    [House Hearing, 106 Congress]
    [From the U.S. Government Publishing Office]

    VACCINES--FINDING THE BALANCE BETWEEN PUBLIC SAFETY AND PERSONAL CHOICE

    =======================================================================

                                    HEARING

                                   before the

                                  COMMITTEE ON
                               GOVERNMENT REFORM

                            HOUSE OF REPRESENTATIVES

                           ONE HUNDRED SIXTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 AUGUST 3, 1999

                                   __________

                               Serial No. 106-84

                                   __________

           Printed for the use of the Committee on Government Reform

         Available via the World Wide Web: http://www.house.gov/reform

                                     ______

                       U.S. GOVERNMENT PRINTING OFFICE
    62-560                     WASHINGTON : 2000

                         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       ROBERT E. WISE, Jr., West Virginia
    ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
    JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
    STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
    JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
    THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
    DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington,
    MARK E. SOUDER, Indiana                  DC
    JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
    STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
    MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
        Carolina                         ROD R. BLAGOJEVICH, Illinois
    BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
    DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
    ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
    LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
    JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
    GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
    DOUG OSE, California                             ------
    PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont
    HELEN CHENOWETH, Idaho                   (Independent)
    DAVID VITTER, Louisiana

                          Kevin Binger, Staff Director
                     Daniel R. Moll, Deputy Staff Director
               David A. Kass, Deputy Counsel and Parliamentarian
                          Carla J. Martin, Chief Clerk
                     Phil Schiliro, Minority Staff Director

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on August 3, 1999...................................     1
    Statement of:
        Kennedy, Ronald C., professor, Department of Microbiology and
          Immunology, University of Oklahoma Health Sciences Center;
          Samuel L. Katz, professor emeritus, Department of
          Pediatrics, Duke University Medical Center; and Marcel
          Kinsbourne, pediatric neurologist..........................   260
        Nelson, Tonya and Gerald, Indianapolis, IN; Rick Rollens,
          Granite Bay, CA; Carola Zitzmann, Voice of the Retarded;
          Antonia C. Spaith, Falls Church, VA; Rebecca Cole, PKIDS,
          Chapel Hill, NC; and Keith Bergen Van Zandt, M.D., PKIDS,
          Winston-Salem, NC..........................................   157
        Satcher, David, M.D., Surgeon General of the United States...   108
    Letters, statements, etc., submitted for the record by:
        Burton, Hon. Dan, a Representative in Congress from the State
          of Indiana, prepared statement of..........................     8
        Cole, Rebecca, PKIDS, Chapel Hill, NC, prepared statement of.   246
        Davis, Hon. Danny K., a Representative in Congress from the
          State of Illinois, prepared statement of...................    96
        Frenkel, Dr. Lawrence, chairman, pediatrics, University of
          Illinois, College of Medicine at Rockford, prepared
          statement of...............................................   105
        Katz, Samuel L., professor emeritus, Department of
          Pediatrics, Duke University Medical Center, prepared
          statement of...............................................   270
        Kennedy, Ronald C., professor, Department of Microbiology and
          Immunology, University of Oklahoma Health Sciences Center,
          prepared statement of......................................   264
        Kinsbourne, Marcel, pediatric neurologist, prepared statement
          of.........................................................   289
        McHugh, Hon. John M., a Representative in Congress from the
          State of New York, information from Pasteur Merieux
          Connaught..................................................   299
        Nelson, Tonya and Gerald, Indianapolis, IN, prepared
          statement of...............................................   161
        Ose, Hon. Doug, a Representative in Congress from the State
          of California, prepared statement of.......................     2
        Rollens, Rick, Granite Bay, CA, prepared statement of........   171
        Satcher, David, M.D., Surgeon General of the United States,
          prepared statement of......................................   113
        Shays, Hon. Christopher, a Representative in Congress from
          the State of Connecticut, prepared statement of............    94
        Spaith, Antonia C., Falls Church, VA, prepared statement of..   240
        Van Zandt, Keith Bergen, M.D., PKIDS, Winston-Salem, NC,
          prepared statement of......................................   249
        Waxman, Hon. Henry A., a Representative in Congress from the
          State of California:.......................................
            Prepared statement of....................................    17
            Various prepared statements..............................    20
        Weldon, Hon. Dave, a Representative in Congress from the
          State of Florida, prepared statement of....................   148
        Zitzmann, Carola, Voice of the Retarded, prepared statement
          of.........................................................   208

    VACCINES--FINDING THE BALANCE BETWEEN PUBLIC SAFETY AND PERSONAL CHOICE

                                  ----------

                            TUESDAY, AUGUST 3, 1999

                              House of Representatives,
                                Committee on Government Reform,
                                                        Washington, DC.
        The committee met, pursuant to notice, at 2 p.m., in room
    2157, Rayburn House Office Building, Hon. Dan Burton (chairman
    of the committee) presiding.
        Present: Representatives Burton, Waxman, Morella, Shays,
    Mink, Mica, Norton, Cummings, Kucinich, Davis of Illinois,
    Terry, Biggert, Schakowsky, and Ose.
        Also present: Representative Weldon of Florida.
        Staff present: Kevin Binger, staff director; Barbara
    Comstock, chief counsel; Daniel R. Moll, deputy staff director;
    James Wilson, chief investigative counsel; David Kass, deputy
    counsel and parliamentarian; S. Elizabeth Clay, professional
    staff member; Mark Corallo, director of communications; Corinne
    Zaccagnini, systems administrator; Carla J. Martin, chief
    clerk; Lisa Smith-Arafune, deputy chief clerk; Phil Schiliro,
    minority staff director; Phil Barnett, minority chief counsel;
    Sarah Despres and David Rapallo, minority counsels; Ellen
    Rayner, minority chief clerk; Jean Gosa, minority staff
    assistant; and Andrew Su, minority research assistant.
        Mr. Burton. The Committee on Government Reform will come to
    order. I know we have a big crowd that wants to get in, but
    we'll have to have the door shut, so we can hear what's going
    on. Officer, will you shut that door, please? Thank you.
        A quorum being present, the Committee on Government Reform
    will come to order. I ask unanimous consent that all Members'
    and witnesses' written opening statements be included in the
    record. Without objection, so ordered.
        [The prepared statement of Hon. Doug Ose follows:]

        [GRAPHIC] [TIFF OMITTED] T2560.001

        Mr. Burton. We will have more Members here shortly, but
    everybody is going to different hearings. This is a very, very
    busy week, as my colleagues all know.
        I ask unanimous consent, at this point, that Representative
    Schakowsky be appointed to the minority vacancy on the Criminal
    Justice, Drug Policy, and Human Resources Subcommittee. Without
    objection, so ordered.
        I ask for unanimous consent that Congressman Dave Weldon,
    who is one of the handful of physician Congressmen, join us on
    the stand and participate in our hearing today. Without
    objection, so ordered.
        Mr. Waxman. Reserving the right to object.
        Mr. Burton. The gentleman reserves the right to object.
    State his reservation.
        Mr. Waxman. Mr. Chairman, we really need to establish a
    policy when Members, who are not on our committee, are
    permitted to come and join us and ask questions. When we were
    in the majority, the policy we applied, whether it was a
    Democrat or a Republican, was that if the Member from outside
    the committee wanted to come and sit with the Members, they
    were certainly welcome to; but they were not permitted to ask
    questions because that wouldn't have been fair to other
    Members. That was the rule we applied, no matter what side of
    the aisle the Member was from.
        I don't know what the policy is now. If the policy is to
    let any Member who wants to come and join a hearing, join us
    and ask questions, it could get out of hand. So, we ought to
    have a policy established.
        Mr. Burton. Well, I think a gentleman's agreement between
    you and I would probably suffice, at this point. What I would
    suggest is if you, Mr. Waxman, have a Member that would like to
    come and ask questions on a specific topic, I don't think we
    would have any objection on our side. The reason we have Dr.
    Weldon here today is because he is a physician. We're talking
    about issues relating to the health industry and he has some
    expertise and some background in this area.
        Mr. Waxman. Well, Mr. Chairman, just to inquire further,
    and I don't--I'm not talking about this in any way personal to
    Mr. Weldon, but there are Members who have interest in hearings
    that this committee will have at one time or another. If you
    say you're going to let him come and you let someone on our
    side come, are we talking about one on each side? Or is it
    anybody who comes can come and--maybe what we could do, rather
    than work out a policy at this moment, is since we don't have
    many Members here, have an agreement that we'll let Mr. Weldon
    ask questions. But, I do think we need to think through this
    whole question.
        We had the issue come up recently with one of our Members
    who wanted to attend a hearing, and we said, look, if it were a
    field hearing, that's one thing, if it's in a Member's
    district. But, since it's a hearing in Washington, we didn't
    think it was proper to have a Member come and ask questions
    because other Members then have to wait until they take their
    turn, either on the first or second round. So, we need to have
    a policy, apply it, no matter who's involved. And this is an
    issue that--we had a policy when we were in the majority. I
    don't know what your policy is, but it sounds like for today,
    the question is Mr. Weldon.
        Mr. Burton. Well, I think the policy generally has been as
    the gentleman has stated. That's why I asked for unanimous
    consent that there be an exception made today. I think that we
    would make that exception, not as a general policy, but as an
    exception from time to time and we could do that for the
    minority. But, I'd be happy to sit down with the gentleman and
    try to work out some kind of a policy for future hearings.
        Mr. Waxman. The only thing I want to point out is that once
    you've made an unanimous consent exception, then others are
    going to say why not an unanimous consent exception for me and
    it gets harder to say no to people. Once you start down that
    road, just realize that we're sending an invitation out to
    anybody who wants to show up for any hearing, and it's going to
    be tough to control in the future.
        Mr. Burton. Well, I understand. And as the chairman--and
    you may be chairman in the next Congress, who knows. I hope
    not; but, nevertheless, it could happen. [Laughter.]
        But, if you're chairman in the next Congress, I will exceed
    to your wishes and, likewise, I hope you will mine. I will try
    not to make this a policy, but I will sit down with you to try
    to work it out, so that we can work with each other when we
    have exceptions like this that we'd like to have made.
        The gentleman will withdraw his reservation?
        Mr. Waxman. I'll withdraw my reservation.
        Mr. Burton. Thank you, very much, Mr. Waxman. Then, so
    ordered.
        We're here today to expand upon the work of two of our
    subcommittees. Both the Subcommittee on Criminal Justice, Drug
    Policy, and Human Resources and the Subcommittee on National
    Security, Veteran's Affairs, and International Relations have
    conducted hearings on vaccine issues. I'm thankful to my two
    subcommittee chairs, Mr. Mica and Mr. Shays, for being so
    diligent in pursuing issues regarding safety, efficacy, and the
    mandating of hepatitis B and anthrax vaccines.
        In this country and around the world, we have made a
    decision to vaccinate the entire population against dreaded
    infectious diseases. Children are required to receive numerous
    vaccines before they enter day care centers or schools.
    Vaccines that we now know contain mercury. Adults in certain
    professions are required to receive vaccinations for
    employment. This policy creates an inherent conflict between
    the interest of the individual and the community.
        The tension between the individual risks and the public
    benefit is a classic ethical dilemma for public health. Some
    have described the current mandating of an increasing number of
    vaccines to children to be a good intention gone too far. Many
    of you may remember the polio crisis earlier this century. It
    was through the work of brilliant scientists, like Jonas Salk
    and Albert Sabin, and their colleagues, that the polio vaccines
    were developed. It was a mad dash to the finish line of
    licensing for the manufacturers of these vaccines, while polio,
    which caused so much illness and heartache, appears to have
    been eradicated. But, there are still cases of polio today,
    cases caused by the vaccine, itself. Jonas Salk spent the last
    months of his life pleading with the government to stop the use
    of live vaccine, because of the cases of polio that it was
    causing.
        Both the Food and Drug Administration and the Centers for
    Disease Control have adverse events monitoring systems. The FDA
    system, the Vaccine Adverse Event Monitoring System, is a
    passive monitoring system. Medical professionals, the
    pharmaceutical industry, and the public report adverse events.
    Over 11,000 adverse events were reported just last year. Over
    5,900 adverse events have been reported so far this year, about
    one-sixth of those are considered serious. In all, 95,103
    adverse events have been reported to this system since its
    inception. The former FDA Commissioner estimated that only 1 in
    10 adverse events are reported, which means that we're talking
    about something close to 950,000.
        Now, what is a serious event? It includes events that
    require hospitalization, events that cause disability, and
    events that kill. When asked about the safety of their
    vaccines, one pharmaceutical representative told my staff,
    everything has adverse events, including aspirin. To the
    academic or bureaucratic realm, the risk benefit ratio is
    numbers on a page. But to the parent of a child, who suffered a
    serious adverse event from a vaccine, that risk becomes a
    reality.
        The risk was too real for the Nelson's, whose 1-month old
    daughter, Abbey, born healthy and hearty, died less than 1
    month after coming home from the hospital. They later learned
    from the doctor, who performed the autopsy, that it was a death
    related to the hepatitis vaccine given to their daughter in the
    hospital when she was 2 days old.
        To Rick Rollens, whose son acquired autism from a vaccine
    reaction, the risk was too great. The autism, vaccine linked,
    is very controversial. But, we have verified with current and
    former NIH neurologists that any injury to the brain can cause
    autism, including the shock to the neurological system by a
    vaccine. They will testify today.
        To Michelle Clements, who is not able to be with us today,
    but who has submitted written testimony, whose son has spent at
    least 3 years in a coma, as a result of the DPT vaccine, the
    risk was too great.
        We, as the government, can no longer keep our heads buried
    in the sand like an ostrich, pretending that there is no
    problem. On the flip side of this discussion is the need to
    protect the public at large from vaccine preventable diseases.
    I am not stating or implying that we should not have vaccines,
    because they are crucial to public health.
        We will hear today from Carola Zitzmann, whose son was born
    in 1964 with severe disability, after being exposed to rubella
    during her pregnancy. We will also hear from Rebecca Cole,
    whose child died from chicken pox; and from Dr. Keith Van
    Zandt, a pediatrician, whose child is living with hepatitis.
        In 1997, President Clinton directed Secretary Shalala to
    work with the States to develop an integrated immunization
    registry system and to require that all children in federally
    subsidized child care centers be immunized. This mass tracking
    of childhood vaccinations has created State registries that are
    tracking children from birth to grave. With these State systems
    reporting back to the Federal level, we have instigated
    something the American people have strongly and loudly opposed,
    national medical tracking and invasion of the American public's
    privacy. One report stated that the long-term tracking strategy
    had three steps: first to notify families with a postcard when
    their child was late for a vaccine; second, if they did not
    comply, then a government official would call them on the
    telephone and remind them; and third, if they still did not
    comply, a government official would come and visit their home.
    I think that's going too far.
        And what of attaching immunizations to Federal child care
    centers? Does this mean if your child has a medical or
    religious exemption, that he or she will not be allowed to
    access a federally subsidized facility? In our rush to
    vaccinate everyone, have we informed members of the public that
    they have choices? No, we have not. In our rush to vaccinate,
    do physicians and health care providers keep current in the
    medical literature, conscientiously reviewing medical
    histories, read package inserts and the Physician Desk
    References for contradictions, and clearly discuss these with
    their patients or their parents? Not very often. Have we become
    complacent in our protecting of our children, just so that we
    can meet some kind of a quota?
        We will hear today also from Antonia Spaith, a Department
    of Defense civilian employee, who suffered serious adverse
    events after taking the anthrax vaccine and other vaccines. The
    mandating of anthrax vaccine in the military is a great concern
    to many in the Congress. I have joined my colleagues,
    Congressman Walter Jones, Ben Gilman, and others, in sponsoring
    legislation to stop the mandating of this vaccine.
        From intense investigations, it has been learned that the
    decision to use this vaccine is fraught with errors. The
    adverse event rate is much higher than indicated and the
    military knows it. The research into its safety and efficacy
    does not provide any sense of security. We're using a vaccine
    that does not provide protection against strains of anthrax
    that would most probably be used, those that come through the
    air.
        As we have learned at the subcommittee level, this issue is
    adversely affecting military readiness. We are losing a lot of
    members of our military, who choose to leave the military,
    rather than take this vaccine. Morale is low, as a result of
    the misinformation campaign, also on the lack of information on
    adverse event reports. We learned that there is fear in the
    ranks about reporting. We learned that the Department of
    Defense filters these reports before sending them to the FDA.
    We, also, learned that in complete defiance of regulations, the
    manufacturing facility was not inspected until 1996.
        That means for 20 years, this manufacturing facility that
    produces the anthrax vaccine was not inspected, at which time
    it was learned that the quality control was deplorable. After
    20 years of producing this vaccine, they found that the quality
    control was deplorable. No vaccine has been produced and
    distributed since that inspection, which means that we've
    stockpiled vaccines that are likely adulterated and still being
    given to our service members, while the plant is being updated.
    Yesterday, a member of my staff reviewed a test video being
    prepared by the military to show to its members to inform them
    about this vaccine. It is full of intentionally misleading
    statements.
        Now, in order to keep the pharmaceutical industry in the
    vaccine development business, Congress created what was
    supposed to be a no fault system for vaccine victims to receive
    compensation. There is concern that the Department of Health
    and Human Services has modified the injury compensation table,
    and in so doing, excluded those injuries that were most likely
    to apply to the program.
        Now, we're pleased that Dr. David Satcher, the U.S. Surgeon
    General and Assistant Secretary for Health will be testifying
    on behalf of the Department of Health and Human Services. We're
    also pleased that Dr. Marcel Kinsbourne, Dr. Ronald Kennedy,
    and Dr. Samuel Katz will be testifying today, and we welcome
    them.
        [The prepared statement of Hon. Dan Burton follows:]

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        Mr. Burton. The hearing record will remain open until
    August 16th for all those who wish to make written submissions
    to the record.
        [Note.--The information referred to is held in committee
    files.]
        Mr. Burton. I now recognize my colleague and ranking
    minority member, Mr. Waxman, for his opening statement.
        Mr. Waxman. Mr. Chairman, there are a few triumphs in the
    annals of medicine like vaccinations. Vaccines have saved more
    lives than any other medical intervention in history. Today,
    they protect us from deadly infectious diseases which spread
    death, disability, and misery in other less fortunate parts of
    the world. Thanks to universal immunization, the United States
    has made tremendous progress against polio, diphtheria,
    whooping cough, and other diseases. According to UNICEF, these
    diseases kill 2\1/2\ million children and cripple 750,000
    children worldwide every year. Without vaccinations, American
    children would also be vulnerable to similar catastrophic
    epidemics.
        I don't think American parents would ever permit their
    children to be exposed to such extreme risks. But today we are
    becoming complacent about our success against infectious
    diseases. Unlike our parents and grandparents, we aren't
    terrorized every year by paralytic polio and whooping cough
    epidemics. This makes it easier to forget the value of vaccines
    and to focus on their potential risks. But, if children are
    frightened and parents discouraged about vaccines, we will
    quickly become vulnerable again to infectious diseases.
        No one doubts that there are adverse reactions to vaccines.
    It is unfortunate that they happen and that children and adults
    suffer as a result. That is why I sponsored the National
    Childhood Vaccine Injury Act of 1986, which established the
    National Vaccine Injury Compensation Program. This program
    relies upon the best available science and medicine to provide
    an alternative to litigation for individuals who suffered
    specific vaccine related injuries.
        Today we must continue to rely upon what science tells us
    about the benefits and risks of vaccines. We must continue to
    educate the public about vaccines, their benefits and risks.
    While everything we know about childhood vaccines tell us that
    their benefits far outweigh their risks, we must remain
    vigilant and continue epidemiological research into potential
    side effects.
        There is a simple way to illustrate the importance of
    vaccination. Two hundred years ago, Edward Jenner developed the
    first small pox vaccine. I was inoculated against small pox; my
    children, who were born in the 1960's, were also inoculated.
    But those of you who were born in the 1970's do not have a
    small round scar that we bear on our shoulders because you
    didn't need the small pox vaccine. Small pox no longer
    threatens our children in our beds or whole communities with
    death. It's just a memory.
        Today, we are tantalizingly close to eradicating the second
    communicable disease in history, polio. But until polio,
    meningitis, diphtheria, hepatitis, and other diseases are truly
    memories, our children and our families will continue to be at
    risk. Vaccination will remain an indispensable public health
    defense and it will be Congress's responsibility to continue to
    support and encourage universal vaccination.
        Mr. Chairman, we will hear from families today who have
    suffered either adverse reactions to the vaccine or health
    problems they believe are linked to the vaccine. We will also
    hear from the families of those who have experienced the trauma
    and stigma of infectious disease. I'm sympathetic to all of our
    witnesses and look forward to their testimony.
        Unfortunately, however, there are many witnesses that we
    will not hear from. The Democrats made a request for witnesses,
    but only half of those requests were granted. We requested to
    hear from a doctor who could have talked about efforts to
    vaccinate worldwide and the ravages of vaccine preventable
    diseases on children around the globe. We asked for a doctor to
    testify who has been doing vaccine studies since 1967 and who
    is an expert on reactions to the pertussis vaccine. And we
    asked to hear from a member of the board of directors of the
    American Academy of Pediatrics. But, these requests were
    denied.
        Many other voices are missing from this discussion. For
    example, there is no representative from the State health
    agencies who actually mandate vaccinations and administer
    vaccine programs. There's no representative from the vaccine
    manufacturers who bear a large responsibility for vaccine
    safety. I deeply regret that these groups are not here today to
    provide us with balanced and informed testimony.
        That's what hearings are supposed to be all about. We hear
    different points of view. And in the course of hearing
    different points of view, we can try to find out what the truth
    may be. But I'm sad that at this hearing we're not getting a
    balanced opportunity to get input from witnesses who have
    something very important to say.
        Now, let me just point out to everybody what that would
    have entailed. Witnesses are given 5 minutes to testify. The
    Republican majority on this committee would not let us hear
    from somebody from the American Academy of Pediatrics for 5
    minutes. The Republicans running this committee wouldn't let us
    hear from a doctor that has been doing vaccine studies since
    1967 and is an expert on reactions to the pertussis vaccine for
    5 minutes. The Republican leadership did not allow us to hear
    from a doctor who could have talked about efforts to vaccinate
    worldwide and the ravages of vaccine preventable diseases on
    children around the globe for 5 minutes.
        But I wouldn't object to a colleague of ours, who is not
    even on this committee, to be able to ask questions for 5
    minutes because I think people ought to be able to have an
    opportunity to say what they have to say. Although when we get
    Members who will hear that this is a committee they can all
    join at any moment to ask questions, we're going to have no
    time for witnesses, because the Members are going to be the
    only ones talking.
        In conclusion, I wish to submit for the record the
    positions of leading medical and patient organizations in
    support of universal vaccination. I want to submit for the
    record a statement from the World Health Organization and the
    Pan American Health Organization, the American Medical
    Association, the Association of State and Territorial Health
    Officials, the American Nurses Association, the American Public
    Health Association, the American Academy of Family Physicians,
    the Children's Defense Fund, the American Pharmaceutical
    Association, the Partnership for Prevention, the Bill and
    Melinda Gates Children's Vaccine Program, the Immunization
    Action Coalition, Every Child By Two, and the National
    Foundation for Infectious Diseases. So when we have a printed
    record of this hearing, we'll have a lot of different points of
    view in that record. It's just today, when the presentations
    are made to us orally, that we will not have the opportunity to
    hear from all of the witnesses that we requested.
        I look forward to hearing the witnesses that are here today
    and I hope that will help us further our understanding about
    vaccinations and policies that would be best suited to help
    improve the health and safety of the children of this country.
        [The prepared statement of Hon. Henry A. Waxman and the
    statements referred to follow:]

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        Mr. Burton. Well, I just like to say to my colleague, I
    regret that we were not able to have those additional three
    people testify, but we had six people on our side that wanted
    to testify and we have to set some limits. We try to respond
    and we did let you pick whomever you wanted, up to three people
    to testify. So, I apologize for not being able to accommodate
    the additional three witnesses.
        Mr. Shays.
        Mr. Waxman. Just to point out, there are nine witnesses----
        Mr. Burton. Yes, I understand.
        Mr. Waxman [continuing]. In addition to Dr. Satcher.
        Mr. Burton. We gave you more than the limit.
        Mr. Waxman. You gave us three out of the nine.
        Mr. Burton. Yes, we gave you more than you gave us when you
    were in the majority. Mr. Shays.
        Mr. Shays. I think some people got out of bed on the wrong
    side this morning. I don't think it was me. I welcome Dr.
    Weldon here and I look forward to others participating, as
    well.
        The Subcommittee on National Security, Veterans Affairs,
    and International Relations, which I chair, held four hearings
    on the Department of Defense [DOD] mandatory force-wide anthrax
    immunization programs. Questions we consider today about
    improving the safety and ensuring the efficacy of all vaccines
    apply with special urgency to the anthrax vaccine. In one
    subcommittee hearing, a DOD physician stated an important
    standard: good medical care requires use of the least evasive,
    lowest risk therapy available. All vaccines should continuously
    be measured against that standard.
        Immunization has been one of the most successful public
    health interventions in human history. It is undisputed
    vaccines have afforded remarkable, effective, and efficient
    protection against diseases that once sickened, disabled, or
    killed millions, particularly children. But as the number of
    mandatory vaccines climbs, great care must be taken, least the
    success begat complacency, or worse, arrogance about the extent
    of our knowledge about the human immune system. We know very
    little about the long-term cumulative effects of immunological
    challenges, both benign and toxic.
        Genetic variance may play a role in each individual's
    immunological response. One size of immunity may not fit all.
    So, as we look for ways to protect the public health into the
    next century, today's discussion on ways to improve the safety
    and efficacy of vaccines is an important one. I look forward to
    hearing the testimony today from all of our witnesses, those
    chosen by our ranking member and our chairman. I look forward
    to other hearings on this, since I know that we can't attempt
    to cover everything in one hearing. I particularly look forward
    to Dr. Satcher's testimony. As Surgeon General, he has been
    outstanding and I appreciate his participation in hearings I
    had when I chaired the Human Resources Subcommittee. Welcome,
    Doctor.
        [The prepared statement of Hon. Christopher Shays follows:]

        [GRAPHIC] [TIFF OMITTED] T2560.084

        Mr. Burton. Thank you, Mr. Shays. I just want to say you
    have done yeoman service with your hearings and you should be
    publicly acknowledged for that, and so should your staff.
        Are there others, who want to make an opening statement?
        Mr. Davis of Illinois. Just briefly, Mr. Chairman.
        Mr. Burton. Mr. Davis.
        Mr. Davis of Illinois. Thank you, very much, Mr. Chairman.
    I want to thank you for holding this hearing, in particular,
    given the fact that I am in agreement with those, who suggest
    that our program of vaccination has been the greatest health
    achievement that we've experienced in the last two centuries.
    I, too, believe that it should be universal, although there are
    some concerns, there are some problems, there are some
    instances, and education must continue to be a real part of the
    thrust.
        In addition to my own opening statement, I am also
    including in that statement testimony from Dr. Lawrence
    Frenkel, who is a physician, pediatrician, and immunologist.
    He's chairperson of the Committee on Infectious Disease of the
    Illinois Chapter of the American Academy of Pediatrics and co-
    chair of the Public Affairs Committee of the Greater Illinois
    Chapter March of Dimes and chairman of Pediatrics at the
    University of Illinois, College of Medicine in Rockford and
    has, indeed, been a health advocate for more than 30 years. So,
    I submit, along with my opening statement, the statement from
    Dr. Frenkel, and yield back the balance of my time.
        Mr. Burton. Without objection, that will be included in the
    record.
        [The prepared statements of Hon. Danny K. Davis and Dr.
    Frenkel follow:]

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        Mr. Burton. Mrs. Morella.
        Mrs. Morella. Thank you, Mr. Chairman. I want to thank you
    for holding this hearing today, to examine the role and
    necessary risks of vaccines and immunization. As we listen to
    the compelling testimony of our witnesses today, I would hope
    that we keep in mind the remarkable benefits society enjoys
    because of widespread vaccination. In fact, Mr. Chairman,
    vaccines and immunization programs have been so remarkably
    successful in eliminating or controlling many of the more
    common infectious diseases of childhood, that their use is
    often taken for granted. It's precisely because of this
    widespread success that the risks from vaccination, and there
    are risks, are causing such alarm today. However, we must not
    forget that vaccinations have been so successful that cases of
    diphtheria, whooping cough, tetanus, measles, mumps, and German
    measles is so unusual in the United States, that these
    infections and their consequences are unknown to most
    Americans.
        To get a clear understanding of the great contributions
    widespread vaccination has made, we need only listen to the
    stories from people like Barbara Hahn. In an earlier hearing on
    the subject, Mrs. Hahn testified about the effects of
    infectious diseases on millions of American families. I'd like
    to just read a short excerpt from her testimony to make the
    point.
        She said,

        I would like to tell you about my mother and all mothers
    like her, who suffered through the loss of a child from an
    infectious disease. Raising a family in the hills of Kentucky,
    where most people were too poor to pay for the little, if any,
    medical help available, my mother struggled to keep her family
    healthy. When one of her babies became serious ill, my mother
    and her parents did everything they could to try to help her.
    Despite their efforts, my mother watched her child, Patsy
    Lynne, die from whooping cough. While making arrangements for
    Patsy's funeral, my mother learned that another one of her
    children was gravely ill. Both children were buried on the same
    day, in the same casket, in the same grave, next to my mother's
    church.

