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




                               before the


                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION


                              MAY 18, 1999


                           Serial No. 106-97


       Printed for the use of the Committee on Government Reform

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


63-308 CC                   WASHINGTON : 2000


                     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
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
    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 
JOHN T. DOOLITTLE, California            (Independent)

                      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

   Subcommittee on Criminal Justice, Drug Policy, and Human Resources

                    JOHN L. MICA, Florida, Chairman
BOB BARR, Georgia                    PATSY T. MINK, Hawaii
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio           JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
DOUG OSE, California

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
          Robert B. Charles, Staff Director and Chief Counsel
                Sharon Pinkerton, Deputy Staff Director
                          Amy Davenport, Clerk
                    Cherri Branson, Minority Counsel

                            C O N T E N T S

Hearing held on May 18, 1999.....................................     1
Statement of:
    Katz, Dr. Samuel, the Infectious Diseases Society of America; 
      Dr. Bonnie Dunbar, molecular biologist, Baylor College of 
      Medicine; Dr. Burton Waisbren, Sr., F.A.C.P.; and Dr. 
      Barthelow Classen, president and CEO, Classen 
      Immunotherapies, Inc.......................................   174
    Margolis, Harold, Chief of the Hepatitis Branch, Centers for 
      Disease Control; John Livengood, National Immunization 
      Program; and Susan Ellenberg, Director of Biostatistics and 
      Epidemiology Division, Food and Drug Administration........   125
    Moakley, Hon. John Joseph, a Representative in Congress from 
      the State of Massachusetts; Michael Belkin; Judy Converse; 
      Marilyn and Lindsay Kirschner; Barbara Hahn; Karen with 
      PKIDS; and Betty Fluck.....................................    58
    Thiel, Thelma, chairman and CEO, Hepatitis Foundation 
      International; and Barbara Loe Fisher, president, National 
      Vaccine Information Center.................................   251
Letters, statements, et cetera, submitted for the record by:
    Belkin, Michael, prepared statement of.......................    67
    Classen, Dr. Barthelow, president and CEO, Classen 
      Immunotherapies, Inc., prepared statements of........... 226, 238 
    Converse, Judy, prepared statement of........................    88
    Dunbar, Dr. Bonnie, molecular biologist, Baylor College of 
      Medicine, prepared statement of............................   218
    Ellenberg, Susan, Director of Biostatistics and Epidemiology 
      Division, Food and Drug Administration, prepared statement 
      of.........................................................   128
    Fisher, Barbara Loe, president, National Vaccine Information 
      Center, prepared statement of..............................   260
    Fluck, Betty, prepared statement of..........................   114
    Karen with PKIDS, prepared statement of......................   108
    Katz, Dr. Samuel, the Infectious Diseases Society of America, 
      prepared statement of......................................   176
    Kirschner, Lindsay, prepared statement of....................    99
    Kirschner, Marilyn, prepared statement of....................    95
    Margolis, Harold, Chief of the Hepatitis Branch, Centers for 
      Disease Control, prepared statement of.....................   143
    Moakley, Hon. John Joseph, a Representative in Congress from 
      the State of Massachusetts, prepared statement of..........    61
    Thiel, Thelma, chairman and CEO, Hepatitis Foundation 
      International, prepared statement of.......................   254
    Tierney, Hon. John F., a Representative in Congress from the 
      State of Massachusetts, prepared statement of..............    56
    Waisbren, Dr. Burton, Sr., F.A.C.P., prepared statement of...   200
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................     5



                         TUESDAY, MAY 18, 1999

                  House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and 
                                   Human Resources,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2247, Rayburn House Office Building, Hon. John L. Mica 
(chairman of the subcommittee) presiding.
    Present: Representatives Mica, Towns, Tierney, and Waxman.
    Staff present: Sharon Pinkerton, deputy staff director; Amy 
Davenport, clerk; Cherri Branson, minority counsel; and Jean 
Gosa, minority staff assistant.
    Mr. Mica. Good morning, I would like to call this meeting 
of the Subcommittee on Criminal Justice, Drug Policy, and Human 
Resources to order.
    This morning, the topic of hearing is ``Hepatitis B 
Vaccine: Helping or Hurting Public Health?'' I will begin this 
morning's proceeding by reading my opening statement, then I 
will yield to the minority for their opening comments and other 
Members who may join us. Finally we will proceed to our four 
panels this morning, and I am sure into this afternoon.
    Public health, including vaccine safety, is critically 
important to our subcommittee. Today we are exercising our 
oversight responsibility for the Department of Health and Human 
Services, and we are committed to ensuring that our national 
immunization policies and programs are functioning properly.
    The Centers for Disease Control and Prevention, the CDC, 
and the Food and Drug Administration are Federal agencies 
primarily responsible for immunization policy and safety. They 
will be sharing their expertise with us later in this hearing.
    There is no doubt that immunizations have greatly improved 
public health in our country. Small pox has been eradicated, 
and cases of polio, tetanus, and diphtheria are today very 
rare. These are great victories for our public health system.
    Unfortunately, however, the history of immunization shows 
that sometimes vaccinations do injure a child or an individual 
rather than inoculating them. That is why Congress created the 
Vaccine Injury Compensation Program in 1986 to compensate those 
who have been harmed by a vaccine.
    My colleague, the ranking member of our full committee, the 
gentleman from California, Mr. Waxman, who I hope will be 
joining us shortly, and my brother Dan Mica, who was then a 
Member of Congress from Florida, worked to successfully enact 
that law.
    Oversight of that law and program, I believe, is a very 
important congressional responsibility. This is the first 
oversight hearing on that law held in 10 years. The purpose of 
which is not only to protect vaccine manufacturers, but also to 
compensate individuals injured from inoculation by a vaccine. I 
do have some concerns whether the compensation fund is working 
in the way Congress intended, and we will discuss that today 
and possibly hold additional hearings.
    The Department of Health and Human Services has issued new 
rules making it harder to receive compensation, so that while 
there is over $1 billion in the fund, only a fraction of that 
was awarded last year. The vaccine experience in the early 
1980's also demonstrates that when a pattern of injuries from a 
vaccine emerges, the vaccine can be made safer.
    The crisis in public confidence in diphtheria, tetanus, and 
pertussis, DPT as it is commonly known, led to creating the 
compensation law and also resulted in the creation of a safer 
vaccine. Today what is termed the ``whole cell vaccine'' that 
caused the controversy is coming off the market, and has been 
replaced by a safer vaccine called ``acellular vaccine.''
    Today, we have convened individuals from a variety of 
government, academic, professional, and citizens groups in an 
effort to provide a structured opportunity for Members of this 
subcommittee to ask questions about the Federal Government's 
hepatitis B vaccine policy and its impact on our public health.
    I want to make very clear at the outset that the purpose of 
this hearing is not to scare parents away from immunizing their 
children. That should not be the result of today's hearing. The 
purpose of this hearing is to examine the effectiveness of the 
1986 law, also to learn more about how our Federal agencies are 
administering immunization policy and monitoring and analyzing 
the safety of the hepatitis B vaccine, and finally to review 
evidence of adverse reactions to the vaccine.
    The hepatitis B virus is certainly a very serious disease. 
We will hear today from witnesses who have experienced the 
terrible effects of this disease. In 1996, the CDC reported 
10,637 new cases of hepatitis B, 279 cases which affected 
individuals below the age of 14. The CDC estimates that 4,000 
to 5,000 people each year die from hepatitis B-related liver 
    To combat this disease, the CDC issued guidelines in 1991 
recommending that every infant receive the hepatitis B vaccine. 
In 1995 the CDC recommended the routine vaccination of 
teenagers. The FDA first licensed a plasma-derived hepatitis B 
vaccine in 1981. In 1986, the FDA licensed the first 
recombinant hepatitis B vaccine, meaning the vaccine is the 
first genetically engineered one.
    Based on CDC recommendations, 42 States mandate that 
children be vaccinated before entering kindergarten; 20 million 
children a year now receive some type of required vaccine. 
Almost 90 percent of all children in this country are now 
    When a parent takes their child in for a vaccine, they are 
supposed to be given an information sheet outlining the risks 
and benefits of the vaccine. While almost all of the States 
mandating childhood vaccinations allow exemptions, the 
information sheet does not tell parents that these exemptions 
    Recent news reports have questioned the safety of the 
hepatitis B vaccine, and have also suggested an association 
between the vaccine and multiple sclerosis and other autoimmune 
    I would like to point out a report I have seen from New 
Hampshire. The 48 reported adverse reactions to the vaccine in 
children aged 1 to 10 in recent years were 16 times greater 
than the cases of the disease. There were only three cases of 
the disease.
    It was reported that there were four times as many child 
deaths, 11, as there were cases of the disease. If this is 
true, I find the information quite shocking.
    We will hear more about these statistics later in the 
hearing from some of the researchers that were involved in 
analyzing this particular series of cases.
    Is it possible that the preventive measure for the disease 
is riskier than the disease itself? We must ask ourselves that 
question. But our job today is not to prove whether or not this 
vaccine causes illnesses or death. Instead, we have created a 
forum for asking questions about what scientific evidence does 
exist and whether further studies should be completed.
    Specifically, I would like this hearing today to examine 
some of the following issues. First, what is being done to 
study the adverse reactions reported in the Vaccine Adverse 
Event Reporting System?
    Second, do the benefits of administering the vaccine to 
infants outweigh the risks?
    Third, what process does the CDC employ to make a 
recommendation for a vaccine? What role do pharmaceutical 
companies play in that process, and do conflicts of interest 
    Fourth, what disclosure is required before the vaccine is 
given, and is that disclosure adequate?
    With this outline in mind, I would like to now recognize 
the ranking member of our full committee. As I mentioned 
before, he was one of the individuals very much involved in 
passage of the 1986 law. I know he worked with my brother Dan 
on this matter, and was very instrumental in reviewing this 
whole matter of vaccinations, adverse reactions, and 
compensation. So I am delighted that he has joined us, and I 
would like to recognize our ranking member, the gentleman from 
California, Mr. Waxman, for a statement.
    Mr. Waxman. Thank you very much, Mr. Chairman. I appreciate 
your recognizing me to make this opening statement and I want 
to thank you for the accommodations that you have made in 
adding additional witnesses to this hearing.
    This hearing today touches on an extremely important public 
health issue. Vaccination is an essential weapon against 
infectious disease, and I think it is important that we pay 
attention to how well we are succeeding in our fight against 
infectious disease.
    While childhood diseases continue to spread death, 
disability, and misery through other parts of the world, the 
United States has made tremendous progress against polio, 
diphtheria, whooping cough, and other diseases.
    Without vaccination, our population would be vulnerable to 
devastating outbreaks of these diseases. We cannot be 
complacent about our success. Unlike our parents and 
grandparents, we are not terrorized every year by the threat of 
polio and whooping cough epidemics.
    Perhaps that makes it easier to doubt the value of vaccines 
and to focus on their potential risk, but if children are 
discouraged and parents frightened from the vaccines and do not 
take these important vaccines, we will quickly become 
vulnerable again to infectious diseases.
    No one doubts that there are adverse reactions to some 
vaccines. They happen. Children and adults suffer disease or 
disability as a result. That is why I sponsored the National 
Childhood Vaccine Injury Act of 1986 which established the 
compensation program. This program relies upon the best 
available science and medicine to provide an alternative to 
litigation for individuals who suffered the specific vaccine-
related injuries.
    Today, we must continue to rely upon what science tells us 
about the benefit and risks of vaccines. We know that hepatitis 
B kills 4,000 to 5,000 people in the United States every year. 
We know that at least 25,000 children are infected with 
hepatitis B each year, and we know hepatitis B is a silent 
killer that waits decades before destroying livers and ending 
    Everything we know about the hepatitis B vaccine indicates 
that its benefits far outweigh its risks. That being said, we 
must naturally remain vigilant and continue epidemiological 
research into potential side effects of the vaccine.
    Today, we are going to hear compelling stories from both 
sides of the controversy over hepatitis B vaccines. We will 
hear from families who have suffered adverse reactions to the 
vaccines or health problems they believe are linked to the 
vaccine. We will hear from the families of those who have 
experienced hepatitis B, the social stigma surrounding it, and 
the fears engendered by this highly infectious disease, and I 
am sympathetic to all of our witnesses and look forward to 
their testimony.
    Mr. Chairman, I wish to submit for the record, along with 
this statement, letters and statements supporting hepatitis B 
vaccine from leading medical and patient organizations, 
including the World Health Organization, the American Medical 
Association, the American Academy of Pediatrics, the American 
Liver Foundation, Hepatitis Foundation, and the National 
Multiple Sclerosis Society.
    I think it is important to have in our record what these 
public health groups say about this vaccine and their support 
of the efforts to continue the vaccination program.
    I am pleased that we have Congressman Moakley, who will 
tell us from his own experience about the hepatitis disease; 
and I welcome all of the other witnesses and look forward to 
their testimony.
    Mr. Mica. I thank the gentleman. Without objection, the 
items that he mentioned will be made part of the record.
    [The prepared statement of Hon. Henry A. Waxman and the 
information referred to follow:]


















































    Mr. Mica. Also, since notice of the hearing, we have many 
associations and groups from all over the country providing us 
with remarks they have requested be entered in the record. I 
would like to ask unanimous consent that they also be made part 
of the record and without objection, so ordered.
    I would now like to recognize the gentleman from 
Massachusetts, Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman, and thank you for 
holding this hearing on the important topic of hepatitis B 
    Less than 100 years ago, infectious diseases were the most 
common cause of death, disability, and disease in the United 
States. Polio, pertussis, measles, and diphtheria killed and 
disabled millions of people. However, because of the 
development and use of vaccines, these diseases are a distant 
memory for most Americans. Unfortunately, as old threats fade 
away, new threats to public health emerge.
    Today hepatitis B, an infectious disease which can be 
eliminated with universal vaccination, unnecessarily kills 
thousands of people a year in the United States. According to 
the CDC, in the United States, 200,000 people contract 
hepatitis B each year.
    Each year over 11,000 people are hospitalized and 20,000 
remain chronically infected. Overall, an estimated 1.25 million 
people in the United States have chronic hepatitis B infection; 
and 4,000 to 5,000 die each year from hepatitis B, related 
chronic liver disease or liver cancer.
    Hepatitis B vaccine prevents both hepatitis B infection and 
those diseases related to hepatitis B infection. The vaccine 
has been available since 1982. The CDC has recommended the 
hepatitis vaccine as part of the routine infant vaccination 
schedule since 1991.
    Prior to the CDC recommendations, approximately 30,000 
infants and children became infected with hepatitis B each 
year. Hepatitis B vaccines are safe and effective. More than 20 
million people have received the hepatitis B vaccine in the 
United States and more than 500 million have received the 
vaccine worldwide.
    Mr. Chairman, I am glad to hear all of our witnesses today, 
but particularly honored with the presence of Representative 
Joe Moakley, dean of the Massachusetts delegation. We all know 
Mr. Moakley as the voice of the 9th Congressional District of 
Massachusetts and the ranking Democrat on the Rules Committee.
    However, many of us are not aware of his personal 
experience with hepatitis B. In the 1980's he was diagnosed 
with hepatitis B. For several years he didn't know that he had 
contracted the disease. However, in 1995 with only a few months 
to live because of the damage the disease had caused to his 
liver, he received a liver transplant. Today he is a healthy 
man, and he is here to share with us his thoughts about the 
hepatitis B vaccine, and I look forward particularly to hearing 
his testimony.
    Mr. Chairman, thank you again for this important hearing.
    Mr. Mica. Thank you again for your opening statement and 
also for your comments and introductory remarks about our 
colleague, Mr. Moakley.
    [The prepared statement of Hon. John F. Tierney follows:]
    [GRAPHIC] [TIFF OMITTED] T3308.051
    [GRAPHIC] [TIFF OMITTED] T3308.052
    Mr. Mica. Our first panel is made up of individuals who 
have had some personal experience with hepatitis B, including 
our colleague. Let me introduce the panel, and I think Mr. 
Tierney has given an introduction to Joe Moakley.
    We have Michael Belkin, Judy Converse, Marilyn and Lindsay 
Kirschner, Barbara Hahn, Karen with PKIDS, and we have Betty 
    That is our first panel, and again all of these individuals 
have some personal relationship and experience with the problem 
of hepatitis B.
    Except for Mr. Moakley--we don't swear in our Members of 
Congress--this subcommittee is an investigations and oversight 
subcommittee, and so we do swear in our witnesses. Again, with 
the exception of our Member, if you could all please stand.
    [Witnesses sworn.]
    Mr. Mica. The witnesses have answered in the affirmative 
and I would like to take this opportunity to welcome each and 
every one of you for participating and for coming forward and 
providing this subcommittee with your important testimony and 
personal experience.
    Since we have such a large number of requests for 
witnesses, we are going to try to adhere pretty strongly to the 
5-minute rule. If you have a lengthy statement or additional 
information you would like made part of the record, upon 
request we will have that entered into the record.
    So with those opening remarks and welcome, I would like to 
now recognize the distinguished gentleman from Massachusetts 
and ranking member, former chairman of the Rules Committee, Mr. 

