[House Hearing, 107 Congress]
[From the U.S. Government Printing 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

                                ________

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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:]

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    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:]

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    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:]

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    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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