        Mr. Chairman, childhood diseases like whooping cough and
    polio have been largely eradicated. As Mrs. Hahn's testimony
    shows, just a generation ago, the coming of summer brought
    fears of epidemics of polio. And now, iron lungs can be seen
    only in museums and dusty hospital storerooms. This has been
    accomplished through the development and use of safe and
    effective vaccines in national immunization programs around the
    world. Small pox was eradicated from the planet in 1977. Polio
    eradication was defined as a goal for the year 2000. And
    remarkably, Americans were declared to be free of wild polio
    myelitis on September 29, 1994.
        As we prepare for the 21st century, the promise of vaccines
    has never been greater. But, a great challenge still remains. I
    understand representatives of PKIDS, the Parents of Kids with
    Infectious Diseases, will testify about their children's
    continuing battle with vaccine preventable diseases. And while
    vaccines have virtually eradicated the childhood diseases of
    the last generation, other diseases, such as hepatitis B,
    baracella, tetanus, and meningitis, are still common and have
    caused serious illness or the deaths of thousands of children.
    It's astounding that approximately 1 million preschool American
    children are not adequately protected against potentially fatal
    diseases that can be prevented with a vaccine. Therefore, Mr.
    Chairman, we have to continue to work to increase the awareness
    of the benefits of disease prevention through vaccination.
        Furthermore, if the promise of vaccines is to be fully
    realized, vaccines must not only be effective in the prevention
    of disease, they have to be safe. Unfortunately, recent reviews
    by the Institute for Medicine have identified many gaps and
    limitations in current knowledge of vaccine safety. Given new
    technologies for the development, production, manufacture,
    regulation, and administration of vaccines, the vaccine safety
    network for the United States must be enhanced to provide
    appropriate evaluation of new candidates. To ensure continued
    public acceptance of vaccines, close monitoring of potential
    adverse effects and adverse reactions, adequate scientific
    evaluation of associates, and appropriate responses to newly
    identified risks of vaccines, including research in targeted
    development of new technologies and vaccines, are critical. So,
    I guess I'm saying we need to look at a balance, Mr. Chairman.
        I certainly look forward to hearing the testimony from
    today's witnesses. I welcome them all, beginning with the
    distinguished Surgeon General, Dr. Satcher. Thank you, Mr.
    Chairman, for indulging me.
        Mr. Burton. Thank you, Mrs. Morella. Are there further
    opening comments? If not, Dr. Satcher, Mr. Surgeon General,
    would you and the people who will be testifying with you from
    your office, stand, so you can be sworn. Oh, you've brought a
    lot of people with you.
        [Witnesses sworn.]
        Mr. Burton. Let the record reflect the witnesses responded
    in the affirmative. Dr. Satcher, we recognize you for 10
    minutes for your opening statement, sir.

    STATEMENT OF DAVID SATCHER, M.D., SURGEON GENERAL OF THE UNITED
                                 STATES

        Dr. Satcher. Thank you, Mr. Chairman. I am Dr. David
    Satcher, Assistant Secretary for Health in the Department of
    Health and Human Services, and Surgeon General of the United
    States. I thank you, Mr. Chairman and distinguished members of
    the committee for your invitation to testify at this important
    hearing on vaccines. With me today are technical experts from
    our department and the agencies especially involved in vaccines
    and immunizations activities. They are: Mr. David Benoir,
    Office of the General Counsel; Dr. Robert Breiman, who heads
    the National Vaccine Program Office; Dr. Walter Orenstein from
    the Centers for Disease Control, where he heads the National
    Immunization Program; Dr. Kathy Zoon and Dr. William Egan from
    the Food and Drug Administration; Mr. Thomas Balbier from the
    Health Resources and Services Administration; and Dr. Regina
    Rabenovitch from the National Institutes of Health.
        As Assistant Secretary for Health and the Surgeon General,
    I'm called upon to use the best available science to protect
    and advance the Nation's health. For over 200 years now, the
    Public Health Service has operated with the understanding that
    in so much as we care for the needs of the most vulnerable
    among us, especially our children, we do most to protect the
    health of the Nation. Throughout our history, the most
    vulnerable have often been those attacked by various forms of
    diseases. Thanks to advances in medicine and public health,
    vaccines have served as a way to offer protection to
    individuals and communities.
        Vaccines represent a remarkable public health success
    story. They are perhaps the 20th century's most important
    medical interventions, having prevented millions of diseases,
    disabilities, pain, suffering, and death. And from a risk
    benefit perspective, they are considered by many to perhaps be
    the safest and most efficacious medical interventions of our
    time.
        During my tenure as Director of the Centers for Disease
    Control and Prevention, from 1993 to 1998, we made a commitment
    and were successful at increasing the Nation's immunizations by
    the age of 2, from 55 percent to 78 percent in 1996. Determined
    not to allow the barriers of access, cost, lack of insurance,
    and others to impede us from boosting immunization rates, we
    went into the community, partnered with organizations, such as
    the National Council of LaRaza, the Congress of National Black
    Churches, and others, to help us overcome the barriers to
    immunization. Today, immunization rates are approaching 90
    percent and we're working still to increase that level. But
    despite our success, disparities in immunization rates still
    exist for some racial and ethnic groups in this country.
    Minority children still lag behind their white counterparts,
    when overall vaccination rates are compared.
        However, we in medicine and public health continue to be
    concerned that some recipients of vaccines suffer injuries, as
    a result of the vaccine. We recognize how important it is to
    acknowledge the significance of the problem of vaccine injury.
        This administration has made immunizations a priority.
    Today, immunization coverage among children in the United
    States is higher than ever before for most vaccines. These high
    immunization coverage levels translate into record--or near
    record low levels of vaccine preventable diseases. So, this
    afternoon, I will briefly discuss issues related to the
    benefits of vaccines, our concerns for injuries because of
    vaccines, our progress through the years, what we're doing to
    ensure that vaccines are as safe as possible, and what we must
    do to continue to enhance vaccine safety.
        Vaccines offer many benefits to individuals and their
    communities. When we vaccinate a child, for example, that child
    becomes protected against a series of illnesses and diseases.
    But not only does the vaccinated child receive protection from
    developing a potentially serious disease, the community also
    benefits when comprehensive vaccination programs are in place.
    Those programs provide what we call community or herd immunity,
    which helps to indirectly protect those individuals who cannot
    be vaccinated, such as those who may be too young for certain
    vaccinations or who have other health problems that prevent
    them from being immunized; yet, they're still susceptible to
    the disease.
        For example, babies that are under 1 year of age are too
    young to receive the measles vaccine, but receive some
    protection from the vaccination of other individuals. Also
    protected are children and adults, who cannot be vaccinated
    with some vaccines for medical reasons, such as children with
    leukemia. So, the entire community benefits from the reduction
    of the spread of infectious agents, and healthier communities
    mean a healthier Nation.
        Vaccines not only save lives and eliminate disability,
    pain, and suffering, they are also cost effective.
    Immunizations are one of the most cost effective medical and
    public health interventions we know.
        Let me give you an overview of our experience with
    immunizations and treatment of vaccine preventable diseases.
    Today, there are far fewer visible reminders of the suffering,
    injuries, and premature deaths caused by diseases that can now
    be prevented with vaccines. By now, many Americans have heard
    my story. When I was 2 years old in Anniston, AL, I came down
    with a severe case of whooping cough, which led to pneumonia,
    and a family physician, who came out to the farm to visit me,
    predicted that I would not live out the week. I was fortunate.
    I survived. That year, 1943, in the United States over 190,000
    children suffered from whooping cough and 3,500 died; 1995, in
    this country, there were 5,000 cases of whooping cough and 5
    deaths. And that's not our best story. In fact, that's one of
    our worst stories, in terms of where we are today.
        A physician entering practice today may never see a case of
    meningitis, due to haemophilus influenza type B. Before the
    introduction of effective vaccines in 1988, approximately 1 in
    200 children under the age of 5 developed invasive haemophilus
    influenza B disease. It was the leading cause of bacterial
    meningitis in children under 5, accounting for about 60 percent
    of all such cases. Today, most residents in pediatrics will not
    see a child with haemophilus influenza meningitis. In fact,
    whereas in 1988, there were 20,000 cases, today, there are only
    about 100; and whereas there were almost 500 deaths a year,
    today, there are very few, if any. By 1998, vaccination of
    preschool children reduced the number of cases by more than 99
    percent.
        Finally, in the 1960's, many people witnessed firsthand the
    terrible effects of rubella, commonly known as German measles.
    During an epidemic between 1964 and 1965, about 20,000 infants
    were born with deafness, blindness, heart disease, mental
    retardation, and other birth defects, because rubella virus
    infected their pregnant mothers. Today, thanks to nearly
    universal use of effective vaccines, the rubella virus poses
    virtually no threat to the children of expecting mothers. So,
    we can see from our track record that vaccines offer a great
    many reasons for placing our trust and hope in them, in
    protecting the health of individuals, communities, and the
    Nation.
        But, we are concerned about vaccine safety. As gratifying
    and as efficacious as the benefits of immunizations are, we
    still have serious concerns. Vaccines are not 100 percent safe.
    They have risk. A small percentage of children still suffer
    adverse consequences, as a result of vaccines. And as long as
    there is a risk of injury or illness in even one child, we
    should not, we will not be satisfied. Our concern for children
    injured because of vaccines is not without tangible expression.
    We've developed a compensation system to provide families with
    financial restitution for vaccine related injuries.
        So, how are we dealing with the problem of vaccine injuries
    today? We're committed to vaccine safety through enhanced
    surveillance systems, vaccine safety research, adopting safe
    vaccine administration policies, and educating and providing
    information to parents, the health care providers, and to the
    general public. We have a draft proposal for a comprehensive
    vaccine safety program built upon the cornerstones of
    surveillance, research, communication, and education. This
    updated proposal has been reviewed and approved by the National
    Vaccine Advisory Committee and is now undergoing review within
    the Department. We're working diligently to ensure that
    vaccines licensed in the United States are safe and effective
    as they can be, and we have one of the toughest vaccine
    approval systems in the world.
        However, even after the extensive studies required for
    licensure, post marketing research and surveillance are
    necessary to identify safety issues, which may only be detected
    following vaccination of a much larger population. This is
    because very rare events may not even be detected and if noted,
    not shown to be due to a vaccine. The National Childhood
    Vaccine Injury Act of 1986, which Congressman Waxman authored
    and mentioned earlier, led to the creation of a unified
    national system to collect, manage, and evaluate the reports of
    possible adverse events. This system, which was initiated in
    1990 and jointly managed by CDC and FDA, is a vaccine adverse
    event reporting system. And recently, the CDC has added to that
    the Vaccine Safety Datalink to really pursue these cases, to
    understand the relationship between them and vaccines.
        In 1997, we had to make the very tough decision, when I was
    director of CDC, to switch our polio immunization strategy from
    primary reliance on oral polio vaccine [OPV], to an inactivated
    polio vaccine [IPV]. We made the switch to IPV, which never
    causes polio, even though OPV only very rarely caused it, 1 in
    2.4 million doses. So, we estimate that we spend $3 million per
    injury or a case of polio from oral polio vaccine; i.e., we
    spend $3 million to prevent one case. And, yet, we think that's
    well spent. If we can save a single child, we feel that it is
    worth it.
        A good example of how the vaccine safety monitoring system
    works is in alerting us to and helping address the recent
    concern about rotavirus vaccines and a type of obstruction,
    which we call intersusception. Between September 1998 and June
    1999, 15 cases of intersusception following rotavirus vaccine
    were reported to our reporting system. The cases tended to be
    younger than most cases of intersusception normally occurring
    in the absence of vaccination. This signal led to special
    studies, to evaluate whether there is truly causal roles of
    rotavirus vaccines in intersusception. On July 16th, CDC
    recommended that vaccination of children scheduled to receive
    the rotavirus vaccine before November 1999 be postponed, until
    the studies are completed and findings are available.
        I've adopted, as one of my priorities as Surgeon General,
    to move this Nation toward a more balanced community health
    system, which balances health promotion, disease prevention,
    early detection, and universal access to health care. One of
    the goals of that health system is to ensure that every child
    has the opportunity for a healthy start in life. A very
    definite part of that healthy start is ensuring that children
    are immunized against vaccine preventable diseases. And we're
    making great progress.
        So, Mr. Chairman, in conclusion, vaccines have given us
    much for which we can be grateful. They've eradicated small
    pox. They've eliminated polio myelitis in the Americas and
    controlled measles, rubella, tetanus, diphtheria, haemophilus
    influenza type B, and other infectious diseases. And they have
    saved millions of lives and avoided disease, disability, pain,
    and suffering, in many people.
        The public has a right to and should expect safe vaccines.
    Although no system is perfect and no medicine or vaccine can
    ever be guaranteed to be 100 percent free of possible side
    effects or adverse events, particularly when administered to
    millions of people, we are still committed to improving the
    safety of vaccines. The Department and its constituent
    agencies, who are represented here today, and the scientific
    community and industry strive to continuous improvement in
    vaccine safety. As we enter the 21st century, promoting optimum
    health of people through the development and administration of
    safe and effective vaccines will continue to be a priority for
    our department.
        Mr. Chairman and committee members, I assure you, in the
    interest of protecting and promoting public health, we will
    continue to make policy decisions and recommendations based on
    the best available science. Vaccines are very safe and
    effective. They are not perfect and will require continuing
    vigilance and research. Thank you for this opportunity to
    testify.
        [The prepared statement of Dr. Satcher follows:]