                  WITH PKIDS; AND BETTY FLUCK

    Mr. Moakley. Thank you very much, Chairman Mica and 
Congressman Waxman and my colleague from Massachusetts, 
Congressman Tierney. I thank you very much for allowing me to 
testify today and give my perspective on the hepatitis B 
    As Congressman Tierney said, I was diagnosed with hepatitis 
B in the early 1980's. The doctors thought I may have gotten it 
on a congressional fact-finding trip to China, but they were 
not sure.
    Mr. Chairman, this is one of the frightening aspects of 
hepatitis B. Thousands and thousands of people contract it and 
have no idea how they got it. In fact, 40 percent of the people 
who get hepatitis B aren't in the so-called high-risk 
categories and don't even realize that they have it for many, 
many years.
    I was sick for years, and had no idea that my liver was 
failing. In the spring of 1995, after a thorough examination, 
my doctor told me I had 2 months to live. The hepatitis virus 
had led to cirrhosis of my liver. I was very sick, had no 
strength; and I was severely jaundiced, but I was one of the 
lucky ones.
    I was put on a waiting list for an organ transplant and 
received a donor organ just before it was too late. This July 
it will be 4 years since my successful liver transplant, and 
there is not a day that goes by that I don't thank God for my 
renewed health.
    Unfortunately, 1.25 million Americans have hepatitis B and 
are potentially infectious to others. Each year 150,000 
Americans get hepatitis B and 4,000 to 5,000 die from it. These 
are very alarming statistics, made even more tragic by the sad 
reality that we have a severe shortage of organ donors in this 
country, and many of these people with hepatitis B will 
eventually require a liver transplant.
    That is why immunization is still the most effective means 
of preventing hepatitis B and its consequences. Hepatitis B 
vaccines are safe and highly effective in preventing hepatitis 
B infection amongst susceptible children and adults.
    You say 42 States; I don't know. It is somewhere between 38 
and 42, including my own State of Massachusetts, that have 
enacted laws requiring children to be vaccinated against 
hepatitis B before they enter kindergarten. Immunization is 
still the best weapon and by far the most cost-effective way we 
have to prevent this devastating disease.
    I have heard of the recent reports which question the 
safety and the efficacy of the hepatitis B vaccine. Some of 
them link the vaccine to multiple sclerosis and other 
autoimmune diseases. But, Mr. Chairman, I have some of the same 
information that Mr. Waxman has. The World Health Organization, 
the American Academy of Pediatrics, and the Multiple Sclerosis 
Society have all recommended that the hepatitis B vaccine not 
be suspended.
    Experts have reviewed the data and determined that there is 
no clinical or scientific evidence whatsoever linking the 
hepatitis B vaccine with multiple sclerosis or other autoimmune 
disorders. The fact of the matter is that the benefits of the 
hepatitis B vaccine far outweigh any of the claimed risks.
    Hepatitis B infection is still a real threat in this Nation 
and throughout the globe. That is why it is so important to 
continue with this immunization. These are programs to prevent 
the spread of this terrible disease. Hepatitis B is a highly 
contagious disease, 100 times more contagious than HIV; and we 
have to continue to immunize our infants and children.
    The truth is, when immunization rates fall the disease 
returns. We saw this a few years ago when there were huge 
outbreaks of measles, which everybody assumed was under 
control. So even though these reports of people developing 
disorders after vaccinations are very, very tragic, we need to 
look at the clinical and scientific evidence.
    The Institute of Medicine, the World Health Organization, 
and the French Government have all conducted studies that 
conclude there is no evidence of a causal relationship between 
hepatitis B and multiple sclerosis or other disorders. As sad 
as these stories are, and I have heard them all, Mr. Chairman, 
they should not determine public health policy in this country. 
Because, Mr. Chairman, if we suspend immunization programs, we 
will only end up with more cases of hepatitis B that could be 
even more tragic.
    Take it from me. I don't wish this terrible disease on 
anyone. There is no reason for anyone to suffer from this 
disease. It is totally preventable. So I look forward to the 
day that hepatitis B meets the same fate as small pox. Mr. 
Chairman, this vaccination will help get us there.
    Thank you very much, and I have a conflict of time so if 
there are any questions, I would be glad to answer them now, 
and then I would like to be excused.
    Mr. Mica. Thank you. We would be glad to extend that 
courtesy to you.
    [The prepared statement of Hon. Joe Moakley follows:]
    [GRAPHIC] [TIFF OMITTED] T3308.053
    [GRAPHIC] [TIFF OMITTED] T3308.054
    [GRAPHIC] [TIFF OMITTED] T3308.055
    Mr. Mica. Mr. Waxman, do you have any questions of Mr. 
Moakley at this time?
    Mr. Waxman. No. I want to thank you very much for your 
testimony. I think you have told us in a very eloquent way, 
from your own personal experience, if we can prevent this 
disease and how important it would be to do so. Thank you.
    Mr. Mica. Mr. Tierney.
    Mr. Tierney. I have no questions. Just to thank you and say 
that we are glad that the results are as they were.
    Mr. Moakley. I am, too. Thank you, Mr. Chairman.
    Mr. Mica. Thank you, Mr. Moakley. I don't have any 
questions at this time, but I am going to listen to all of the 
panels that we have, and I may personally get back with you.
    Mr. Moakley. That would be great.
    Mr. Mica. And, hopefully, have some more educated questions 
at that time.
    Mr. Moakley. And I would be willing to present myself to 
the panel once again, if necessary.
    Mr. Mica. We will now hear from Mr. Michael Belkin.
    Mr. Belkin. Thank you for holding this hearing, Mr. 
    First of all, I would like to submit for the record, the 
25,000 adverse reaction reports from the government reporting 
system and my recorded testimony which is an investigation of 
those reports.
    Mr. Mica. I don't know if we will be able to submit all of 
those in the record. But what we can do is make reference to 
them, and they can be kept with the committee. I think that 
would be appropriate. Is that acceptable?
    Mr. Tierney. That is fine.
    Mr. Mica. We will do that because it is almost impossible 
to include all of those in the report. We will make reference 
to them, and they will be kept with the committee records. 
Without objection, so ordered.
    Mr. Belkin. My daughter Lyla Rose Belkin died on September 
16, 1998, at the age of 5 weeks, about 15 hours after receiving 
her second hepatitis B vaccine booster shot.
    Lyla was a lively, alert 5-week-old baby when I last held 
her in my arms. Little did I imagine as she gazed intently into 
my eyes, with all of the innocence and wonder of a newborn 
child, that she would die that night. She was never ill before 
receiving the hepatitis B shot that afternoon. At her final 
feeding, she was extremely agitated, noisy and feisty and then 
she fell asleep suddenly and stopped breathing. The autopsy 
ruled out choking.
    The New York medical examiner ruled her death sudden infant 
death syndrome, but in the notes and in the conversations with 
our pediatrician on the day of the autopsy--this is in the 
pediatrician's notes--what the coroner said, ``Brain swollen. 
Not sure cause yet. Could not see how recombinant vaccine could 
cause problem.''
    SIDS is a diagnosis of exclusion. It means it is not this, 
it is not that. A swollen brain is not SIDS. It turns out in 
the medical literature a swollen brain, brain inflammation, is 
one of the most common signs of an adverse reaction to a 
    I set out to do an investigation of this vaccine and 
adverse reactions, and these are my conclusions and I urge you 
to read them. I have some prepared remarks that are far too 
lengthy to summarize here.
    First of all, let's look at the vaccination policy in this 
country, this Rube Goldberg flowchart that I have. This 
committee has oversight over the CDC, which has oversight over 
the ACIP, the Advisory Committee on Immunization Practices.
    This committee sets immunization policy, and I urge you to 
really concentrate on this. I think there is a conflict between 
the public interest and the private interest of drug companies 
and the interest of the bureaucracy that is violating the 
public interest. As an oversight committee, I think this is 
something that you should look into.
    This committee sets mandates which go out to the States and 
go to the children, and some small percentage of children have 
adverse events which go into this thing called VAERS, Vaccine 
Adverse Event Reporting System. From VAERS they go into an 
empty drawer, and they pile up and go nowhere and nothing is 
done. The CDC and the FDA do studies saying we don't see any 
problem with anything.
    Can you please change the chart.
    First of all, newborn babies are not at risk of getting 
this disease. I quote you the risk groups from the CDC 
hepatitis B disease fact sheet: injection drug users, sexually 
active heterosexuals, homosexual men, infants from disease 
endemic areas, low socioeconomic levels, sexual household 
contacts of infected persons, infants born to infected mothers, 
healthcare workers, chemodialysis patients. Not newborn babies.
    Then why do you say are newborn babies infected with 
hepatitis B? The vaccine is the first thing that they get in 
the first 24 to 48 hours of their lives in the hospital. Here 
is the ACIP's original statement from 1991. ``In the United 
States, most infections occur among adults and adolescents. 
Efforts to vaccinate persons in the major risk groups have had 
limited success. In the long term, universal infant vaccination 
would eliminate the need for vaccinating adolescents and high-
risk adults.''
    And then they say, ``Hepatitis B vaccination is recommended 
for all infants. The first dose can be administered during the 
newborn period, preferably before the infant is discharged from 
the hospital.'' That is where it came from.
    I quote you from government statistics, summary of 
notifiable diseases, 54 cases of hepatitis B in the 0 to 1 age 
group in 1996. And if we compare that, that is that. In the 
VAERS reports in that year, there is more than 1,000 adverse 
reaction reports, and there are 47 deaths of these reports. So 
this needs to be investigated.
    I am not saying that every report in VAERS is directly 
related to the vaccine, but I have torn apart the VAERS data, 
and I am trained in statistics. I am an advisor to some of the 
largest financial institutions in the world and a former 
proprietary trading strategist at Salomon Brothers.
    One of the most striking findings of this data is that 
almost 80 percent of the reports of hepatitis B, 77 percent are 
in females; only 23 percent in males. More than three times as 
many women are having adverse reactions reported in VAERS. No 
one is looking at this.
    Dr. Chen of the CDC dismisses it and says nurses tend to 
over-report. I think that is a big mistake. Independent doctors 
with no financial interest should take a look at this.
    I would just like to conclude with the way vaccine policy 
is set in this country. Dr. Modlin at the ACIP meeting on 
February 19, which I attended in Atlanta said--first of all he 
said at a debate in New Hampshire: ``How do we decide 
something? Is the theory biologically plausible? Has it been 
tested by appropriate methods? Is the study well concluded? Are 
the results statistically sound?''
    Now I read to you from the transcript of the ACIP meeting 
regarding the approved rotavirus for premature infants: 
``Available data are insufficient to fully establish the safety 
and efficacy of rotavirus vaccine in premature infants.'' There 
is a section under Adverse Events that details what little 
information there actually is with respect to premature 
infants. To my knowledge, we don't have data from a clinical 
trial specifically. Some bit of information, as I recall, 
suggested that there was a relative risk for hospitalization. 
Obviously, a situation where we have to make a judgment in the 
absence of data and with a vaccine that has not yet been tested 
in this group.
    They voted 9 to 1 to approve rotavirus vaccine for 
premature infants with no scientific statistical studies on it. 
I think that is a big problem.
    This is my charge to you. I am afraid that this vaccine 
policy is dominated by forces that are not in the public 
interest and this committee should investigate the 1991 ACIP 
recommendation establishing universal hepatitis B vaccination 
of newborn babies; and if, as with the rotavirus vaccine 
examples were done, no studies were done to prove that this was 
safe in a broad sample of racially and genetically diverse 
babies less than 24 to 48 hours old when they established this 
recommendation, we can find those studies.
    We have a Freedom of Information Act request in from the 
National Vaccine Information Center. Then the CDC has been 
experimenting on babies like guinea pigs, and this committee 
should suspend that universal at-birth immunization policy. 
Thank you.
    Mr. Mica. Thank you for your testimony. We will hold 
questions until we have heard from all of the witnesses.
    [The prepared statement of Mr. Belkin follows:]
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    Mr. Mica. Judy Converse, you are recognized.
    Ms. Converse. Thank you for the opportunity to testify. I 
regret having a reason to speak here today and have no other 
reason to do so except for the sake of truth. I live in 
Massachusetts. I wish to state also that I hold a master's 
degree in public health and I am a registered dietician, I was 
trained to accept and encourage immunization and was in no way 
inclined against immunizing my son Benjamin. He is 2\1/2\ now.
    I would like to say there is no history of autism or 
seizure disorder in my family or my husband's family. If Ben 
were here in front of you today, he would seem completely 
normal, but I will try to explain a little bit about his 
disability which he struggles with every day. He was born full 
term, normal in every way. Vaginal birth with no interventions 
or drugs. His Apgar scores were 9 and 10, which means that all 
of his reflexes were perfect and present.
    Before discharge, he was immunized with Recombivax HB 
against hepatitis B. Neither I nor my husband recall receiving 
informed consents for this vaccine, nor do we recall seeing him 
get the shot, but it is in his immunization record. No signed 
informed consent specific to this hepatitis B vaccine was 
present in the copy of Ben's medical record which we recently 
    His fourth night in this world was his first at home. And 
about 5 hours after arriving home, he had his first seizure. 
Frantic calls to maternity and pediatric staff fell on deaf 
ears. The extent of the medical advice we received was to put 
him on our clothes dryer and turn it on.
    No one mentioned the vaccine. No one expressed concern that 
he was turning blue, that he couldn't stop screaming or that he 
appeared to be having tremors or full-body spasms. Ben had 3 
more seizures, losing consciousness in the next 8 days, as well 
as many episodes of arching his spine rigidly without losing 
    He vomited forcefully every day, had a recurring mild 
fever, eczema, was unable to remain asleep, had diarrhea and 
cried constantly, but no one thought any of this was out of the 
ordinary. I was told these thing are normal for a breast fed 
infant which, of course, I knew was not true. He was only 12 
days old.
    The third time he passed out, he did not resume 
consciousness. He was cyanotic. At the emergency room he was 
tested for several diagnoses and all were negative or 
inconclusive. He was observed overnight, and after nearly 
losing him, we were sent home the next day with a shrug.
    No one mentioned the vaccine. No one expressed interest or 
concern for the events of the previous week and no one advised 
us in any way about what appeared to be seizures and a struggle 
for his life.
    Ben's medical record even states in a gross understatement 
that his first days of life prior to this admission were 
uneventful. The same doctor who wrote this note privately 
admonished me for agreeing with the attending pediatricians to 
spare Ben the trauma of another spinal tap.
    Convinced Ben had meningitis, he said, ``It is people like 
you who cause lifelong mental retardation.'' Ben's discharge 
note states only that he had apnea, despite having tested 
negative for it. We entered the hospital looking for answers 
but left with none. He worsened with the second immunization 
for hepatitis B at age 4 weeks.
    This was when I realized he had been given the shot at 
birth and that was probably causing his problem. I asked for a 
delay for Ben's other immunizations at 2 months and was 
refused. I knew that accepted pediatric practice dictates that 
a sick child should not be immunized, but the doctor refused. 
When I persisted, he told me we could either immunize Ben on 
schedule, which we had to do because it was the law, or we 
could call DSS.
    With this threat, Ben was immunized and all of his symptoms 
worsened. At 4 months he was immunized again. At 6 months, I 
refused further shots and switched doctors. He was seen by 
neurologists and developmental specialists, but no one could 
explain why he was too floppy to attempt normal developmental 
tasks, couldn't sleep, suckled poorly, kept vomiting, why 
eczema persisted, despite being breast fed, why he passed out 
in shock when he heard Velcro, plastic bags, or aluminum foil.
    By age 10 months, he could not pull himself to sitting or 
crawling and could not roll over. We sought help from the Early 
Intervention Program, and Ben qualified for services based on 
his motor delays. For the first time, a formal acknowledgment 
of his delays was drafted. Reflexes which were normal at birth 
had disintegrated and protective responses inexplicably 
    Ben had two or three seizures a week during his early 
infancy and early toddlerhood. The events of these seizures 
never vary and Ben had one as recently as 2 months ago. He 
cries hard with one breath which seems to empty his lungs; and 
he is then silent, mouth open, not breathing and struggling for 
    Excuse me. As he suffocates, he turns red, blue, and then 
purple. His extremities become blue, his limbs flail as if he 
is drowning. Often on his left side Ben will have a flapping 
tremor of his hand while his arm, neck, and shoulder are 
rigidly flexed.
    As his asphyxiation is complete, he is gray. His eyes lose 
their luster, his pupils dilate and his eyes roll back in his 
head and then he is unconscious. He usually regains 
consciousness quickly once his muscles are relaxed and he can 
breathe again, but these episodes are traumatic, exhausting, 
and frightening for Ben. They invariably occur in response to a 
stimulus he cannot manage, whether it is auditory anxiety 
related or from a fall or bump.
    Even though Ben had seizures like this when he was just a 
few days old, we were told they were breath-holding spells 
which he consciously contrived in response to our 
overprotectiveness. The doctors told us we were causing Ben's 
seizures, odd behaviors, and delays by bad parenting.
    I was told I over-nursed him by one neurologist, and asked 
why I needed something to be wrong with my son by a pediatric 
developmental specialist. I believe this is a grossly ignorant 
assessment of what may be grand mal seizure episodes.
    Ben also appears to have petit mal seizures in which he 
rolls his eyes back in his head and grimaces, pierces the air 
above his head with his left hand, elbow locked, and hand 
quivering. Ben was diagnosed with autism recently and sensory 
integrative disorder last fall.
    He cannot reliably sense, organize, or prioritize 
information that he receives about anything in the world. He 
cannot be placed in group daycare. He is terrified of his own 
peers. These few examples don't describe how profoundly 
disabled he is now.
    I would especially like to state that our pediatric 
providers were very unsupportive, and I do believe my son would 
have died if I followed their advice. We have had very little 
guidance from them through this journey. His current physician 
agrees not to immunize him and has supported our refusals, but 
she has not reported his reaction and discouraged me from doing 
    She told me we would be harassed by the Massachusetts State 
Department of Public Health and forced to prove damage from 
