data, it's in the best interest of
the program in making sure the kids continue to get vaccinated.
And I don't know what it will take to get the answers to this
question, but I'm certainly ready to work with you.
Mr. Chairman, I got to go apologize. I'd love to linger.
Mr. Burton. God bless you, my son, go in peace. But let me
just say to Dr. Foote, you will be getting a call from him in
the next couple of days, I promise you that. And I probably
will be on the phone with you in a conference call. Thanks, Dr.
Weldon.
I have to put on my specs here because vanity prohibits me
from wearing them all the time like Cyrano de Bergerac, you
have to read about him. Here is an e-mail, and this e-mail is
from who? See, I want to read to you an e-mail we got yesterday
from a father of an autistic child. Ray Gallup's son, he's 17,
he's vaccine injured and an autistic child as a result. 17
years old.
Our family is living in hell. With our 17-year-old son
Eric, who is 6 feet tall and 150 pounds. Now, imagine 6 feet
tall 150 pounds like that boy you saw on television or on the
monitor a while ago. He attacked Helen, Julie my daughter, and
myself. He head butted Julie and bit my wife on the head. Eric
bit one of my fingers.
This isn't the first time and it's getting worse. We have
to help and I'm afraid for the safety of our family and our
son. Eric was like he was 6 foot 5 and 300 pounds on Sunday
when he had his tantrum. I held him down but he tried to bite
me and kick and scratch me. I was so exhausted I couldn't
breathe and I thought I would have a heart attack. When we
closed the doors to lock ourselves from Eric--lock ourselves
from Eric--he kicked on the door breaking some of the wood.
I don't know what to do any more short of calling the
police. We're at our wit's ends. This is our lot in life. We're
trusting the medical profession that vaccines are safe. We're
paying a bitter price for that trust. It is hard to have any
holiday feelings when we see what has happened to our son and
our family.
Again, I'm sorry I couldn't attend but we are under siege.
You know, Dr. Midthun, and Dr. Foote, and Dr. Portier, when
you hear those stories, doesn't it bother you a little bit and
you keep telling us you come up here week after week, month
after month, year after year saying, well, mercury doesn't
cause that. But when we read your reports it doesn't say that.
It doesn't tell us anything. It says well, we're not sure. So
you take the position since there's no scientific evidence for
sure that the mercury is causing it, that we should go ahead
and leave it in there or have been leaving it in there.
But you don't take the other side, which is the side that
errs on the side of safety. Let's go to these pharmaceutical
companies and say OK, we know it's going to cost a little more
for single-shot vials, but we want you to do it. We want to
recall, recall all of the vaccines that contain mercury because
it is a toxic substance, and we don't know all the answers. And
until we do know all the answers, we want to err on the side of
safety so we don't have anymore 6 foot 5 kids beating the heck
out of their parents, biting their father, kicking in doors and
injuring the mother and sister. But that's going to happen more
and more.
You know my grandson, who's autistic, is going to be 6 foot
10 according to the doctors. My father was 6 foot 8, his
father--his grandfather on the other side was about 6 foot 8.
So he's going to be a tall kid. Can you imagine when he's 16
years old trying to control him if he goes out of control? What
are we going to do? What are all these families going to do?
And yet we don't have a vaccine injury compensation fund that's
responsive to these people. The language that was put in the
homeland security bill blocks an avenue through the courts. And
these families continue to fight this hardship with their own
money because they have no place to go, and you continue to
put, you continue to let this substance in there. I just cannot
understand it. I just don't understand it.
I have one question for you, Dr. Portier, and then we'll
submit some questions for the records that I hope you'll answer
for me. Dr. Portier, does the study recently published in The
Lancet identify the effects of mercury on infants who are
vaccinated with thimerosal?
Does the study recently published in The Lancet identify
the effects of mercury on infants who are vaccinated with
thimerosal?
Dr. Portier. No.
Mr. Burton. It does not. Are you familiar with the CDC's
vaccine safety data project evaluating thimerosal containing
vaccines in children that found a weak signal between the
receipt of these vaccines and neurological developmental delays
and the attention deficit disorder?
Dr. Portier. Not familiar enough with the study to give you
any intelligent comment.
Mr. Burton. Has the NIEHS and the NIH conducted any further
analysis of the VSD data base?
Dr. Portier. No, we have not, to my knowledge.
Mr. Burton. Has the NIEHS evaluated why some children seem
to hold on to mercury in their brains and their bodies? Or why
some hol onto heavy metals rather than flush it from their
bodies? If not, why not?
Dr. Portier. That is one of the issues specifically for
mercury and that's being looked at at our centers program.
That's part of the research agenda of the National Toxicology
Program and for other metals, that is certainly part of our
research agenda.
Mr. Burton. OK. Well, thank you. I think I'm going to
submit questions to you. One more thing, and this is very
important. I hope you will join with me as health professionals
in urging the President to have a White House conference on
autism which will bring parents in, scientists who have
differing points of view as well as people from our health
agencies in to discuss the problems with autism, what people go
through, what the causes are and so on and so forth. This is
such an epidemic, gone from 1 in 10,000 to more than 1 in 250
that it's something that we can't hide anymore.
I'd like for to you join me in asking the White House to
make this a real focal point by having this conference on
autism. And I guess you can't probably give me an answer until
you talk to your superiors, but I'm making that official
request, an official request. I hope you'll do that and get
back to us.
Let me conclude by saying we will continue on with this
subject. You have gotten mercury out of a lot of the vaccines.
I berated you a lot in the past and a little bit today because
it's still in some. But we have moved in the right direction.
It's a shame that it has taken this long to get it out as much
as we have. But I can tell you there's going to be a lot more
Congressmen very concerned about there because we're start
together tell all of them that when they get their flu shot,
they're getting mercury in them. And that there's a growing
body of evidence that mercury in vaccines may be a major cause
of Alzheimers.
And when I tell my colleagues that, there's going to be
more and more of them wanting to raise Cain about this. And I
know you don't want to have to deal with you know another 200
Dan Burtons, my God, that would be something even I wouldn't
want to deal with. So I hope that you'll take this to heart and
I hope we don't have to have too many more hearings like this,
but we will if we don't see some real change and see some
studies on this.
With that we'll submit some questions to you for the
record. I hope you'll answer them. Thank you for being here. We
stand adjourned.
[Whereupon, at 5:02 p.m., the committee was adjourned.]
[The prepared statement of Hon. Wm. Lacy Clay, additional
information submitted for the hearing record, and a complete
set of exhibits follow:]
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