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        Mr. Burton. Thank you, Dr. Satcher. We have to go and vote.
    It will take about 10 minutes.
        [Recess.]
        Mr. Burton. Would everyone please take their seats. We have
    other Members who will be drifting back in. We had two votes on
    the floor of the House. I apologize for the delay, but this is
    a very hectic week. In order to make sure that we keep the
    hearing moving, I will go ahead and start the first round of
    questioning. I'm sure Mr. Waxman will be back here shortly.
        Dr. Satcher, first of all, I would like to preface my
    questions by saying we think the Department of Health and the
    National Institutes of Health, the National Cancer Institute,
    and the Food and Drug Administration do a great deal of very,
    very good work. I don't think anybody on this committee or
    probably in the entire country believes that vaccinations
    should be done away with. We all believe that vaccinations have
    provided a quality of life and health in this country that is
    unparalleled in the annals of world history.
        However, there have been some disturbing things that we
    have been told over the past couple of years. I, myself, have
    experienced some things that have been of concern to me. My
    granddaughter, whom I told you about before the hearing, when
    she was very, very young--she's 5 years old now and doing very
    well, I might add--she got a hepatitis B shot and within 12
    hours, she was in the hospital and not breathing. It was a
    direct result of a reaction to the hepatitis B shot. She came
    out of it and the doctors did a good job, but that was of great
    concern to us.
        My grandson--I only have two grandchildren--my grandson got
    a DPT shot, and he's now been adjudged to be somewhat autistic.
    We've talked to other people who have had similar problems.
        So, what we want to find out, if we can, if not today, at
    some point in the future, whether or not these are problems
    that emanate from these shots, because there are a number of
    cases like that across the country. We're going to hear from
    some witnesses today who will talk about that.
        So, let me start off with hepatitis B cases. Can you tell
    us what percentage of hepatitis cases are not from sexual
    transmission or from blood or needle exchange properties? What
    percentage is caused by either needle exchanges or blood
    transmissions or from sexual transmission?
        Dr. Satcher. You want to know what percentage are not from
    one of those causes?
        Mr. Burton. Yes.
        Dr. Satcher. OK. Well, let me ask Dr. Orenstein to respond.
        Dr. Orenstein. Thank you, very much. About 25 to 30 percent
    of cases have no identified risk factors that are reported.
        Mr. Burton. About 25 to 30 percent have no identified risk
    factors, that's correct?
        Dr. Orenstein. Yes.
        Mr. Burton. When I talk to some other physicians, who are
    in the Congress, and they thought the percentage was much lower
    than that. But, is that a scientific fact?
        Dr. Orenstein. Those are data collected from both Sentinel
    Surveillance System, is the main area that information comes
    from. These are people, who are interviewed and do not admit to
    any risk factors. And you will hear about cases--or have seen
    cases in prior hearings that have had no identified risk
    factors.
        Mr. Burton. How many children under the age of 5 have been
    infected with hepatitis B from things other than needle
    exchanges, blood products, or from sexual transmission?
        Dr. Orenstein. I don't have the data broken down by under
    5. But under 9, the CDC estimates that about 19,000 infections
    with hepatitis B virus occur----
        Mr. Burton. What percentage would that be, Doctor?
        Dr. Orenstein. Overall, it would be, in the absence of
    vaccination, about 350,000 infections. So, I'd have to do the
    math, but it's about----
        Mr. Burton. So, 350,000 infections about. And how many did
    you say from under the age of 9?
        Dr. Orenstein. Under the age of 9, with no known risk
    factors, there are about 19,000.
        Mr. Burton. So, 20,000 out of--so, it's about one-
    twentieth?
        Dr. Satcher. For that age group, it would be much higher
    than that.
        Dr. Orenstein. For that age group, it would be----
        Mr. Burton. No, but I mean overall cases.
        Dr. Orenstein [continuing]. Higher. But for all cases, it
    would be, I guess, 6 percent, isn't it--about 6 percent.
        Mr. Burton. OK. But under the age of 5, it would be much,
    much less than that?
        Dr. Orenstein. According to some of our data on serology,
    the incidence occurs between--often between age 2 and age 5.
    And so, it's not clear that there is like a continuous level
    increase up through age 9.
        Mr. Burton. If you keep statistical data, for the record,
    I'd like to have you submit, the number of cases and the
    percentage of hepatitis B cases under the age of 5. When do we
    require children to get the hepatitis B shot, at what age?
        Dr. Orenstein. It depends on the State, because it----
        Mr. Burton. Well, most States.
        Dr. Orenstein. Most States would be school entry, age 5 to
    6.
        Mr. Burton. I think it's very significant, because like I
    said, my granddaughter had to get it at a very, very young age
    and there were very severe side effects. I'm sure other parents
    have that same problem.
        Dr. Satcher. Well, I think the question here is when is it
    recommended----
        Mr. Burton. Right.
        Dr. Satcher [continuing]. As opposed to when is it
    required.
        Mr. Burton. It's recommended at what age?
        Dr. Satcher. Well, now--at birth for most children. As you
    know now, we've at least relaxed that for children of mothers,
    who have not shown any evidence of exposure. But the
    requirement relates to day care or school entry.
        Mr. Burton. That's usually 5 to 6 years old?
        Dr. Satcher. Right.
        Mr. Burton. We talked a while ago about the filing deadline
    of August 6th for hepatitis claims to the National Vaccine
    Injury Compensation Program. As I understand it, that is
    statutorily set for August 6th, which is about 3 days from now;
    is that correct?
        Dr. Satcher. Well, I will ask the person who heads that
    program, to respond.
        Mr. Balbier. Mr. Chairman, you are correct. August 6th is
    the deadline for filing claims that are----
        Mr. Burton. Well, there are a number of people, I'm sure,
    across the country that were unaware of that. I was wondering,
    would you work with us to try to get that extended for, say, 3
    or 4 months, so that people across the country, who may be
    paying attention to what we're talking about today, would have
    a chance to file a claim, if they need to?
        Mr. Balbier. It would require legislation to extend the
    deadline. I would point out that that did happen once before in
    the history of the program for claims arising prior to 1988.
        Mr. Burton. Well, what method has been employed to make the
    public aware of that?
        Mr. Balbier. We have several ways of doing that. We have
    vaccine information statements that are provided routinely.
    Every time a child is immunized, it provides information on the
    Vaccine Injury Compensation Program, including our 800 number
    and our website, where they can get more information.
        Mr. Burton. Well, unfortunately, we had a problem in our
    family and I didn't know about it and I'm chairman of this
    committee. So, I know that it must not have been as far
    reaching or as effective as it could have been. So, I wish we
    would work together to try to get an extension and try to
    inform the public, because I'm sure there are a lot of people
    who would like to at least make that kind of a claim.
        Mrs. Mink. Would the chairman yield?
        Mr. Burton. I'd be happy to yield to my colleague.
        Mrs. Mink. I wanted to inquire why we have a statutory
    deadline? Why did Congress set a deadline?
        Mr. Balbier. The deadline that we're going to reach at the
    end of this week is the deadline for filing claims that
    occurred for the 8 years prior to the coverage of the hepatitis
    B vaccination. Hepatitis B vaccination was covered under the
    National Vaccine Injury Compensation Program on August 6, 1997,
    when the excise tax went into effect to cover that vaccine. At
    that time, the vaccine was covered for any injury that was
    thought to be related to the vaccine, and people had 2 years to
    file a claim, for any vaccine administered during the 8 years
    prior to 1997, and they had 2 years to do so. So, we are now
    reaching the August 6, 1999 deadline for filing those 8 year
    retroactive claims. So, it's only for those claims that
    occurred prior to the coverage of hepatitis B vaccine under the
    compensation program.
        Mrs. Mink. So, subsequent to 1988, there are no statutory
    deadlines. Is that what I'm to understand?
        Mr. Balbier. There are deadlines of 3 years for filing an
    injury claim from the onset of injury and 2 years from the date
    of death, if a death is thought to be related to the vaccine,
    or 4 years from the onset of the injury that led to the death
    from an injury thought to be----
        Dr. Satcher. We wish to point out, Mr. Chairman, that the
    Secretary has submitted proposed legislation that would extend
    some of those times.
        Mr. Burton. Well, I would like to work with you and the
    Secretary, then, to get that extension passed through the
    Congress, because, like I said, I'm not sure the American
    people have really been well informed about that.
        Dr. Satcher. I believe it would extend it to 6 years,
    right?
        Mr. Balbier. That's correct.
        Mr. Burton. Oh, to 6 years?
        Mr. Balbier. It would double the statute of limitations to
    6 years for injury requirements.
        Mr. Burton. That would be even better.
        Mr. Balbier. We have already proposed legislation to do
    that, and we would like very much to see that happen.
        Mr. Burton. We'll work on that. Would you make sure we do
    that?
        The other things that I wanted to ask you about, do you
    keep records on people's concerns about the side effects of
    certain vaccines, like hepatitis B and the DTP shot?
        Mr. Balbier. With the compensation program, itself?
        Mr. Burton. Not necessarily the compensation, but where
    people are making claims that their child or have been making
    inquiries about their child being affected, they believe, by
    the shot.
        Mr. Balbier. We have several ways of tracking that. We have
    what we call a passive surveillance system, called the Vaccine
    Adverse Event Reporting System, whereby any provider of the
    vaccine can report any injury thought to be related to vaccine.
        Mr. Burton. Wait a minute, any provider of the vaccine?
    You're talking about the pharmaceutical company?
        Mr. Balbier. No, the administrator of the vaccine. That's
    one way.
        Mr. Burton. Which would be the doctor?
        Dr. Satcher. But, it also could be--it's not limited to the
    doctor.
        Mr. Balbier. Right. In fact, one of the advantages of the
    system that was developed, the Vaccine Adverse Event Reporting
    System, is that it allows anybody to report. The law also
    requires that physicians give out vaccine information
    statements to parents before their child is immunized. And on
    that statement, it gives the parent the number that they can
    report a case. And that was put in purposely, because some
    parents were concerned, in the 1980's, that their doctors
    weren't reporting cases. So, we offer the opportunity for
    parents to report, as well.
        Mr. Burton. Could we get the statistical data on at least
    two of those: hepatitis B and the DTP shot?
        Dr. Satcher. There's another point that I think we should
    probably make and that is the reporting system is one thing.
    And as you know, there are about 12,000 incidents reported a
    year. Recently, CDC has initiated what is called the vaccine
    survey data link. So, we are actually aggressively studying the
    relationship between the vaccine and adverse events, in about 2
    percent of the population?
        Dr. Orenstein. It covers about 2 percent of the U.S.
    population of children. And it allows us to look at when a
    given illness occurs, how often it's occurring without
    vaccination, so that we can compare the two.
        Mr. Burton. If you could provide that information, we would
    really appreciate it.
        Now, regarding anthrax and the anthrax vaccine, we have
    been told by the General Accounting Office [GAO], in two
    separate hearings that my colleague, Mr. Shays, held as
    chairman of that subcommittee----
        Mr. Shays. Four hearings.
        Mr. Burton. Four hearings, that for 20 years, the person,
    who was producing this, really wasn't checked thoroughly, as
    far as the quality control at their facility, I believe it was
    in Michigan. And when they found out about it, they went up
    there and checked, and they found that it was way below par and
    that the serum that was being used, and is still being used,
    might be, in many cases, tainted. Now, we've had 300,000 people
    vaccinated in the military with this serum and I just don't
    understand how we could allow that to happen, if there's some
    question about the cleanliness of the product, whether or not
    it might cause side effects simply because it might be tainted
    and why that product was not inspected more thoroughly over
    that 20-year period and why the producer of that product is
    still producing it, to the best of my knowledge.
        Dr. Satcher. I'm going to ask Dr. Kathy Zoon, who is head
    of the Center for Biologic Evaluation and Research at FDA, to
    respond. You know that the anthrax program is a DOD program,
    but your question is still relevant.
        Mr. Burton. I understand. But, I understand that they're
    talking about expanding the anthrax vaccination program to
    children. And that troubles me a great deal, because we have
    had a number of service people, who are not only getting out of
    the service, but have had severe side effects.
        Dr. Satcher. We have not made that recommendation and that
    kind of recommendation would come through the Advisory
    Committee on Immunization Practices.
        Mr. Burton. Well, maybe it was just for military children;
    I don't know. But, that's what I've been told.
        Dr. Zoon. Thank you, Mr. Chairman. I would like to, one,
    say that vaccine safety to the FDA is extremely important and
    with any vaccine, including anthrax, there are four levels, in
    which we oversee the safety. One is through the review of the
    data that comes in during the development of a vaccine and then
    data that comes into the agency, as part of the licensure
    procedure. That is the beginning of the vaccine and the
    surveillance that FDA does. Subsequently to that, we do
    inspections of facilities that produce vaccines. And we, also,
    are involved in release of lot material and review of protocols
    for lot release before any product can be distributed. And
    finally, that we are involved with surveillance, which includes
    the VAER system and work with the CDC very closely on followup.
        With respect to your question regarding the facility
    producing anthrax vaccine, there have been many inspections of
    that particular facility over the years. On each inspection,
    not every part of the facility may be inspected completely at
    each time. However, many of the records are inspected on each
    of the inspections. And, in fact, there have been multiple FDA
    inspectors in the course of the past 10 years in the facility
    at which you're speaking. So, there has been followup. In
    addition, FDA reviews all the lot release protocols for this.
    And right now, the company is not manufacturing and
    distributing vaccines.
        Mr. Burton. Thank you. I'll followup on that later. Mr.
    Waxman.
        Mr. Waxman. Dr. Satcher, you're the head of the Public
    Health Service, and that Public Health Service in the United
    States, as I recall, was set up in the last part of the 18th
    century, 1798. I also recall the reason that we have the Public
    Health Service in the United States was because of the yellow
    fever epidemic, which was transmitted by merchant sailors who
    had wiped out 10 percent of the population of Philadelphia. As
    a result, we set up the Public Health Service. Isn't that
    right?
        Dr. Satcher. Yes, an act of Congress, because at that time,
    as you know, Congress was located in Philadelphia. President
    John Adams signed the act of Congress in 1798, giving rise to
    what we then called the Marine Hospital Service to take care of
    merchant seamen. But, you're absolutely right, it was in 1793
    that this yellow fever outbreak hit Philadelphia and it was
    felt to have been related to merchant seamen, who were going in
    and out of the country. It was a devastating experience. As you
    said, it wiped out over 10 percent of the population; 50
    percent of the population of Philadelphia fled because of that
    epidemic.
        We were back there last year, in fact, to begin the 200th
    anniversary celebration of the Public Health Service, because,
    later, the Marine Hospital Service became the Public Health
    Service. So, we went back there in July to begin our
    celebration. And we retraced the trail of the yellow fever
    epidemic and it was really quite an experience. But, it was
    this outbreak that gave rise to the Marine Hospital Service,
    which would later on become the Public Health Service.
        Mr. Waxman. I think we shouldn't forget history.
        Dr. Satcher. I agree.
        Mr. Waxman. And I worry sometimes that the successes that
    the immunization program has brought to this country and to the
    world might be a victim of the--the program might be a victim
    of its own success, when people forget about these dreaded
    diseases----
        Dr. Satcher. Right.
        Mr. Waxman [continuing]. That still occur. Right now, as a
    matter of fact, in certain parts of the world, mainly Russia,
    according to press accounts, there are over 2,000 reported
    cases of diphtheria since January 1 of this year. Can you
    explain how existence of a disease in a foreign country, such
    as diphtheria in Russia, can threaten unvaccinated children in
    the United States?
        Dr. Satcher. Let me give another example, measles.
    Virtually all of the cases of measles that we have seen in
    recent years have been imported. They've come in from other
    countries and they've led to, in some cases, outbreaks in this
    country, when they got into a population that was not
    vaccinated. The risk to the population of people, who take
    exemptions for vaccinations, the risk of measles is 35 times
    what it is in the rest of the population and you know less than
    1 percent of the population takes advantage of religious or
    philosophical exemptions. We're talking 0.64 percent. But even
    with that small number, there's a 35 time full risk of measles.
    And most of the measles comes from other countries.
        Mr. Waxman. So, in the United States, some people don't get
    vaccinated?
        Dr. Satcher. They take exemption because of religious
    reasons there are 48 States that allow for religious
    exemptions, every State except Mississippi and West Virginia.
        Mr. Waxman. Now, as I understand the chairman's statement,
    I don't want to attach any policy to it because he has to speak
    for himself, but it sounds like he and others are saying maybe
    we ought to leave a choice to everybody, whether they want
    their kids to be immunized or not. I don't know if that--let me
    not attribute it to him. Would that make sense as a policy for
    public health, if we just let people make that choice for
    themselves?
        Dr. Satcher. I think by definition in public health, we're
    concerned about the health of the individual; but, we're also
    concerned about the health of the community, the population.
    And we make rules to protect the community. In fact, you can't
    even protect the health of the individual, unless there is a
    community approach to things like immunization. So, it is true
    that when we make decisions and recommendations about
    immunization, we're concerned about the population. That's very
    basic to public health.
        Mr. Waxman. What if I say it's my child and I'm willing to
    take the chance because I heard that there are some adverse
    reactions. I heard about a congressional hearing that seemed to
    put a spotlight on those adverse reactions and I don't want to
    take a chance for my child. My child might be at risk, but am I
    putting other children at risk?
        Dr. Satcher. Well, no question about it. I mean, when a
    child is not immunized--and many States, as I said, allow
    exceptions--exemptions for religious, and then 15 States, I
    believe, allow philosophical exemptions. But, we know from much
    of our experience, and certainly Dr. Orenstein can give more
    details about outbreaks that have occurred in population for
    religious reason and others that took exception--I respect
    people's religion if they decide to take an exemption. But,
    clearly, if States did not have any rules about what it takes
    to get into school, many more children would be affected by
    infectious disease outbreaks.
        Mr. Waxman. Now that means we've got to be sure that these
    vaccines are as safe as possible. What mechanisms are in place
    to assure the vaccines are safe?
        Dr. Satcher. Well, there are quite a few of them, and I'll
    just give an overview. We have a very tight surveillance
    system. And I believe the most important thing, of course, is
    what Dr. Zoon said. We take new vaccines through at least four
    phases. I mean after the animal studies, there's the phase one
    study, looking at safety in a small number of individuals. Then
    there's the phase two studies, which look at dose ranges for
    vaccines. Phase three studies, like the one that they're
    beginning now in Thailand for HIV vaccine, really implements
    the vaccines in a larger population of people, who are at great
    risk for an infectious disease like HIV. And it evaluates what
    happens, in terms of safety and efficacy. And only after you've
    been through that does FDA then approve implementation of that
    program. And even after that, there's a so-called post
    marketing phase, in which you really look at what happens when
    you make this vaccine available to a broader population.
        Mr. Waxman. That's the Vaccine Adverse Event Reporting
    System?
        Dr. Satcher. That's right.
        Mr. Waxman. That's the post-marketing surveillance?
        Dr. Satcher. Post-marketing surveillance is the Vaccine
    Adverse Event Reporting System, and, in some cases, even some
    more detail followup. As I mentioned, the Vaccine Safety
    Datalink, which is primarily with managed care programs, but
    involves more than 2 percent of the population, looks at these
    events and sees to what extent they relate to the vaccine.
        Mr. Waxman. Mr. Chairman, I appreciate getting a little
    extra time because I want to ask some questions about the
    Vaccine Compensation Program, which I am proud to have
    authored, and I also have a conflict because I'm supposed to be
    at a conference on another piece of legislation. It has nothing
    to do with anything we're discussing today.
        The Vaccine Compensation System was set up to try to make
    sure that people didn't have to go to court and go through all
    the expense of litigation in order to be compensated when they
    had an adverse reaction from vaccines. And I think it's well
    worthwhile, Mr. Chairman, for us to use our oversight authority
    to be sure that program is working.
        Now, the administration is proposing that there be a
    lifting of the time limits for people to come in with their
    claims. Could you tell us about that?
        Dr. Satcher. We have--and I'm going to ask--where is----
        Mr. Balbier. I'm right here.
        Dr. Satcher [continuing]. In terms of how the litigation
    process has worked and how well it's worked. But, I think what
    we're concerned about is making it as easy as possible for
    people to file claims and to report adverse events. So, the
    Secretary made some proposals--legislative proposals that would
    make that process much easier than it is now. And I, also, want
    to say that when in doubt, we try to give the benefit of the
    doubt to the petitioner.
        Mr. Waxman. I sure hope so.
        Dr. Satcher. We do. Without question, we do it in this
    program.
        Mr. Waxman. Well, we're going to hear testimony contrary to
    that and I'm concerned about it, because I think we ought to
    give the benefit of the doubt.
        Dr. Satcher. I think we can demonstrate that. I can give
    some specific examples, where the Advisory Committee on
    Childhood Vaccines, made up, in addition to experts, parents of
    children, who have suffered events, are members of that
    committee. And there have been times when that committee has
    used its authority to override other committees, to make sure
    that we give the benefit of the doubt to the petitioner.
        Mr. Waxman. I want to get more detail on that and I want to
    get more for the record. The administration is going to propose
    some legislation. And if Congress is going to deal with
    legislation, I think we can recognize the fact that there is a
    lot of money in that vaccine fund at the present time. Mr.
    Chairman, maybe one area where we can work together is to make
    sure that if there are excess funds, we devote those excess
    moneys for more vaccine safety research and surveillance.
        I don't know if you're in a position to comment on that,
    because the administration would have to take its position. But
    do you think that might make some sense?
        Dr. Satcher. Well, obviously, Congress is going to have to
    make that decision. I believe there is about $1.4 billion in
    that trust fund now and there have been various proposals
    suggested. One proposal would reduce the excise tax from 75
    cents to 25 cents. Another proposal would be to use money from
    that fund to fund safety research. And, you know, obviously, I
    would--I favor vaccine safety research, because I think, as I
    said in my testimony, we should do everything we can to make
    vaccines as safe as possible. But, using the trust fund for
    that purpose is something the Congress must decide.
        Mr. Waxman. Yes. Now, you get these reports about adverse
    reactions. What do you do with them? Do you have any examples
    of where you've gotten the information and have been able to do
    something to make vaccines safer?
        Dr. Satcher. Tom, I believe that you----
        Mr. Waxman. Rotavirus is one issue that I've heard about.
    Can you tell us----
        Dr. Satcher. Oh, yes, no, that's the one, OK.
        Dr. Orenstein. I think there are a number of things to
    evaluate the reports and to take action when action is
    indicated and to do further research when signals are generated
    that there may be a problem with vaccine safety. Vaccine safety
    is absolutely critical to the immunization program.
        Rotavirus is probably a very good example, because it's a
    recent example, in which a signal was generated about potential
    intestinal blockage in children younger than the usual age at
    which the blockage would have occurred in the absence of
    vaccine. Because of that, we did two things. It was such a
    strong signal, and combined with other data we had, that we
    recommended a postponement to vaccination, at least until
    November, so we could clarify whether, indeed, rotavirus is
    causing intestinal obstruction or not. And we are in the
    process of undertaking a major national study to evaluate that.
        There are other signals that have been suggested in the
    Vaccine Adverse Event Reporting System, such as the
    relationship of Guillian-Barre Syndrome, a paralytic illness
    with influenza vaccine. We undertook research to look at that,
    which suggested that about once in a million doses of influenza
    vaccine, there could be a problem. There is continuous
    monitoring. The FDA looks at death reports. It looks at
    clinical reports. There are meetings regularly with FDA and CDC
    in order to try to take a comprehensive look at vaccine safety.
        Mr. Waxman. Let me say if in rare cases there is an adverse
    reaction, we ought to compensate the victim as best we can for
    that adverse reaction. But I don't want this country to become
    lax in the area of vaccinating our kids, because I don't want
    these diseases to come back and I don't want people looking at
    a hearing like this and thinking, oh my gosh, more people are
    hurt than helped when the child's immunized.
        Because that isn't any cost benefit evaluation--we always
    hear we ought to have cost benefit evaluation--but the benefits
    outweigh the costs enormously to have our children immunized.
    Do you agree with that?
        Dr. Satcher. Well, a good example is just the followup on
    what Dr. Orenstein just said about the one in a million risk of
    Guillian-Barre Syndrome for influenza. The risk of
    hospitalization from getting the disease influenza ranges from
    200 to 1,000 times that. That's the risk of not just having
    influenza but having to be hospitalized with influenza. It's
    1,000 times greater than the risk of getting Guillian-Barre
    Syndrome.
        Mr. Burton. Thank you again, and let me just apologize to
    you for trying to impute some views. I don't know what your
    views are on the subject so I should not have asked the
    question in that way.
        Mr. Shays. Thank you.
        Mr. Burton. But I appreciated the witnesses answering the
    question.
        Mr. Shays. Thank you, Dr. Satcher, and your staff for being
    here. We are not looking at the issue of vaccines for children
    right now, but my subcommittee is looking at the issue of
    whether we should have a mandatory program for our military
    personnel to protect against various biological agents; one is
    anthrax. But there are many others, and there are questions of
    different types of anthrax and which you should be protected
    from. I'm going to focus more on that, and I'm just going to
    accept as a fact that besides just teaching general
    cleanliness, which has probably done a world of difference to
    society, vaccines have been second only to that in terms of
    their benefit to society.
        And so I don't know if this would be Dr. Zoon or anyone
    else, but I will ask you and you can defer. How long might it
    take to review and approve a new recombinant vaccine against
    anthrax? How long would it take, or should it take?
        Dr. Zoon. If a biologic license application came in and it
    was evaluated that a new recombinant anthrax vaccine would
    presumably be a priority for the FDA, which would probably mean
    we would review the application within 6 months.
        Mr. Shays. But overall, from start to the end, review an
    application, so much more, would have to go in before they
    could make that application.
        Dr. Zoon. Yes.
        Mr. Shays. What's the sense of the total--it would just
    take you 6 months, or it would take the Government 6 months,
    but in addition----
        Dr. Zoon. I think you're asking about the development time?
        Mr. Shays. Right.
        Dr. Zoon. Is that correct?
        Mr. Shays. Yes, ma'am.
        Dr. Zoon. Yes. It varies for a product how long it can take
    under development. And presumably, once you've discovered it
    through the time it has all the pre-clinical information,
    manufacturing information, and clinical information can vary in
    the timeframe. Generally, the shortest timeframe to collect all
    that information is 2 years, and sometimes it can take much
    longer.
        Mr. Shays. What kind of data would FDA require to
    demonstrate efficacy of a new anthrax vaccine against aerosol
    challenges in humans?
        Dr. Zoon. At this point in time, there are a number of
    different opportunities and models that we would look at for
    both pre-clinical data and data in humans. Because of the
    seriousness and the ethics involved with doing a challenge
    study with anthrax, clearly that would not be possible. Also,
    the incidence of anthrax in the United States is very, very low
    and therefore a natural history could not be done. What could
    be, what we would have to look at would be several things, and
    this is not all-inclusive, but just to give you some sense is,
    we'd look at pre-clinical data, animal model data, looking at
    challenge data in good animal models. We'd also look at safety
    data in humans and we'd look at immunogenicity data in humans
    as a start.
        Mr. Shays. Which leads to the question, what is the status
    of the FDA regulations on correlating the data on animal immune
    response to the likely response in humans?
        Dr. Zoon. My understanding, there is a proposed regulation
    that has been drafted. I am not certain as to the status of it
    right now.
        Mr. Shays. And finally, of the most widely discussed
    biological warfare agents, one is smallpox, another is anthrax,
    another is the plague. Now there's botulism, glanders and
    others. How many do we have vaccines against?
        Dr. Zoon. Currently there is a licensed smallpox vaccine,
    of which there is limited quantity. There's one licensed
    anthrax vaccine.
        I thought they--I'd have to get back to you on the rest,
    sir, because I'm not 100 percent sure.
        Mr. Shays. But clearly one of the challenges we have is
    developing vaccines. The military is talking about ultimately
    vaccinating for a good number of perceived potential attacks
    against our military. The challenge that we are going to have,
    it seems to me, is developing a vaccine that we think will do
    the job given the challenge of how you test it. And it will be
    interesting to see how you all weigh in on this, because that's
    the direction our military's going in and it raises gigantic
    questions. Thank you.
        Mr. Burton. If the gentleman would yield. I think a lot of
    people who are paying attention to this discussion right now
    might not understand what kind of questions you're asking, in
    layman's terms. So I'd just like to clarify a couple of things.
    As I understand it right now, the anthrax vaccine has been
    proven effective to a degree against the kind of anthrax that
    is communicated through the skin and through touching. As far
    as anthrax being communicated through an aerosol or through a
    missile that would explode and spray anthrax into the
    atmosphere where people would breathe it, it has not been
    proven effective in that. As a matter of fact there was one
    test, as I understand it, or one case where they had given
    people the anthrax vaccine in a farm environment, where five
    people died who inhaled the anthrax bacteria. The thing that a
    lot of people in the military would like to know is, does the
    anthrax vaccine work against an aerosol or an aerosol-type
    dispensing of this, this dread disease? And along with that, if
    it doesn't--because the most likely way that an enemy would try
    to attack the U.S. military operation would be through an
    aerosol-spread bacteria--why are we using this vaccine? If it's
    not effective against that, and that's the most likely way that
    an enemy would attack us with it, why are we using that vaccine
    and mandating it right now?
        Dr. Satcher. I don't think we're going to try to answer
    that because--I think it's a very good question, but I think--
    --
        Mr. Burton. It needs to be answered because 300,000 of our
    troops have been vaccinated, and right now, according to what
    I've been able to understand, it isn't going to protect them if
    an aerosol attack with anthrax ensues.
        Dr. Satcher. I just mentioned the question of why because
    the Department of Defense obviously has risk information that
    we don't have in terms of terrorism. We can answer the other
    question you raised. But if you say, why, the Department of
    Defense made the decision; they certainly have security
    information that we don't have about the risk that we're
    facing. And they make decisions based on that. We can answer
    the question about the relative risk.
        Dr. Zoon. Yes, Mr. Chairman----
        Mr. Burton. Would the gentleman yield? Just to clarify the
    information being provided. If you could, and National
    Security, Veteran's Affairs, and International Relations
    Subcommittee would love the answer to the question that you
    said you would get back to us on. I'm going to have my staff
    followup on that, so it would be helpful. You may answer, then
    I'll yield to Mr. Davis. Thank you, Mr. Davis.
        Dr. Zoon. Thank you, Mr. Chairman. There is, while be it
    limited data looking at the ability of the current anthrax,
    licensed anthrax vaccine to be protective of inhalation
    anthrax, you are very right, sir, that the primary incidence of
    the disease in the mills where the study was done on the
    original anthrax was cutaneous, or skin. However, there were
    five cases of inhalation anthrax. And when the data was looked
    at, four of these five cases were fatal cases. When the data
    was looked at this single-blinded control study, it was
    discovered that of those deaths from inhalation anthrax, two
    were in the placebo group and three were in the unvaccinated
    group, and zero were in the vaccinated group.
        Mr. Burton. So you have none that were vaccinated, that you
    can tell one way or the other about the aerosol.
        Dr. Zoon. Well, in fact, those people that were vaccinated
    did not have any cases of inhalation anthrax.
        Mr. Burton. So using deductive reasoning, you say it was
    effective against that?
        Dr. Zoon. Within that limited data base, for that study, we
    have that information, which would suggest some protection
    against inhalation anthrax. Subsequently, studies were done in
    a primate model looking at protection challenge studies that
    were done by Dr. Ivens. And this was a study where they used a
    spore challenge in rhesus monkeys. And it was shown to protect
    against the aerosol challenge.
        Mr. Burton. Mr. Davis.
        Mr. Davis. Thank you very much, Mr. Chairman. Dr. Satcher,
    let me thank you for your testimony, and also the advances that
    I think we're making in public health under your leadership and
    with the assistance of your team. I agree that the greatest
    weapon we have, the greatest defense that we have against
    childhood diseases are vaccinations. According to Evan, Rachel,
    Brian, David, Katie, Tim, Catherine and Natalie, these are all
    children who live in Illinois, whose vaccinations produced
    terribly devastating results for them. They are children who
    cannot walk, children who cannot play, and they're children
    whose parents believe that their conditions were caused by
    their vaccinations. In addition to that, there is a group in my
    community headed by a woman named Barbara Mallarky, who is the
    spokesperson for the Illinois Coalition for Vaccine Awareness
    and a health activist who lives in my community. I see her
    quite frequently. She believes that strong anecdotal evidence
    suggests that children are being adversely affected by
    vaccinations, especially hepatitis B. My question is, what can
    we tell the parents of these children, and what can I tell Ms.
    Mallarky and her group?
        Dr. Satcher. Thank you, Congressman Davis. And I appreciate
    your background in public health, too, so I know I don't have
    to tell you how we go about making decisions and the struggles
    that we go through. There are a few issues involved here. And
    the first one, of course, is that there are adverse events that
    occur from vaccines. They are very rare. They don't compare
    with the benefits, but--they are very rare, but they are very
    significant for the people who are affected. That's the first
    thing, and we are determined to reduce adverse events to as
    near zero as possible. The other thing, of course, is that it
    is sometimes difficult for us to determine when an event occurs
    temporally related to vaccines, that the vaccine caused the
    event. And the only way we can determine that to the best of
    our ability is to investigate. That's why we have a system that
    allows those kinds of investigations to take place. People can
    petition, and in many cases it has been found--I believe there
    have been 1,400 families who have received a little over $1
    billion from the system, because they filed complaints about
    injuries that occurred. I don't believe it is possible to
    compensate people adequately for the kind of thing that we're
    talking about. But there is a system set up to investigate and
    to determine the likelihood that an adverse event was due to
    the vaccine. And if it is determined that it was, we have a
    system to attempt to provide some compensation. So the system,
    I think, is there. The most important system is the one in
    which we are working night and day to continue to improve
    safety.
        Mr. Davis. So I can assure them that the Public Health
    Service is doing everything in its power to continue with the
    research, to investigate, to try and reduce as near to zero as
    we can, these situations that may occur.
        The other question that, that I'd like to ask--we have the
    injury compensation program, which is publicly funded. Are
    there any liabilities for the manufacturers of the vaccinations
    that we use?
        Mr. Balbier. If a petitioner under the program chooses to
    reject an award or is unsuccessful in obtaining an award, that
    individual may then sue the manufacturer. So the program is not
    an absolute protection of the manufacturers by any means.
        Mr. Davis. So it is the first line of defense for the
    consumer. Then if people are not satisfied, they can go beyond
    that in terms of seeking redress.
        Dr. Satcher. That is correct. But there is a very important
    point here, and I don't know if we've made it yet. Part of the
    value of this program--sort of a no-fault, where the Government
    takes responsibility--is that we have been concerned and are
    concerned that manufacturers are willing to continue to take
    the risk to develop vaccines. We have been successful in
    developing effective vaccines because there is a program like
    this available in which we share the risk of vaccines.
        Mr. Benor. Absolutely.
        Dr. Satcher. I think one of the major benefits of this
    program is that manufacturers are encouraged to continue to do
    research. And as Dr. Zoon described, it's an odious process of
    bringing a vaccine to market.
        Mr. Davis. So you're really saying that we are co-partners
    in a way, in trying to make sure that we have available to us
    the, the medicines or the pharmaceuticals that are needed to
    address some of the problems. Well, I appreciate that. And let
    me, Mr. Chairman, thank you, and also just say that, I have
    studied the public health system for a long time and I can tell
    you it is so refreshing to see that we are moving toward a
    public health modality in terms of really trying to move beyond
    just the individual protections, to the point of protecting our
    communities, our cities, our States, and indeed our Nation. I
    thank you very much.
        Mr. Burton. Before I yield to my colleague, let me just say
    that we should be concerned about the public health and public
    welfare. But our country was set up in such a way as to try to
    maximize the protection of the individual as well. And that's
    why, one of the reasons we're having this hearing today,
    because we want to make absolutely sure that people are getting
    as much information as possible about these vaccines and the
    possible side affects. Now I don't want to prolong this because
    I want to yield to my colleague. But my granddaughter had a
    hepatitis B shot, and within 12 hours, she was in intensive
    care; she couldn't breathe. One of my daughter's best friends
    is in the audience, and her child had a hepatitis B shot and
    died. Now that's 2 people that I know personally. Now this may
    just be a coincidence, but if those kinds of side-effects
    occur, then we need to know why. We need to be able to inform
    people across this country of the risk. Maybe we're giving too
    many shots in too short a period of time. Maybe, unlike Japan,
    we're not checking the immune systems of children before we
    give the shots. Do we check the number of the antibodies? Do we
    check these really thoroughly before we give our children
    shots, or do we just indiscriminately give them shots? Twenty-
    one shots before they're 6 years old. Can their little immune
    systems stand that much onslaught? Those are the questions that
    need to be answered. But I know that in my family, I've got an
    autistic grandchild--out of two grandchildren, one's autistic,
    the other almost died from the hepatitis B shot, and one of her
    best friend's child did die from a hepatitis B shot. Now you
    can call that coincidence if you want to. I kind of think it's
    more than coincidence. That's why we're having this hearing--
    not that we don't want to vaccinate, but we need to have an
    informed population to make sure that parents, while conforming
    to the rules of society to make sure that the whole population
    is safe, protects their family and their children as well.
        Dr. Satcher. Chairman Burton, let me just say I agree with
    you. I think this is a very important hearing. I can't think of
    any hearing that could be more important. So there's no
    question in my mind about the importance of this hearing and
    the importance of this issue.
        Mr. Burton. I look forward to working with you, Doctor.
        Dr. Satcher. We want safe vaccines.
        Mr. Burton. I think you're a sincere fellow, and from what
    I can tell, you've done a good job. Of course, I'm a layman;
    I'm not a doctor. [Laughter.]
        Mr. Mica. Thank you, Mr. Chairman, Dr. Satcher. I have a
    couple of questions. In January I took over a subcommittee that
    deals with the oversight of HHS and was immediately deluged by
    people contacting our subcommittee about the need for oversight
    of some of the vaccine programs, particularly hepatitis B. We
    did some studies and investigation, and we conducted a hearing
    on May 18. I'm pleased that you, and the administration,
    shortly thereafter have taken some actions. You told us today
    that you have several actions which you are recommending. One
    is lifting of the time limits; two, I heard about dollars for
    research--two items that were raised at our hearing. Could you
    tell me about the specifics of lifting the time limits, what
    this involves? And then, we now have $1.3 billion in the fund.
    Are we talking about taking money out of that for additional
    research purposes?
        Dr. Satcher. To respond to your last question, we don't
    have the authority to do that. Any use of those funds other
    than----
        Mr. Mica. Oh, I know. But you're recommending to Congress
    that we change the law to give you the authority, but to what
    degree?
        Dr. Satcher. Well, I'm not sure we have made that specific
    legislative recommendation.
        Mr. Mica. You don't have a specific legislative proposal.
        Dr. Satcher. No, we don't.
        Mr. Mica. When can we expect that?
        Dr. Satcher. I hate to try to make predictions--because
    it's been discussed between the administration and Congress.
        Mr. Mica. Can we get a recommendation from you, say by
    September since we're well into the 106th session? We're going
    to do a hearing on the compensation fund because it's been
    brought to light that there were problems, and this is the
    first time that I've heard of the administration's proposal in
    this regard. Maybe sometime in September, could we get that?
        Dr. Satcher. Let me say there exists now a set of
    legislative recommendations from Secretary Shalala to Congress
    about how to improve this system to improve the benefits to
    people who are adversely affected by vaccines. Those are in
    place now. I don't want to say exactly when the administration
    will submit other proposals because I don't know.
        Mr. Mica. Well, maybe we can work with you.
        Dr. Satcher. Yes.
        Mr. Mica. One of the things that also came out in the
    hearing is the frustration with the compensation and that the
    average length of time to go through the process is 2 years.
    That's average length, and many of these take more time. Do you
    know if you have any recommendation about how to deal with
    speeding up that process for compensation?
        Dr. Satcher. I'm going to ask the attorney but--let me just
    say, there are times when we compare this system to the regular
    tort system. As you know, it's been much more efficient, but
    still we're not satisfied with it--but it's much more efficient
    than the----
        Mr. Mica. Then that would be one area too we'd like to--if
    we don't have a recommendation. I have a press account that
    says, that relates to a surprise announcement. It says, a
    surprise announcement late yesterday. And this was a change in
    policy relating to mandatory vaccination of children with
    hepatitis B vaccine. It says, the surprise announcement came
    late yesterday afternoon, just 7 weeks after a May 18th hearing
    on the safety of hepatitis B vaccine. The vaccine policies in
    the U.S. House--our subcommittee conducted--brought out
    problems with that. And I guess the announcement related to
    eliminating mercury content in hepatitis B vaccine. It was a
    joint announcement by the Public Health Service, your folks,
    and the Academy of Pediatrics. OK. Our hearing was May 18th.
    When did you have the first information that there might have
    been a problem relating to the mercury content? Was that after
    our May 18th hearing and before your announcement, or before
    our hearing?
        Dr. Satcher. I can speak to that from the Public Health
    Service. I was involved in that announcement with the American
    Academy of Pediatrics, and the announcement was to give
    pediatricians and parents more flexibility in terms of
    implementing the hepatitis B vaccine.
        Mr. Mica. What I'm interested in, I want to know when you
    had the information. When did you know----
        Dr. Satcher. I'm going to get to--Dr. Zoon----
        Mr. Mica. And was that in your possession before the
    hearing that we held, or did they come to you after the hearing
    that we held?
        Dr. Satcher. It was after the hearing that you held.
        Mr. Mica. It was.
        Dr. Satcher. In fact, it came to my attention, it came, I
    believe, less than a week before we made the decision. We--and
    this included the American Academy of Pediatrics. Now there
    have been some studies in other countries about thimerasol and
    its effect. But in terms of FDA looking and getting reports
    from manufacturers in this country, and the information coming
    to us, it was a few days or weeks before--Dr. Zoon, do you want
    to comment?
        Mr. Mica. Would you supply the committee and the
    subcommittee with any communications you had, all
    communications you had, relating to this particular matter,
    say, in the last year? Would that be possible?
        Dr. Zoon. Yes. Certainly we can provide you--would you like
    me to give you some background, sir, or would you just like it
    for the record?
        Mr. Mica. I'd just, I'd like to have the information for
    the record.
        Dr. Satcher. We can say more about that if you'd like.
        Mr. Mica. The last thing--and my time is about up. You are
    the Surgeon General, the Chief Health Officer of the United
    States, and I noticed an article that was included here. I
    don't know if you gave it to us or if it was provided in our
    packet. But you talk quite a bit about some health issues,
    particularly smoking, excess, not eating enough vegetables, and
    not exercising. I chair the Criminal Justice, Drug Policy, and
    Human Resources Subcommittee, and our concern is, of 14,000
    young people and others die every year in drug related deaths.
        Dr. Satcher. Would you like for me to read the Surgeon
    General's prescription?
        Mr. Mica. No. But I just----
        Dr. Satcher. It, includes advice against the use of drugs.
        Mr. Mica. Yes, but again, I noticed this. I think you threw
    away your pipe to set an example.
        Dr. Satcher. That's a good article.
        Mr. Mica. My concern is, having survived one of your
    predecessors, the infamous Jocelyn Elders, that she sent the
    wrong message out on drugs. And that, to me, is our biggest
    social and societal problem, with 2 million Americans behind
    bars, 70 percent of them because of drug-related offenses, and
    with skyrocketing teen addiction rates and usage rates. Since
    this administration has taken office--again, people have to
    look up to folks. And you, as the Chief Health Officer, I would
    hope, would give us every bit of support relating to hard
    narcotics--heroin, cocaine, and the methamphetamine addiction
    that we're facing. I count on you for that.
        Dr. Satcher. Yes, you can. But I would also like to just
    say that I believe that the program that General McCaffrey is
    running, dealing with the use of illicit drugs, is the most
    aggressive in the history of this country, and we're seeing
    results.
        Mr. Mica. That's only as a result of the predecessor to Mr.
    Shays' subcommittee, Mr. Hatcher, who came forward to lead the
    subcommittee and restore the funds and----
        Dr. Satcher. I will be willing to give credit to as many
    people as possible.
        Mr. Mica. Thank you.
        Dr. Satcher. I'm just happy to see that the program is
    working.
        Mr. Mica. But we need you; you're our chief health
    spokesperson.
        Mr. Burton. The gentleman's time has expired. Ms. Scha-
    kowsky.
        Ms. Schakowsky. Thank you, Mr. Chairman and Dr. Satcher.
    It's a pleasure to meet you. As a new Member of Congress, and
    someone who comes from a State legislature where we have had to
    make decisions about mandatory vaccination programs, I've been
    a supporter of those because I think, as we look around at the
    chief reasons that we've been able to extend life expectancy
    and improve the general health of our population, that one of
    the chief public health strategies has been these vaccination
    programs for polio and rubella and smallpox, et cetera. But I
    am concerned because under the strong leadership of my
    subcommittee chairman, Mr. Shays, I have been hearing a lot
    about the anthrax vaccine. And one of the things that came up
    is that there was very little research done on the different
    reactions that women may have to vaccines, that there's a
    different kind of immune system. And I'm wondering if there are
    gender-difference studies that are required, and if you're
    aware of this?
        Dr. Satcher. Let's ask Dr. Zoon from FDA.
        Dr. Zoon. The original anthrax vaccine, which is the
    licensed vaccine we have today, was licensed back in 1970. And
    at that time there were not guidance documents available in
    general on inclusion of different populations. Subsequent to
    that though, there are guidances now that the FDA issues in
    drug development on the inclusion of different populations, of
    which women are a significant population. So I think that I
    cannot give you the breakdown of male and female that were in
    the original trial, and in fact, we had tried to go back and
    find some of those data, and they're not as easy to find in
    terms of the way they were recorded, based on the participants
    in those studies. But I think I would like to assure that right
    now, the information we do gather on vaccines do include
    different populations.
        Ms. Schakowsky. Well, let me ask you then about another
    population, which is hyper-reactors. That came up also in the
    anthrax discussions. And it may refer back to what the chairman
    was asking, that there are individuals whose bodies do produce
    adequate immune response with a lower dosage, for whom a higher
    dosage may pose a real problem. Is there any way to identify
    these individuals and provide alternative vaccination schedules
    or lower doses, et cetera, so that in the future we may be able
    to avoid some of these adverse reactions?
        Dr. Zoon. In vaccine and other product development that is
    done today, there are--as Dr. Satcher alluded to in phase II
    studies of clinical development, these are generally dose
    ranging studies, where they look at the immune response,
    immunogenicity, as well as safety. I would have to go back to
    look at those original data, and I'm not sure that all that
    data would be available from the old studies, because those
    were done in the 1950's.
        Ms. Schakowsky. Well, it seems to me that might be a
    direction that we need to go in.
        Dr. Satcher. Let me just say that's a very important
    question, and it is a very important subject of research. We
    need to be able to better predict how individuals will react to
    a vaccine much better than we can now. Now in the other
    medications too, I think you're right--Chairman Burton's
    example sounded like an anaphylactic-type reaction. I wouldn't
    know, unless I had the records, but that's what it sounded
    like. A very dangerous reaction; they can occur with any
    medication. I've seen them occur with the dye used for renal
    tests, and people can go into anaphylactic reaction soon after
    being exposed. We need better ways to predict who will respond
    in different ways to vaccines and different medications than we
    have now. That research has to continue.
        Ms. Schakowsky. One other line of questions--let me just
    ask them, and then you can respond. The VAERS system, which is
    really a rather passive system of reporting adverse reactions--
    there were a lot of reasons again, in hearing the anthrax
    debate and testimony, to doubt the system, not the least of
    which was, it seemed some people from the Department of Defense
    were discouraged, some of the people in the Armed Services were
    discouraged from making those reports. But in a broader sense,
    how satisfied do you feel that we're getting an adequate
    representation? Some have projected maybe we only hear about 1
    in 10 adverse reactions. And I wonder if you have thought about
    ways that we can improve the VAERS system so it's more useful
    to us in making these important decisions.
        Dr. Satcher. Dr. Orenstein of CDC is here.
        Dr. Orenstein. Thank you very much. The VAERS system is
    really our warning system for problems. It generally can be
    very helpful, particularly at finding serious problems. The
    reporting efficiency of VAERS, which is what you're getting at,
    is how often are events reported. This varies with the severity
    of the reports. We find, for example, with regard to vaccine-
    associated polio that about 70 percent or so of the cases that
    are known get reported to VAERS. With regard to other serious
    events like seizures, we generally see about 25 to 40 percent
    of what we would expect to be reported. When we deal with more
    mild events, or events that require, let's say, a laboratory
    test to document an abnormality, the reporting efficiency goes
    down substantially. But it's very difficult with any passive
    system to get a feel for how much is out there and whether it's
    causing something, because many of the illnesses that occur
    after vaccination also occur in the absence of vaccination. For
    example, in 1990, there were over 5,000 deaths from Sudden
    Infant Death Syndrome--children who died from Sudden Infant
    Death Syndrome, children who were well, most of them, and then
    were found as crib deaths, or may have had some mild illness
    beforehand. We would expect when we vaccinate large numbers of
    children--and we're talking about a birth cohort of 4 million
    children--that you're going to get deaths after vaccination.
    The real issue is, is the clinical syndrome different, or is it
    occurring more frequently than expected? And that's when we use
    our Vaccine Safety Datalink. The Vaccine Safety Datalink is a
    project where we fund independent researchers in 4 large
    managed-care organizations, in the Western United States, who
    have access to all of the medical records, so they can
    determine the expected incidence in the absence of vaccination
    to compare with the incidence in the presence of vaccination.
    We need to do more with VAERS. And I think that we are not
    satisfied with where VAERS is. Each year we send out a letter
    to 200,000 individuals to encourage reporting to VAERS. We've
    put in our standards for pediatric immunization practices that
    we want reported to VAERS, serious events even if you don't
    think that it's related to vaccination. We've done a lot; we
    need to do more. And I think that what you're pointing out is
    some of the weaknesses to VAERS.
        Mr. Burton. The gentlelady's time's expired.
        Mr. Weldon. Thank you, Mr. Chairman. I want to thank you
    for extending an invitation to me, and I want to thank the
    ranking member for withdrawing his objection.
        [The prepared statement of Hon. Dave Weldon follows:]
        [GRAPHIC] [TIFF OMITTED] T2560.112