each vaccine with invasive blood tests. When we asked for a 
medical waiver, she gave us only a vague philosophical one.
    She acknowledged to me that the hepatitis vaccine is an 
unnecessary affront to an infant's well-being and she refuses 
to give the younger two or her three children this vaccine 
because it is of no benefit.
    I have no doubt in my mind that this vaccine damaged my 
son, not just because he was normal at birth, full term with a 
family history void of these problems, but because the 
progression of events after the shot are in keeping with 
criteria for a hepatitis B vaccine adverse event listed by the 
Vaccine Injury Compensation Program.
    The fact that the pediatric community failed to recognize 
his reaction in no way exonerates them or the vaccine industry. 
It simply means that thousands of healthy newborns will slip 
through the cracks with severe reactions and be untreated and 
    After reading data on hepatitis B in the United States, as 
a person trained in public health sciences, it is plain to me 
that a program to vaccinate newborns is of no worth to anyone 
except those who sell vaccines. The immunity it imparts wears 
off before a child is old enough to have sex with an infected 
partner or use contaminated needles, which are the foremost 
modes of transmission. Therefore, it is my opinion that there 
is no benefit and only risk for newborns receiving this 
vaccine. Thank you.
    [The prepared statement of Ms. Converse follows:]
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    Mr. Mica. Thank you for your testimony. We now recognize 
Ms. Kirschner and Lindsay Kirschner at this time.
    Ms. Marilyn Kirschner. I thank you for having us here 
today. I am here with my daughter Lindsay, maintaining a 
commitment to pave the way so that other parents can make an 
informed choice in regard to the hepatitis B vaccine. Lindsay 
is representative of all of the children who fall under the 
    Six months before the vaccine, we had an idyllic life, 
reveling in the joy of Lindsay's bat mitzvah, perfect in every 
way. Lindsay received the hepatitis B vaccine 2 days before 
entering high school.
    The next day she seemed flu-like. The day after that, so 
dizzy she couldn't stand up without holding the walls. The 
following day she passed out. So our life goes since August 
    Lindsay has had syncopal and pre-syncopal episodes. Her 
ability to stand was compromised for almost 6 months due to 
unremitting dizziness. Following our doctor's advice, unknown 
the vaccine was the culprit, Lindsay had the series of three. 
It was on the third shot Lindsay became so violently ill within 
2 hours that I knew the vaccine was the catalyst of her 
    At 16, Lindsay should be having fun with friends, dating 
and driving. Instead, her days are filled with doctor visits, 
15 specialists, MRIs, CAT scans, spinal taps, ER visits, and 
hospital admissions. Lindsay is plagued on a daily basis with 
headaches of a severe kind, joint pain, seizures, nausea, hair 
loss, dizziness, gastroesophogal reflux, and extreme fatigue.
    She has been diagnosed with an Acquired Dysautonomia and is 
unable to hold food down with frequent retching and vomiting. 
She takes a minimum of 10 medications daily; and if she misses 
one, her ability to stand is in serious jeopardy for up to a 
    We have traveled to specialists in four States and will be 
traveling to doctors in two more States before July. 
Unfortunately, Lindsay is not isolated in her journey. After 
WPLG Miami health reporter Kristi Krueger broke Lindsay's 
story, the first one to air in the country, I heard from dozens 
of people who have themselves been, or have family members, 
affected by this vaccine.
    Please join me in viewing some clips from the Emmy Award-
winning broadcast that brought national attention to this 
    Mr. Mica. Maybe while they are trying to get that working--
    Ms. Marilyn Kirschner. I will finish my testimony.
    Family life as we knew it has been destroyed. This illness 
is an emotional and an extreme financial drain, as I am hardly 
able to work, depending on my family to support us and feeling 
like a beggar for our survival.
    As a single parent, this vaccine has ripped out a part of 
our lives that can't be replaced. Lindsay, my former National 
Junior Honor Society president in 8th grade, is now on a 504 
disability plan, missing 70 days of 9th grade and pushing 
beyond that in this, her 10th grade year. What about her 
future, college, a career?
    Will my son David ever forgive me for being so unavailable 
last year when he was a senior now that he is 3,000 miles away 
in L.A.? The joy of his scholarship offers and prom departure 
all took a back seat to Lindsay's illness. Or the fact that he 
is spending his birthday on a plane so we could be at this 
hearing after just returning Sunday from his first year at USC. 
What about Lindsay's puppy, Frisbee, and bird, Boca, who are 
boarded almost as much as they are at home?
    What about our shattered lives, barely a fragment left of 
what used to be? Tragedy is not supposed to be the American 
way. Lindsay, nor anyone, should have to live like this because 
scientific studies weren't done to determine if this vaccine 
was safe to give to every child. My daughter shouldn't have to 
suffer like this because government officials and drug company 
executives didn't do their jobs. Thank you.
    [The prepared statement of Ms. Marilyn Kirschner follows:]
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    Mr. Mica. Thank you for your testimony, and now we will 
recognize Lindsay Kirschner.
    Ms. Lindsay Kirschner. Thank you. I would just like you to 
imagine having a life like the one that follows. Your day 
starts at 2 a.m., when your body starts jerking uncontrollably 
and a burning smell fills the air. After your body relaxes, you 
drift back to sleep only to be awakened a short hour later 
overcome by nausea.
    You reach for the bowl that is always on the side of your 
bed because you've had this feeling before, and you know it is 
not going to be pretty. Maybe you get another 2 or 3 hours of 
sleep, but a soothing voice awakens you at 6:15 because it is 
time to get ready for school.
    You feel a killer headache approaching on the ride and you 
dread the thought of sitting in classrooms for the next 6\1/2\ 
hours while fighting constant dizziness and nausea.
    When you try to take your Algebra II tests, you realize 
that you have forgotten the formulas to use, even though you 
wrote them more than 25 times in your homework last night.
    As the day passes, you look at other kids and long to be 
normal like them. And maybe for 10 minutes in between constant 
aches and pains, you manage to forget your problems and feel 
like you do belong. But then a sudden sharp pain in your arm or 
the urge to vomit reminds you how different you truly are.
    Let's face it. You haven't made it through one full week of 
school in your 10th grade year of high school. You struggle to 
keep your head up throughout the remainder of the day and are 
relieved when the dismissal bell finally rings.
    When you get home, forget watching Rosie or MTV. Your eyes 
are already closing, and so you fall into the comfort of your 
bed and stay there for the next couple hours. If you manage to 
wake up in time to do all of your homework, then you struggle 
to finish it because sitting at the computer brings constant 
    Later, when you start retching, you instantly regret eating 
the food you had for dinner, whether it be nachos or pasta, and 
you vow never to eat it again, no matter how delicious it 
    Although you are anxious to get more sleep, the thought of 
nighttime evokes anxiety because as you lie in bed, you know 
that in just a few short hours, the painful cycle will begin 
again and your struggle will continue.
    To most of you, this would just be a bad dream. But it is 
the reality I have faced for the past 2 years; and no matter 
how hard I pinch myself, it won't go away. Thank you.
    Mr. Mica. Thank you for your testimony.
    [The prepared statement of Ms. Lindsay Kirschner follows:]
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    Mr. Mica. I don't know if we can get this to restart there. 
These are clips that you have provided, Mrs. Kirschner.
    [Video shown.]
    Mr. Mica. I would like to thank both of you for your 
testimony and recognize at this time Barbara Hahn. Barbara, you 
are recognized. Welcome.
    Ms. Hahn. Thank you. I would like to thank also Congressman 
Mica for allowing me to be here to testify today. My name is 
Barbara Hahn. I am from the greater Cincinnati area north of 
Kentucky. Up until several months ago, I was employed as an 
interpreter for the deaf which takes a lot of concentration, 
and also I am a chaplain.
    In June 1995 I was diagnosed with hepatitis B. That was 
about a week before my 25th wedding anniversary. My doctor told 
my husband and I that I had a sexually transmitted disease and 
that he should be tested and vaccinated.
    What the doctor failed to tell me at the time was that 
hepatitis B could be spread in many other ways. I had complete 
trust in my husband and thank God he had faith and trust in me. 
So the suggestion of sexual promiscuity did not harm our 
marriage in any way.
    Within a week, we were informed that my husband tested 
negative as did my children who have all been vaccinated since 
this ordeal began. Incidentally, none of them have had any 
adverse reaction to the vaccination.
    Shortly after my diagnosis of hepatitis B, an employee of 
the Cincinnati public schools where I formerly worked informed 
me that it was the belief that a student I had worked with had 
hepatitis B. This employee and the child's nurse had gotten 
themselves vaccinated.
    I was furious because no one had bothered to tell me about 
the vaccine, and I had worked very closely with this child as 
an interpreter. I had even gone to gym class, a place where 
children are frequently hurt, with this student. However, I 
have since been informed that this child did not have hepatitis 
and had only been vaccinated for protection since this student 
was in a high-risk group, being that he had multiple 
    This story caused a great deal of pain to the student's 
family, and I deeply regret if they were hurt in any way by my 
checking out this rumor. I was eventually told by the 
representative of the Cincinnati school occupational safety 
department that I probably contacted hepatitis from a dentist 
since this is thought to be one of the easiest places that we 
can pick up the virus.
    I never pursued this possibility any further because my 
doctor told me in June 1995, at that same time that I was 
diagnosed, that I already had cirrhosis of the liver which 
meant that I probably had had the virus for years. I tried for 
years to find out how I got this virus.
    Had it been from my mother who died of liver cancer as a 
result of breast cancer? Did I get it from grade school or 
dental work surgeries? Did I get it from one of the hospitals 
or clinics where I happened to be an interpreter? Did I get it 
from a child who ran into me on the playground or from the 
little girl who was upset and bit me while I was working at the 
Cincinnati public schools?
    Recently, the immigration policies have brought an 
increasing number of foreign students into our school systems, 
and the incidents of hepatitis are much higher in other 
countries. Is that how I got this disease? I am part of the 40 
percent of hepatitis B patients who will never, repeat, never 
know how we got this chronic, possibly terminal, disease.
    I would wish to see no one else go through this. While the 
possibility of a liver transplant looms in the future, at 
present I suffer from what is called portal hypertension, which 
is related to cirrhosis, and chronic fatigue. Portal 
hypertension means that I wake up every once in a while feeling 
nauseous and throw up great amounts of blood and end up in the 
    It's through repeating bandings of 3 to 6 month intervals 
that they are controlled. That's where they put a tube down my 
throat and try to tie off these little bulges before they 
rupture. I am constantly nauseous, constantly fatigued. 
Sometimes I get confused about what I'm going to say, and I 
have not been able to fully enjoy my grandchildren.
    The only thing that I can be sure of, is I did not get 
hepatitis B from sexual contact, drug use, or tattoos. However, 
I have now arrived at a place in my life--I accept the fact 
that I will never know the path of my transmission. I no longer 
search for that answer.
    Now I focus on how the virus can be stopped from spreading. 
Hopefully, someday our schools will be as worried about 
hepatitis as they are with other vaccines. I was required to be 
tested for several things before becoming employed by the 
school, but no one ever asked me to be tested for hepatitis.
    Now, ask yourself how easy it would be for your children to 
contract the disease while playing basketball, soccer, 
baseball, or track. What about the fights in the school lunch 
lines? Or what about the little girls and boys who trade 
pierced earrings back and forth perhaps unknowingly infected 
with hepatitis B since it is a silent disease that we don't 
know about for years.
    I don't mean to frighten anyone here with the ease of 
contacting hepatitis, but statistics show that it's easier 
spread than AIDS, as others will no doubt testify to.
    In closing, I make one personal point. I know by being here 
today I have added another brick to my wall of isolation 
because of the fear some people have of contracting my disease. 
I also know that many people will not believe that I have only 
had one intimate partner in my life for 29 years, but my 
husband does. And you know, that's really all that matters to 
    Oh, yes, there is one more thing. The best thing my doctor 
did tell me is I needed to get my kids and my grandchildren 
vaccinated, and I did. So you cannot even imagine the joy when 
several weeks ago, I received in the mail my son's blood donor 
card. Actually, he received it. I took it. And he is now an 
eligible blood donor.
    Why am I happy? This means that I have successfully 
prevented my son from contracting this terrible disease and he 
is safe. So all I'm asking of this committee is to consider and 
help me to protect other children the same way I am trying to 
protect my own, through vaccination. Thank you.
    Mr. Mica. Thank you for your testimony and I will recognize 
Karen with PKIDS.
    Ms. Karen. Chairman Mica and members of the committee, I 
appreciate the opportunity to speak today. I am here today to 
talk about my family. I won't add to the list of statistics 
related to the immunization issues. I would like to personalize 
them to bring them to a level that you can relate to from the 
heart, rather than from a business, political, or clinical 
    My husband and I have three young children. Unfortunately, 
I can't bring them with me, but these are the three children. 
One of us became infected with hepatitis B and is now a 
carrier. One of our twins is the face of this virus. Although 
he has no apparent symptoms yet, his liver is dying.
    This is an invisible process until the end. Biopsies at 
ages 3 and 4 confirmed that he already had cirrhosis, and as 
you have heard from other people on the panel that's quite 
unusual. It usually takes decades, but at age 3 he already had 
cirrhosis, which is permanent scarring of the liver.
    He did not respond to a 7-month course of Interferon, which 
is a form of chemotherapy, and no other treatment has been 
available for him. He has had cirrhosis long enough now that he 
must be monitored frequently for liver failure and cancer.
    There is a four letter F word which we try to shield our 
children from, and it's something they shouldn't know anything 
about at such a young age, and that word is fear: fear of 
social repercussions, fear of financial ruin, fear of sickness, 
death, and loss.
    You may have noticed that I have not provided our family 
name, and that's because I can't. The first thing hepatitis B 
families learn, usually after rejection by friends and family, 
is to go to extreme lengths to protect their children's 
    We cannot risk exposing our children's plight on news 
programs such as 20/20 to help inform others of the dangers of 
this disease. We desperately want to reach out for comfort when 
we learn our child has an incurable illness, but we can't. 
Local hospitals offer support groups for parents of children 
with diseases such as cancer, but not hepatitis.
    We, therefore, formed a nonprofit group, PKIDS, or Parents 
of Kids with Infectious Diseases. PKIDS is determined not only 
to help families with infected children but also to educate the 
public about viruses including hepatitis.
    My work with PKIDS enables me to accomplish my personal 
goal of ensuring that other families are prepared to deal with 
the complicated issues related to living with an infectious 
disease. Parents feel an overwhelming need to warn day care 
workers, teachers, Sunday school teachers, playmates and their 
parents of the extra care that needs to be taken if our child 
scrapes his knee, bites or is bitten, or has a bloody nose.
    We want to tell everyone to get shots, yet we agonize over 
the negative consequences of telling. Will our child be treated 
fairly? Will he be ostracized on the playground? Will our kids 
be singled out as the kids at school that everyone needs to 
avoid? Will information given to the school nurse in confidence 
wind up as the topic of conversation at a PTA meeting?
    There are discrimination and disability laws that guarantee 
my child a public education, but there are no laws to protect 
his heart. My husband and I attended a school parent meeting 
and during casual conversation, a mom mentioned that she had 
visited the school superintendent because she had heard there 
was a child in the district with hepatitis B. She wanted the 
superintendent to identify that child so that she could isolate 
her child from him.
    My husband and I sat there paralyzed in silence waiting for 
everyone to look at us. And all I could think of was if you 
wanted to protect your child, get the shots; have him get the 
    We supervise our child's play. We watch his soccer games. 
We coach his soccer games. We are there as much as possible in 
order to protect other people's children. But it's obviously 
impossible to continue this vigilance as the children grow 
    When a neighbor tried to put a bandage on our child's 
bleeding cut, I pushed her away; and she thinks I am 
overprotective. But what she doesn't realize is that I was 
protecting her. No one else should have to live with this virus 
because it's preventable.
    We worry about our ability to provide the best medical care 
for our child. His Interferon treatment cost well over $20,000 
and only a portion was covered by insurance. We are self-
employed and we watched our health insurance premiums triple 
over a 3-year period. Those premiums now exceed our mortgage 
    We wonder if we will ever be able to afford college or 
retirement for our children. If no cure or control is found for 
hepatitis B in the very near future, our son will most likely 
need a transplant, a liver transplant. We have been warned that 
transplant and post-transplant care could ruin us financially.
    At worst, it's only a temporary solution for him, as the 
virus could eventually take the new liver as well. I call this 
virus IT, capital I, capital T. Those of you familiar with 
Stephen King's Master will understand why. IT invades our 
lives, our thoughts, our spiritual beliefs no matter what 
defenses we erect.
    I watch my happy children playing, and IT reminds me that 
we will soon have to tell my son that he has a serious illness. 
Whenever he doesn't feel well, I wonder if this is IT. How long 
will IT allow him to play the sports he loves? How will IT 
affect his school performance? Hepatitis statistics make it 
very difficult for us to be optimistic.
    You can all look at your children and fantasize about their 
senior proms, their weddings, and their careers, but I cannot. 
My son is a leader, he is clever, he is creative, he is 
charming, and he is very protective of his brothers and they 
look up to him. I fear the effect IT will have on his brothers, 
and I worry about how they will deal with this illness or 
    I fear that I will watch my child die, the worst possible 
thing that can happen to a parent. No other family should ever 
have to experience this pain because three shots can prevent 
IT. Hepatitis B is transmitted primarily through blood and 
sexual contact with infected persons.
    My child can infect yours by sharing tooth brushes at camp. 
He is losing his baby teeth and when children lose their teeth 