        Mr. Weldon. I certainly want to thank you, Mr. Surgeon
    General, for your testimony. I know some of the people who are
    joining you there have been in my office to talk about these
    issues. And I want the record to reflect that I am a strong
    supporter of vaccination; that I vaccinated my patients
    according to CDC recommendations when I was practicing. But I'd
    like the record also to reflect that there is an increasingly
    growing level of public concern about the safety of our
    vaccines, and therefore I think it's extremely important that
    this issue be aired before the Congress. And if the light of
    scrutiny makes a determination that the system is safe, then we
    have the ability to broadcast that information to the public.
    And as well, if there are areas that need to be investigated
    further, we have the ability to appropriate the funds necessary
    to make sure the appropriate studies are done. I'd just like to
    start off with a couple of questions I have about the hepatitis
    B vaccine, the decision to recommend that for all newborns. My
    understanding of the transmission of hepatitis B is obviously
    it can be done through blood-borne contamination, through
    transfusions or infected needles, but as well through the route
    of sexual transmission. And indeed it's the sexually
    transmitted route that's deemed to be the most rapidly
    increasing segment of that problem. Am I correct in my
    understanding of this disease?
        Dr. Orenstein. The known modes of transmission are the ones
    that you have mentioned. Clearly, there has been much greater
    recognition of transmission among heterosexuals because, with
    regard to multiple sex partners. And that has accounted for a
    substantial proportion of hepatitis B cases. On the other hand,
    there are cases that we are not getting any, any history of any
    of these known risk factors for transmission. We presume in
    some way that they've been exposed, to either blood on abraded
    skin, a bite, or some other means. But there are these 25 to 30
    percent of cases in which, at least, there is no admitted risk
    factor for transmission.
        Mr. Weldon. How did hepatitis B compare to some of the
    other diseases where decisions were made to inoculate the whole
    population in terms of its incidence, as compared to polio,
    pertussis--I realize hepatitis B is a very serious illness and
    it costs a tremendous amount of money. But did the cost benefit
    analysis of this disease include the consideration that it's
    obviously different? The point I really am curious about is,
    being that a major mode of transmission is sexual transmission,
    we have never proposed inoculating the whole population for a
    sexually transmitted disease, am I correct?
        Dr. Orenstein. I'm not aware of anything where we've
    recommended the whole population be vaccinated for a sexually
    transmitted disease. But clearly this has more--sexual
    transmission is very important and I don't want to minimize
    that, but it's not the sole way of transmitting it.
        Mr. Weldon. Do you know what percentage is through sexual
    transmission, or could you speculate?
        Dr. Orenstein. I could get that data for you, for the
    record--a substantial proportion.
        Dr. Satcher. Let me just say one other thing. The process
    by which we decide to initiate an immunization program for any
    given agent is a very interesting and open process, as you
    probably know. The Advisory Committee on Immunization Practices
    is widely publicized. It includes experts from clinical
    practice, research----
        Mr. Weldon. I assume the American Academy of Pediatrics as
    well.
        Dr. Satcher. Yes. Very important representation from AAP
    and the American Academy of Family Physicians. But it's a very
    good question. They debated extensively before recommending.
        Mr. Weldon. I'm running out of time. The context of my
    concern is, it's three more shots, and one of the complaints
    is, it's getting to be a lot of shots. I think we have to
    address those issues.
        Dr. Satcher. Right.
        Mr. Weldon. I have a couple of other questions that maybe
    you can, you may just need to supply for the record. One is, if
    you can supply for the record the studies that are currently
    being done through CDC and NIH on vaccine-related side effects.
    I know there's--and as I said, some of you have come in the
    office and talked to me and there's a lot going on. But I think
    it would be important for us to have that for the record. And
    the other question I had was, is a legislative fix going to be
    needed if you're going to use the vaccination compensation fund
    to fund research studies? Because I know there's some
    discussion of that. And is that allowed under current law?
        Dr. Satcher. My understanding is that it would require an
    act----
        Mr. Weldon. An act of Congress.
        Mr. Benor. Yes, I can confirm that.
        Dr. Orenstein. Can I answer your other question that we
    never answered, and that is to put hepatitis B in perspective
    with some of the other vaccine-preventable diseases? We
    estimate that about 4,000 to 5,000 persons die each year from
    hepatitis B related liver cancer and hepatitis B related
    cirrhosis. If we compare that to measles in the pre-vaccine
    era, there were about 400 to 500 deaths from measles. If we
    compare it with haemophilus influenza type B, which is a severe
    cause of meningitis, we estimated that it was about 400 to 500
    deaths. So hepatitis B, when you look at the long-term
    consequences, was one of the most severe of the vaccine-
    preventable diseases.
        Dr. Satcher. If you have time, Dr. Regina Rabinovich from
    NIH can respond to your other question about research.
        Mr. Burton. We'll let her answer and then we'll go to Mr.
    Cummings.
        Dr. Rabinovich. Your question, I believe, related to the
    research that's ongoing looking at vaccine-adverse events. And
    I think that I'd have to emphasize that looking at all aspects
    of vaccine safety begin with evaluation of pre-clinical data
    prior to going to, and deciding that there's enough safety data
    to go into your first phase I study in humans. The NIH conducts
    a broad program of clinical research in the number of different
    candidate vaccines, and for every study, safety is integral to
    that evaluation. And that is particularly true of the phase I
    studies, where it it's the first time that it goes into humans,
    as well as the phase III trials where you can really get more
    information in larger numbers of the target population.
        Mr. Burton. Thank you. The gentleman's time has expired.
    Mr. Cummings.
        Mr. Cummings. Thank you very much, Mr. Chairman. I want to
    thank all of you for being here. In Baltimore we have probably
    one of the most effective immunization programs in the country.
    It is patterned after, as I understand it, the method of
    getting people vaccinated in Third World countries. I don't
    know if any of you are familiar with it?
        Dr. Satcher. Yes.
        Mr. Cummings. You, Dr. Satcher?
        Dr. Satcher. Yes.
        Mr. Cummings. Is that done other places also?
        Dr. Satcher. Well, let me just say in terms of Third World
    countries, we've made a lot of progress in recent years working
    with the World Health Organization. And among other things,
    coming up with schedules, but also implementing national
    immunization days. I was in India on December 7, 1996, when we
    immunized 120 million children in 1 day against polio. We've
    used strategies like that, which we don't have to use in this
    country because of ongoing programs. But in those countries
    because of where they were, we had to. And that's why we're
    very close to eradicating polio. I know CDC has funded
    Baltimore directly. It's one of those cities we funded
    directly, and not through the States, to develop exemplary
    immunization programs. And I agree, that program there has
    included a variety of strategies to get children immunized that
    have been very effective.
        Mr. Cummings. It's my understanding the hepatitis B is a
    blood-borne disease. How do children transmit it? Young
    children?
        Dr. Orenstein. You're absolutely correct. It is a blood-
    borne disease. It is in the blood; it can be in other body
    fluids. It's in a low amount in saliva. The presumption for
    childhood transmission is, one, there is transmission from
    mother to affected baby if the mother is a chronic carrier.
    Aside from that, we think it may be perhaps from sharing
    washcloths with abraded skin; bites that might occur that would
    break the skin; children with rashes who might be exposed to
    someone bleeding. It's not really clear how it's happening; we
    just know it is happening in young children. And about 10
    percent of the infections overall are occurring by 9 years of
    age, about 6 percent of those with no known risk factors.
        Mr. Cummings. Say that last sentence again.
        Dr. Orenstein. We estimate that about 6 percent of all of
    the infections that occur with hepatitis B annually would occur
    without a vaccination program, occur with children with no
    known risk factors. That includes, that's primarily in
    Caucasian and African American children.
        Mr. Cummings. So a universal vaccination for infants
    against hepatitis B is very important, is that correct?
        Dr. Orenstein. Universal vaccination of infants for
    hepatitis B is important to protect them both from infection in
    early childhood as well as from infection later in life. The
    risk of infections are different when you get them. If you get
    infected as an infant, one, you're likely to have no symptoms
    at all. You're likely to never know you were infected. And you
    have a 90 percent chance of becoming a chronic carrier. And
    about a quarter of those go on to develop either liver cancer
    or cirrhosis of the liver 20 to 40 years or so afterwards, and
    they may never know how they got it. So we vaccinate them
    because the risk of the consequences of hepatitis B is much
    more severe, the younger you are. Contrast that with an adult.
    An adult who gets infected with hepatitis B, they have only a 6
    to 10 percent chance of becoming a chronic carrier. About more
    than one-third of all chronic carriers in the United States are
    believed to be from childhood infections.
        Mr. Cummings. Dr.--I'm sorry, I forgot your name. Next to--
    --
        Dr. Satcher. Dr. Rabinovich.
        Mr. Cummings. Yes--you were shaking your head. Did you have
    something?
        Dr. Rabinovich. No, I agree that those figures indicate
    that hepatitis B is an important disease to prevent and that
    children are at particular risk.
        Mr. Cummings. Have there been any published peer review
    studies that show a link between hepatitis B vaccine and
    conditions such as multiple sclerosis and SIDS?
        Dr. Orenstein. There have been case reports that have
    suggested that this is a possibility, and that's why we are
    doing more comprehensive research. The people who are
    developing these illnesses after vaccination have very, very
    severe illnesses; there's no question that these are terrible
    tragedies. The problem is that there are people who develop
    these same kinds of tragedies, these same kinds of illnesses in
    the absence of vaccination. And that's why we're engaged, we
    and others are engaged in substantial research to try and see
    whether the vaccine increases the risk over what would be
    expected.
        Dr. Satcher. It's important to point out, as Dr. Orenstein
    said, ``and others,'' because it's not just the Government. The
    Institute of Medicine has been one of the major players in
    looking at these relationships between adverse events and
    vaccines. And a lot of the information has been reviewed
    thoroughly by the Institute of Medicine, as well as the
    Advisory Committee that we relate to. So it's not just those of
    us within government looking at this. Congress often relies
    upon the Institute of Medicine and other agencies--the National
    Academy of Sciences, which the Institute of Medicine is a part
    of--for independent reviews of issues like this. And we have a
    lot of reviews from the Institute of Medicine.
        Mr. Cummings. My time has run out. Thank you.
        Mr. Burton. Thank you, Mr. Cummings. Mrs. Biggert.
        Mrs. Biggert. Thank you for having this hearing. Many of
    those who have been concerned regarding mandatory vaccinations
    would like to see the States and/or the Federal Government do
    more in the area of advised consent. I would just like to know
    from the panel how you would define ``advised consent?''
        Dr. Satcher. You mean informed consent.
        Mrs. Biggert. Well, it's called ``advised consent,'' but it
    would be ``informed consent,'' whether parents should make up
    their mind whether to have such a vaccination.
        Dr. Satcher. Oh, yes. I'm sorry. So you're talking about a
    parent having the choice and obviously having the information
    to make that choice.
        Mrs. Biggert. Right.
        Dr. Satcher. Well, I think as we said earlier, the whole
    issue of immunizations are looked upon both from the standpoint
    of benefits to the individual, but also benefits to the
    community. And as you know, the requirement for immunizations
    are at the State level. But 48 States allow religious
    exemptions; 15 States allow philosophical exemptions. In all of
    those States, less than 1 percent of parents decide not to have
    their children immunized when they have those exemptions. So
    decisions are being made--but religious and philosophical
    exemptions are a very small percentage. But States have a
    responsibility to protect children in schools. And therefore,
    the requirements for immunization, in the absence of religious
    or philosophical exemptions, are based on the desire to protect
    the entire community, not just the individual.
        Mrs. Biggert. What I'm asking is, what action has CDC taken
    to improve the accuracy of information relating to the adverse
    impacts of a vaccination? Is that given to, to parents, or----
        Dr. Satcher. Yes.
        Mrs. Biggert [continuing]. Do you have an information
    campaign really targeted both to doctors and to prospective
    patients?
        Dr. Orenstein. CDC believes very strongly in the need to
    provide information to parents. We've done a lot. I think we
    need to do more. I think it's very clear that the information
    isn't always getting out. We helped develop a vaccine
    information statement that is required, actually by law, to be
    given to children for vaccination, if they receive a vaccine
    covered by the injury compensation program, which contains
    information on the risks of disease, the complications from
    disease, known risks, scientifically accepted risks from
    vaccines. It tells them about the compensation program; it
    tells them how to report adverse events; who might be at risk
    for these complications where it is known. And we distribute
    them to the States for distribution to all vaccine providers.
    In addition, we have developed websites where people can get
    more information. We have hotlines, which are listed in these
    information statements, where people can get more information.
    And we also put in each of these information statements, for
    the parent who wants more, one, to ask their doctor or nurse,
    and also even refer them to--some parents maybe want to see the
    package insert, which will contain more detailed information. I
    think we do a lot and are continuing to do more, and we will
    need to do more because we know of instances where this is not
    being done.
        Mrs. Biggert. I would imagine that some of these reactions
    would be something in common, like coughing or rashes or
    something that might start out that way. But how is it
    determined that these could be tied to the vaccination? Is
    there a problem making that connection? Are doctors given
    enough information?
        Dr. Orenstein. I think we provide information as well as
    others--the American Academy of Pediatrics, the American
    Academy of Family Physicians--about vaccines, both risks and
    benefits. I think there are issues, we encourage reporting of
    serious adverse events, regardless of whether the physician
    thinks they are vaccine-related or not. I realize there are
    still physicians who only report adverse events if they think
    they are related to vaccines. We are trying in multiple venues,
    and we will continue to try, to get all serious adverse events
    reported. What's difficult with many of the adverse events that
    are reported is that, while they are, can be very serious and
    very problematic, many of them are also occurring in the
    absence of vaccination. And when that occurs, and the clinical
    syndrome is not unique, then we need to do special studies. And
    that's why we have a system we call our Vaccine Safety
    Datalink, which works with four managed care organizations in
    the Western United States and independent researchers, to look
    at what the expected incidence of this illness would be in the
    absence of vaccination, to compare with the incidence in the
    presence of vaccination. And if it's higher after vaccination,
    that will be strong evidence that vaccine is actually causing
    it.
        Mrs. Biggert. I know there was a school in Illinois at one
    time where there was a measles outbreak. And it was a school
    for religious purposes, and nobody was vaccinated. Well, the
    school was shut down for a while until everybody recovered, and
    I think some of them probably had vaccinations. But is there a
    plan, if that happens, that addresses that problem in such a
    school?
        Dr. Orenstein. I think that each State would decide how
    best to deal with that situation. Although we may recommend
    mandatory immunization because we've seen how effective it is,
    how it's implemented is a State decision. So in terms of
    dealing with an outbreak in a college, for example, where there
    are large numbers of people who are unvaccinated and who can
    infect the community, that's usually worked out on a case-by-
    case basis, and there may be actual plans as to whether the
    States would quarantine the school so that the children didn't
    go and spread it into many communities, or whether they just
    tried to make voluntary efforts to vaccination, or other kinds
    of efforts to vaccinate.
        Mrs. Biggert. Thank you. Thank you, Mr. Chairman.
        Mr. Burton. Gentlelady, thank you very much. Let me--I want
    to apologize to all the other panelists who are here because I
    know it's been a long day. It's extremely important though that
    we get through a few more questions and then we'll get to our
    next panel. I apologize once again for everyone getting saddle
    sores.
        First of all, why are individuals not tested when a series
    of three or five vaccines is given to determine their antibody
    levels, since this level would indicate that they may already
    be protected? Along with that, I understand, as I said before,
    in Japan they check the antibody levels to make sure a person's
    immune system is not depressed before they give them some of
    these shots. And they wait, or they wait until they're a little
    bit older. I just wonder why we don't look into that as well?
        Dr. Satcher. Well, I guess it gets back to risk and
    benefits, because a lot of the deaths that we have seen from
    these infectious diseases occur very early in children, 1 and 2
    years of age. So----
        Mr. Burton. Well Japan, I think, has a very, very good
    record in this regard. I think they have as good a record or
    even a better record as far as deaths or diseases caused in
    infants from these diseases. In fact, I've ordered the studies
    they have done and they are going to be sending those to us.
    But the fact of the matter is, they're as good or at least as
    good or better. And they check the immune system first, before
    they start administering some of these vaccines. I just wonder
    why we don't look at that. The cost benefit ratio, is that what
    you're saying?
        Dr. Orenstein. I'm not aware of what's done in Japan. I
    know Japan had two deaths after pertussis-containing vaccines
    in the 1970's. They stopped their pertussis vaccination and
    then had 41 deaths in an epidemic of pertussis afterwards. I do
    not know what they test for, but I do know that for some of
    these diseases, there aren't antibody tests. We don't know, for
    example, what----
        Mr. Burton. Where there are, why don't we?
        Dr. Orenstein. In many of them it may be maternal antibody.
    Maybe another antibody passed from the mother to the child. And
    by the time we would find out that they were susceptible, they
    may have already become infected. From any of this, it becomes
    a very difficult thing to do in the setting of a public
    clinic----
        Mr. Burton. Are you indicating to me that there are not
    antibody tests that can be performed prior to giving these
    children these shots? Because they get 21 by the time they're 6
    years old.
        Dr. Orenstein. There are antibody tests that could be
    performed in some children for some diseases, but as a matter
    of trying to assure vaccination and assure protection from
    vaccine-preventable diseases, it would be very difficult to do
    that for large number of children.
        Mr. Burton. But I understand that they do that in Japan. I
    wonder why?
        Dr. Satcher. But these are some areas where we're still
    doing research in terms of how much can we know about the
    individual's immunogenicity.
        Mr. Burton. Well, if you have any information, please
    submit it to us for the record. We have heard from individuals
    who have had remarkable healing after vaccines events through
    the use of homeopathic remedies. Has our Government or is our
    Government doing any research into that area?
        Dr. Satcher. As you know, Congress has established the
    National Center for Complementary and Alternative Medicine
    Center at NIH, so we are doing more research in the different
    approaches to clinical care.
        Mr. Burton. Their budget's very----
        Dr. Satcher. It's very early. It's very early.
        Mr. Burton. Their budget's very small. Would you recommend
    that we increase that a little bit?
        Dr. Satcher. Well, you know, we have certainly recommended
    that you increase the budget of NIH overall.
        Mr. Burton. Well I know, but when you do that, I'd kind of
    like for you to shove a little bit into the alternative thing.
        Dr. Satcher. And I think that will certainly happen.
        Mr. Burton. Would you do that?
        Dr. Satcher. Yes.
        Mr. Burton. Thank you. How do you explain the huge jump in
    autism and developmental delays?
        Dr. Satcher. Again, I'm taking the prerogative here on some
    of the questions, but many studies have been done looking at
    the relationship between autism and vaccines, and there have
    not been any conclusive studies showing that vaccines cause
    autism. That's still----
        Mr. Burton. There is a large increase.
        Dr. Satcher. Yes, and we're still studying it. But to date,
    we cannot demonstrate the causal relationship, but we continue
    to look at the issue.
        Mr. Burton. Well, if you have any additional information on
    that, we'd like for you to----
        Dr. Satcher. We certainly will. We will update you on what
    we have.
        Mr. Burton. Mr. Waxman, do you have any questions before we
    break?
        Mr. Waxman. Yes, sir. Thank you very much, Mr. Chairman. We
    know that when we immunize a child, we're trying to protect
    that child from certain diseases. But we're also protecting
    children who cannot be immunized, for example, children who
    have leukemia who can't be vaccinated. Isn't it true that some
    children who are vaccinated do not respond to the vaccine and
    develop an immunity to the disease?
        Dr. Satcher. Definitely. But the other point you made is so
    important--in response to Congresswoman Biggert's point about
    the school, the real question is, in addition to the children
    in that school who got measles, we don't know how many other
    people were exposed to measles because of that, who themselves
    might not have even been subject to vaccination because of an
    immune problem, or leukemia, or what have you. So when a group
    of people become infected by an infectious disease like
    measles, a lot of other people are exposed.
        Mr. Waxman. Isn't it the case that there will always be a
    small percentage of children who will not be immune to these
    vaccine-preventable diseases, so a parent who chooses not to
    have his or her child vaccinated is therefore putting these
    other children who cannot be vaccinated or do not respond to
    vaccines at a greater risk of----
        Dr. Satcher. Yes, I think that's the basis on which States
    have made the kind of decisions that they've made in terms of
    requiring immunizations.
        Mr. Waxman. I wasn't here for a lot of the questions on
    anthrax, and I know one of our subcommittees has held hearings
    and I haven't been a part of those hearings. But, what is your
    role on the anthrax vaccine compared to the Department of
    Defense?
        Dr. Satcher. Yes, I pointed out that the decision to
    immunize the troops was a decision made by the Department of
    Defense, and in some cases using information that's really
    security information that we don't have access to. I think what
    we can talk about is the vaccine and the studies that have been
    done to show both its safety and efficacy. And the FDA has been
    involved in those studies. It is on that basis that we can say,
    the vaccine is safe, and it's also effective.
        Mr. Waxman. And you haven't made a recommendation that
    everyone be immunized for anthrax, have you?
        Dr. Satcher. No, we haven't.
        Mr. Waxman. So that's not even an issue at the moment.
        Dr. Satcher. No, we don't anticipate making it. But
    obviously, as you know, in the area of bioterrorism, it just
    depends on what happens in the future in terms of what the real
    risks are.
        Mr. Waxman. Thank you very much, Mr. Chairman.
        Mr. Burton. Thank you. You've been very patient, this
    panel, and so have been all of the rest of the people who are
    going to be testifying. We have to go vote. We will be back as
    quickly as possible. I think we only have one vote on the
    floor. As soon as we return, we'll have the next panel. Mr.
    Surgeon General, thank you very much for being here. We really
    appreciate it. We stand in recess.
        [Recess.]
        Mr. Shays [presiding]. Ms. Nelson, Ms. Spaith, and Ms.
    Cole.
        I'm not succeeding in my coup. We have two we are still
    waiting for. Can we swear them in privately?
        Here is what we are going to do. We are going to ask you to
    stand, and then we will--we are calling our witnesses to come
    forward on panel two.
        Would you raise your right hands, please.
        [Witnesses sworn.]
        Mr. Shays. We will note for the record all our witnesses
    were sworn in except Ms. Spaith, and we will start with Tonya
    and Gerald Nelson. We will invite you to give your testimony.
        What we are going to do is we are going to turn the clock
    on for 5 minutes, and then we will roll over if we have to and
    welcome your testimony. And please feel relaxed. It is
    wonderful to have you here, you should feel very comfortable
    being here.
        Ms. Nelson. Thank you.
        Mr. Shays. Thank you for being here.
        Are you both going to give testimony, or one of you?
        Ms. Nelson. I will give mine, and then he will continue.
        Mr. Shays. OK. Ms. Nelson, why don't you start.