their gums bleed. And kids share things. A toothbrush is one of 
the things they share. He can infect your children through 
biting or leaving blood residues on a hard surface.
    He has frequent nosebleeds as a result of the virus. It 
affects his clotting factor, and the virus lives on hard 
surfaces such as tables for up to a week. He doesn't even have 
to be there and another person can become infected or through 
sports as mentioned by other people.
    There are infected kids out there with no symptoms. They 
are not reported, no one knows they have it. They have not been 
diagnosed yet. Infected children and young adults will be 
socializing with and dating your children. It is clear to me 
that those who oppose immunizing our children are well informed 
about things such as vaccine composition and side effects.
    However, I beg you to educate yourselves about the 
hepatitis virus and disease progression as well because only 
then will you be able to make a truly informed decision 
regarding immunizations and help us to protect our children. 
Thank you.
    Mr. Mica. Thank you for your testimony.
    [The prepared statement of Ms. Karen follows:]
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    Mr. Mica. And we will recognize our last witness in this 
panel, Betty Fluck. You are recognized. Welcome.
    Ms. Fluck. I would like to thank you for allowing me to 
come before you today to share my experience with you. Never 
did I dream that I would have this opportunity. I am a 
diagnosed victim of the hepatitis B vaccine. My husband and I 
are not antivaccine. Each of our three boys has been vaccinated 
per health department guidelines. However, they will not have 
the hepatitis B vaccine.
    On December 2, 1997, I took my second hepatitis B vaccine 
in the series of three. I was required to have the immunization 
for my job. I am a registered nurse and have been for 20 years. 
I had just started a new job as a public health nurse for the 
local health department in Kokomo, IN. Part of my job 
description was to give immunizations in the department's 
weekly clinic.
    Roughly 12 hours after receiving my vaccine, I woke up in 
severe pain. I developed a 104 degree fever, nausea, vomiting, 
respiratory problems, a rash, severe head, neck and back pain, 
swollen joints, and I was unable to move my legs.
    When the fever broke several hours later, I regained a 
small percentage of my leg strength, but the severe damage had 
already been done. I had to use a cane to move around. I had 
absolutely no energy, and I had constant joint and leg pain.
    I was sleeping approximately 22 hours per day. I continued 
to run intermittent low-grade fevers. The first doctor that I 
went to said that I had a reaction to the hepatitis B vaccine 
but was unable to help. I went from doctor to doctor looking 
for help.
    I ended up at Indiana University Medical Center in 
Indianapolis. I first saw a doctor who was very kind and told 
me that he had read about some of the problems with the 
vaccine. He promised to do some research into the vaccine's 
adverse reactions. He asked me to see one of his colleagues at 
IU Med Center, a rheumatologist.
    This rheumatologist from IU was simply hostile to the idea 
that the hepatitis B vaccine could have caused my problems. He 
suggested that some of my problems could be caused by or 
attributed to a kidney stone. Please be aware that at this 
point, my fingers were so painful that I could not open a soda 
    I returned to the first doctor at IU Med Center 1 month 
later for a scheduled followup. This doctor, who had been 
encouraging and sympathetic 1 month ago, now refused to use the 
word vaccine and attributed some of my problems to the aging 
    Unhappy with both of these doctors, I requested a meeting 
with a patient advocate and the IU doctors. At this meeting the 
first doctor finally told me that I had a ``political problem, 
not a medical one.'' My condition continued to deteriorate from 
cane to walker to knee braces.
    Finally, in September 1998, I was put in full leg braces 
that run from my toes to my hips. With the use of the braces 
and forearm crutches, I have some mobility. Eight months after 
the initial injury, I was able to find an out of State doctor 
who was treating people for vaccine damage.
    I must now see him every 3 months. The vaccine has caused 
nerve damage to my legs and hands. The medical name for my 
problem is chronic inflammatory demyelinating polyneuropathy 
[IDP]. I also have multiple types of autoimmune disorders, and 
I now have an elevated rheumatoid arthritis factor.
    I undergo weekly IV treatments that cost several thousand 
dollars per week. Although I have more energy now, there is no 
real prognosis for my condition. Immediately after I was 
injured, I contacted the pharmaceutical company asking them for 
help. They told me that they had never heard of this problem 
    I realized at that point that I was not that unique and 
decided to write to the FDA through the Freedom of Information 
Act. I requested any reports on file about adverse reactions to 
the hepatitis B vaccine for one particular company from 1991 to 
    Four months later, I received a box containing a 1,045-page 
report. On each page, there were summaries of approximately 
eight reactions. These 8,000-plus reactions ranged from mild to 
death. I made an appearance on ABC's 20/20 in January 1999, on 
their story about the hepatitis B vaccine.
    Since that show was aired, I have received numerous calls 
from adult victims and parents of children who had been injured 
after taking the hepatitis B vaccine. One common theme among 
the victims is that their doctors told them it couldn't be the 
vaccine because it was perfectly safe.
    I recently testified before the State senate committee in 
Indiana with the intent of removing the mandate for the 
hepatitis B vaccine for school entry. The proposed amendment 
was designed to give parents the choice to waive the vaccine 
for any reason.
    On March 2, 1999, it passed the State senate by a vote of 
45 to 4. However, the House sponsor of the original bill killed 
it rather than bring the bill up for debate. In Indiana, a 
doctor from the department of health told the Senate committee 
that one of the arguments for the vaccine was that it was the 
``first anti-cancer vaccine.''
    Fortunately, we were able to show that the ``anti-cancer 
vaccine'' theme was taken from the PATH website. PATH is an 
organization within the World Health Organization. PATH 
suggested that the ``first anti-cancer vaccine'' theme was a 
good marketing tool to bring about interest in a ``boutique'' 
    I have minutes from the CDC study group meeting on the 
hepatitis B vaccine held in March 1997. The minutes of the 
meeting show that it would take at least a 60-day study to show 
the onset of MS. Clinical studies done by the two manufacturers 
were 4 and 5 days in length respectively.
    It should be noted that the afternoon session of this 
meeting was chaired by Dr. Robert Sharrar of Merck. This group 
was to decide how to identify various types of adverse 
reactions, such as MS, and demyelinating disease and to plan 
meaningful studies.
    When Dr. Sharrar appeared on ABC's 20/20 in January, he 
said that he honestly believed that hepatitis B vaccine had not 
caused any problems. Can an employee of a pharmaceutical 
company that manufactures the vaccine be objective in designing 
experiments to show fault in a product that generates close to 
$1 billion in sales for his company?
    The form that people are given about the vaccine was 
written by the CDC. It does not address serious adverse 
reactions. When you look at the vaccine insert provided by the 
manufacturer, several adverse reactions are noted.
    I have since talked to many healthcare professionals who 
are also unaware of the potential adverse reactions listed on 
the vaccine insert. It makes me wonder why the pharmaceutical 
company representative that I talked with earlier, the one who 
was unaware of any adverse reactions, was unaware of what their 
own company's insert said.
    A vaccine that still has so many unanswered questions 
should not be mandated for children. It just does not make 
sense. The right to decide if it's in the best interests of the 
child should be made by the parents. After all, it appears that 
for the most part, when a child is severely handicapped by this 
vaccine, the parents are on their own.
    No one pushing the mandate is there for help or comfort. In 
an article on the hepatitis B vaccine that was printed in the 
Washington Post, a spokesperson for the CDC said that nothing 
unexpected had been observed in the way of adverse reactions.
    At first, I thought they meant that their position was that 
no adverse reactions had occurred. Now, I really don't think it 
was denial. Despite over 20,000 reports to VAERS for the two 
manufacturers, nothing unexpected had occurred. I really 
believe that the number and type of injuries is no surprise for 
the CDC. Maybe the only surprise to the CDC is just how hard 
the victims are fighting back. Thank you.
    Mr. Mica. Thank you for your testimony.
    [The prepared statement of Ms. Fluck follows:]
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    Mr. Mica. I would like to thank all of our witnesses for 
their testimony this morning. I have a couple of questions, the 
first for Mr. Belkin. I believe you testified that you did not 
have any notice as to possible adverse reactions before the 
    Mr. Belkin. Yes. We received no warning. Our pediatrician 
seemed to think this was like giving an Advil or Tylenol or 
something. No warning, no ``watch out, this is dangerous, this 
could cause convulsions.'' Nothing whatsoever in any way, 
shape, or form.
    Mr. Mica. Of course you have experienced a tremendous 
personal tragedy. Based on what you know now, do you think 
there should be some warning or some signoff by parents, such 
as informed consent?
    Mr. Belkin. Yes, absolutely. And I think the doctors should 
be held responsible. The bureaucracy should be held 
responsible. Right now, I have taken about 40 other reports 
from other parents where the same kind of thing has happened--
where they found about 10 other SIDS cases, and numerous other 
nurses that have the same kind of things as Betty.
    In every single case the doctors have denied 
responsibility. No, it's not the vaccine. It's happened over 
and over. Convulsion, oh, it is not the vaccine. Second time 
around, convulsions. No responsibility. As well as disclosure 
and choice, the doctors should be held responsible for 
reporting adverse reactions so when a dangerous medicine is out 
there, it doesn't keep happening. That's my only goal in doing 
    Mr. Mica. Now, I know that they eliminated some factors for 
the cause of the death of your child. Was there a specific 
scientific or pathological forensic study that linked your 
child's death to this vaccination?
    Mr. Belkin. No, not yet. I intend to pursue that. I have 
not done that yet. I am going to take the autopsy results. I'm 
trying to find someone who knows and will not deny it. What I 
found is that the New York City medical examiner and every 
doctor, they call up Merck and Merck says, ``you are the first 
person that has ever called us, this has never happened 
before.'' So then they say, ``well, how can I say this child 
died from the vaccine?'' and it turns out there are 400-
something other deaths in VAERS.
    So what is happening is, from the top down they are denying 
that this is happening. And the people at the bottom, the 
pediatricians, the people that are doing the autopsy say 
``well, they say it's safe; it couldn't be the vaccine.'' There 
has to be some disclosure from the top down to the bottom.
    There is a huge body of evidence of brain swelling in 
causing encephalitis, which is basically the result which they 
are denying. So I still have to go forward with this to 
actually go to another neuropathologist, which I intend to do.
    Mr. Mica. Thank you. Ms. Converse, your child had reactions 
and you stated to the doctor, the physician, that your child 
was having reactions. Were you warned in advance that the child 
might have adverse reactions?
    Ms. Converse. No.
    Mr. Mica. Then, after you said that there were problems, 
you said that the doctor ignored those and went ahead with the 
    Ms. Converse. Right. Because I knew that the pediatricians 
would be unsupportive if I mentioned that I suspected the 
vaccine, I never told them that.
    Mr. Mica. You did not tell them.
    Ms. Converse. I simply explained his symptoms.
    Mr. Mica. Each time your child was vaccinated, there were 
adverse reactions?
    Ms. Converse. Yes. But the most profound was with the 
hepatitis B.
    Mr. Mica. Do you have professional or scientific evidence 
that the vaccine has been the cause of your child's condition?
    Ms. Converse. The evidence that I am using is that he fits 
all of the criteria that the Federal Government describes. We 
do not have a blood test which I have just learned that we can 
get to--Myelin Basic Protein. I just learned of that.
    Mr. Mica. Have you taken advantage of or applied for 
compensation under the Vaccine Injury Compensation Program?
    Ms. Converse. No, not yet because of the discouraging 
comments that my pediatrician gave me in terms of basically 
coming out and saying that we have had a reaction. But my 
position on that is changing. I think the other reason why we 
haven't is we have been very overwhelmed in caring for our son.
    Mr. Mica. In the reporting system that we have, the Vaccine 
Adverse Event Reporting System, do you know if your child has 
been included in that--either through doctors or your report?
    Ms. Converse. He has not.
    Mr. Mica. What about your child, Mr. Belkin?
    Mr. Belkin. Yes.
    Mr. Mica. Ms. Kirschner, were you warned in advance that 
your child might have an adverse reaction? How old was she when 
she had her shots?
    Ms. Kirschner. Lindsay was 14. I had no warning at all. In 
fact, on the appointment that she was vaccinated, the doctor 
didn't even see us. There was no consent form. Nothing. Even 
the day after we went back to him when she had flu-like 
symptoms, he told me she had the flu. I did not even make the 
connection that it was tied into the vaccine. When I called him 
every day because she was just getting worse and worse, he 
didn't know.
    Mr. Mica. Thank you. Ms. Hahn, you contracted hepatitis B 
and you said that you didn't know how you contracted it. You 
have heard some of the stories today about individuals who had 
their child vaccinated under the mandatory program. After your 
condition was discovered, you had your family vaccinated. Was 
that the case?
    Ms. Hahn. Yes, it was.
    Mr. Mica. So they hadn't been vaccinated before. You didn't 
experience adverse reaction in your family. First of all, what 
do you think about the additional requirement for informed 
consent before these vaccines are given, particularly for the 
parent since of course, the child can't give intelligent 
consent to vaccination? And do you think we should have some 
other limits on vaccination?
    Ms. Hahn. I can't speak for their situation. In mine, I had 
my doctors, who are with Group Health Associates of Cincinnati, 
and I have always been informed of every vaccination my 
children have received. We have had the same doctor all of 
their lives. My oldest is 27 and my youngest is 21. I have 
always been informed of the risk. My husband was even informed 
of the risk.
    Mr. Mica. How old were your children when they were 
    Ms. Hahn. My youngest son was 16.
    Mr. Mica. But if they had been vaccinated--one of the 
questions we will get into a little bit later is how long this 
vaccine is effective for. So they might have to be vaccinated 
again if they were 16 and had it done at birth?
    Ms. Hahn. No one has ever informed me of that. I read a 
little bit on the Internet of some people suggesting it, so I 
can't answer. My doctors haven't seen any need. I believe 
before you would do that, from what I understand when I ask my 
doctor about that, is that you would do a simple blood test 
first to see if they needed to be, you know----
    Mr. Mica. Finally, were they given any warning that there 
might be an adverse reaction or were you given any warning that 
your husband or children might have an adverse reaction to the 
    Ms. Hahn. Yes. I also encouraged all of my family members, 
my grandchildren who are all under the age of 4, my sister, and 
my brother to be vaccinated. I don't know of one of my friends 
yet that has had a problem.
    Mr. Mica. I have additional questions, but I will recognize 
Mr. Waxman.
    Mr. Waxman. Thank you very much. Let me thank all of the 
witnesses and tell you how sorry I am to hear about the 
misfortunes all of you have suffered, some from the vaccine 
reaction, apparently from the vaccine reaction, and some from 
hepatitis itself. We are dealing with a difficult issue. We 
want to control this disease, but evidently there are, in some 
cases, horrible reactions to vaccines and we want to be sure 
that they are minimal and that everything is being done to 
prevent those adverse reactions.
    Mr. Belkin, you showed us some charts that were pretty 
surprising. The question, of course, is one of causation, 
whether those lists of reactions were, in fact, caused by the 
vaccine itself. Have you conducted controlled research such as 
might be peer reviewed and published?
    Mr. Belkin. No, and I think that's exactly what should be 
done. You cannot go through--I encourage you to go through the 
VAERS reports and look at them yourself. I spoke at the New 
York City Rotary Club. I was invited to speak on this subject. 
A gentleman came up and refuted me and he said he had been sent 
by Merck.
    He was the chairman of the American Academy of Pediatrics. 
It is a major thing when Merck sends the chairman of the local 
district of the American Academy of Pediatrics. I asked him 
what he thought about VAERS, and he said that it's garbage. I 
said, what would you do to improve it? He said, there is no 
money for that.
    So what is happening is it is just going nowhere.
    Mr. Waxman. Let me interrupt you, because we have to have 
research done. Any manufacturer of any kind of pharmaceutical 
product has got to continually check, in my view, about adverse 
reaction reports. One of the concerns I have had is that the 
FDA is under such pressure to approve drugs, they get them 
approved, and we want to know before they are sending them out 
to be used widely that they check for all of the adverse 
reactions. And if they are out there and they learned about 
adverse reactions, they respond to it.
    We are going to hear from somebody from the FDA in a 
minute. I'm making that as a general statement. But the charts 
that you held up have not been peer reviewed themselves. They 
are the list of statistics of people who have had adverse 
reactions; is that right?
    Mr. Belkin. That's correct.
    Mr. Waxman. You haven't had anything peer reviewed or 
published in any scientific----
    Mr. Belkin. No, I haven't. That needs to be done.
    Mr. Waxman. Do you have a dispute with the national 
statistics that show that a third of all hepatitis B cases 
occur in people who are not in high-risk groups?
    Mr. Belkin. Those studies are very interesting. Are they 
done on the basis of epidemiological study or are they done by 
questionnaires? That's the question. I think that the science 
really has not been done. I am not an expert on the subject, 
but from what I have heard, those little pie charts showing so 
many intravenous drug users, that's the result of 
    I'm not absolutely certain about that. I think this whole 
area needs to be looked at by independent scientists without 
ties to drug companies or the government.
    Mr. Waxman. If you have people who are identified as high 
risk because of certain activities that they engage in, that's 
pretty clear. If you have people who never engage in those 
kinds of activities and whom you wouldn't consider high risk 
contract hepatitis B, we have to wonder why.
    The report that I am referring to indicates a third of all 
of the hepatitis B cases occur in people who are not considered 
high risk. I am sure it is based on some questionnaire, because 
how would you know whether somebody is in a high risk group or 
not? But that doesn't invalidate the conclusion. The reason 
that I raise this is that it has got to be of concern to all of 
us that hepatitis B is a pretty awful disease.
    It's not just limited to people who are high risk. If we 
can prevent this disease we ought to do so. The question is can 
we do it in a way without these costs?
    I have a letter from a woman in Santa Monica, which is in 
my district. She says,