     STATEMENTS OF TONYA AND GERALD NELSON, INDIANAPOLIS, IN; RICK
        ROLLENS, GRANITE BAY, CA; CAROLA ZITZMANN, VOICE OF THE
     RETARDED; ANTONIA C. SPAITH, FALLS CHURCH, VA; REBECCA COLE,
       PKIDS, CHAPEL HILL, NC; AND KEITH BERGEN VAN ZANDT, M.D.,
                        PKIDS, WINSTON-SALEM, NC

        Ms. Nelson. Thank you.
        Thank you Mr. Chairman and members of the committee. I am
    grateful to be here today to share with you our story regarding
    vaccines.
        I am the mother of four children. Abigail was my third.
    Abigail was born at 11:27 p.m., on March 22, 1994. She was a
    very healthy baby. We stayed 2 days in the hospital. Prior to
    our release from the hospital, she was given the hepatitis B
    vaccine.
        Mr. Shays. Ms. Nelson, I am going to ask you to put that
    microphone a little closer to you. That is the problem. It
    needs to be down. That is all right. We have to remind
    ourselves that, too. And you don't have to rush. You can speak
    more slowly.
        Ms. Nelson. I asked questions about the injection and was
    given a booklet to read that stated to expect no side effects
    except soreness in the area of the injection.
        We came home after receiving the vaccine. She was very
    cranky and her cry was very disturbing. It was more of a scream
    than crying. She began to spit up a lot.
        I called the doctor and was told to give her some water
    between feedings and to call back in a week. I did as the
    doctor suggested, but I began to get scared because her stool
    became loose and greenish-yellow. So I called back in a week
    and was told that was normal and to keep an eye on her and call
    if I needed to.
        The second week was worse. Her cry was just as bad and
    stool seemed loose. She became cold to the touch and shivered a
    lot. I called the doctor again. She told me to put her in her
    infant hat and to check her temperature four times a day and to
    call back the following week.
        I did this. Her temperature stayed at 96 degrees. Then her
    third week she began to turn purple in her hands and feet and
    around her lips. I called the doctor and was told to watch her
    breathing and they would see the baby the next week for her 1-
    month checkup and to keep her wrapped tightly in blankets.
        I was becoming scared. I asked him to get her in before her
    checkup and was told they had no appointments. I hung up from
    that call and called my son's old doctor. She told me that she
    could not help without seeing the child, and since Abby was on
    Medicaid and she was not a Medicaid provider, she was
    restricted from seeing Abby. I offered to pay cash, but she
    said she could not take the money from a Medicaid patient. At
    this point Abby is still crying and vomiting and having loose
    stools and very cold.
        The night before she died she screamed for 6 hours
    straight, plus she had a lot of bowel movements. She finally
    fell asleep at 11:30 p.m. We woke up to find her dead at 6 a.m.
        I placed my 9-1-1 call and started CPR. The firemen and
    paramedics showed up. They pronounced her dead shortly after
    they arrived. The coroner said it would be 2 weeks before the
    cause of death could be determined.
        About 2 months later we received a telephone call from Dr.
    Thomas Gill of the Marion County Coroner's Office. He told us
    the cause of death was the hepatitis B virus, which she could
    only have gotten from the vaccine. He told me that he would get
    the death certificate out to me soon.
        Sixteen weeks later we received the death certificate in
    the mail, and the cause of death was natural causes, otherwise
    known as SIDS, Sudden Infant Death Syndrome.
        I was shocked to say the least. I called the coroner's
    office and spoke to a Dr. Manders, the coroner of Marion
    County, and was told that Dr. Gill had been asked to resign.
        Dr. Manders stated he had signed the death certificate. I
    asked how he could sign the death certificate if he did not
    perform the autopsy. He told me that he had done so since Dr.
    Gill was no longer there. We had not been able to determine how
    he came to the cause of death, since he did not perform the
    autopsy, and that Dr. Gill told us something very, very
    different. He told me that if I had questions to call a Dr.
    Pless, a pathologist at Indiana University.
        I did call and made an appointment to speak to Dr. Pless.
    He was a man without compassion, and the most cold-hearted I
    have ever met. He told me to stop trying to place the blame on
    my child's death and to go on with my life. He also stated that
    if the vaccine did kill my daughter, it was saving more lives
    than it was taking.
        I contacted a lawyer and he said to get all the information
    together and to call him back. I contacted the Infectious
    Disease Center at Riley Children's Hospital and spoke to a
    registered nurse. She was very helpful. She told me the vaccine
    has been known to take infants' lives and also to make them
    very sick. She could not help me other than that. She was
    scared she would lose her job. She also told me that the infant
    does not develop its own immune system till 3 to 4 months of
    age. I confirmed this with other doctors, who said they are
    very uncomfortable giving the injection at such an early age.
        I tried to contact the Center for Disease Control and
    Prevention and the vaccine company. I left messages that were
    never returned.
        To retain my own emotional well-being and to care for my
    two older children I had to take a break from this, thinking I
    had plenty of time to pursue this with the Government. I had to
    return to work because we were already behind the 8-ball
    financially. Having to pay for a funeral and headstone for Abby
    only made that worse.
        I was not the only member of the family who needed to heal
    from this trauma. My husband Gerald will share his experiences
    shortly. My older child needed counseling we could not afford,
    and the school told us she was young enough, she would soon
    forget.
        Finally I was able to call the attorney back and was told
    that it was too late. He said I only had 2 years to get
    compensated for our loss unless she had lived. Then I would
    have had 7 years.
        We had a lot of bills and misfortunes due to this one
    vaccine. We had lost the most important things in our lives,
    and nobody cared. They were too busy or too afraid of losing
    their jobs or paying too much malpractice insurance.
        I also know that my child was not a priority of getting an
    appointment with the doctor because she was on Medicaid. The
    doctors do not get enough compensation to encourage them to
    make Medicaid patients a priority.
        Since we were in such financial distress already, I tried
    to get State funding for her funeral, and was told it would
    take a few weeks to get approved for this, and that I would
    have to fill out paperwork. I didn't feel that I could hold off
    for weeks to bury my child while paperwork was being filled out
    and reviewed.
        I gave up hope and contacted Beth Clay on the committee
    staff. This has been like an open wound that has been trying to
    heal for 5 years but has not. I feel like coming and telling
    our story will be worth it if I can help save just one child's
    life. I hope through my own experience I will be able to help
    other parents also.
        Of course none of this will make up for the loss we
    encountered 5 years ago. By testifying today my husband and I
    may finally be able to bring closure to our grieving. So far we
    have been so busy trying to survive that we have not done so.
    Our Abby would have been in school now learning to read and
    writing songs. Instead we have a baby book that has never been
    filled out.
        Mr. Nelson. Tonya and I are like many other Americans,
    ordinary Americans, hard-working, struggling to survive. Tonya
    came into our marriage with two beautiful children, Sabrina and
    Kegan, whom I love dearly. Abby was a beautiful and healthy
    child. She was my first child. I was the proudest of fathers.
        This tragedy compounded with other family losses really
    tore me apart emotionally. I ended up losing my job. We have
    struggled to recover from this tragedy and to further
    understand how it is appropriate for babies whose immune
    systems are not even fully developed are being vaccinated. We
    also want to see more information be provided to parents prior
    to vaccination and that they be informed that there are medical
    and religious exemptions.
        Physicians also have to be educated about these exemptions
    and be comfortable giving them. We were told that the worst
    that would happen to our little Abby was that she would have a
    sore leg. That was certainly not accurate information.
        By coming today we hope that the Government will move
    forward with more research in the safety of vaccines in infants
    and the combination of vaccines. We also want medical freedom
    to be a consideration in finding the balance between public
    health and each individual's health and safety.
        Thank you, Mr. Chairman and members of the committee for
    this opportunity for us to testify.
        Mr. Burton [presiding]. Mr. Shays, you had something you
    wanted to say?
        Mr. Shays. Mr. Chairman, I first wanted to say to both Mr.
    and Mrs. Nelson that it is, one, very important that you are
    here. Second, that there is not a person in this room who
    doesn't find it outrageous that you would have encountered such
    resistance, one, to look at your child, and, two, that you
    weren't given the kind of sympathy that any grieving mother and
    father deserve. I am just glad to know about your case and see
    how I can be helpful to you. I do appreciate you being here,
    and since I did swear you in, I want to say that.
        Mr. Chairman, we do need to swear in Ms. Spaith. You might
    want to do that right now.
        Mr. Burton. I will be happy to do that.
        Before I do that, Mrs. Nelson and Mr. Nelson are friends of
    my daughter, and of course I told you earlier about my
    granddaughter having a problem with the hepatitis B vaccine. I
    want to also express my concern about what you folks went
    through. I have instructed my assistant here, Beth, to help you
    make a claim, which I think is justified, against the
    Government for this problem. And I hope--you have to do that by
    August 6, so we have got only 3 days, and we will assist you in
    doing that so that you can be at least partially compensated
    for that horrible thing.
        Ms. Nelson. Thank you.
        [The prepared statement of Mr. and Mrs. Nelson follows:]

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        Mr. Burton. Ms. Spaith, would you stand, please?
        [Witness sworn.]
        Mr. Burton. Mr. Rollens, you are next.
        Mr. Rollens. Mr. Chairman and members, my name is Rick
    Rollens. I currently reside in Granite Bay, CA, which is
    located 30 miles east of Sacramento, with my wife of 23 years,
    Janna, and my two sons, Matthew, 13, and Russell, 8.
        Thank you for inviting me today to testify. For me this is
    somewhat of a homecoming, for in 1973 I had the privilege of
    serving on the Washington staff of former Representative Jerome
    Waldie of California.
        Following my service in the House, I embarked upon a 23-
    year career of public service with the California State Senate.
    Working through the ranks, I was elected by the Members of the
    Senate to serve as their Secretary of the Senate, until I chose
    to resign my position in 1996 in order to dedicate myself to
    the pursuit of effective treatments and a cure for my beloved
    son, Russell.
        I am here today to share with you the story of my son's
    case of vaccine-induced autism and to report on the growing
    autism epidemic in California and the pandemic of autism
    throughout this country. Russell began his life as a normal,
    healthy, and robust child, meeting all his age-appropriate
    milestones. At 7 months old, within 72 hours after receiving
    his third DPT and first hep B vaccination, Russell developed a
    high fever and shrieked with a high, wailing scream for days.
    After these vaccinations, he started losing eye contact,
    smiling less, losing interest in people, developed constant
    croup, and was chronically sick. At 7 months old, Russell's
    life had begun to change along with the lives of all who know
    and love him.
        Within days after his first MMR vaccination, at 18 months,
    Russell began his final journey into the abyss of what my wife
    and I now know is autism, losing most of his remaining skills,
    developing severe sleep irregularities, chronic
    gastrointestinal problems, and expressing constant pain
    exhibited by harrowing days of endless crying. Russell was
    officially diagnosed at 2\1/2\ years old with autism.
        After many months of medical investigation of Russell's
    condition, including state-of-the-art brain scans,
    immunological and neurological and genetic workups, we
    consulted a noted pediatric neurologist who thoroughly examined
    Russell and reviewed all of Russell's medical history. He
    advised us that in part Russell's brain dysfunction had very
    likely occurred as a result of some form of encephalitis
    resulting in bilateral damage to the temporal lobes of his
    brain.
        Based on the facts that we have absolutely no family
    history of autism or any other type of brain disorder in our
    family, that he was born a normal, healthy child, that there
    exists a strong temporal relationship between the timing of the
    DPT vaccination he received at 7 months old and the onset of
    his autistic condition, his classic DPT vaccine reactions,
    coupled with the 18-month-old hit from the MMR and subsequent
    deterioration of his condition, as well as the scientific
    evidence that one of the many serious adverse effects of DPT
    vaccine is encephalitis and brain damage, I believe that
    Russell is a victim of vaccine-induced autism.
        My story is far from unique. Mr. Chairman and members, next
    week when you return home to your district, talk to your
    constituents, many of whom are among the growing number of
    parents who have children with autism. I can assure you that
    you will hear firsthand accounts from those parents about their
    normally developing children and the introduction and reaction
    to a vaccine or multiple vaccines, the timing of their
    children's regression and vaccination, and the onset of a
    multitude of other medical conditions and complications that
    accompany this acquired autistic condition.
        The first rule of medicine is to listen to the patient. A
    child born today in California will have received his first
    vaccination between 6 to 8 hours old. By the time that child is
    6 months old, he will have received 15 doses of vaccines, and
    by the age of 5 years old, 33 doses of vaccines.
        Vaccines contain numerous active agents such as live
    viruses, killed bacteria, and toxic chemicals, including
    aluminum, mercury, and formaldehyde. Where are the safety
    studies on the short- or long-term effects of the interaction
    of these numerous multiple vaccines and their agents on the
    developing brain and immune systems of our children? Where is
    the science?
        Many safety studies of individual vaccines only include a
    few days of followup periods for reactions, but the CDC tells
    parents and the news media that the onset of autism after
    vaccination could only be ``an unrelated chance occurrence.''
    Dr. Satcher, show me the studies. Show me the science. Is it
    appropriate to continue to entrust the CDC and the indemnified
    vaccine manufacturers with the responsibility of guaranteeing
    parents of this country that these vaccines do not cause autism
    or other serious brain disorders when these same groups are the
    most aggressive promoters of vaccine use?
        The situation can easily be likened to charging the tobacco
    industry to undertake independent scientific studies to find
    out if there is any relationship between lung cancer and
    smoking. The science on the safety of vaccines and their
    relationship to the development of autism is not there. Not
    there because the pleas of parents have been ignored. I
    suffered the ultimate betrayal of trust by blindly allowing my
    child to be injected with a multitude of vaccines, trusting my
    Government had made sure that my child would not become
    autistic after his vaccinations.
        Responding to the outcry of parents such as myself,
    professionals, and educators over the concern of the rapidly
    increasing number of children with autism and autism spectrum
    disorders, the California legislature and two Governors of
    different political parties have responded within the past 12
    months by requiring a study on whether autism was increasing in
    the State, and after finding that there was a huge unexpected
    increase, appropriated several million dollars for independent
    research as well as an independent followup study into the real
    factors causing the increase.
        Under the leadership of State Senator, now U.S.
    Representative Mike Thompson, last year the legislature
    required the Department of Developmental Services to report on
    the increase of autism from 1987 through 1998. The report was
    released earlier this year, and documents a very conservative
    273-percent increase in the number of children with autism
    entering the developmental services system, 1,685 new children
    last year alone, when incidence projections for that population
    would have predicted between 105 and 263 new children. The
    report led the Los Angeles Times to declare that the State has
    an epidemic of autistic children. An epidemic of autistic
    children? Isn't that an oxymoron? We all know there is no such
    thing as a genetic disease epidemic. So clearly other factors
    are involved.
        According to the department, this year from January 6 to
    July 7, 1,027 new children with autism were added to the
    system, which means that California alone on average is adding
    6 new autistic children a day, 7 days a week, 1 new child every
    4 hours. Besides the unmeasurable human costs on the child and
    the family, the thousands of autistic children already in our
    system, along with these 1,027 new children, are according to
    the Department of Developmental Services going to cost the
    taxpayers of California and the country a minimum of $2 million
    each for the lifetime of their care.
        Surely any intelligent, thoughtful person with a straight
    face could not suggest that this huge increase in one of the
    most easily recognizable of all childhood disorders is all due
    to genetics, better recognition, or to minor changes in the
    diagnostic criteria that occurred 10 years after the massive
    increase in autism had already begun over two decades ago.
        Earlier this year the local and national news media
    extensively covered the story of the observations by parents in
    Brick Township, NJ, that there were a lot of kids with autism
    in their community. In fact, the CDC publicly announced that
    they had discovered a cluster of autism in Brick. What the CDC
    found was that the prevalence of autism in Brick was 1 in 150
    children; 1 in 150 children represents a prevalence rate 12
    times higher than the published prevalence rate. My family and
    I live in a community approximately 3,000 miles away from Brick
    Township, a community that is almost in every way as different
    from Brick as two communities in America can be. Where we live,
    our children are served by a single public elementary school
    district. The prevalence of autism in our elementary school
    district is 1 in 132 children.
        Mr. Chairman and members, Brick Township, NJ, and Granite
    Bay, CA, are not clusters of autism, but snapshots of what is
    occurring everywhere. Numerous parent organizations around the
    world, including the Autism Research Institute, the National
    Vaccine Information Center, Families for Early Autism
    Treatment, Autoimmunity Research Project, Cure Autism Now, and
    Allergy-Induced Autism are all constantly hearing from scores
    of parents reporting vaccine-related autism. You will find
    these children throughout the neighborhoods of your own
    districts.
        Vaccine policy has always been a cost-benefit proposition.
    I am here to tell you today that the once numerically rare
    sacrificial lambs that society has been willing to tolerate for
    the good of the whole could now very likely before our eyes be
    turning into herds of casualties of the most precious resource
    we have, our children and our grandchildren. We must act
    quickly by investing in good,
    independent research and science to pursue the truth about the
    link between vaccines and autism. If we don't discover all the
    causes, we will never find a cure.
        Thank you for your time.
        [The prepared statement of Mr. Rollens follows:]

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        Mr. Burton. Mr. Rollens, that was a very eloquent
    statement, and I will just pledge to you personally that we
    will do everything we possibly can as a committee to find out
    everything we can. We will ask people from the Surgeon
    General's office and the Departments of Health to stay. They
    heard your statement as well, and I will just say to them that
    this isn't the only hearing we are going to have on this. We
    are going to be beating on this issue as long as I am chairman
    of this committee, which hopefully will be for a while.
        So I hope that you folks will do everything you possibly
    can to help us find a solution to this problem, because not
    only does Mr. Rollens have an autistic child, I have an
    autistic grandchild. I also have a granddaughter that almost
    died from the hepatitis B shot, I believe. So, you know, we
    have people that have had that problem with hepatitis B and
    autism, and the chairman of this committee has had both with
    two grandchildren. So I don't think it is just a coincidence.
        Ms. Zitzmann.
        Ms. Zitzmann. Mr. Chairman and members of the committee, I
    would like to thank you for allowing me as a mother to come
    here today and testify before you. My story will probably be a
    little different from what you have heard just now.
        When two people marry, they have dreams of life together
    and having a family. One day this becomes true, but something
    suddenly goes wrong. You are told that your child has problems
    but they don't know what because they need to do testing. Much
    later you discover that while traveling to work on the transit
    system, a bus and two trains into Manhattan, someone infected
    you with the rubella virus. You find out later it went directly
    into the developing fetus in the early stages of your
    pregnancy, causing the disabilities your son now experiences.
    But you only find this out after your baby is born, because the
    virus does not show signs of infection on you. The rubella
    virus does damage while the infant is developing, and now there
    are vaccines to prevent this.
        The guilt you experience when you learn your child is not
    normal and will never be is very difficult and hard on the
    family, and you begin to ask yourself, what did I do wrong to
    have this happen? Thankfully, I have had a very supportive
    husband in these last number of years.
        My story is that Robert, who is now 34 years old, was born
    with mental retardation and disabilities because of the lack of
    the vaccination. I was born and raised in Brooklyn and lived in
    Queens after I got married, but traveled to Manhattan every
    work day. Perhaps you recall it was mentioned earlier the 1964
    New York rubella outbreak that had happened.
        Soon after our son was born in 1964, we knew something was
    wrong. He couldn't nurse, his sucking reflexes were poor. To
    this day, he cannot suck on a straw, blow out a candle or blow
    his nose. He was delayed in holding objects in his hands,
    sitting, walking, and he didn't know how to hold onto you when
    you picked him up. He had many bouts of respiratory infections
    and pneumonia. His eyes were also affected and he has been
    wearing glasses since he was 3, and they continue to
    deteriorate, and I am being told he will develop cataracts.
        He has no speech, therefore, no language skills. He needs
    to be dressed, undressed, bathed, shaved, toileted, many times
    because he soils himself still. His foods need to be prepared
    and carefully selected. He has certain food intolerances. He
    can feed himself when his food is cut up, most of the time with
    a spoon, a lot of the times with his hands.
        His motor skills and coordination are also poor. Bob will
    wander off if not watched, and we have had to put bolt locks on
    our front doors to prevent him from leaving, and we have had to
    call the police to try to find him. We now have an ID bracelet
    on him.
        All through Bob's growing years, I have met many families
    who share my experiences due to the rubella exposure and have
    always been a strong proponent for parents to immunize their
    children against such viruses, recognizing, however, that the
    decision remains one of family choice, but also knowing that
    since the vaccine has been developed, many individuals have
    been prevented from becoming disabled.
        Bob lived at home with us for 21 years, when we made a
    critical decision in his life and placed him in a private,
    intermediate care facility for the mentally retarded [ICFMR],
    which is a Medicaid funded and federally certified residential
    program. He thoroughly enjoys his home in Wide Horizons. When
    he comes to visit us, within a few days he signs he wants to go
    back because he is bored.
        Before he moved to Wide Horizons, though, and was living
    with us, we were not able to go out to dinner together, attend
    church together, picnics, movies, or vacations. I was changing
    diapers and pants daily on this young man. Sometimes I had to
    change and strip him twice during the night, which meant little
    sleep for both of us.
        Bob and others like him need more supervision, more
    structure, and do well with routine and not so well with
    changes in their daily life. Because his home is an ICFMR, it
    means that his medical, dental, therapeutic, and recreational
    needs are also arranged by the facility through community
    providers.
        As a parent, I needed a guarantee of safety and oversight,
    because he is so vulnerable. He is happy and doing well, even
    with all his disabilities. We as a family appreciate having the
    ICFMR available to us to choose from.
        As a citizen, we select Members of Congress to serve as our
    proxy when it comes to matters of public policy, and I thank
    you for your time today, and trust that you will keep
    preservation of family choice foremost in your mind as policies
    impacting people with regard to vaccines is decided, and I
    truly hope that this committee will consider looking into why
    there are reactions to these vaccines when it is supposed to be
    helping people, not hurting them. I always wonder, if we had
    had this vaccine back then, what would my son be like today?
        Thank you.
        [The prepared statement of Ms. Zitzmann follows:]

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        Mr. Burton. Thank you, Ms. Zitzmann. Thank you very much.
        Ms. Spaith.
        Ms. Spaith. Thank you for inviting me here today. I will
    preface what I am about to say with the fact that the opinions
    that I will express in my testimony are my own personal beliefs
    and not those of the organization for which I work. I would
    like to request that my formal official testimony be entered in
    as part of the official transcript for today's hearing, and I
    will just talk to my abbreviated testimony in the interest of
    time.
        Mr. Burton. That's fine.
        Ms. Spaith. I have served at the Department of Defense and
    in the U.S. Naval Reserve now for 26 years, 5 months. The last
    4 years have been in the Office of the Secretary of Defense,
    Acquisition and Technology, Nuclear, Chemical and Biological
    Matters, which is now called Defense Threat Reduction Agency,
    and I work in chemical and biological elimination. My official
    title is International Project Manager, Biological Weapons
    Proliferation Prevention.
        I manage a team of scientists, veterinarians, and
    technicians in collaborative research with the Russians at the
    Russian Biological Weapons Institutes. I travel to Russia, to
    the various institutes where dangerous pathogens are
    stockpiled, both bacterium and viral.
        In August 1988 I was told by my supervisor to get my shots
    prior to my first deployment to Russia. I received typhoid,
    hepatitis A, and tetanus diphtheria vaccines at my agency,
    Defense Threat Reduction Agency, in late August, early
    September. I received one anthrax and one botulism vaccine at
    the U.S. Army Medical Research Institute for Infectious
    Diseases at Fort Detrick, MD in September and one additional
    anthrax vaccine in January 1999.
        I was never told that any of the vaccines that I was
    receiving were experimental or investigational, and, in fact,
    the botulinal toxin, bot-tox, was investigational.
        The blood work-up that was done at Fort Detrick indicated
    that I fell into the normal range--this was prior to receiving
    the vaccines--I fell into the normal range in terms of the
    assessments that were conducted on my blood at that time, which
    was chemistry and hematology.
        After receiving the vaccines, my blood chemistry changed
    significantly. A blood work-up was done at Walter Reed during a
    routine occupational health physical, and showed that I was
    anemic in the tests that they did run at that time, and a
    physical exam by the doctor revealed that I had a severely
    enlarged thyroid. There had been at that point no followup by
    any of the medical personnel at Fort Detrick.
        My first real symptoms began in October 1998 with
    significant loss of energy. I had trouble sleeping, which
    exacerbated the problem. In November 1998, I started having
    severe headaches in the very back of my head, where I have
    never had headaches before, way back here. I developed acute
    diarrhea. I had hair loss, blood sugar problems, mood swings,
    sleep deprivation, and acute anxiety.
        By December 1998, I had menstrual cycle interruptions,
    increased PMS symptoms, abnormal feelings of tension,
    tremendous--tremendous hair loss, extreme fatigue and loss of
    energy, severely reduced reflexes, and psychological problems.
        I had been completely healthy with no medical problems
    prior to receiving the vaccines. I ran 2 miles every day prior
    to receiving the vaccines. Every day of my adult life I have
    done this. I have not been able to resume that activity.
        I might also mention as an aside, each time I went to Fort
    Detrick, MD for my vaccines, I was bled. In other words, they
    drew blood each time, and I had to prove two different ways
    that I was not pregnant prior to them administering the
    vaccines to me. One was that I had to be on the first day of my
    menstrual cycle to receive the shot. The other was they drew
    blood and made me wait for 2 hours to prove through the blood
    test that I was not, in fact, pregnant before they would
    administer the shot.
        This is basically why I believe that the vaccines I
    received at Fort Detrick, combined with the ones that I
    received at my own agency, and their cross-reactivity,
    contributed to or directly caused my illnesses and conditions.
        By December 1998, I was terribly distraught and suffering,
    and having psychological problems. I went to an endocrinologist
    specialist. She conducted blood work and it revealed that I had
    no thyroid function at all, whatsoever. It was completely dead
    and not functioning. She told me that I had Hashimoto's
    Disease. She started me on Levathoid, which is a synthetic
    thyroid medicine.
        The thyroid regulates the pituitary gland and regulates
    messages from the brain. However, my thyroid produces no
    thyroxin, which results in mixed signals that my body was
    receiving from my brain. As messages were sent from my
    pituitary, and my brain to my thyroid, there were no receptors
    to stimulate secretion of the thyroid gland hormone and no
    thyroxin was produced, so the messages go right back up in a
    closed loop. I was not performing in quite the organized way as
    people whose thyroids function properly. I am currently on
    three types of medications. The Levathoid is for the thyroid
    condition and I am also on Paxol and Adavan.
        What caused my thyroid to stop functioning? That is the
    question that I have. There is no history of this in my family.
    I believe it was the vaccines that caused the change in my
    brain chemistry and my thyroid to stop functioning, which have
    further resulted in this very debilitating auto-immune
    deficiency which I am classified as having.
        While I have had some favorable progress from the
    medications, I believe that my health will never be restored as
    it was before I received the vaccines. My psychological
    problems continued and worsened. I was over-reacting to
    situations and having terrible mood swings, still not sleeping.
    I could get upset very easily over the least little things. I
    developed a great deal of difficulty in my inter-personal
    relationships at work, particularly when I thought people were
    not cooperative. I got overly upset and said things that were
    not characteristic of me. I felt out of control, filled with
    anxiety, and nothing but despair. I was also disoriented and I
    had a great deal of difficulty focusing. I basically thought I
    was losing my mind.
        At work the situation became so bad that my supervisor
    found my behavior to be so out of character, and my personality
    so radically changed, that I was called in and counseled on my
    behavior problems and given a letter of reprimand. This had
    never before happened to me. It was an emotional nightmare, and
    it was the lowest point in my career.
        Then I realized that if management thought that I had
    changed that much, that something was seriously wrong with me,
    enough to write me a letter of reprimand, that I had better get
    back to a doctor. So I went back to the endocrinologist, and I
    discussed it with her, and I told her exactly what was going
    on. She immediately referred me to the mental health facility.
    I went that same day. I was diagnosed with depression and
    anxiety disorder, those are the other two medications that I am
    taking.
        I learned that anxiety disorder is a biological malfunction
    in the body and not just something which is in your mind. It
    stems from a malfunction in brain chemistry. Depression, on the
    other hand, is a whole body illness and it affects the nervous
    system, mood swings, thoughts, and behavior. It, too, begins
    with a disturbance in the part of the brain that governs moods.
        Medical experts believe that thyroid disorder, as well as
    chemical imbalances in the brain, can actually cause
    depression. I attended classes at my HMO's mental health
    facility where I learned these facts, as well as new skills to
    cope with my disorders.
        I believe that my agency placed me in harm's way and then
    abandoned me in my personal crisis. Instead, they told me I had
    behavior problems and wrote me a letter of reprimand.
        Now, I am worried about blood pressure, it has always been
    very low and now it is very high, and the doctors are
    monitoring that. I also recently discovered that I have
    arthritis in several parts of my body. I am now taking anti-
    inflammatory drugs and waiting to get scheduled to see a bone
    specialist. That is on top of the other three medications.
        Again, no one in my family has any history of these
    disorders or illnesses. I continue to perform my job, however,
    I will not take any more vaccines. I will be on the synthetic
    thyroid stimulating hormone every day for the rest of my life.
    As for the other two psychotropic drugs that I am taking, I
    will continue for as long as the doctors feel it is necessary.
        I would like to ask a question. I have a daughter who is a
    First Lieutenant in the Air Force, and since we share the same
    DNA and biological make-up, wouldn't it make sense that she not
    be forced to have to take these shots, considering what she has
    inherited from me and my predispositions? I am very concerned
    for her. The Air Force has told her that she and the other
    people at her command, which is Space and Missile Command in
    Los Angeles, will have to take the anthrax vaccines. It is
    either that or they will leave the service. I have great
    concerns for her. She has got an application in to become a
    pilot.
        [The prepared statement of Ms. Spaith follows:]

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        [GRAPHIC] [TIFF OMITTED] T2560.184

        [GRAPHIC] [TIFF OMITTED] T2560.185

        [GRAPHIC] [TIFF OMITTED] T2560.186

        Mr. Burton. Does that conclude your remarks, Ms. Spaith?
        Ms. Spaith. Yes, sir.
        Mr. Burton. Well, in answer to your last question, there
    are a number of Congressmen, myself included, that have
    legislation that is going to be introduced and will be
    pending--we had a press conference today--that would allow
    members of the Armed Services to decline to have the anthrax
    shot. But we are working on that right now.
        Ms. Cole.
        Ms. Cole. I have a poster with some children on it. Could
    somebody put that up, please?
        Mr. Burton. Would somebody post that, please?
        Ms. Cole. I want to show you mine. This is Christopher.
        Mr. Burton. How old is Christopher?
        Ms. Cole. Christopher was 12 when he passed away.
        Mr. Chairman, members of the committee, thank you for
    letting me speak to you today.
        My name is Rebecca Cole and I am from Chapel Hill, NC. I am
    the mother of five children. I am here today because I faced
    the worst nightmare any parent can possibly face. There is no
    experience on Earth that compares to the horror and devastation
    of losing a child. It is shattered dreams, crushed wishes, and
    a future that suddenly vanishes before our eyes. It cannot be
    wished away, slept away, prayed away, or screamed away. It is
    darkness, agony and shock. It leaves our hearts broken,
    bleeding and bursting with pain and it changes us forever.
        My life changed forever on June 30, 1988 when I had to
    stand by helplessly as an infectious disease claimed the life
    of my oldest child, Christopher Aaron Chinnes, at the age of
    12.
        Christopher was a beautiful little boy who had light blond
    hair and deep brown eyes. He was full of compassion, joy and
    energy. He loved baseball and every living creature on the
    Earth. He wanted to be a scientist or doctor. I can honestly
    say that my son was one of the most beautiful human beings I
    have ever known, and I am proud to have been his mother.
        Christopher was born a very healthy child but at the age of
    8 he developed asthma. It was never a problem for him and it
    never kept him from doing the things he loved. But, on June 16,
    1988, 4 years after he was diagnosed, he suffered his first and
    only severe asthma attack. He had to be hospitalized and was
    treated with all of the normally prescribed drugs including a
    corticosteroid. For those who don't know, corticosteroids are
    anti-inflammatory drugs. They are used routinely in asthma,
    arthritis, and allergies. Oral surgeons also prescribe them for
    swelling in the gums.
        Well, Christopher was released from the hospital 4 days
    later with several medications to finish at home, and he was
    well on his way to recovery. On June 23rd, exactly 1 week after
    the asthma attack, he broke out with the chicken pox. ``Don't
    worry, you will get over it,'' I told him. What I didn't know
    was that the corticosteroid had lowered his body's immune
    response and he could not fight the disease.
        The chicken pox began to rampage wildly through his young
    body. As I drove him to the emergency room on June 27th my four
    younger children watched silently in shock and horror as their
    brother went into seizures, went blind, turned gray, and
    collapsed due to hemorrhaging in his brain. That afternoon
    Christopher was flown from Camp Lejeune's Naval Hospital to
    East Carolina University School of Medicine's Medical Center,
    but the chicken pox was uncontrollably sweeping through him
    like a wildfire, and there was nothing anyone could do.
        The next day he suffered cardiac arrest and slipped into a
    coma. As my beautiful little boy lay swollen beyond recognition
    and hemorrhaging from every area imaginable including out into
    the blisters on his skin, I learned that a vaccine existed but
    was not yet licenced by the FDA. A vaccine that could have
    prevented the unimaginable suffering of my child and all who
    knew him.
        On June 30, 1988, exactly 1 week after breaking out with
    chicken pox, Christopher passed away. He died. He was not
    injured. He did not act differently. He was not crippled. He
    died. My priceless little boy lay on a cold, steel table
    swollen beyond recognition, cold and dead, gone from me, gone
    from life itself.
        I cannot hold him, kiss him, see him smile or listen to his
    laughter as he chases a ball or bullfrog. The chicken pox virus
    destroyed every organ in his body and it cut pieces from the
    hearts of everyone who witnessed its devastation.
        Vaccines prevent countless deaths each year. Without them
    the number of valuable human beings we would lose would be
    staggering. Yes, sadly, some injuries and deaths occur as a
    result of vaccines, but unfortunately there are risks with
    every single drug we use. We have and will not ever reach
    perfection. We must remember that the benefits of our vaccines
    far outweigh the risks. Especially for those who are ill or
    immunosuppressed like Christopher was. There are innocent
    children and adults who come in contact with the public every
    day who would die if they were exposed to the diseases we can
    prevent.
        If everyone around them is vaccinated, they are also
    protected. We owe it to them and to ourselves as a Nation to
    achieve the highest level of safety and protection possible. We
    must win the war against infectious disease, and vaccines are
    our most powerful weapons. We cannot win, however, if we do not
    use them. Leaving any of our population unprotected is like
    surrendering to a defeatable foe, and we must never surrender.
    Thank you.
        Mr. Burton. Thank you, Ms. Cole.
        [The prepared statement of Ms. Cole follows:]

        [GRAPHIC] [TIFF OMITTED] T2560.187

        Mr. Van Zandt. Thank you, Mr. Chairman and committee
    members. My name is Dr. Keith Van Zandt, and as a practicing
    family physician I appreciate the opportunity to address this
    committee regarding vaccines.
        I have degrees from Princeton and Wake Forest Universities
    and completed residency training in family medicine here in
    Washington at Andrews Air Force Base. Today, however, I am here
    as a dad. I have five children, two of whom my wife, Dede, and
    I adopted from Romania. Our youngest, Adriana, was nearly 4-
    years-old when we adopted her from the orphanage and was found
    to have chronic active hepatitis B when we performed bloodwork
    prior to bringing her home. She had contracted this from her
    mother, who died when Annie was 9 months old from the effects
    of her liver disease as well as tuberculosis.
        We have been very fortunate to have had some excellent
    medical care for Annie, but her first year with us was an
    endless procession of liver biopsies, blood draws, and over 150
    painful Interferon injections that I gave my new daughter at
    home. Interferon is a form of chemotherapy for hepatitis B that
    has many side effects and only a 25 to 40 percent response
    rate. We know first-hand the pain and family disruption this
    completely preventable disease can bring.
        As a family doctor, I see patients every day whose lives
    have been significantly improved by the immunizations we now
    have available. My forbearers in family medicine struggled in
    the pre-vaccination era with the ravages of horrible diseases
    that are now of only historical interest. Preventive
    immunizations have so changed our world that I am afraid that
    we no longer remember how horrible some of these diseases were.
        My family and I have made multiple trips to Romania to work
    in the orphanages and unfortunately I have seen the effects of
    many of these diseases there. I am certainly aware of the
    potential for adverse reactions to our current vaccines but we
    must maintain the perspective that these reactions are
    extremely rare.
        My partners and I in Winston-Salem care for over 40,000
    patients, and I can honestly say that in over 20 years of
    practice, we have never seen a serious adverse reaction to any
    vaccine. I believe that the vast majority of family physicians
    around the country can say the same. Certainly I do not wish to
    minimize the suffering and losses of families who have
    experienced these problems, but we must remember that
    immunizations remain the most powerful and cost-effective means
    of preventing disease in the modern era.
        Personally, it still sickens me to know that the disease
    that my daughter has was completely preventable if hepatitis B
    vaccines had been available to Annie and her mother. Whereas 90
    percent of adults who contract hepatitis B get better, 90
    percent of children under the age of 1 go on to have chronic
    disease and 15 to 20 percent of them die prematurely of
    cirrhosis or liver cancer.
        I know first-hand the gut-wrenching feeling of being told
    your child has a chronic disease that could shorten their life.
    I know first-hand the worry parents feel when their hepatitis B
    child falls on the playground and you don't know if her
    bleeding knee or bloody nose will infect her playmates or
    teachers. Our kids are all over this country. They play with
    your kids in preschool. They date your kids in high school. I
    know first-hand the concern for my other children's health with
    a 1 in 20 chance of household spread of hepatitis and the
    thankfulness I feel that they have had the availability of
    successful vaccines. I know first-hand the pain a parent feels
    for their child as they undergo painful shots and procedures
    for their chronic disease with no guarantee of cure.
        I am not the world's leading expert on hepatitis B or the
    hep B vaccine, but I am an expert on delivering the best
    medical care I can to my patients in Winston-Salem, NC. I am
    also not the world's leading expert on parenting children with
    chronic diseases, but I am the world's best expert on parenting
    my five children.
        I know professionally that immunizations in general have
    hugely improved the lives of those patients who have entrusted
    their medical care to me. I know personally that had the
    hepatitis B vaccine been available to my daughter, her life and
    mine would have been drastically different. I am also thankful
    that my other children have been spared Annie's suffering by
    being successfully vaccinated.
        Anecdotes of vaccine reactions are very moving, but they
    are no substitute for good science. Please allow me to continue
    to provide the best medical care I can with the best system of
    vaccinations in the world and allow me to keep my own family
    safe. Thank you very much.
        [The prepared statement of Dr. Van Zandt follows:]