    I understand your committee is hearing from individuals 
concerned about the dangers of immunization against hepatitis 
B. As a school nurse, I would like to urge you to keep in mind 
the devastating effects of this liver infection against which 
the vaccine protects both individuals and society in general by 
lowering the pool of infected people. It's true that a few 
people do suffer adverse reactions to various immunizations. 
Nevertheless, although it may seem harsh to say so, the public 
health benefits of preventing disease by immunization outweigh 
the relatively low risk of harm to the rare susceptible person. 
In California, the State requires hepatitis B immunization of 
public school students in specific grades, but allows waivers 
for individuals with personal beliefs or medical conditions 
which render them unwilling or unable to be vaccinated. The 
availability of such waivers should allow your vaccine critics 
to decline personal vaccinations without depriving other 
individuals in society as a whole of this life-saving 

    What do members of this panel think of that idea, allowing 
    Ms. Converse. If I could respond to that, Mr. Waxman. I 
think it is very interesting to be here today because I am 
noticing that victims on both sides of this share a lot of 
problems, both the course of their illness--there is some 
cross-over, and there is cross-over in terms of isolation and 
lack of treatment.
    What this is telling me is, clearly we don't understand the 
whole picture of transmission and why there is this chunk of 
people who we can't identify as to how this is being 
transmitted. And the second thing, it is very clear that we 
don't understand who reacts adversely and why.
    My beef is that unless you profile criteria about who will 
react adversely and unless that is very much part of an 
informed consent--for instance, if you are of northern European 
extraction and you have a history of allergies in your family--
I am making that up. I don't know what the criteria would be--
that you should be informed that you may be adversely affected. 
That doesn't exist right now.
    Mr. Waxman. Do you think we even know that information?
    Ms. Converse. No, we do not know that. My point being that 
you cannot mandate this universally for newborns until you know 
who may be adversely affected because you will damage thousands 
of people.
    Mr. Waxman. We know with every immunization that we have 
there are going to be some rare cases where there is going to 
be an adverse reaction, sometimes horrible and even deadly.
    Ms. Converse. I think what is emerging with this one is a 
profile, if I might go out on a limb and say. I recently 
attended an autism parents support group on Cape Cod where I 
live, a small group, 10 parents. All of them had red hair. That 
is rare, and I think these are the kinds of things that might 
emerge that really should be looked into. That may be different 
from other vaccines.
    Mr. Waxman. I hope we can find a profile and find a reason 
for adverse reactions. We need to have it done, however, 
through scientific methods.
    Ms. Converse. But until that's done you cannot make it a 
law that a newborn get this shot because it's criminal. You 
have no way of knowing----
    Mr. Waxman. You have no way of knowing, except we do know 
that the overwhelming majority of people are not adversely 
affected and the disease is prevented. On that basis, most 
people want their children to be immunized from polio, 
diphtheria, whooping cough, and hepatitis B.
    Every single one of those immunizations has an adverse 
reaction with some individuals. If we knew why some individuals 
react that way, we wouldn't have them take the vaccine. But as 
a society, we do require people to be vaccinated. In Santa 
Monica, CA, according to this letter that I received, they 
allow people to opt out if they have this concern or fear.
    Ms. Converse. If I could just interject one more comment 
and then I will stop. Our experience--I'm assertive, educated. 
I have a public health background and very much accept 
immunization. I was persistent and tactful with our providers. 
I never told them I think the vaccine caused a problem because 
I knew that might be an inflammatory comment for them. They 
failed to recognize not just that it was a reaction, but that 
my son was even ill.
    So this experience tells me that there will be many, many 
children who don't get reported. So when you say there are a 
few that have a problem, I think it's the tip of the iceberg.
    Mr. Waxman. Did you ask your doctor about the possible risk 
of the hepatitis B vaccine or about any of the childhood 
vaccines that you put your child through?
    Ms. Converse. Yes, but we weren't aware that he was going 
to be given that shot at birth. It was not discussed at all.
    Mr. Waxman. So you were aware that there is a possible 
    Ms. Converse. I was aware through my public health 
    Mr. Waxman. But you didn't talk to your doctor about it 
    Ms. Converse. I wouldn't agree with that. Through my public 
health training, I was aware of other vaccines and the risks 
associated with them.
    Mr. Waxman. My question is, did you talk about it with your 
    Ms. Converse. Yes, absolutely.
    Mr. Waxman. Why were you, as a public health person, afraid 
to tell your doctor that you thought your child was having an 
adverse reaction to the vaccine?
    Ms. Converse. Because my training taught me that these are 
very rare and there are a few sacrificial lambs for the good of 
the whole and that's just the way it goes. I wanted to 
    Mr. Waxman. I thank you very much for your----
    Ms. Converse. I wanted to encourage my provider to help us, 
and I did not want to discourage them by antagonizing them.
    Mr. Waxman. I appreciate what you had to say, and I am 
sorry for all of the terrible things that you have gone 
through. Did you want to raise a comment? I think my time is 
up, but why don't you go ahead.
    Ms. Hahn. Chairman Mica and Congressman Waxman, the subject 
of the questionnaire about hepatitis--and it only asked 
questions. I have had the same health maintenance provider for 
over 20 years. He and they are very aware of my medical 
conditions. I was told that I would have preventive care and 
they would know anything before it happened.
    When I first became a little ill, or rather I was very 
ill--I lost 44 pounds--it was looked at first as just chronic 
diarrhea and stuff. Within a matter of a couple of weeks, 
hospitals. Then they were even telling me possibly cancer. They 
were going to remove my spleen for blockage. All of that got 
narrowed down after they did some tests.
    Then the very last thing they looked at and they said, 
Chaplain Hahn, you have a sexually transmitted disease. I 
believe that was more for the safety of my husband. They wanted 
to make sure that this didn't go any further. So even the best 
of prevention, best of care, best of trying to take care, you 
don't know.
    I worked with your children. I didn't know I had it for 
probably 20 years. The only way that I can prevent your 
children from getting it and trying to be the best at my 
universal precautions is for you to have your children 
    Mr. Waxman. Thank you, Mr. Chairman.
    Mr. Mica. Mr. Tierney.
    Mr. Tierney. Thank you. I don't want to prolong this for 
any of you. I am really very sympathetic to all that you said, 
and I understand how difficult this must be for you. 
Particularly Lindsay, I want to say that your courage here 
today has been noted by everyone.
    Rather than going to a more extensive question, because I 
think that you have all been excellent in your testimony and 
very informed, I only want to pursue one area. I think, Ms. 
Converse, you made the statement, if I am correct, that you 
thought the effects of the vaccine wear off within a certain 
period of time.
    Ms. Converse. That's my understanding.
    Mr. Tierney. Could you expand on that a little bit and tell 
me where you get that information and that conclusion.
    Ms. Converse. I get that information from a Massachusetts 
Department of Public Health flyer on hepatitis B for parents, 
which says that your child will need a booster by the time they 
reach--I think it's either age 11 or 14.
    Mr. Tierney. I was thinking that you had excluded the 
booster part of it, including that the booster was going to 
wear off.
    Ms. Converse. Correct.
    Ms. Fluck. Can I say something, please?
    Mr. Tierney. Absolutely.
    Ms. Fluck. In regards to that question, my husband and I 
have done a lot of research since I have been stricken with 
this. We noted that in India where there is a very high rate of 
hepatitis B, that one of the hospitals there recommend 
boostering every 4 years for hepatitis B. That's a 
recommendation from a hospital in India where hepatitis B is 
very rampant.
    But what I'm saying is, they don't say how long these 
immunities will last for. But some places where they do have a 
very high risk, they boost every 4 years.
    Mr. Tierney. Are you saying that the entire Nation has a 
policy of boosting every 4 years or that single hospital?
    Ms. Fluck. In India, they do but that's their policy.
    Mr. Belkin. The Merck package insert says that the time is 
indeterminate. That's the way they define it on the package 
    Mr. Mica. Thank you, Mr. Tierney. One last question, Ms. 
Fluck. Your particular affliction has been medically diagnosed 
and connected to the vaccination?
    Ms. Fluck. Yes, it has.
    Mr. Mica. Have you filed a claim in the Vaccine Injury 
Compensation Program?
    Ms. Fluck. No, not as of yet. Again, part of the reason is, 
I guess, one of the things that happened, my husband made some 
calls to the CDC and he talked to Dr. Chen. Dr. Chen 
recommended that he talk to Dr. Evans. Dr. Evans called our 
house, and we had no idea who this gentleman was.
    So my husband really didn't want to give him too much 
information. We found out eventually that he is among the 
people who decide who gets what, and if they get anything from 
the claims. He seemed very proud of the fact that they hadn't 
paid out anything to any of the victims of hepatitis B unless 
they had anaphylactic shock.
    Over the phone, without any kind of information about me 
whatsoever, except for the fact that I can't walk, he told my 
husband, your wife did not have an adverse reaction to 
hepatitis B. That's what we are dealing with. I also told you 
in my testimony how I was told my problem is a political 
problem, not a medical problem. I have gone from doctor to 
doctor. It's like they are afraid to say anything.
    Mr. Mica. Well, I would like to thank you and all of our 
panelists for your testimony today, for coming forward and 
providing our panel with your personal experience and 
recommendations as we move forward in our oversight capacity. 
So I thank each of you, and I will excuse you at this time.
    Our second panel today----
    Mr. Waxman. Mr. Chairman, just a word to Ms. Fluck. We are 
checking about the assertion about the vaccine compensation 
system. Don't be so trusting of a comment that you have heard. 
There is more data for the anaphylactic shock than any of the 
other adverse reactions, but the compensation system does look 
at other reactions. So I would urge you to pursue it if you 
feel there is a connection----
    Ms. Fluck. I am diagnosed. I have all the medical testing 
and immunological testing. But what I'm saying is, this doctor 
seemed awfully proud to say that they have never paid out 
anything to anybody unless they have had anaphylactic shock.
    Mr. Waxman. You seem awfully willing to take what he has to 
say at face value, and you don't seem to be willing to take 
what others say at face value; and I think that you have had 
enough reason to be more independent-minded. I'm urging you to 
go ahead and pursue this vaccine compensation.
    Mr. Mica. Thank you. Again, I appreciate your providing us 
with your personal experience--each and every one of you--and 
we will excuse you at this time.
    I will now call our second panel, which consists of 
primarily government officials. Harold Margolis, who is the 
Chief of the Hepatitis Branch of the Centers for Disease 
Control. We also have Susan Ellenberg, Director of 
Biostatistics in Epidemiology Division of the Food and Drug 
Administration. If we could have them come forward.
    I would like to call the meeting back to order here. Those 
who are leaving, please do so and others cease conversation so 
we could proceed. Dr. Margolis, you have someone with you. Is 
that individual going to testify?
    Dr. Margolis. No, he is not. I will introduce him. Dr. John 
Livengood from the National Immunization Program.
    Mr. Mica. Thank you for identifying him. And as I mentioned 
to our other witnesses, this is an investigation and oversight 
panel under Government Reform. We do swear in our witnesses, so 
those two who are going to testify please, if you are going to 
answer questions, I will swear you in.
    [Witnesses sworn.]
    Mr. Mica. And we have another witness or somebody who may 
be answering questions. Could you identify yourself? Dr. 
Ellenberg, could you identify the individual?
    Dr. Ellenberg. This is Dr. Marcel Salive who is Chief of 
the Epidemiology Branch in the FDA's Center for Biologics 
Evaluation and Research.
    Mr. Mica. Thank you. Again, welcome each of you. If you 
have lengthy statements, we would like to make them part of the 
record. We do have a number of panelists today. If you have 
additional, information we will by unanimous consent make it 
part of the record within reason. So I would like to first 
recognize Susan Ellenberg, Director of Biostatistics and 
Epidemiology Division of the Food and Drug Administration. You 
are recognized and welcome.


    Dr. Ellenberg. Thank you, Mr. Chairman. Good morning. I 
appreciate the opportunity this morning to discuss the Vaccine 
Adverse Event Reporting System [VAERS], with you. My written 
testimony is more detailed, and I'm pleased that you are 
willing to include it.
    Mr. Mica. Without objection that will be made part of the 
    Dr. Ellenberg. Before I begin, I would like to say that as 
a parent I certainly have the greatest sympathy for those who 
have testified today in the previous panel. The job of the 
public health service is to investigate and hopefully prevent 
all of these kinds of problems. That's what we are dedicated to 
    Vaccines are among the most significant public health 
achievements of all time and have been responsible for saving 
millions of lives and preserving health worldwide. They are 
extremely safe.
    Nevertheless, like all medical treatments, vaccines are not 
entirely risk free. Vaccines are unique in that they are 
administered to healthy individuals, often children, and in 
some instances are required by State law. While serious 
complications are extremely rare, they can occur.
    Because of the virtually universal exposure of our 
population to vaccines, it is important to identify even those 
very rare adverse reactions. VAERS was initiated in 1990 as a 
joint program of the FDA and the CDC. It receives reports from 
vaccine manufacturers, health professionals, State and local 
public health clinics, and vaccinees themselves or their 
parents or guardians.
    To encourage reporting of any possibly vaccine-induced 
adverse event, the criteria for reporting to VAERS are 
deliberately nonrestrictive. The system accepts and includes 
any report submitted, even when there is no obvious connection 
to vaccination other than timing. Such reporting systems are 
essential to the discovery of potential rare adverse 
consequences of medical product that may not become evident 
until millions of people have been exposed to them.
    There are important limitations, however, as I will discuss 
later, but first a brief overview. VAERS receives 11,000 to 
12,000 reports a year. About 15 percent of these reports 
describe a serious event. Most of the remaining 85 percent of 
the reports describe self-limited transient events such as 
injectionsite reactions, irritability, prolonged crying, and 
    Currently, all reports of serious events and fatalities are 
followed up in detail by health professionals. Medical staff 
carefully monitor trends in adverse event reporting for 
vaccines. VAERS performs a critical function by generating 
signals of potential problems that may warrant further 
    This is especially valuable in assessing the safety of 
newly marketed vaccines. As an example, a review of reports of 
adverse events in infants following the hepatitis B vaccine was 
performed by FDA staff several years ago. This comprehensive 
review concluded that no new concerns had emerged in the first 
few years following the recommendation for universal infant 
    It's important to recognize that VAERS data alone are often 
inadequate for drawing firm conclusions or providing any basis 
for regulatory actions. Probably the most important reason is 
that it is unable to establish causality for most reports of 
serious adverse events, the issue that Mr. Waxman had alluded 
    Most of the types of serious problems reported to VAERS 
occur in unvaccinated, as well as in vaccinated, individuals. 
With 4 million babies born each year in the United States and 
virtually all being vaccinated beginning at birth or shortly 
thereafter, almost any adverse experience in a child will 
follow a vaccination, and some of these will by chance follow 
within a few days of the vaccination.
    Thus, even if a vaccine was not the cause of certain rare 
medical problems, it is a certainty that some number of these 
problems will occur within a short interval following a 
vaccination. For this reason, the fact that an event, even a 
very serious event such as a death, happens to occur shortly 
after a vaccine has been administered cannot by itself lead to 
the conclusion that the event was caused by the vaccine.
    When the review of VAERS data identifies a signal of a 
potential new vaccine associated event, this association, 
therefore, must be further investigated in more rigorously 
controlled studies before causal conclusions can be drawn.
    VAERS data have contributed to our understanding of vaccine 
safety and vaccine risks. Several investigations of VAERS data 
have uncovered previously unrecognized problems that may occur 
rarely in vaccine recipients and examples of these are provided 
in the written testimony.
    Sometimes VAERS findings which we routinely publish in 
medical journals may provide useful and reassuring information 
that new problems have not been identified after additional 
exposure with a vaccine, as previously noted.
    I want to thank the committee and the chairman for this 
opportunity to discuss the VAERS system and will be happy to 
answer any questions.
    [The prepared statement of Dr. Ellenberg follows:]
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    Mr. Mica. Thank you. We will defer questions until after we 
have heard from Dr. Harold Margolis, Chief of the Hepatitis 
Branch of the Centers for Disease Control. You are recognized, 
    Dr. Margolis. Thank you, Mr. Chairman, and our written 
testimony is submitted for the record.
    Mr. Mica. Without objection, that entire statement will be 
made part of the record.
    Dr. Margolis. I am here with Dr. John Livengood of the 
CDC's national immunization program. We are here to discuss the 
importance of the hepatitis B vaccination and the prevention of 
hepatitis B-related liver disease and cancer and the safety of 
the vaccine.
    I am both a parent and a pediatrician. Nothing matters more 
to me than the health and safety of my children and the 
children of others. Based on my 20 years of work in the field, 
I have concluded, first, that hepatitis B is a serious risk to 
infants, children, and adults; second, we have a safe and 
effective vaccine for addressing that risk; and, third, it is 
our responsibility to protect the health of our children and 
future generations by using this vaccine.
    Persons who become infected with hepatitis B either recover 
in several months or go on to have chronic infection. In the 
United States, one and a quarter million persons are 
chronically infected with hepatitis B and are at high risk of 
cirrhosis and liver cancer.
    Hepatitis B is a silent killer destroying the liver in 
someone who thinks they are completely well. When first 
infected, two-thirds of adults and more than 90 percent of 
young children do not have symptoms of hepatitis. Studies have 
shown that each year 20,000 to 25,000 children have been 
infected with hepatitis B in the United States. These children 
acquire their infections in their households as well as in 
their community.
    The importance of these childhood infections is illustrated 
in figure 1. If infected, 90 percent of infants and 30 to 60 
percent of children less than 5 years of age, will remain 
chronically infected. Thus a large proportion of adults with 
chronic hepatitis B became infected as infants or young 
    If we do not prevent childhood infections, we cannot 
control hepatitis B in the United States. Hepatitis B 
immunization prevents greater than 90 percent of infections. 
Studies have shown that routine vaccination of infants and 
children eliminates transmission of chronic infection and 
reduces liver cancer. They have also shown that vaccinated 
persons retain long-term immunity.
    The CDC vaccine recommendations are made with the advice of 
the Advisory Committee on Immunization Practices, or the ACIP. 
Hepatitis B immunization issues have been discussed at ACIP 
meetings on 20 occasions since 1986. In 1991, a comprehensive 
immunization strategy to stop transmission of hepatitis B 
infection in the United States was adopted by the ACIP and 
recommends, one, prevention of perinatal hepatitis B infection; 
two, routine hepatitis B vaccination of infants and 
adolescents; and, three, vaccination of high-risk adolescents 
and adults.
    The decision to vaccinate a child protects that child and 
the community. Because hepatitis B produces a chronic 
infection, a decision not to vaccinate a child not only puts 
that child at risk of infection, but puts others in the 
community at risk as well.
    The CDC is strongly committed to ensuring the safety of 
vaccination. Hepatitis B vaccines are among the safest we have. 
Since licensure, the safety of the vaccine has continued to be 
monitored. Several reviews have been done and have not shown a 
causal association between hepatitis B vaccination and a 
variety of severe, neurologic adverse events. In addition, 
ongoing studies are investigating whether other alleged adverse 
events are associated with vaccination, including multiple 
    As the FDA has discussed, case reports of serious adverse 
events following vaccination rarely provide a convincing link 
between the event and vaccination. Sudden infant death syndrome 
is such an example. Because almost 10 million doses of 
hepatitis B vaccine are administered to infants each year, some 
infants unfortunately will die shortly after vaccination by 
coincidence alone. Available scientific data do not support any 
causal role for vaccination in SIDS.
    As shown in figure 2, 1992 was the first full year that the 
hepatitis B vaccine was recommended for routine infant 
immunization. Vaccine coverage was 8 percent, and there were 
4,800 SIDS death that year.
    In contrast, by 1996, when hepatitis B vaccination coverage 
had risen to 82 percent, there were only 3,000 SIDS deaths. 
These data are reassuring because if the hepatitis B vaccine 
was a major cause of SIDS, we would have expected an increase 
in cases, not a decrease.
    In summary, hepatitis B causes 4,000 to 5,000 deaths a year 
in the United States. If exposed to the virus, infants and 
young children are most at risk of chronic infection and death 
as adults 20 to 40 years later. Fortunately, we have a safe and 
highly effective vaccine to prevent the transmission of this 
deadly virus and to prevent liver cancer. Immunization of 
infants, children and adults is supported by the American 
Academy of Pediatrics, the American Academy of Family 
Physicians, the American Medical Association, the American 
College of Obstetricians and Gynecologists, the Hepatitis 
Foundation International, and the American Liver Foundation, 
among others. Only by achieving high vaccination rates can we 
optimally protect Americans from this serious disease.
    Thank you for your attention. Dr. Livingood and I will be 
happy to answer questions.
    [The prepared statement of Dr. Margolis follows:]
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    Mr. Mica. Thank you both for your testimony. I have several 
    First of all, Dr. Margolis, you mentioned in your 
presentation that studies have shown that at least 25,000 
children are infected with the hepatitis B virus each year. Is 
this an estimate or are these reported cases?
    Dr. Margolis. As I pointed out, infection in young children 
is rarely symptomatic. We have looked, using blood tests, at a 
very large sample of the United States, and this is an estimate 
from that large study called the National Health and Nutrition 
Examination Survey, and those estimates come from those surveys 
done actually on two occasions 10 years apart.
    Mr. Mica. So this is an estimate. If it is an estimate, 
what age group are you talking about in children?
    Dr. Margolis. The data comes from looking at children down 
to 5 years of age. The study didn't go below that, at least for 
hepatitis B, but repeated on two occasions, has again shown 
consistency of that estimate in terms of those numbers.
    Mr. Mica. Did it go below 5 years of age, 5 to what, 
teenage or 18?
    Dr. Margolis. It actually went through adults. The first 
study was done through 2 to 70-year-olds. The second study 10 
years later----
    Mr. Mica. So the figure is sort of an estimate and it 
doesn't deal with those under 5 and it includes adults, so it 
does not really deal with children?
    Dr. Margolis. No, it is a statistical sample of the United 
States. So it represents the U.S. population of children under 
5 years of age. That was done in 1970--1979; and then in 1990 
it also included children 6 years of age and over. So it is our 
best estimate with a valid scientific sample.
    Mr. Mica. So these are estimates.
    Can you tell me the number of reported cases of hepatitis B 
in children under the age of 1, for example, for say the last 
    Dr. Margolis. Well, I can tell you reported cases. Now, one 
of the things, I have to go back 1 minute, from the estimate we 
then matched that with our reported cases, and we can put what 
we call a correction factor in there that takes into account 
that very high rate of asymptomatic infection.
    Mr. Mica. Reported cases under 1 in a timeframe like the 
last year?
    Dr. Margolis. Yes. In 1997 there were 95 reported cases of 
children under 2 years of age.
    Mr. Mica. Across the entire United States?
    Dr. Margolis. Yes. That has been since immunization began 
in 1991. So 1997, if we go back to 1990 before immunization 
began, there were 266 reported cases of children under 2 years 
of age.
    Mr. Mica. That is under 2?
    Dr. Margolis. That is the way that we have the data put 
    Mr. Mica. And there were 87----
    Dr. Margolis. Ninety-five in 1997.
    Mr. Mica. In 1997, there were 95 children reported?
    Dr. Margolis. Under 2 years of age.
    Mr. Mica. Under 2 years of age, and you are comparing 
apples and apples then?
    Dr. Margolis. In 1990, which was before immunization of 
children began, there were 266.
    Mr. Mica. I mentioned, I think, in my opening statement a 
study in New Hampshire. For example, there were 48 adverse 
reactions to the vaccine in children aged 1 to 10 in recent 
years. There were 16 times greater the number of cases of the 
disease--16 times more, I guess, adverse reaction than cases of 
the disease. There were three reported cases of the disease in 
    Dr. Margolis. Correct. That is what you said in your 
opening statement.
    Mr. Mica. Well, is it possible that the preventive measure 
is riskier than the disease itself, given these statistics?
    Dr. Margolis. The first thing I would like to go back and 
readdress is, since an infant or a young child who becomes 
infected is very unlikely to be a case, to have symptoms and 
thus be reported, as we heard, this is a silent infection. As 
we heard today, many people did not know they were infected. 
That is the problem with early childhood infections. You can 
only discover the magnitude by doing these surveys with the 
blood test. So what I would say is, those three cases represent 
many infections and, in fact, the multiplier may be as high as 
    In other words, for a symptomatic case, you may see--90 
percent are going to be asymptomatic and not reported.
    Mr. Mica. There were 3 cases of the disease and there were 
four times as many child deaths, 11 reported; is that correct? 
Are you aware of this New Hampshire study?
    Dr. Margolis. I am not aware of the New Hampshire data.
    Mr. Mica. If there were 11 reported deaths--and this brings 
me to the reporting system--what kind of statistics do you have 
in children 1 and under, or 2 if we can use 2 as a comparison--
I don't know if you would have the same timeframe--but how many 
died from adverse reactions?
    Dr. Ellenberg. Well, we cannot tell you from these data how 
many died from adverse reactions. What we can tell you is how 
many deaths occurring shortly after a vaccination were reported 
to our system.
    Mr. Mica. Can you give me that figure?
    Dr. Ellenberg. Yes.
    Mr. Mica. We have 95 reportable cases in children under 2 
in 1997, is that correct, across the country?
    Dr. Margolis. Correct.
    Dr. Ellenberg. If you will give me just a minute--I have 
too many folders in here. Find the one with the deaths. We will 
give you the exact numbers in a minute, the number of deaths 
under a year of age, and you must remember that most of these--
    Mr. Mica. We want to be fair. I think we are trying to 
compare 2 years. Dr. Margolis' statistics are 2 years.
    Dr. Ellenberg. The vast majority of the deaths in children 
are under age 1 because most of them are attributed to SIDS and 
that occurs only in infants, so there are very few deaths in 
children over the age of 1.
    1997, is that the year?
    Mr. Mica. I think that is your year. I am just trying to 
get some idea. If, in the case of the New Hampshire data, you 
have four times as many child deaths as we have cases of the 
    Dr. Ellenberg. Right. I can tell you the numbers, but the 
problems are all in the interpretation.
    In 1997, VAERS reported 41 deaths in children under the age 
of 1; two deaths in children aged 2; and two additional deaths 
in other children.
    Mr. Mica. So we are looking at about 43 deaths, and we had 
95 reportable cases?
    Dr. Ellenberg. But it is important to recognize that these 
deaths have not been causally attributed to the hepatitis B 
vaccine. The bulk of these were reported after children 
received multiple immunizations with multiple vaccines. We have 
no way of knowing whether any of them had anything to do--this 
is simply an association in time that is reported.
    The number of deaths has been going down as consistent with 
the data that Dr. Margolis showed. In 1994 we had 64; this is, 
in age, under 1, we had 64. Then 60 in 1995, 48 in 1996, and 41 
in 1997.
    The number of childhood deaths is going down, just as the 
increase in hepatitis B vaccine coverage in this age group is 
going up.
    Mr. Mica. Well, again we had the number of deaths that we 
think were caused by adverse reactions.
    Dr. Ellenberg. No, I have to take exception to that. We 
have no idea whether these--there is nothing in the medical 
record to indicate or suggest that these deaths were caused by 
anything in the vaccine. As Dr. Margolis said, we have 4 
million babies a year vaccinated.
    Mr. Mica. So basically you are telling me we can't tell?
    Dr. Ellenberg. We can't, from what is in the medical 
record. The SIDS rate today is 1 in 2,000. Until the Back to 
Sleep campaign, the rate was about 1 in 1,000. You don't have 
to be a mathematician to see that with 4 million babies and the 
rate of 1 in 1,000 per year, you are going to have a certain 
number of deaths following vaccination.
    Mr. Mica. Well, you said that you also did a study. Was it 
in--sometime in the 1990's, about problems with adverse 
reactions, possible signals of potential problems, I think you 
said, and there was no new consensus as a result of that study 
about problems. When was that conducted?
    Dr. Ellenberg. We did a thorough investigation. This was 
several years ago, actually prior to some of these concerns 
being raised. We did a thorough review of all of the adverse 
    Mr. Mica. What year was it?
    Dr. Ellenberg. 1996 it was published, so we were doing the 
study in 1995 or even earlier. And we have reviewed all of the 
data in VAERS from 1991 to 1994 in infants to see whether there 
were any patterns, any particular pattern of events that 
suggested that they might be associated with the vaccine--this 
is what we do with the VAERS data, we review them very 
carefully--and there was nothing. Most of the reports, as I 
indicated, were of transient, self-limited conditions, only 
about 50 percent.
    Mr. Mica. Is that a published study?
    Dr. Ellenberg. Yes, it is a published report.
    Mr. Mica. And peer-reviewed?
    Dr. Ellenberg. Yes, sir.
    Mr. Mica. There are 42 States that mandate this hepatitis B 
vaccination. Can you tell me how many children are getting this 
vaccination, say, at birth or how many are getting the 
vaccination at a later date? Because if they are not getting 
the vaccination, you might have lower figures.
    Dr. Ellenberg. I think that would be something that Dr. 
Margolis might better answer.
    Dr. Margolis. We know that approximately 85 percent of 
children are fully vaccinated--that is, as of this last year--
by the time they are 18 months of age. Thirty percent----
    Mr. Mica. With the hepatitis B vaccine?
    Dr. Margolis. With the hepatitis B vaccine.
    And 30 percent of children begin their immunization some 
time within the first month of life. So ``near birth'' or ``at 
birth,'' the way that the question is asked. The schedule 
allows much flexibility to give the vaccine over the first 18 
    Mr. Mica. The vaccine hasn't been mandated by the Federal 
Government, but the States have instituted a requirement for 
entering public school or other public activities, I guess. We 
have 42 States, and I am trying to get a picture; was that 
instituted in 1991 or 1992, 1993, or has this been a 
    Dr. Margolis. That is correct. It has been transitional and 
evolving, and many States actually--now their school entry 
requirement is only beginning to happen in 1999, in 2000. As 
you see from that coverage data, that yellow line has a higher 
proportion of children. Remember, you are vaccinating in the 
first 2 years of life, and then they come into school. So the 
majority of these States now, by the year 2000 or 2001, will 
require a child to be fully vaccinated.
    Mr. Mica. The studies or reports indicated an increase in 
incidence of adverse reaction as we are having an increase in 
vaccination. Maybe you can answer that, Dr. Ellenberg?
    Dr. Ellenberg. No, I don't believe there has been any 
increase in the total number of adverse events. Well, I should 
back up because as a vaccine becomes--as the coverage 
increases, you will certainly have increases in the number of 
reports. Most of the reports in the system are actually of 
things that we can relate causally to vaccines, things like 
injectionsite reactions, running a fever, we know that vaccines 
can cause these problems.
    While we had very few reports involving hepatitis B in 
children in 1991 when the recommendation for universal 
immunization was first made, the numbers shot up in successive 
years because millions of children were then receiving the 
vaccine. But over the last few years, there has been a tapering 
off and a decrease in the total numbers of reports.
    Mr. Mica. So there was an increase in adverse reactions and 
reporting in the system, as there was an increase in the 
    Dr. Ellenberg. That is right. As one would expect.
    Mr. Mica. And now you have seen that trailing off?
    Dr. Ellenberg. Yes.
    Mr. Mica. One of complaints that we heard today is that 
individuals, parents or those who were inoculated as adults or 
later, did not feel that they had adequate warning about the 
adverse reactions. Today we have developed an incredible 
warning system. Cigarettes have warning systems on them. Every 
time you turn on the television, half the ad is the warning 
about the potential of the drug that you may be taking.
    From your experience and from seeing the statistics that we 
have seen here, it sounds like there are cases of adverse 
reaction. Does it not appear that there is inadequate warning 
either to the parents or those about to be vaccinated?
    Dr. Margolis. Well, I can speak both from the vaccine 
information statement that the CDC supplies--and again it is up 
to the individual to use that--where we say that a vaccine, 
like any medicine, is capable of causing serious problems such 
as severe allergic reactions. The risk of the hepatitis B 
vaccine causing serious harm or death is extremely small. As a 
clinician, when I talk to parents, I advise them of this 
    Mr. Mica. Is the warning adequate, given the numbers of 
adverse reactions? If we just take the New Hampshire incidence, 
we have more deaths from the vaccine than we have deaths from 
the disease.
    Dr. Margolis. The CDC and the ACIP, whom we go to with 
these potential or alleged adverse events, review the data in 
terms of association, scientific association and potential 
causality, and at this time there are no data that would show 
that these deaths, including the SIDS deaths or the other 
serious neurologic adverse events that we have heard about, are 
associated with the hepatitis B vaccination; and that is why at 
this time they are not included in the information statement.
    Mr. Mica. Dr. Ellenberg, did you want to respond about 
adequate warning?
    Dr. Ellenberg. Just to say that the adverse reactions that 
are known at the time that a vaccine is licensed are included 
in the label for the product. And as we learn new information 
about possible risks of the vaccine, those can be added to the 
    Mr. Mica. Do either of you recommend additional studies? 
Another complaint we heard today and something that should be a 
concern to us is that we don't have enough data, enough 
studies, to find out what is really going on here.
    Dr. Margolis.
    Dr. Margolis. The CDC has seven studies ongoing at this 