        [GRAPHIC] [TIFF OMITTED] T2560.188

        [GRAPHIC] [TIFF OMITTED] T2560.189

        Mr. Burton. Thank you, Dr. Van Zandt. I hope that the
    impression has not been given that anybody on this committee
    thinks vaccinations aren't important. I think we all agree that
    they are. The question is, are all of them absolutely necessary
    and are there things that can be done to make sure that they
    are necessary?
        In your particular case, you adopted a child where they
    probably didn't have available to them on a regular basis those
    kinds of vaccines. I mean Romania has had some difficult times
    and had some very unfortunate situations, but I just talked to
    a family where, and I won't identify them because the lady did
    not want anyone to know she has hepatitis B, but she had
    hepatitis B and she came to the United States and married and
    her child was born with hepatitis B.
        Had she been tested for hepatitis B during her pregnancy,
    it would have been very clear that the child should get a
    hepatitis B shot to prevent hepatitis. As I understand it,
    hepatitis B is spread through blood or from birth through the
    mother, or from needles, or from sexual contact. That being the
    case, it seems to me that if there are side effects to
    hepatitis B shots, as I believe there are because my
    granddaughter almost died--I think you heard that in my
    comments--then it seems to me that one of the first lines of
    defense would be to test every pregnant woman while she is
    pregnant to see if she has the hepatitis B virus.
        Mr. Van Zandt. We do that.
        Mr. Burton. Well, this woman was not tested when she was
    pregnant. The hospital evidently neglected to do that.
        If the mother doesn't have hepatitis B, then it may or may
    not be necessary for that child to have the hepatitis B vaccine
    and that I think should be something that parents should be
    aware of, especially if there are side effects. Now this is
    just my own opinion. I am not a scientist or a doctor, but I
    have talked to a lot of people who feel the same way I do who
    do have this expertise.
        If you would like to comment, I would be happy to have
    you----
        Mr. Van Zandt. If I could respond to that, we have heard
    earlier today that 40 percent of the cases of hepatitis B there
    is no identifiable cause, no identifiable risk factor.
        Mr. Burton. About 25 percent I think.
        Mr. Van Zandt. It varies. I have read different, but
    nonetheless like I said I will defer to my CDC colleagues on
    that. The problem is that children with infectious diseases are
    out there. They often are totally asymptomatic. We don't know
    that they have these infectious diseases and that puts the
    population at risk.
        We cannot simply target those populations that we think are
    prone to the disease and only gear our immunizations toward
    them. We tried that with hepatitis B in the past with
    adolescents. We tried to simply immunize adolescents. It didn't
    work.
        Mr. Burton. Let me ask you this question----
        Mr. Van Zandt. We got dismal immunization rates by doing
    that and it didn't work and we moved back to the infancy time.
        Mr. Burton. May I ask you a question?
        Mr. Van Zandt. Sure.
        Mr. Burton. This lady's child died and it is believed by
    the coroner that it was caused by the hepatitis B shot, because
    we called the coroner this week, did we not? We called the
    coroner and asked him.
        My granddaughter, within 12 hours of the hepatitis B shot,
    wasn't breathing. She was in a hospital, turned blue, and they
    thought she was going to die. She had to go on oxygen and she
    did survive, thank goodness.
        What do you say to the two of us?
        Mr. Van Zandt. Certainly I can't speak specifically to the
    cases. That would be unfair to you and to me. I don't have the
    details.
        What I can say is that the system of vaccinations we have
    in this country works well. My personal experience is all I can
    speak to on that. The experience of my partners in Winston-
    Salem is all I can speak to on that. The reaction rates are
    rare. We rarely see them. There may be associations between the
    timing of the shot and diseases that develop. I think we need
    more data and more information to truly determine whether there
    is a cause-effect relationship or simply an association between
    those two and that is a big difference.
        Mr. Burton. Well, I agree with that and I think those are
    things that the Surgeon General and CDC and the FDA and
    everybody else ought to get on with as quickly as possible
    because vaccinations are absolutely necessary. But if
    vaccinations are causing autism, like in my grandson, or almost
    killing someone, like my granddaughter, or killing these
    people's child, then I think that it ought to be found out so
    that we can make corrections.
        Mr. Van Zandt. Absolutely.
        Mr. Burton. We agree.
        Mr. Van Zandt. We are all on the same page. I think that we
    don't want to throw out the whole system based on that,
    however.
        Mr. Burton. Ms. Spaith, did your supervisor get those
    shots?
        Ms. Spaith. No, sir, he didn't.
        Mr. Burton. He did not?
        Ms. Spaith. No, sir, he did not.
        Mr. Burton. Why did he ask you to get those shots?
        Ms. Spaith. Because I travel to Russia to dangerous sites,
    as he does, and my second level supervisor and other people in
    the office do.
        Mr. Burton. And they didn't get the shots?
        Ms. Spaith. No, sir, they did not. They said they didn't
    have time.
        Mr. Burton. So you were the only one and you ended up being
    the guinea pig?
        Ms. Spaith. Yes, sir.
        Mr. Burton. Let's see. Mrs. Cole, if a child is immuno-
    suppressed, could they be vaccinated?
        Ms. Cole. They hold off on that with the live virus
    vaccines. There are children who can't be vaccinated because of
    a drug they are on or a disease they have and that is why it is
    important that the rest of the population be protected so they
    are not exposed to it.
        There could be four or five children in one classroom in a
    school that haven't been able to be vaccinated because their
    immune system is down a little, not enough to make them
    obviously ill, but down, and anything they are exposed to in
    that room could really, really harm them and as in my son's
    case, kill them.
        Mr. Burton. Mr. Waxman.
        Mr. Waxman. Thank you, Mr. Chairman, I regret that I wasn't
    able to be here to listen to all the oral presentations, but we
    do have written testimony and I thank all the witnesses for
    being here, and I know it is not easy to come before Congress
    and share your personal loss and pain.
        Dr. Van Zandt, how has contracting hepatitis B affected
    your daughter's current health and future health, and will she
    be more susceptible to diseases of the liver?
        Dr. Van Zandt. This is unknown at this time. She did
    respond fairly well to the Interferon shots we gave her. Her
    viral titers, which is how we measure that, are undetectable at
    the present time. The problem is we never know. She fell
    several months ago and split her forehead, like anybody,
    parents have had children that do that, and with blood all over
    the floor, my first thought was hepatitis B. Not will she scar,
    or will we need to clean the rug? It was hepatitis B and who is
    at risk, and who will be at risk for that. If it had happened
    at school, without universal precautions being performed, I
    don't know.
        Mr. Waxman. Some physicians have stated that hepatitis B is
    more a disease of sexual behavior and drug needle use and that
    it is unethical to mandate the vaccine for school children. Do
    you agree with that sentiment?
        Dr. Van Zandt. I think those are two mutually exclusive
    sentences. I believe that it is more likely to be related to
    sexual patterns and IV drug abuse, but to say that it is
    morally unethical to vaccinate against it, I don't get the
    connection on those. Certainly, the higher risk population
    groups of sexual activity and IV drug abuse do have a higher
    incidence of hepatitis B.
        What I am here to tell us is that our kids are out there
    with hepatitis B and they may be completely asymptomatic. You
    don't know it, and they are at risk, or there is a risk of them
    transmitting the disease. Because of that, I feel that the
    vaccinations--it is morally unethical not to vaccinate in that
    sense, to protect the public health.
        Mr. Waxman. As a family physician, what do you tell your
    patients about the risk of possible adverse effects of
    immunizations?
        Dr. Van Zandt. We use the CDC's vaccine information sheet
    to get out to every parent. The tough part about that, as many
    people on this panel will say, is that it has information that
    may or may not be really relevant and comprehensible to what
    can happen.
        We know there are serious adverse reactions, and to counsel
    accordingly is appropriate. But it is also very important to
    counsel the risk of not getting the vaccine and the risk of
    having an infectious disease, and what that can do to your
    life.
        Mr. Waxman. As a scientist, have you heard of any work that
    would show that there may be a connection between immunizations
    and autism?
        Dr. Van Zandt. I am not aware of that, but, again, I am a
    practicing physician, not a research physician.
        Mr. Waxman. I just don't know if there is something in the
    scientific literature. You know, I must say that I hear there
    is an increase in autism. I hear there is an increase in
    dyslexia and learning deficiencies. Maybe in the latter it may
    be more of an ability to discern these problems.
        It is frustrating to think that we may be causing all these
    terrible things happening to our children, and we don't know if
    it is environmental. Just yesterday, the EPA started to deal
    with the problems of pesticide residues in foods that we know
    from the Institute of Medicine adversely affect children more
    than adults. We don't know what other things we are being
    subjected to.
        Whenever many of us try to fight for environmental
    protections, we get all the industry groups coming in and
    saying, oh, it can't be us, we are fine. But you wonder with
    all the information that comes out, in dribs and drabs
    sometimes, what we are going to learn later on, whether it is
    immunization. If it is immunizations, if it is chemicals in our
    food, if it is toxic substances in the air, in the water, we,
    as a society, have got to understand what is happening and try
    to protect people, particularly children.
        Mrs. Cole, many parents are not aware that chicken pox can
    be fatal. How have you been able to educate others about
    chicken pox and the need for vaccines? Have you taken that on
    to talk to folks about?
        Ms. Cole. I worked more or less as a mom through FDA to get
    warning labels put on all cortico-steroids about their dangers,
    potential danger with chicken pox and measles. Chris has been
    gone for 11 years. I worked for 7\1/2\ years through letters
    and phone campaigns to see the vaccine for chicken pox licensed
    by the FDA.
        I went to FDA twice and spoke before two FDA Advisory
    Committees about my experience with chicken pox. I listened to
    what they had to say about the vaccine, and there were many,
    many articles written about Christopher, because chicken pox
    being fatal is something not many people ever hear about. Most
    people think, OK, I can expose my children on purpose and it is
    better for them, but they don't realize that it can be
    dangerous.
        Yes, I have worked for a long time to try to educate the
    public as to the facts. It is not just immuno-suppressed
    children or individuals that can have a problem with chicken
    pox. From what I understand, and this may have changed, about
    half of the people that die each year of the varicella virus
    are not immuno-suppressed, they are healthy, normal people.
        Mr. Burton. Thank you very much.
        Mr. Weldon. I have seen that. I had a 21 year old come in.
    He acquired--actually, he was about 25, acquired it from his
    child who ended up passing away. So it is a mistaken notion
    that chicken pox is a harmless disease. Occasionally, it can be
    fatal.
        I want to thank each and every one of you for coming. I
    guess the question that I would have, and maybe I can start
    with you, Mr. Rollens, what do you think we should be doing? I
    have a constituent in my congressional district who believes
    that his son became autistic in response to the MMR. You
    provided testimony that you thought in your particular
    situation it could have been the DPT and the MMR might have
    made it worse.
        We have testimony from the people sitting next to you about
    the devastating effects of the lack of immunization for some of
    these diseases. There are epidemiologists who have come into my
    office and explained to me the tremendous impact that it could
    have on our population if there was a large scale rejection of
    these immunizations on the part of parents, if we were to have
    outbreaks of these clearly preventable diseases.
        I would be very interested to hear comments from the other
    panelists. What do you recommend we do as policymakers? You
    know, we are here to pose the tough questions and get the
    answers. But then after all the talking is done, where do we go
    from here? Your thoughts?
        Mr. Rollens. Yes, sir. The first thing that needs to be
    done is to stop politicizing this issue. There isn't anyone
    sitting in this room who is in favor of infectious diseases,
    and everyone is in favor of eradicating infectious diseases. So
    I think it is an issue that, unfortunately, those sometimes on
    both sides tend to politicize to make either pro-vaccine or
    anti-vaccine. I don't think that is the case at all.
        I know the parents that I deal with in the world of autism
    around the country and around the world, all are conscientious
    parents who want the very best for their children. They don't
    want their children to pass away from any infectious disease.
    They want to provide the very best they can for their kids.
        What we are asking, and what I am asking particularly from
    you is that before we deal with bringing new vaccines onto the
    market, and before we decide to mix such potent chemicals and
    potent viral and bacterial agents together, that independent
    safety studies be done about their effects.
        And when I say independent, I mean devoid of the public
    health community's involvement. It is a conflict of interest to
    have the CDC, the NIH or anyone else who is involved with the
    promotion of vaccines to be telling us if they are safe or not.
    Like I said before, it is like asking the oil industry to come
    in and tell you that there is no relationship between smoking
    and lung cancer. It is ludicrous to have these people who are
    in charge of promoting this policy to be telling you if they
    are safe or not.
        We have able immunologists, virologists, and neurologists
    around this country and around this world who are very able to
    look at the science of the interactions and the effects that
    these vaccines have on a certain percentage of the population.
        I would also say that when I keep hearing that it is a rare
    chance occurrence, or this is a rare effect, I am telling you,
    as honestly as I can, that I have witnessed in the last 6 years
    alone, since my son was diagnosed, an explosion of autism, and
    parents are reporting objective reports, nothing besides the
    parent's observation of what happened to their children, of
    this strong temporal relationship between the vaccinations that
    they received, primarily the DPT, hepatitis B, and MMR, to the
    onset of their child's autism. The numbers are there. The
    California Department of Developmental Services has reported
    two reports within the last year on this epidemic of autism in
    California.
        I challenge you again, when you go home next week to your
    districts, walk the neighborhoods, talk to the parents, they
    will tell you what is going on.
        Mr. Burton. Thank you. Mr. Rollens, I don't want to belabor
    this point, but you quoted some statistics from California. I
    have just instructed Beth here to contact the Departments of
    Health in California to get that statistical data.
        Mr. Rollens. Yes, sir.
        Mr. Burton. But we got an e-mail last night from a doctor
    in Louisiana who said that she has had reported to her over 600
    vaccine-related autism cases. So that is Louisiana, it is not
    California. Have you talked to anybody in other States? I know
    that you are very involved in this, and I am very interested in
    it, too, because of the personal problem we have in our family.
    Have you talked to people in other States to see how pervasive
    it is?
        Mr. Rollens. Yes, I have, and I can speak in volumes to
    what is happening in California, because I have been very
    involved in that.
        Mr. Burton. Well, tell me about other States that you are
    conversant with.
        Mr. Rollens. Well, this is anecdotal. Once again, there has
    not been the kind of comprehensive study that was compiled in
    California in any of the other States. But the U.S. Department
    of Education has reported increases in every State in reported
    cases of autism.
        What makes the California situation interesting and very
    significant is that in California we have something called the
    Lanterman Act, and I am sure Mr. Waxman remembers, in the
    California legislature, passed in 1969, which is essentially a
    program that entitles people who are diagnosed with autism,
    cerebral palsy, mental retardation, and epilepsy to services
    from the State. In order to qualify for those services, you
    have to have a diagnosis by the regional centers of our State
    in order to receive those services.
        The report that California came out with last year shows
    that in the cases of what is known as DSM4-autism, this is full
    blown autism, not pervasive developmental disorder, or any
    other autism spectrum disorder, that there was an unexpected
    huge increase in the numbers of cases coming to the regional
    centers.
        Now, one would say, well, this is an entitlement program,
    so people are coming for services. That is true. But they don't
    get those services unless they are diagnosed by a licensed
    psychologist or a professional person who uses the DSM4 for the
    criteria to diagnose for autism.
        The other issue is that in California we have almost 16,000
    children in the Early Start program, this is a program for
    children ages zero to 3 with developmental delay and language
    delay, but have yet to receive a diagnosis. When you see
    development delay and language delay, many people, including
    myself, feel, and I am sure time will show this, that a number
    of those children will also be added to the ranks.
        The other concern that we have, of course, in California is
    that in the last 6 months, from January until July of this
    year, we have added 1,027 new children to our system. On
    average, six new kids a day, one new child every 4 hours. As
    you can see from my chart over there, that baseline of 200 new
    children stayed very steady all the way until the late 1970's,
    and there was a massive increase that occurred, it broke the
    200 new cases a year, and has continued to go up, till today we
    are adding people at a rate of one child every 4 hours.
        Mr. Burton. Let me ask one more question. There is the
    chart he is talking about Henry. I don't think you saw that
    earlier. The other thing I would like to ask, and we have some
    people from the health agencies here, you implied that there
    might be a vested interest in them not giving information to
    the Congress and to the country regarding various vaccines.
    That is a pretty serious allegation. You said we ought to have
    independent studies from outside. What makes you say that?
        Mr. Rollens. Well, first of all,----
        Mr. Burton. I mean do you think they are being influenced
    by pharmaceutical companies or what is it?
        Mr. Rollens. The lack of responsiveness to the call that we
    have made for years now about this growing problem between the
    relationship between our children being damaged by vaccines and
    becoming autistic, and no response, or being literally blown
    off, that it is a rare chance occurrence that your child has
    become autistic right around the same time as the vaccine, with
    absolutely no safety studies to back it up.
        I want to see from Dr. Satcher and others where the CDC's
    safety studies are that tell me as a parent, and as a taxpayer,
    and as a good person, a father who loves his child, that these
    vaccines will not cause autism or that my child, most
    importantly, did not become autistic because of the vaccines
    that he received.
        Mr. Burton. When they come up with a new drug at CDC and
    FDA, I have talked to them, they say they have to do a double
    blind study and sometimes more than one before they will attest
    to the veracity of the particular product. Since they are
    vaccinating everybody in the country, how do you propose they
    do a double blind study?
        Mr. Rollens. Well, sir, I am not a scientist.
        Mr. Burton. No, I am just curious, from your perspective.
        Mr. Rollens. Yes. I feel that when someone asked me to turn
    over the most precious thing in my life to them and trust them
    that my child would be out of harm's way, that the people that
    are doing the medical procedure, it is their responsibility. It
    is not my responsibility as a parent to ensure that every
    vaccine that I give my child, when I have been told that they
    are safe by the pediatrician, I have been told by society that
    there is no such thing, essentially, as an adverse effect.
        You know, we are all sitting here with this issue on our
    minds, but how many parents out there really understand what
    can possibly happen from the documented research that has been
    done, and documented cases of adverse vaccine reactions?
        Mr. Burton. Thank you very much.
        Mr. and Mrs. Nelson, you have come out here and I know you.
    Let me just ask you, when your child passed away, as I
    understand it from my daughter, when she talked to you, you
    called the doctor a number of times telling them of various
    symptoms, the temperature dropping, wrap her in blankets they
    said, and so on and so forth, and then, of course, the child,
    you took her to the hospital and she didn't make it. Can you
    really quickly tell us what happened, what the initial decision
    was that was made or what initial analysis was that was made of
    the death of the child, and what they told you?
        Ms. Nelson. In the beginning they told us it would take 2
    weeks to get the cause of death back. It was approximately 2
    months later we heard from the coroner's office, Dr. Thomas
    Gill, who told us our daughter died of hepatitis B due to the
    vaccine. Sixteen weeks later we received the death certificate
    in the mail stating that she died of natural causes, SIDS. I
    called to find out how they determined that.
        Mr. Burton. Who told you that she died of SIDS?
        Ms. Nelson. Dr. Karl Manders, the coroner of Marion County.
        Mr. Burton. The coroner of Marion County, Dr. Manders. OK.
        Ms. Nelson. He stated that he had read over the autopsy
    documentation and that he signed the death certificate due to
    the fact that Dr. Gill was asked to resign. They filed the
    autopsy report the day after the autopsy. They did not wait for
    the toxicology report to come in, which came in 2 months later.
        I asked him why he did not go back and check that over. He
    told me it was already signed. Then recently I have contacted
    the coroner's office. They refuse to give me her records. They
    refuse to give me any notes of Dr. Gill's, and they continue to
    tell me it was SIDS.
        Mr. Burton. I want those subpoenaed. We will subpoena those
    records. We will get those records. We will look into that.
        Ms. Nelson. And they refused to tell me Dr. Gill's
    location, where he was or anything like that.
        Mr. Burton. All right.
        We talked to the coroner's office and they said it was
    hepatitis. So, evidently the records do reflect that. So we
    will check into it.
        Ms. Nelson. OK.
        Mr. Burton. Do you have any more questions Mr. Waxman?
        Mr. Waxman. Yes, Mr. Chairman.
        Mr. Rollens, you said that you entrusted the care of your
    child. People told you there were no such things as adverse
    reactions, and I think it is a mistake when people are told
    that there is no risk. As we know, there is some risk.
        I know it is frustrating because so many of these people
    that you are looking at don't see it the way you see it. They
    don't see the connection. You may be right, they may be wrong.
        Mr. Rollens. I hope I am wrong, sir.
        Mr. Waxman. But they are people who are scientists, and
    they are not making any money out of having vaccines out there,
    and they are certainly not doing a service to anyone if they
    are not monitoring whether these vaccines are safe. I just want
    to point out there is an Advisory Commission on Childhood
    Vaccines and its membership is made up of public
    representatives as well, and I hope maybe we can look at that
    commission with you and it would give a sense of comfort that
    it is not just people who are professionals at the CDC.
        But I have to say that I have always had the highest regard
    for the people at the CDC, and I think they are trying to do
    the best job they can, and I don't think they have any ulterior
    motives.
        Mr. Chairman, I know there are people here from the NIH and
    maybe they could tell us, although it is probably unfair to ask
    anybody to come up and talk about what research is going on in
    the area of autism. But if we don't have a response now, I
    would like to hold the record open, ask you if you could hold
    the record open. I want to know what our Government is doing in
    terms of autism research.
        Mr. Weldon. Would the gentleman yield?
        Mr. Waxman. I find what you have said, Mr. Rollens, and
    others, very, very sobering and of great concern.
        Yes, I yield.
        Mr. Weldon. I had CDC and NIH in my office on this issue,
    and there is really quite a bit of research going on. I have
    already asked them to provide that for the record.
        Mr. Waxman. Good.
        Mr. Weldon. I will share with you, though, that I think
    they need to do more, but, in that regard, they will need
    funding to cover it. I think that I would like to see that
    ultimately be one of the recommendations that comes out of
    these hearings is that the Congress of the United States takes
    initiative and funds more studies on this issue, particularly
    because I think it is going to be very important to restore
    public confidence in the system.
        Mr. Waxman. Well, I certainly agree with you that we have
    got to spend more money on this research and try to find out
    what is causing autism and to try to see if we can find a way
    to prevent it or cure or control it because it is a very
    painful situation for everybody involved.
        I don't want to say that because we don't have the answer
    to what causes autism that there is a lack of confidence in the
    system because science doesn't always give us the answer we
    want right away. We have got to make a commitment to invest in
    scientific research so that we can find some answers that can
    be replicated, can be validated and believed in because it has
    been scientifically established, not believed in because people
    want to believe in something, because that is not going to lead
    us to where we want to go.
        So I want to join you in saying that perhaps one of the
    good results of this hearing might be a commitment that all of
    us will share to increase the research in this particular area.
        I have no other questions and I thank all the witnesses.
    Thank you, Mr. Chairman.
        Mr. Burton. Thank you. I want to thank this panel very,
    very much, and I think, regardless of what your position is on
    vaccinations, we all share the heartache that you have gone
    through. I really feel empathy and sympathy for all of you.
    Thank you very much for being here.
        The next panel is Dr. Kennedy, Dr. Kinsbourne, and Dr.
    Katz, and I would like for them to come forward at this time,
    and I apologize to you folks for this panel being so late.
        One thing while they are coming up, I would like to say to
    our friends before you leave from the health agencies, I hope
    that somebody, if you haven't done this research, if they could
    look into whether or not all of these vaccinations coming in
    such a short period of time might cause overload on the immune
    systems of these children. Maybe the vaccinations, if given
    over a longer period of time might be less hurtful to the
    children, and maybe you can give me some information on that.
        We heard from the people who just testified that some of
    them experienced 30 vaccinations by the time their child was 3
    or 4 years old. We understand there are 21 different
    vaccinations they have to get from the time they are born to
    the time they get into school in many States. I know when we
    had the old electric system, if you put too much electricity on
    one fuse, you would blow the fuse, and I know that is an
    oversimplification of the problem, but it seems to me that
    might be one of the causal effects of too many vaccines in too
    short a period of time.
        Would you gentlemen please stand?
        [Witnesses sworn.]

       STATEMENTS OF RONALD C. KENNEDY, PROFESSOR, DEPARTMENT OF
      MICROBIOLOGY AND IMMUNOLOGY, UNIVERSITY OF OKLAHOMA HEALTH
    SCIENCES CENTER; SAMUEL L. KATZ, PROFESSOR EMERITUS, DEPARTMENT
       OF PEDIATRICS, DUKE UNIVERSITY MEDICAL CENTER; AND MARCEL
                   KINSBOURNE, PEDIATRIC NEUROLOGIST

        Mr. Burton. We will start with you, Dr. Kennedy.
        I apologize for it being so late in the day.
        Dr. Kennedy. It's OK. I apologize for putting on these
    glasses and not being able to see any of the members of the
    committee anymore.
        Mr. Burton. They will all be informed of your testimony.
    There are a lot of people paying attention across the country.
    Thank you.
        Dr. Kennedy. I would like to take this opportunity to thank
    you for the invitation to speak to this committee regarding
    issues related to vaccines, public safety, and personal choice.
    My name is Ronald Kennedy, and I am a professor of microbiology
    and immunology and obstetrics and gynecology at the University
    of Oklahoma Health Sciences Center. I am a research scientist
    and teach medical and graduate students.
        My education has taken me from Connecticut, where I was
    born, to New Jersey, to Hawaii, where I received my master's
    and doctoral degrees, Houston and San Antonio, TX, and finally
    Oklahoma City.
        My training is in microbiology and immunology and I have
    been working in the area of vaccinology since 1981, when I
    first started working on the immune response to hepatitis B
    surface antigen, the component of the hepatitis B vaccine.
        Since that time I have performed basic and applied research
    as it relates to a variety of viral, bacterial and cancer
    vaccination strategies. Included in these efforts were studies
    to develop and/or improved vaccines to hepatitis B virus, the
    human immunodeficiency virus, HIV, hepatitis C virus, and
    simian virus 40, among others a virus that been recently
    associated with cancer in humans.
        Because of my expertise in animal models for infectious
    diseases, particularly non-human primate models, I've also
    performed a number of collaborative studies with investigators
    on vaccines for haemophilus influenza type B, group A and group
    B streptococcus and meningococcus, among others.
        As a number of these infectious diseases cause diseases in
    newborns and infants, I have become aware of the difference
    between how newborns respond to vaccination when compared to an
    adult.
        I consider myself pro-vaccine. However, growing up in the
    field of vaccinology as I have, I am aware of a number of
    issues and considerations that should be brought forth when it
    comes to vaccines, public safety, and personal choice.
        I would like to briefly mention three issues as it relates
    to the subject of this hearing.
        The first is a lack of a mechanism to study the basis for
    adverse reactions to vaccines.
        The second is, how can we improve vaccine safety,
    particularly when immunizing infants?
        The final issue is that certain vaccines are just not
    appropriate and have not been tested well enough to mandate
    mass vaccination of infants, and this deals with informed
    consent and the parents' right to personal choice.
        Regarding the lack of a mechanism to study the basis for
    adverse reactions to vaccines, I along with several colleagues
    have submitted grant applications to the National Institutes of
    Health to study the basis and mechanism of adverse reactions
    seen as a result of the hepatitis B vaccine. We made three
    attempts.
        In each attempt the grant application was not considered
    for funding. The reasons of the peer review panel were the
    application was descriptive and a fishing expedition. We had
    compelling evidence but no direct cause and effect, and limited
    preliminary data.
        As someone who has been funded continuously from the
    National Institutes of Health since 1984 and who has served on
    grant review panels for the National Institutes of Health since
    1987, I was aware that such comments were a kiss of death. More
    importantly, I did not disagree with the panel's perception of
    the grant application. However, it was the nature of the
    subject matter. Since everyone has a perception that vaccines
    are completely safe, why would they want to study adverse
    reactions?
        If the National Institutes for Health or Centers for
    Disease Control and Prevention will not support research by
    investigators outside their institutions into the basic
    mechanisms of adverse reactions of vaccines that are presently
    being used to immunize infants, perhaps the pharmaceutical
    companies who make the vaccines would fund such work by outside
    investigators. Honestly, I do not think that the vaccine
    manufacturers would be interested in supporting efforts that
    might show that their product is harmful.
        I would urge you to provide research funds that are
    currently unavailable to study serious adverse reactions to
    vaccination such as those seen with hepatitis B.
        My second issue is how can we make vaccines safer,
    particularly in infants? In my opinion, this requires more
    substantial testing, a requirement that each lot of vaccine be
    tested in non-human primate models for safety and comparative
    potency. Many of the present vaccine products have bypassed
    non-human primate studies and gone directly from rodent studies
    into human clinical trials. This was based on cost and
    comparability issues.
        Additionally, other vaccines have shown problems in non-
    human primate models, and these were ignored and the product
    went into human clinical trials anyway.
        It is important to test vaccines in immunologically similar
    animals and in an outbred population like us, particularly when
    addressing issues like long-term safety and comparable potency
    of a given vaccine lot.
        My final issue relates to whether certain vaccines are
    appropriate for infant immunization and whether parents should
    be informed about the risk versus benefit of vaccination. More
    importantly, the physician who administers that vaccine is
    probably not aware there are any risks.
        Two specific vaccines come to mind, hepatitis A and
    hepatitis B. I will not go into a long-winded scientific
    process and simply state that the chance of an infant or child
    getting either hepatitis A or hepatitis B is close to none or
    nonexistent. When the potential for exposure does exist, those
    risk factors are easily identified. Even more disturbing is
    that hepatitis A causes a self-limiting infection and does not
    cause chronic disease. It is my opinion that parents should be
    made aware of the risks and benefits of each vaccine where the
    chance for infection during infancy is minimal to nonexistent.
        Certain vaccines, such as the enhanced and inactivated
    polio, diphtheria, tetanus, acellular pertussis, and the
    haemophilus influenza type B conjugate vaccines have
    significantly reduced infant mortality and morbidity and should
    be considered for infant immunization. However, other vaccines
    such as hepatitis B may be more effective when given at a later
    age rather than at birth. Informed consent for vaccines such as
    hepatitis A and hepatitis B should be considered and parents
    allowed to choose based on their perceived risk to benefit from
    vaccinating their infant.
        To further illustrate my points, I would like to discuss
    adverse reactions and the need to support funding activities.
    The example I am going to pick is the whole cell pertussis
    vaccine.
        This vaccine started for universal immunization of infants
    in developing nations in the 1940's. The whole cell pertussis
    vaccine causes frequent systemic symptoms such as irritability,
    lethargy, loss of appetite, and fever in 72 hours following
    immunization in up to 50 percent of subjects. More severe
    reactions include prolonged inconsolable crying, high pitched
    fever, screaming, fever above 104.9 degrees Fahrenheit, febrile
    and afebrile seizures, and shock-like states that can last up
    to 36 hours. In comparable trials, these adverse effects were
    more common in DTP recipients than in DT vaccinees. This
    suggested that the pertussis vaccine caused these reactions.
        The public believes that the whole cell pertussis vaccine
    causes brain swelling and permanent neurologic damage and is
    widespread. However, scientific epidemiologic data to support a
    casual relationship are said to be inadequate, and this is
    simply not true.
        Why is this the perception? First, there is no support for
    basic research into adverse reactions. The data on the casual
    relationship and inadequate nature to show a cause and effect,
    a lot of the data comes from the vaccine manufacturers. New and
    improved vaccines should decrease the adverse reactions, and
    the acellular vaccine is certainly associated with the lower
    incidence of these reactions.
        Will we ever understand the mechanism of how the whole cell
    vaccine produced these side effects, and is there any
    association with neurologic problems? This is unlikely, because
    this has been going on for 50 years, and what research really
    has been done? My question is, why then is the whole cell
    vaccine still being used?
        Regarding the area of informed consent, I would like to
    quote from Chapter 17 in a textbook entitled Pediatric
    Infectious Disease, Principle and Practices. The editors are
    two pediatric infectious disease specialists. The textbook was
    published in 1995 and it is one that I use to teach medical
    students. In the area of informed consent, I am quoting
    directly from the book.

        Vaccines should be administered only after consent has been
    obtained from the parent, guardian, or in some cases the
    vaccine recipient. In the United States informed consent should
    be in writing and include an explanation of the disease to be
    prevented, the benefits and risks of immunization and the side
    effects that parents should look for following immunization.

        Relative to requirements, again I am quoting from this
    chapter.

        Every time a public or private health care provider in the
    United States administers a particular vaccine, it is required
    to provide a legal representative of a child or any other adult
    or individual receiving a vaccine a copy of the vaccine
    informed statement prepared by the CDC. In addition, the names
    of the patient and parent, the date, site of immunization,
    dose, manufacturing vaccine lot number, name of person who
    administers the vaccine, and the place where the vaccine is
    administered should be recorded. This information is absolutely
    important if an adverse reaction occurs following immunization.