time to look at the various types of adverse events which have 
been described, to see if there is----
    Mr. Mica. What is the sequence of their being initiated? Is 
this recent or ongoing?
    Dr. Margolis. The first studies with the hepatitis B 
vaccine began in the mid eighties, and they were two reviews 
looking at neurologic events at that time; and then additional 
studies have begun, subsequent--there was an early study 
looking, soon after widespread use of the hepatitis B vaccine 
in infants in 1993-1994, and then these additional studies in 
the last several years for which data collection is still 
ongoing and final results are not in.
    Mr. Mica. So you think that this does need more study? Is 
it getting more study? And you recommend additional study?
    Dr. Margolis. Yes. It is part of our keeping vaccines safe.
    Mr. Mica. Dr. Ellenberg.
    Dr. Ellenberg. Vaccine safety is so important, I don't 
think that we can ever have enough studies. It is very 
difficult sometimes to uncover very, very rare risks because of 
all of the problems in interpreting data. So more studies, yes, 
would be very useful.
    Mr. Mica. We heard from Mr. Belkin, and he brought a chart 
up here that showed the sequence of events as he saw them. And 
when it got down to the VAERS study or repository, his chart 
indicated that the information went nowhere. What is the case 
with the reporting system?
    Dr. Ellenberg. Well, we have a staff that review these 
reports very carefully. There is more detail----
    Mr. Mica. But beyond reviewing them, what happens? Is there 
anything happening with that information?
    Dr. Ellenberg. Yes. When we review them, when we do a 
thorough review, we provide this information to the medical 
community in the way of presentations and publications.
    If there is a need for making this information--putting 
this information on the label, we can work with the 
manufacturers to have that happen.
    I am not quite sure--that is our job, to see what 
information is in there that people need to know in order to 
improve everybody's understanding about vaccine safety.
    Mr. Mica. Dr. Margolis.
    Dr. Margolis. The other things that VAERS do, these case 
reports generate--these larger studies, one looks at vaccinated 
versus unvaccinated children to see if there is a true 
association. So it is fed back into a loop.
    Mr. Mica. Do we have information on that as it relates to 
hepatitis B?
    Dr. Margolis. Those are part of the seven studies that I 
described, but we don't have the complete information at this 
    Mr. Mica. My last question deals with its efficacy, for how 
long the vaccines are effective. I have read 7 years in one 
report. The manufacturer says--indeterminable was something 
that was said, testified to. Someone else said 4 years in 
India. It doesn't sound like we know how long these 
vaccinations are effective for. Do we, Dr. Margolis?
    Dr. Margolis. Unfortunately, when we start out with any 
vaccine, we don't know how long it is going to be effective. 
Hepatitis B vaccine is one where we started following children 
and adults, and we are out now 15 years, to see how long the 
immunity will last.
    Yes, there has been controversy, and our friends in Europe 
and India, some have said we should test everybody and 
revaccinate every 4 years. There has been a change as data has 
become available. There are studies out 15 years showing that a 
child vaccinated either as an infant or a young child is still 
protected, including as they have grown up, become sexually 
active, and are exposed in settings where there is a high rate 
of hepatitis B.
    So we feel comfortable that we know about 15 years. We 
don't know about the future, but these studies are ongoing. 
They are part of CDC's program to follow this vaccine and 
determine if we need booster doses.
    Mr. Mica. Did you want to respond, Dr. Ellenberg?
    Dr. Ellenberg. No, that is a very complete answer.
    Mr. Mica. The hearing so far raises as many questions as I 
think we have had answers provided, but at this time I would 
like to yield to Mr. Tierney.
    Mr. Tierney. In that vein, let me say that one of our 
colleagues, Rod Blagojevich, asked me to put a question to you 
on the record, Dr. Margolis. I think you have answered it, but 
in deference to him, I am going to ask it again.
    What efforts have been made to compare the overall outcomes 
of children who are vaccinated against those who are not 
    Dr. Margolis. Again, there have been several long-term 
studies in populations. One is among the Alaskan native 
children and has shown the ongoing effectiveness of 
immunization now for 10 to 15 years.
    Mr. Tierney. The second part of his question, are there 
clinical trials, control groups or other ways of measuring the 
general health of the vaccinated versus the unvaccinated?
    Dr. Margolis. These again have been done in these large 
population-based studies, and especially where one is looking 
for a potential adverse outcome.
    Mr. Tierney. I want to pose to you a question one of the 
skeptics of the vaccine has published before. The question that 
this doctor says is worth asking is, does a baby born of stable 
parents in a good environment have enough chance of getting 
hepatitis B to warrant subjecting it to what he perceives as an 
unknown danger?
    Dr. Margolis. When we look at the 20,000 to 25,000 
infections that occur in children in the United States, and the 
majority don't have a risk factor, there is not someone in 
their household who is infected, and so those are a very 
important group because if we don't prevent those, they are 
going to grow up and have chronic liver disease.
    Also, as people may have high-risk behaviors as adolescents 
or adults, we have found it very difficult to vaccinate before 
you get infected. There is that additional margin of protection 
that occurs.
    Subjected to a rigorous and peer-reviewed analysis of this, 
both in terms of prevention--and we were quite conservative in 
our prevention; we only said 60 percent of children would be 
vaccinated, we have done better--it becomes both cost-effective 
and prevention-effective to do this.
    Mr. Tierney. How many manufacturers produce the vaccine?
    Dr. Margolis. There are two that are licensed in the United 
States. There are many more worldwide.
    Mr. Tierney. Dr. Ellenberg, we have--I think you talked 
about one study that seemed to document people who use 
vaccines, and then looked at the reactions that were claimed.
    Do we actually ever do an analysis of VAERS, things that 
are claimed, to see if there are any common characteristics 
between the individuals who are making those reports?
    Dr. Ellenberg. You mean to see whether one could identify 
people who are particularly at risk for having reactions?
    Mr. Tierney. Yes.
    Dr. Ellenberg. We have done that, but we need to do more of 
that. It is something that with regard to--for example, the 
gender issue that was raised by a previous witness, this is 
something that we have studied.
    Mr. Tierney. You have studied the gender difference?
    Dr. Ellenberg. To some degree; not as intently--we have not 
completed our investigation.
    Mr. Tierney. Do you have any preliminary results on that?
    Dr. Ellenberg. With regard to the hepatitis B vaccine, I 
can say that there is a predominance of reports in females in 
the adult age group. That is because the largest group of 
people who get the hepatitis B vaccine as adults are healthcare 
workers, and this is a predominantly female occupation.
    When we look at the adverse events in children, there was 
no difference, males versus females, in the adverse events 
reports. But this is an important issue not just for vaccines, 
but for other medical products, and it is something that we 
hope to pursue in more detail.
    Mr. Tierney. What are we doing exactly to pursue it?
    Dr. Ellenberg. Trying to get additional resources.
    Mr. Tierney. You have made an application to Congress for 
    Dr. Ellenberg. Yes.
    Mr. Tierney. Let me ask you, Doctor, are there any criteria 
for reporting to VAERS? Are there any conditions that have to 
be met before a report can be filed?
    Dr. Ellenberg. That is correct. Any time anybody feels that 
there might have been--a vaccination might have been 
implicated, they are encouraged, because we have found things 
that nobody would have thought were associated with the 
vaccine. And when we have a number of reports, we are able to 
see that maybe in some rare cases it is, and some of that 
example is in the written testimony.
    Mr. Tierney. Can you tell us what your datalink project is 
designed to do?
    Dr. Ellenberg. The Vaccine Safety Datalink is actually a 
program of the CDC, so they may want to elaborate on this. But 
it is a collaboration of four health maintenance organizations 
where you can link the vaccination history of children with 
their medical outcomes. And so we don't have some of the 
problems that we have in VAERS in terms of knowing how many 
people were vaccinated and how many people had certain kinds of 
    One can construct rates in a way that you can't do with the 
VAERS system. When we identify a signal of a possible problem 
in VAERS, we can go to the Vaccine Safety Datalink, which met 
last week, and suggest that perhaps these things could be 
looked at in the Vaccine Safety Datalink, and that has happened 
on numerous occasions.
    Mr. Tierney. Has there been a problem with the VAERS system 
for double counting?
    Dr. Ellenberg. Yes. We get duplicative reports. We have 
continued work to develop algorithms to sort these out. We 
don't want to discourage--we are more anxious to get the 
reports in the first place, but it is problematic. We have more 
duplicative reports of the serious events and fatalities; 10 to 
15 percent of those are duplicates as compared to the less 
serious reports where there is not as much of a problem with 
    Mr. Tierney. Is there anything that Congress can do with 
that particular issue? Is that something that you are working 
with within the administrative end of it?
    Dr. Ellenberg. The issue of trying to do quality control of 
the data base is difficult. Anything that Congress can do to 
provide us additional resources to analyze these data bases and 
to do followup studies would be most appreciated.
    Mr. Tierney. Is it accurate to say that the majority of 
people that are contracting hepatitis are, in fact, infants or 
adolescents, or do you have it broken down?
    Dr. Ellenberg. That, I will have to defer to my CDC 
    Dr. Margolis. As that pie chart showed, still the majority 
who contract it are adolescents and adults.
    Mr. Tierney. That is diagnosed or contracted?
    Dr. Margolis. Both. If you look at it both in terms of 
reported, or if one goes to the surveys and the estimates, you 
see it both--you see it as being similar.
    Mr. Tierney. So there is no way to tell when someone 
contracted it once you have diagnosed it?
    Mr. Margolis. That is correct, but the two appear to mirror 
each other. You can use acute disease reporting to show you 
what happened in the past.
    Mr. Tierney. I have no other questions. Thank you.
    Mr. Mica. Thank you.
    Let me go back if I can just a second. I discussed the 
number of cases of children under 2, and we got to 95 reported 
cases of hepatitis B nationwide. Was that right, Doctor?
    Dr. Margolis. Correct.
    Mr. Mica. That was in 1997. Then I asked Dr. Ellenberg the 
number of deaths attributed to adverse reactions in the same 
period, and we got to about 45?
    Dr. Ellenberg. Well, those were deaths reported to VAERS, 
but one could not attribute them to the vaccination. They are 
associated in time, but there is no way to determine that the 
vaccine was responsible for those deaths.
    Mr. Mica. They are attributable under some circumstance, in 
some way, or does the reporting make any sense if----
    Dr. Ellenberg. As I have said, there is no restriction on 
reporting. If someone's child----
    Mr. Mica. You said there was also underreporting?
    Dr. Ellenberg. There is underreporting----
    Mr. Mica. And we don't have that causal evidence on other 
cases, so we are guesstimating that these 45 would be adverse 
reaction deaths, right?
    Dr. Ellenberg. No, we cannot draw that conclusion.
    Mr. Mica. Do you have any idea what is going on?
    Dr. Ellenberg. We have a nonrestrictive system so that 
anything that happens after a vaccine we can look at. We might 
be able to find some cluster of symptoms that does suggest that 
the vaccine was causal. But we don't have that.
    Mr. Mica. So our guesstimate is 45 adverse----
    Dr. Ellenberg. That is not my estimate. I don't know how 
many of these deaths, if any, were related to the vaccine.
    Mr. Mica. How many deaths did we have in infants or 
children under 2 from hepatitis B, as reported--deaths? Now, if 
they have hepatitis B, we can probably get that in a task, and 
that would be reportable as a death, OK.
    Who can tell me?
    Dr. Margolis. Deaths from hepatitis B in children under age 
2 or in children in general are very rare.
    Mr. Mica. I am trying to get one----
    Dr. Margolis. There is----
    Mr. Mica. We are looking at children under 2. Is there any 
evidence? I know that has to be reported somewhere, because we 
can definitely tell who has hepatitis B in children under 2.
    Dr. Margolis. I don't have that number. I can tell you----
    Mr. Mica. Is it more than 45?
    Dr. Margolis. No, it is going to be less than that. That is 
again because as you have heard from me and other witnesses, 
that the deaths from hepatitis B occur many years later. They 
occur from the chronic liver disease. Death from acute 
hepatitis B, we estimate there are only 150 to 200 in all of 
the United States. That is from the new acute infection; 
fomenting hepatitis is rare.
    Mr. Mica. That is from hepatitis nationwide in 1997?
    Dr. Margolis. Yes.
    Mr. Mica. How many were there?
    Dr. Margolis. Around 100. That is acute. That is the new 
case. If one looks at chronic liver disease, that is the 4,000 
to 5,000.
    Mr. Mica. Attributable to hepatitis B?
    Dr. Margolis. Attributable to hepatitis B. You asked me 
about new acute cases. That is what is reported to us or acute 
cases. People who get ill with hepatitis acutely, the new 
    Mr. Mica. Given some of what we have heard today and some 
of what you know, there are--currently 16 States have 
conscientious or philosophical exemptions available from the 
mandatory vaccination laws. Do you feel we should expand this? 
Sixteen States now have it--or redefine it?
    Mr. Livingood. This is John Livingood from the National 
Immunization Program. The construction and implementation of 
State laws for mandatory immunization has been entirely a State 
function and not a Federal function.
    We have been prepared to support States, however they chose 
to enact and implement their State law.
    Mr. Mica. We also penalize them----
    Mr. Livingood. We do not penalize them for the content of 
their State law. States receive incentive funding based upon 
the amount of four doses of diphtheria, tetanus, and pertussis 
    Mr. Mica. So, in effect, they are not being financially 
    Mr. Livingood. Hepatitis B does not play a role in 
incentive funding. It is not included in the formula for 
incentive funding. Incentive funding is based on DPT, MMR, and 
polio containing vaccines.
    A State also measures immunization levels at the time of 
school entry, but we don't reward or allocate funds based on 
hepatitis B as a component of the immunization program in a 
reward or incentive way.
    Mr. Mica. So basically no one is going to commit to 
anything from this panel as far as any exemptions for 
conscientious or philosophical exemptions from the vaccine?
    Mr. Livingood. If States implement such a law, we will 
support them; and we are in complete agreement with however the 
States choose to do their own----
    Mr. Mica. There are 16 States that have this exemption. 
Have we done any study, if there are any higher or lower 
vaccination rates or incidents? Is that part of any ongoing 
study, Dr. Margolis?
    Mr. Livingood. Not for hepatitis B, but there is an article 
that will be coming out in the next several months in the 
Journal of the American Medical Association. Not surprisingly, 
States that have persons who are allowed philosophic 
exemptions, those persons themselves are at increased risk of 
disease because they are not immunized compared to the other 
    There is also a small increased risk that appears for the 
general population of those States, but it is not a major 
impediment to immunization coverage levels per se, since most 
States have rather low levels of philosophic exemptions by the 
time of school entry. It is usually in the single digit 
    Mr. Mica. Well, I thank our witnesses. Did you have any 
additional questions, Mr. Tierney?
    We have been joined by Mr. Towns, the gentleman from New 
York. Did you have any questions at this time?
    Mr. Towns. I have a couple, Mr. Chairman.
    Mr. Mica. Go right ahead. You are recognized.
    Mr. Towns. Let me also thank you for holding this hearing.
    Today it is fashionable, among teenagers in particular, to 
get tattoos and engage in body piercing, and also fraternities 
have fraternity brands. Knowing what you know about the 
transmission and effects of hepatitis B, what do you think 
about this trend from a health standpoint?
    Dr. Margolis. Well, anytime one puts a needle into their 
body, there is a potential for transporting blood-borne 
viruses. I had this discussion with this committee for 
hepatitis C and HIV.
    However, if you look at persons with acute disease where we 
do the surveillance to find out risk factors, we do not see 
this as a substantial risk factor. The potential is there and 
so we feel that if people choose to do it, they should do it 
    Mr. Towns. Don't you think we should be a little more 
aggressive about it in terms of getting information out, 
because nobody really talks about it? Colleges are doing it and 
they are doing it on university campuses. Don't you think some 
statement should be coming forth in terms of the possible risk 
    Dr. Margolis. Actually, the CDC has made that statement as 
the possible risk. In information about hepatitis C, there have 
been a number of health education materials from non-CDC groups 
that point out that potential. And as information--and about 
all blood-borne infections, that that potential is there. We 
    Mr. Towns. One other question. I am concerned about daycare 
workers. Are there any Federal guidelines which require daycare 
workers, who have close contact with children by changing 
diapers and all of those other kinds of things, be tested for 
or immunized against hepatitis B?
    Dr. Margolis. In a number of studies----
    Mr. Towns. By not doing this, are we jeopardizing our 
    Dr. Margolis. For hepatitis B, many studies have shown 
there is not transmission either from the child to the daycare 
worker or from daycare workers to children. And at the time, 
the occupational safety and health regulation about blood-borne 
pathogens was developed and implemented in 1991, this actually 
had been looked at and so that is not considered an 
occupational risk and it is really not considered a risk from 
the daycare worker to the child. And there have been a number 
of studies that have looked at that.
    And so again, while this is a blood-borne infection that is 
relatively easily transmitted, it has not been transmitted in 
the daycare setting.
    Mr. Towns. Let me ask you this. Do you have any other 
feelings of explanation for that if that is actually true?
    Dr. Margolis. Well, we know actually in the hospital 
setting that a transmission, again more likely because of 
needle sticks and those kinds of sharp injuries, goes from the 
patient to the healthcare worker. Transmission from a possibly 
infected healthcare worker does not go to the patient. So 
again, those blood exposures are rarely there, and they are 
even more rare in the daycare setting.
    Mr. Towns. I just think that for some reason we are not 
paying enough attention to prevention. I could be wrong. In 
fact, I hope that I am wrong, but I am willing to bet that I am 
not wrong.
    Dr. Margolis. I think now children--because of routine 
childhood immunization, most children in daycare are 
vaccinated. So the potential for transmission between children 
or from a child to a daycare worker would even be rarer than it 
already is.
    Mr. Towns. My other question is, are we requiring this 
daycare worker to be immunized?
    Dr. Margolis. Not against hepatitis B.
    Mr. Towns. OK, I have no further questions.
    I just think, Mr. Chairman, that really once we--if we 
stressed it at the beginning, I think we might be able to solve 
some problems later on.
    There is not enough information out. I think that is a big 
problem here. Once a person has hepatitis B or C, there is no 
treatment for it.
    Dr. Margolis. It is largely treatment through interferon 
treatments. With end-stage liver disease, a transplantation is 
required. So prevention is the thing.
    Mr. Towns. Let me ask a question, what is the difference 
between B and C?
    Dr. Margolis. Two different viruses. Both live in the 
liver, but two different viruses in terms of their outcome.
    Mr. Towns. Can I say that C is much more aggressive and 
much more devastating?
    Dr. Margolis. There are more people infected with C, but 
they are actually both equally aggressive.
    Mr. Mica. Thank you, Mr. Towns.
    We did hear today different instances about the effect on 
people's lives and some pretty dramatic testimony. You 
mentioned in your testimony about some studies that you are 
doing, and also I think you mentioned that the British and 
French have conducted studies.
    I have got a headline from an Associated Press wire story 
from October 1998. It says ``French Suspend Hepatitis B 
Inoculations,'' and it starts out, ``Faced with a potential 
health disaster, France has suspended hepatitis B vaccine 
inoculations of school children 4 years after mass immunization 
program began.''
    I am just wondering if you would like to respond to what 
the French have done.
    Dr. Margolis. What I would like to do is clarify what 
happened in France, and several of us were involved with the 
World Health Organization and close to that issue.
    The French did not suspend infant, adolescent, or adult 
high-risk hepatitis B vaccination. What they suspended was 
vaccination of teenagers in schools, and what they said was, 
you as a teenager should be vaccinated in your healthcare 
providers' office, not in the school. Often in the 
translation--that was not there in the early headlines, but 
that is in fact the policy in France.
    Mr. Mica. I hate to say this, Dr. Margolis, that raises 
even more questions because now we have taken--well, we have 
questions already about the infant adverse reactions based on 
several studies, and we will hear some more about that; but 
this raises a whole new area of concern about teenage 
vaccination and why one country would suspend that. And it 
sounds like you----
    Dr. Margolis. They did not suspend teenage vaccination. 
They suspended it in the schools. So the recommendation is 
still there, as we have in the United States, for routine 
vaccination of adolescents.
    What the French Minister of Health said is, go to your 
physician and have it done, do not come to the school and have 
it done. They did not do that because there were any data that 
showed that there was an association with adverse events.
    Mr. Mica. Well, I guess this is a hearing to be continued. 
We have gone on with this panel for some time. I will have 
additional questions that I would like to submit to you and ask 
that they be made part of the record, without objection. And if 
we have any other questions, we will submit them. We will 
dismiss you and thank you for your participation and call our 
third panel of experts on the subject.
    We have a series of doctors who will testify, including Dr. 
Samuel Katz, with the Infectious Disease Society of America; 
Dr. Bonnie Dunbar, a molecular biologist with Baylor College of 
Medicine. Dr. Burton Waisbren, Sr., F.A.C.P., and Dr. Barthelow 
Classen, president and CEO of Classen Immunotherapies.
    With our witnesses in place, I would like to welcome all 
four of you as experts on the subject at hand. I would remind 
you that we try to limit your oral presentation before the 
subcommittee to 5 minutes, and if you have a lengthy statement, 
we will enter it as part of the record.
    This is an investigation and oversight subcommittee of 
Congress and so if you don't mind, please stand and we will 
swear you in.
    [Witnesses sworn.]
    Mr. Mica. The witnesses have answered in the affirmative.
    We are going to recognize Dr. Samuel Katz who is with the 
Infectious Disease Society of America. Dr. Katz, welcome. You 
are recognized.