        I think this is part of the problem with the adverse
    vaccine effects reporting system. Health care providers are not
    required to obtain the signature of the patient, parent or
    child's legal representative to acknowledge receipt of the
    vaccine information statement. This is an absolute must.
        I want to thank you for the opportunity to appear before
    this distinguished committee. I would be happy to answer your
    questions at the end of the testimony.
        Mr. Burton. Thank you, Dr. Kennedy. I will have some
    questions in just a minute.
        Dr. Katz.
        [The prepared statement of Dr. Kennedy follows:]

        [GRAPHIC] [TIFF OMITTED] T2560.190

        [GRAPHIC] [TIFF OMITTED] T2560.191

        [GRAPHIC] [TIFF OMITTED] T2560.192

        Dr. Katz. Good evening, Mr. Chairman. I am Dr. Samuel L.
    Katz, a pediatrician involved in immunization research,
    development, patient care, teaching, and policy for over 40
    years. I have served and continue to serve on a number of
    national and international committees that study, review, and
    formulate vaccine research and immunization recommendations.
        Also, I am a father and grandfather whose eight
    grandchildren have all received their recommended childhood
    immunizations. The deliberations and recommendations that come
    from committees such as this will eventually affect every child
    and grandchild in the United States, including my own.
        Today I am here representing the American Academy of
    Pediatrics [AAP], or Academy, and the Infectious Disease
    Society of America [IDSA].
        I want to emphasize and restate three points.
        First, our vaccines are highly effective and safe, but the
    diseases they prevent are still spreading through many other
    parts of the world.
        Second, the system of research and development, of clinical
    testing, of licensing, of recommendation and monitoring of
    vaccine use, that system is in place and working well.
        Third, there is a need to continue the education of parents
    and clinicians about diseases they no longer see because these
    serious diseases have been prevented so effectively by our
    immunization policies, but they are only a jet plane ride away
    from our shores.
        Immunization is the single intervention that has most
    dramatically reduced childhood morbidity and mortality in the
    United States. Immunizations have reduced by almost 99 percent
    the vaccine-preventable infectious diseases in this country,
    although once again the causative germs continue to circulate
    widely elsewhere.
        Most young parents cannot appreciate, fortunately, as I do,
    the horror of polio with iron lungs and crutches; measles with
    encephalitis; meningitis due to haemophilus influenza B, with
    death or with crippling or with mental retardation; the
    deafness, blindness and brain injury that you heard about from
    Ms. Zitzmann, caused by congenital rubella; tetanus of newborn
    infants with overwhelming mortality; and a number of the other
    infectious diseases that we fortunately do not see.
        It is true that despite all that vaccines have done to
    improve the health of individuals and communities in the United
    States and throughout the world, they are not perfect. However,
    one simple fact cannot reasonably be disputed--the benefits of
    immunizations far outweigh any possible risks.
        Dr. Satcher pointed out a number of features which I won't
    reemphasize, but how susceptible unimmunized individuals in a
    community threaten not just their own well-being, but that of
    their contacts, whether they are in day care, in school, in
    various settings where people crowd and gather.
        I would just like to remind you of a few anecdotal events.
    Where were the last big measles outbreaks in older youngsters
    in this country? In a school for Christian Science college
    students where there were deaths due to measles because they
    don't follow immunization. I respect their religious point of
    view. I only use it as an example.
        The last epidemics of polio in this country, where were
    they? In a boys school in Greenwich, CT, for a religious group
    who do not practice immunization; among an Amish population in
    Pennsylvania and several other States because they do not
    practice immunization.
        These are only examples, and there could be many quoted to
    you. You heard about diphtheria. We've only had one case of
    diphtheria in this country in the last year. There were over
    100,000 in the countries of the former Soviet Union within the
    last several years. The bacillus of diphtheria hasn't
    disappeared; we've just protected our population well.
        You heard about haemophilus influenza B disease. Over
    20,000 cases a year in children under the age of 5, causing
    meningitis, pneumonia with empyema or other invasive disease.
    Do you know how many cases there were last year in just the 10-
    years since we've had that vaccine? 125 cases in contrast to
    20,000. Our results are striking and remarkable.
        You heard about deaths from varicella. There have been an
    increasing number of deaths from varicella among children who
    are not immunized because of the interaction of what you have
    read about in the newspapers of the ``flesh eating''
    streptococci, the group-A streptococci which superinfect
    youngsters with varicella and can cause death.
        The fact that States have inaugurated requirements for
    school entry are based on trying to prevent these episodes
    occurring within their own venues. A recent article, which
    again I believe Dr. Satcher quoted, in the Journal of the
    American Medical Association pointed out the 35-fold greater
    risk of contracting measles among unimmunized individuals as
    compared to those who had been immunized, and that paper also
    demonstrated that the disease that occurs more commonly in
    these exemptors has the ability to initiate and propagate an
    epidemic in the community at large.
        Should we allow our community immunity to wane, we will
    negate all the progress we have made and allow our communities
    to be at risk from threats that are easily prevented.
        Immunization has a clear community benefit in addition to
    its benefit to the individual patient. An individual's freedom
    to ignore a stop sign while driving, to pollute the
    environment, to drive with his child without a car seat or a
    seat belt, or to spread disease do not serve the public good
    ultimately. We do place certain restraints on individual
    freedom because of our belief in the greater social well-being
    and the community well-being of certain responsibilities.
        Ongoing vaccine safety efforts and continuous monitoring of
    adverse events, be they alleged, potential, or real, are
    crucial to our Nation's childhood immunization program. As
    science and resources allow, we are obligated to continue to
    improve the effectiveness of these safety monitoring measures.
        The Academy and the IDSA have seen allegations that a
    variety of illnesses may be caused by various vaccines. It's
    easy to understand how a family with a tragedy can believe that
    a vaccine caused the sudden unexpected death of a child or the
    appearance of autism or another illness of unknown cause.
        We give these vaccines in the first 2 years of life when
    all of these disorders have their common onset, so that guilt
    by temporal association is very difficult to separate from
    guilt by causality. The available scientific data have shown,
    for example, that with increasing use of hepatitis B vaccine
    there has been a marked diminution in Sudden Infant Death
    Syndrome [SIDS] in this country. I don't think the two are
    related. Don't misunderstand me. Why are we seeing less SIDS?
    Because we are placing babies on their backs instead of their
    stomach. The same thing has been observed in the United
    Kingdom, a remarkable reduction in SIDS, but having nothing to
    do with more or fewer vaccines.
        A robust system of checks and balances exists to monitor
    the safety and effectiveness of our vaccines, a system that we
    strive continuously to perfect. These efforts are designed to
    ensure that our recommendations about immunization and
    procedures reflect the best available science. There can be no
    doubt the public and private sectors and academia continue to
    be alert and responsive to vaccine safety needs.
        The identification of potential safety issues, rapid
    review, and broad dissemination of interim guidelines
    demonstrate that we have an early warning system in place, that
    has the ability to detect and rapidly respond to new
    information. We must pay attention to this system to assure
    that it performs to the best of its ability. When any concern
    about vaccine safety arises, we have the capacity to evaluate
    the issue scientifically, to act both rapidly and prudently in
    the interest of what is best for our children, which is our
    overriding concern.
        The role of parents as well as physicians in vaccine safety
    is paramount. Physicians must regularly update their knowledge
    about specific vaccines and their use. Information about the
    safety and efficacy of vaccines and recommendations relative to
    their administration continue to develop even after a vaccine
    is licensed.
        As pediatricians we know that families are more likely to
    have their child immunized if they understand the risks and the
    benefits of immunizations and the consequence of the diseases
    they prevent. To ensure that parents and other caregivers take
    advantage of the benefit of immunizations, particularly for
    preschool children, the AAP and the IDSA recommend public
    education efforts on the importance of immunization, and that
    these continue. The Academy provides a variety of easily read
    patient educational materials for parents, for guardians, for
    physicians, for nurses, for whomever is involved in the
    setting.
        Mr. Chairman, I greatly appreciate this opportunity to
    present this statement and will be pleased to answer any
    questions that you and your colleagues may have.
        Thank you.
        Mr. Burton. Thank you, Dr. Katz.
        Dr. Kinsbourne.
        [The prepared statement of Dr. Katz follows:]

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        Dr. Kinsbourne. Thank you, Mr. Chairman. I am Marcel
    Kinsbourne. I am a neurologist with a special interest in
    children, and particularly in learning disability, attention
    deficit, and in developmental disability such as autism.
        I have not had the good fortune of Dr. Katz to have any
    grandchildren, but all four of my children have been
    vaccinated. One is healthily present with us in this room
    today.
        I would like to talk to you briefly about serious adverse
    effects of vaccination. Many are known. In some cases we don't
    know quite whether there are any, and some we have not yet
    identified.
        Briefly, there are three types of vaccines that may cause
    three types of adverse reactions.
        There are those that cause toxic or poisonous reactions.
    The whole cell pertussis vaccine is the best example of that.
    That poison may attack a child's brain within hours or a few
    days of the vaccination. That one issue has been subjected to
    adequate epidemiological study, unlike almost all the other
    issues that I will be mentioning.
        A second way of being damaged by vaccine is when the
    vaccine is a live virus, attenuated virus particles made
    harmless, except not always so harmless, and occasionally the
    infection that is protected against in fact happens. Polio is
    an example of that.
        Both bacterial and virus vaccines are apt in susceptible
    people to generate autoimmune disorders. These are disorders
    where the immune system of the person defends not only against
    the vaccine itself, but also, as it were, mistakenly against
    some crucial component of the person's own body, say the
    nervous system, causing damage which can be severe.
        Incidentally, if there is a relation between the MMR
    vaccine and autism, this may be a mechanism for it to happen,
    and I totally agree with Mr. Rollens. There has been no
    approachingly adequate study of this possibility in this
    country to my knowledge, and I am unaware of any going on now.
        It is easy to say do studies; studies are not easy, not at
    all straightforward. I would like to mention some reasons why
    that is.
        One reason is that every disorder that a vaccine can cause
    other causes can also cause. So one has to distinguish the
    vaccine causation from coincidence. To do that, one has to
    study epidemio-logically. These studies are expensive; they
    take a long time. Many have not been done. A report of the
    Institute of Medicine has stressed how often they could not
    draw conclusions about whether a particular alleged side effect
    was due to vaccine or not because the epidemiology has not yet
    been done.
        The second point I would like to stress is that indeed some
    of these are rare complications. To study those, you have to
    have large populations. Most studies that have been done don't
    have adequately sized populations to investigate one way or the
    other whether a rare complication was due to the vaccine or
    not. That needs to be done.
        The third point is that not all vaccine reactions happen
    immediately, as in pertussis. In the case of viruses and
    autoimmune disorders they may take weeks; they may take months
    to emerge. And most safety studies don't last for weeks and
    months. What we are left with is passive monitoring which has
    major weaknesses, which had been alluded to and which we could
    discuss further.
        Yet another problem is that you may have an acute reaction
    to a vaccine which, however, appears to get better, and the
    child appears to become normal again. Yet months or years or
    several years later the child shows cerebral palsy, a learning
    disability, attention deficit, autism, and the studies have not
    yet been done to determine whether these were late consequences
    of those early vaccine reactions or not, and they should be
    done.
        Finally, in my list, and that has been mentioned already
    by, I think, Dr. Kennedy, vaccine safety tends to be
    established for individual vaccines, but they are nowadays
    increasingly often given in combination. That's a new
    administration, needs new safety studies all on their own,
    because there is no guarantee that the combined vaccine will
    only show the adverse effects that each individual constituent
    shows.
        It's my opinion that if studies of the kind I've indicated
    were done and known to be done and perceived to have been done
    that this difficulty of balancing the public health against
    personal choice would be much mitigated.
        I would like to briefly add to a point Dr. Kennedy made
    about informed consent. It is very difficult in a busy
    pediatric practice for the patient to get access to the doctor
    or the nurse, to ask proper questions, read the materials,
    understand them. I would suggest that the information be given
    to the families well ahead, maybe even when the baby is
    discharged from the hospital at birth, so they have time to
    study the materials and ask their questions before they bring
    the children to the vaccination.
        A brief point, sir, has to do with the compensation
    program. As you very well know, the Congress meant this program
    to be expeditious, to be generous, and to be non-adversarial. I
    have extensive experience as a witness in these programs, and I
    find them not to be any of those things. I have to say that the
    special masters who are in charge of adjudicating these matters
    are, in my opinion, highly competent, compassionate, and
    courteous.
        Nonetheless, it is a lucky person who actually gets their
    case resolved in 2 years, as was mentioned before. I have many
    cases in my files that have been around for many more years
    than that, and to my mind the proceedings are nowadays much
    more like civil litigation in their rigor than they are in any
    sense not nonadversarial.
        It has also been mentioned that in 1995 there was a change
    in the regulations relative to the most important, often
    complained of, vaccine, the pertussis vaccine, making
    compensation for alleged injury by that vaccine virtually
    impossible to secure. I think that deserves reviewing.
        A final point, sir, is I heard mention of what is called a
    surplus in the moneys available to compensate victims. I am
    perplexed at this, because I know that there are many children
    whose cases are still being adjudicated and many more whose
    petitions have not yet been filed. They will be filed. And I
    don't know how anybody could tell that the available moneys are
    too great relative to the needs of those children.
        Thank you very much.
        [The prepared statement of Dr. Kinsbourne follows:]

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        Mr. Burton. Thank you, Dr. Kinsbourne.
        Dr. Kennedy, you said you submitted an application to NIH
    for a research grant on the hepatitis B vaccine; is that
    correct?
        Dr. Kennedy. Yes. Myself and a number of other colleagues.
        Mr. Burton. You have had grants before? You have done
    research before?
        Dr. Kennedy. Yes, since 1984. In fact I had the early
    grants on looking at the immune response to the plasma-derived
    hepatitis B surface antigen.
        Mr. Burton. Did they give any reason why they turned your
    grant request down?
        Dr. Kennedy. Yes. Essentially that it was--the term
    ``fishing expedition'' means that you have a big juicy worm and
    you are throwing it out there and hoping that someone will bite
    on it.
        Mr. Burton. Do you still have a copy of that grant
    application?
        Dr. Kennedy. Yes. I can provide that.
        Mr. Burton. Can you give me a copy of it?
        Dr. Kennedy. Certainly can.
        Mr. Burton. I would like to have a copy as soon as
    possible.
        Dr. Kennedy. We did two additional revisions on the grant
    through the process.
        Mr. Burton. I want to take a close look at it, if I could.
        Dr. Kennedy. OK.
        Mr. Burton. Maybe we will have a hearing on that grant
    application itself and haul the people in here.
        Dr. Kennedy. I would rather you not. The process of NIH
    does work, but I think the problem is the understanding of----
        Mr. Burton. Wait just a minute. You say the process does
    work. How long ago did you submit this grant application?
        Dr. Kennedy. 1997. And how we are supporting our present
    efforts to address these issues relative to adverse reactions
    are kind of through private funds.
        Mr. Burton. I don't mean to interrupt you, but my
    granddaughter almost died. While your grant application sits
    there, how many other adverse reactions have occurred like that
    and how many other parents may have lost their child like the
    lady that was sitting over there? I think something as
    important as that should get timely review. So I would like to
    see your application. You let me worry about what to do with
    it, OK?
        Dr. Kennedy. OK.
        Mr. Burton. Dr. Katz, have you had any kids suffer adverse
    reactions?
        Dr. Katz. Yes.
        Mr. Burton. What kind?
        Dr. Katz. I've had a youngster whose arm got so swollen it
    ran from his wrist up to his shoulder. I've had children who
    have developed what apparently were febrile seizures. That is,
    they got such high fevers that they had a seizure following a
    previous immunization.
        Mr. Burton. Do you have any that were autistic?
        Dr. Katz. No. I happen to work in an institution with a
    neurologist whose life work has been on autism, and he has
    presented us as well as published in the neurology literature,
    some as recently as June 1999, his approach to autism, and it
    has nothing to do with vaccines.
        Mr. Burton. I'm sure. The question that I would like to ask
    is the pertussis vaccine that they were talking about a while
    ago. If you thought that it caused autism in some children,
    would you give it to your grandchildren?
        Dr. Katz. I think that if I believed it caused autism, I
    would have severe reservations. I agree with you.
        Mr. Burton. That's all I want to know, because there are a
    lot of people that believe that it does, and I'm one of them.
    Do you think that people that feel there is a real risk to
    their loved ones should give that kind of a vaccination or be
    required to do it?
        Dr. Katz. I don't believe that you should labor under the
    burden of saying I really believe this and I don't want my
    child to be immunized. I think you have to accept the fact,
    however, that if your child goes to school or to day care, for
    example, and there is a case of whooping cough in the school,
    your child would be banned from school because they are not
    immunized.
        Mr. Burton. Let me ask Dr. Kennedy a question. What did you
    say was the percentage of reactions to the pertussis vaccine
    within the first 48 hours?
        Dr. Kennedy. It was within the first 72 hours. Approaching
    50 percent.
        Mr. Burton. Fifty percent. Just a second. Fifty percent
    would have an adverse reaction within the first 72 hours?
        Dr. Kennedy. I will provide you with the documentation that
    quotes that.
        Mr. Burton. In many cases that is not of long duration.
        Dr. Kennedy. Right. Correct.
        Mr. Burton. It is something that comes and goes.
        Do you have any percentages that show the adverse reaction
    that is of long duration?
        Dr. Kennedy. No, I don't.
        Mr. Burton. So we really don't know. You know that there is
    an adverse reaction that is pretty substantial within the first
    72 hours in half of the cases where they give those shots.
        Dr. Katz. We haven't used that vaccine for several years,
    Mr. Burton. I think one of the things that I would love to
    point out to you is that we do improve. We use the acellular
    vaccine in this country. The British continue to use the
    vaccine that Dr. Kennedy has described. We haven't used it for
    several years in this country.
        Mr. Burton. Is the DTP vaccine rather than the DTaP vaccine
    still being used?
        Dr. Katz. The DTaP vaccine is being used, which has an
    infinitesimal degree of reactivity compared to the DTP.
        Mr. Burton. The Department is behind you. Is the DTP
    vaccine still being used in this country?
        Mr. Egan. Yes.
        Mr. Burton. It's still being used in this country. So, Dr.
    Katz, you are incorrect. It is being used in this country.
        Dr. Katz. If it is, it's in a very small percentage.
        Mr. Burton. It doesn't matter if it's your kid or your
    grandchild. If they get a DTP vaccine and there is this adverse
    reaction that Dr. Kennedy is talking about, it's of great
    concern to people, and we don't know whether it leads to autism
    or not, but I have an autistic grandchild, and we've had a
    number of other people that have seen tremendous problems with
    autism, and they are still using that vaccine. You said you
    didn't think they were.
        Dr. Katz. I said they are still using it in the United
    Kingdom. They don't use acellular pertussis vaccine.
        Mr. Burton. That's the United Kingdom. It's not the United
    States of America.
        Dr. Katz. The World Health Organization is using it
    throughout the world. We are the only country with the
    exception of Japan that made the switch.
        Mr. Burton. I know, but if it's causing adverse reactions
    that are so severe that they affect people in the first 72
    hours, 50 percent of them, it should be something that is
    clearly looked into, and if there is any indication it may
    cause autism, it should be really scrutinized.
        Let me yield to the doctor here, and I will come back for
    some more questions in a moment.
        Mr. Weldon. Maybe our friends in the back can answer. I
    thought we withdrew all the DPT, the cellular pertussis in the
    United States. It is still licensed and it is still sold in the
    United States; is that correct?
        Mr. Egan. Yes.
        Mr. Weldon. The FDA has never ordered that to be withdrawn?
    Why was it not ordered to be withdrawn considering the higher
    incidence of side effects? They felt that the side effects were
    not sufficiently life-threatening to warrant it's withdrawal?
    Is that the rationale?
        For the record, Mr. Chairman, this pertussis issue is
    something that I followed through the years, and I thought it
    was completely off the market. That may be something that we
    may need to address.
        If I may just go a little bit further. Dr. Kinsbourne, I
    really enjoyed your testimony. You seem to get at a lot of the
    problems. Some of the issues that you brought up I've had
    conversations with other scientists and some of the folks that
    have already testified. The real bottom line issue is that
    there would have to be very significant funding to get at these
    issues, because it would require some very large studies that
    would have to be extended over many, many years, correct?
        Dr. Kinsbourne. Yes, sir.
        Mr. Weldon. Unless those studies are done, the questions
    that you were posing are very difficult for us to answer,
    correct?
        Dr. Kinsbourne. Could not be answered until they are done.
    So the sooner they are started the sooner they will be
    answered.
        Mr. Weldon. The only other point I would like to make, Mr.
    Chairman, is that if these studies are done, they may show that
    the vaccines are much safer than is being alleged by some of
    the people who have provided testimony. Until they are done,
    the public discontent that exists among some element in our
    country is not going to go away, and it would be a mistake for
    us to just take the face value of some who have testified
    alluding to the fact that all is well. All may not be well, and
    the responsibility ultimately is going to fall to political
    leaders in this country to make sure that the proper research
    is done.
        I again want to thank you, Mr. Chairman, for holding these
    hearings.
        Mr. Burton. Thank you, doctor.
        Mr. Weldon. Did you want to respond to my comments at all?
        Dr. Kinsbourne. Only to agree wholeheartedly. I think even
    if the public were to see that the work was being done they
    would comply more willingly with the mandates.
        Mr. Weldon. I will share this with you, Dr. Katz. In
    politics they say perception is reality. If your opponent buys
    $500,000 worth of TV ads and says that you cheated on your wife
    even though you have never cheated on your wife, if the end
    result is that three out of four voters conclude that you
    cheated on your wife and therefore they should vote against you
    and you lose your reelection, that is reality. Even if our
    vaccines are extremely safe, if the perception is growing out
    there that the vaccines are not safe and people are starting to
    refuse their vaccinations, then we've got a problem. The way to
    address this, though, is we need to better fund the agencies
    that need to do the research.
        Mr. Burton. I think that is a very good point, doctor.
        Who manufactures the DTP vaccine?
        Dr. Kinsbourne. Lederle.
        Dr. Kennedy. Wyeth Lederle Pediatric Vaccines it is now
    called.
        Mr. Burton. Is that the only one that manufactures that?
        Dr. Kennedy. No. There are a couple others that make the
    whole cell pertussis. I don't know it off the top of my head.
        Dr. Kinsbourne. Connaught is another company.
        Mr. Burton. Those are both domestic companies here in the
    United States?
        Dr. Kinsbourne. I think Connaught is largely Canadian.
        Dr. Kennedy. It's Pasteur Merieux Connaught, but they have
    a manufacturing facility in the United States, in Pennsylvania.
        Mr. Burton. You may not know this. I may have to check into
    this in a later hearing or something. Do you know if they give
    any funds or grants or honorariums to anybody over at NIH or
    CDC?
        Dr. Katz. No.
        Mr. Burton. They do not?
        Dr. Katz. No.
        Mr. Burton. You're sure about that?
        Dr. Katz. I am sure that people at NIH are not allowed to
    take funds even from universities. If I invite an NIH
    investigator to give a lecture at Duke, I can't even pay him an
    honorarium.
        Mr. Burton. According to my assistant here, that isn't the
    case.
        Dr. Katz. Maybe you could ask Dr. Rabinovich. She works at
    NIH.
        Mr. Burton. They can accept honorariums, I believe. Can't
    you?
        Dr. Katz. Regina, do you want to respond?
        Mr. Burton. Aren't you the general counsel?
        Dr. Rabinovich. No. I'm here from the National Institutes
    of Health. We do receive ethics training, and I've never
    accepted an honorarium. There may be other situations in which
    intramural investigators can. We can provide that information
    for you.
        Mr. Burton. I'd like to have that.
        Dr. Rabinovich. But I do not.
        Mr. Burton. Thank you. I would like to have that
    information if I could.
        I just can't for the life of me fathom why that one vaccine
    is still on the market and being manufactured and sold here and
    used in the United States. I just don't understand that.
        Can you explain that, Dr. Kennedy?
        Dr. Kennedy. I can maybe address the situation relative to
    the issue of combination vaccines and why it may still be
    there. There were studies done where they were combining the
    DTaP vaccine with the haemophilus influenza type B glyco-
    conjugate vaccine, and a number of studies, both in non-human
    primate models and in children, suggested that by combining and
    then giving it at a single site that you would interfere with
    the ability to respond to the haemophilus influenza type B
    [HIB] component, and the interference appeared to be as a
    result of the acellular components.
        They do not know the mechanism. They knew if they took out
    the acellular component and did a DT/HIB combination, it went
    fine. If they did the DTaP at one site and then the HIB at the
    other site, the response was fine. If they did the DTP/HIB, it
    appeared to be fine from a standpoint of responding to all four
    of the components.
        That could be one of the potential reasons, because some of
    the first licensed combination vaccines are DTP/HIB, et cetera.
    It doesn't make sense, but that's----
        Mr. Burton. I'm not sure I comprehend if there is that kind
    of a reaction in 50 percent of the cases in the first 72 hours
    why it's on the market. I just do not understand that.
        Do you have any reason why that would be the case, why they
    would keep that on the market and continue to use it?
        Dr. Kennedy. Yes. If people are not complaining, you can
    make quite a bit of money. What it comes down to the vaccine
    manufacturers, it's money if the vaccine has already been
    produced; its already licensed.
        Mr. Burton. I know, but the people sitting behind you are
    not influenced by these pharmaceutical companies. I'm sure of
    that. So why would they not insist that it be taken off the
    market?
        Dr. Katz. This vaccine has been used for 40 years in this
    country and its record of achievement has been a very
    successful one. What he is describing as 50 percent is sore
    arms, sore legs, redness, fever. It's not life-threatening
    reactions. It is more reactive than the acellular vaccine,
    which is why most people have switched to the acellular
    vaccine, but these are not life-threatening reactions that have
    been shown with the whole cell pertussis to be any more than
    with any other acellular pertussis.
        Mr. Burton. These are FDA serious events in 1999. How many
    are in here, 1,500 or more?
        Dr. Kennedy, of these 50 percent of the reactions were any
    of them pretty severe?
        Dr. Kennedy. Yes. Quite a few were more severe, such as the
    high pitched screaming, the crying, the fever, the shock-like
    syndrome.
        Mr. Burton. Running around and waving their arms and that
    sort of thing?
        Dr. Kennedy. Yes, but the percentage I could not find.
        Mr. Burton. I will tell you that is exactly what happened
    to my grandson. Exactly. He ran around waving his arms, a high
    pitched scream, waving his arms up and down, and everything
    else, and he's autistic now.
        I'm getting a little emotional about this. I think we will
    conclude this hearing. But I want to tell you, this isn't the
    end of it.
        We stand adjourned.
        [Whereupon at 7:30 p.m., the committee was adjourned.]
        [Additional information submitted for the hearing record
    follows:]

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