                        THERAPIES, INC.

    Dr. Katz. Thank you, Mr. Mica. It is a pleasure to appear 
before you and Mr. Towns and Mr. Tierney. I also have submitted 
a more lengthy statement.
    Mr. Mica. Without objection, that will be made a part of 
the record. And if people in the audience have conversations, I 
would like them to take them outside so we can hear the 
    You are recognized, Dr. Katz.
    Dr. Katz. I am Dr. Samuel Katz, a pediatrician who has 
spent the last 42 years of my life working to develop the best 
vaccines in the world to protect the health of infants, 
children, and adults. I was privileged to be one of the two 
scientists who developed the measles vaccine more than 35 years 
ago that has saved tens of millions of lives of children in 
this country and around the world.
    Today, I was invited to speak on behalf of the American 
Academy of Pediatrics, as well as the Infectious Diseases 
Society of America and the Pediatric Infectious Diseases 
Society, groups whose membership represent more than 55,000 
pediatricians and 6,000 infectious disease experts who take 
care of patients, do research and teach, and participate in 
public health in the United States.
    Parenthetically, I would add in relation to an earlier 
discussion, that I am currently a member of the Advisory 
Commission on Childhood Vaccines, the one that you discussed 
that was established by the 1986 National Childhood Vaccine 
Injury Act, and the membership consists of parents, attorneys, 
and physicians.
    Today, we are here to talk about hepatitis B, a 
particularly insidious disease, as you have heard, especially 
for children who acquire it within the first 5 years of life. 
Of those 25,000 hepatitis B-infected children, 30 to 90 percent 
are destined to acquire chronic hepatitis, which then leads to 
cirrhosis of the liver and liver cancer 30 to 40 years after 
they acquire the infection.
    However, we can prevent this disease with a vaccine that 
has been in use for more than a decade. It is effective and it 
is safe. It has been given to more than 500 million people 
around the world with the most striking results imaginable. The 
benefits of this vaccine are so impressive that more than 100 
countries around the world routinely administer it, and in 
those countries the incidence of cirrhosis and liver cancer due 
to hepatitis B has plummeted.
    It is important, Mr. Chairman, to note that everyone is at 
risk for this disease. No matter their age, their race, their 
lifestyle or their socioeconomic status. As you have heard, at 
least 30 percent of people who have the hepatitis B virus have 
no idea how they acquired it. It is far more contagious than 
the virus that causes AIDS, and in this country it causes at 
least 5,000 deaths each year.
    The vaccine, like all recommended vaccines, has gone 
through rigorous, exhaustive processes of testing for safety 
and effectiveness by multiple groups, both within and outside 
our government, as well as in countries abroad. The safety 
systems currently in place are highly effective, and we persist 
in assessment of the safety of the vaccine, continually seeking 
new ways to decrease any possible risks.
    Parenthetically, Mr. Chairman, let me note that some of the 
statements you may hear in the media border on the 
irresponsible. The statements are not based on solid scientific 
facts, and they serve to shake the public's trust and threaten 
to reverse the incredible gains that this vaccine has provided.
    When you heard from parents today whose children have 
acquired hepatitis B, you can be certain there is nothing they 
want more than to turn back the clock so they might have made 
this vaccine available to their children.
    Parents can continue to have the utmost confidence in their 
pediatricians and other health professionals and rest assured 
that they are focused solely on providing the best health and 
happiness for these children in recommending the vaccine to 
prevent hepatitis B.
    Let me add, in closing, that I am a grandfather whose eight 
grandchildren ages 2 months to 4 years have all received 
hepatitis B vaccines, as their parents and their pediatricians 
strive to assure them the best in healthy and happy lives.
    Hopefully, all American children will continue to receive 
these same benefits. Hepatitis B is a serious, often life-
threatening infection. The vaccine is both effective and safe. 
Pediatricians will continue to provide parents the most 
reliable information regarding all vaccines, including that to 
prevent hepatitis B.
    Time does not permit my answering many questions you may 
pose, but I will be happy to respond to any in the discussion. 
Thank you.
    [The prepared statement of Dr. Katz follows:]
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    Mr. Mica. Thank you. I recognize now Dr. Waisbren. Is that 
    Dr. Waisbren. Waisbren.
    Mr. Mica. Senior, FACP. Thank you.
    Dr. Waisbren. I would like to thank this committee for the 
opportunity to share with them my concerns regarding the 
vaccination policies of the Centers for Disease Control and 
Prevention and the Food and Drug Administration.
    I am a physician and clinical investigator who has 
practiced internal medicine, infectious diseases, and 
immunology in Milwaukee, WI, for 48 years. I am a member of the 
Infectious Disease Society of America, and I will point out 
that nobody asked me, as a member, my opinion about this 
subject. No ulterior motives or special interests are 
responsible for my being here.
    I am here because I feel an injustice has been done to the 
children of the United States. Included among these children 
are my 16 grandchildren. I want to make it clear from the onset 
that I fully support hepatitis B vaccination for individuals 
who have known risk factors for hepatitis B infection.
    My involvement in the field of vaccine toxicity began in 
1979 when I discovered that central nervous system 
demyelination as evidenced by multiple sclerosis had been cause 
in some individuals by the swine flu vaccine. My involvement 
was heightened when I found the same thing occurred after 
hepatitis B vaccination. Incidentally, everything I am saying 
is documented in this material that I'm going to submit.
    These findings have been confirmed by many others and have 
been extended to include other untoward reactions to the 
hepatitis B vaccine. Reactions include other autoimmune 
diseases such as rheumatoid arthritis, optic neuritis, 
postvaccinal encephalomyelitis, which one of the persons who 
talked to you has, and possibly juvenile diabetes which you 
will hear more about.
    An autoimmune disease is defined by the fact that it is 
caused by the body's immune system turning against its own 
tissue, be it the nervous system, the heart, or the cartilage. 
Since the discovery of the autoimmune aspects of vaccine 
complications and confirmation by numerous investigators, I 
have been searching the medical literature and studying a good 
number of patients to try to figure out the mechanism or 
mechanisms by which these autoimmune complications occur.
    While many explanations have been suggested, the exact 
mechanism is still unknown. However, this study of the medical 
literature of the patients and a great number of the reports 
sent to the Vaccine Adverse Event Reporting System [VAERS], has 
convinced me that a serious, probably unique, problem with that 
exists in regard to the hepatitis B vaccine.
    There are at least 16 articles in the peer-reviewed medical 
literature about the occurrence of diseases of autoimmunity, 
such as multiple sclerosis, after hepatitis B vaccination. The 
editors of these renowned medical journals in which these 
articles appear felt that these cases should be brought to the 
attention of the medical professions.
    There are thousands, yes thousands, of reports by health 
professionals to the VAERS that adverse events have occurred 
after hepatitis B vaccination. I am aware of dozens of cases 
brought against pharmaceutical companies because of damage due 
to the hepatitis B vaccination. Many of these cases have been 
settled out of court with the proviso that the settlements 
remain a secret.
    The fact that these well-established adverse reactions to 
the hepatitis B vaccine have not been acknowledged or are being 
denied by both the CDC and the FDA is the root cause of the 
concerns that I am to share with you now. The first concern is 
that caused by the experiment, not the strategy, sponsored by 
the CDC, which is designed to determine if vaccination at birth 
of all babies in the United States will eventually decrease the 
frequency of cancer of the liver caused by hepatitis B 
    To arrive at the end point of this experiment will take 
many years. This experiment is based on the following 
assumptions. One, the vaccine is safe and effective. While the 
vaccine is effective, we all know that no vaccine is entirely 
safe as evidenced by the above mentioned information.
    The second assumption: I have read that they say that 5 to 
20 percent of the people in the United States will eventually 
contract the hepatitis B infection. I doubt these statistics as 
I doubt many of the other statistics that have been presented. 
They mentioned up to 25 or 30 percent of patients with 
hepatitis B infection cannot remember where they got the 
    Isn't it understandable that people with risk factors such 
as multiple sex partners and injected drug use will not be able 
to pinpoint where and when they were exposed to the disease?
    The fourth assumption, and they repeatedly say this: There 
is no other way to control hepatitis B infection in the United 
States. Does anyone in this room agree that there is ever only 
one way to accomplish a purpose?
    I hope this committee will ask for an independent analysis 
of the rationales for the universal hepatitis B vaccination. In 
looking at the data, they should remember that the reports by 
the CDC are not peer reviewed and are reports, and that much of 
the data that is cited were given at symposiums sponsored by 
medical journals by invited speakers. Therefore they were not 
peer reviewed.
    This brings up my second concern, that is, how can an 
experiment such as universal hepatitis B vaccinations be 
adopted nationwide without congressional involvement or 
    Apparently this was accomplished by the joint efforts of an 
official of an agency that stood to gain much influence and 
power by the program and by an executive of a drug company 
which stood to make billions of dollars by the project. The 
references in that regard are available to you. What techniques 
were used and were conflicts of interest involved? Were the 
rights of parents and children infringed upon?
    My third concern lies in the fact that the FDA has 
apparently not been reacting to the many theories in the 
medical literature regarding the causes of neurologic 
complications of vaccination. The FDA does not ask if proposed 
vaccines exhibit molecular mimicry with human tissue, a 
possible cause of the difficulty.
    They do not ask if a vaccine exhibits complimentarity with 
common viruses that may be in the patients. Again, a possible 
explanation. They have not demanded that HLA patterns of 
patients who have untoward results be determined. This would 
react to the question brought up here today of who would get 
    They have not encouraged the development of synthetic 
vaccines that contain only immunogenic antigens and nothing 
else. I am very concerned that we may see the same or similar 
adverse reactions to new vaccines.
    The new Lyme vaccine is a case in point since that vaccine 
has more theoretic dangers than does the hepatitis B vaccine 
because of the autoimmune nature of the disease itself. When 
the material I have presented here is considered en toto, I 
believe that it indicates that the present universal hepatitis 
B vaccination experiment being conducted in the United States 
should be abruptly halted for the following reasons.
    It appears likely that serious untoward events, 
particularly of the nervous system, involve the vaccine. In 
view of this, is it reasonable to suppose that some babies who 
have little or no chance of getting hepatitis B will suffer 
unnecessary damage to their nervous system?
    Three, information regarding the risk-benefit ratio of this 
vaccine is not known and therefore cannot be given to parents 
in an informed consent.
    Four, there is some doubt as to whether the rights of 
babies are being violated when they are subjected to an 
experiment even with their parents' consent.
    France has already at least mediated their program of 
hepatitis B vaccine because of reports about multiple sclerosis 
following the vaccination. I hope this country will follow 
their lead. If not, I'm afraid that public confidence in our 
vaccination programs will decrease, and they are excellent as 
described by Dr. Katz.
    This would be detrimental to the excellent vaccination 
programs already in place in the United States. I would like to 
thank the committee again for allowing me to share my concerns 
with them. Documentation of all that I have said here is 
available in the supplemental material that I have given this 
committee. Thank you.
    Mr. Mica. Thank you for your testimony and that 
supplementary material will be made part of the record. Thank 
you. We will withhold questions until we have heard from 
    [Note.--Additional information provided by Dr. Waisbren may 
be found in subcommittee files.]
    [The prepared statement of Dr. Waisbren, Sr. follows:]
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    Mr. Mica. Next we will hear from Dr. Bonnie Dunbar, 
molecular biologist with Baylor College of Medicine. You are 
    Dr. Dunbar. Thank you, Congressman Mica, for your 
invitation to speak to this committee. I also have a full 
report and some documentation that I would like to submit.
    Mr. Mica. That will be made part of the record without 
    Dr. Dunbar. Thank you. I have been a professor at Baylor 
College of Medicine for approximately the last 15 years, but I 
have been working in vaccine development for 26 years.
    I will get to why I am going to be speaking here, but 
inasmuch as this is my first time addressing Congress and my 
time is limited, I have taken the advice of my lawyer, Mike 
Butler, who is a former chairman of the Federal Energy 
Regulatory Commission and who has testified on numerous 
occasions. He suggested I summarize the detailed report that I 
sent you and follow up with some questions.
    Mr. Butler and his wife are here at the hearing today, not 
as my legal counsel but as concerned grandparents whose 
grandchild was vaccinated with the hepatitis B vaccine against 
his mother's specific wishes and became subsequently vision 
    With respect to your first question, on the FDA VAERS 
reporting system and how it works, I have a few comments. I got 
involved in this issue about 5 years ago when I reported 
serious and permanent adverse reactions to the hepatitis B 
vaccine by two individuals working in my laboratory.
    One of those is my brother, Dr. Bohn Dunbar, who is 
currently disabled and has been acknowledged by over 12 
physicians to have permanent disabilities due to this vaccine. 
He could not be here today because of his serious reaction to 
one of his treatments.
    Despite the seriousness of these reactions, there has been 
no followup to my reports to the FDA adverse reporting system. 
I have also found that there is no scientific or official 
mechanism for research scientists studying these reactions to 
communicate with the FDA or to get adequate information.
    I did find out, however, that the thousands of reactions 
reported to the FDA show the overwhelming correlation with the 
reactions that I reported to the FDA. I have received hundreds 
of calls from patients and doctors now about their patients 
having similar reactions.
    What is interesting is that these reactions are also 
identical to the over 100 published reports of adverse 
reactions that are currently in the literature. Many of these 
are in excellent peer review articles, and I have submitted 
this for the committee's review.
    Finally, and I think a big concern, has come from 
communication with my former medical students. I have been 
teaching medical students basic sciences for over 15 years. A 
student told me in tears, on one occasion, that the supervisory 
physicians in the hospitals have told them not to report 
vaccine adverse reactions or to get involved.
    In one situation, two babies were dying and they were 
specifically told not to report it. I feel strongly that this 
reporting system needs to be improved so that we can have a 
greater impact on vaccine safety.
    With respect to the risk benefit issues of infants, you 
have heard much about this today and I won't reiterate. But 
from a scientific viewpoint, I challenge any of my colleagues, 
scientifically or medically, to claim that we understand the 
newborn immune system.
    Without detailed scientific studies to demonstrate vaccine 
safety, efficacy, and duration of protection for an adult 
behavior-associated disease, I find it hard to justify wide-
scale immunization. In fact, in our animal models, we can 
easily perturb the immune system of the newborn to cause 
adverse immune reactions.
    With respect to the CDC and pharmaceutical company 
interactions in conflict, I as well as other people here have 
overwhelming documentation on organizations receiving funds 
from drug companies, doctors carrying out clinical trials while 
being paid handsomely as expert witnesses and consultants for 
promoting the vaccine, doctors who have switched from being 
expert witnesses for the plaintiffs that were injured by the 
vaccines when they got paid more money to become an expert for 
the drug companies.
    Lobbyists have been paid simultaneously by healthcare 
organizations and drug companies. I recommend strongly that 
your distinguished committee investigate and evaluate these 
conflicts of interest, and I have documentation on that that I 
will be glad to provide you.
    Finally, with respect to the informed consent issue, many 
of our current and former medical school curricula do not 
emphasize details of immunology, a scientific field which has 
expanded tremendously within the past two decades. This 
expansion includes many of the scientific hypotheses which Dr. 
Waisbren just discussed. These could easily explain the 
autoimmune problems that are associated with genetic groups of 
populations in particular.
    They can also explain what has not been brought up today by 
any of the speakers, which I find surprising: the fact that 
many individuals--depending on the publication as many as 10 
percent, and in some reports 30 percent of people--don't even 
respond and make antibodies to this vaccine.
    Therefore, it may be that if we are not following up who is 
a nonresponder, we may not be affecting the incidence of the 
disease itself in some genetic populations.
    So in summary, no one, especially myself, would ever assert 
that the hepatitis B virus is not causing serious health 
problems in the world. However, if this or any other vaccine by 
nature of the proteins or the parts of that protein, native or 
produced from a recombinant cDNA protein, has the ability to 
adversely affect the immune system of large numbers of 
individuals resulting in severe adverse reactions, even if 
restricted to some genetic populations, then all of the public 
reaction to all vaccines including those that we don't have 
related adverse reactions will be doomed in the public's eye. 
This includes the development of vaccines to evolving airborne 
viruses that might become a serious threat to the world 
    Thanks to the success of the Government-funded Human Genome 
Project and advances in our computer programs, it may soon be 
possible to evaluate potential molecular structures to predict 
these problems with the vaccines in advance or in early vaccine 
    In addition to your investigation with adverse reactions to 
this vaccine, I would urge you to help provide research funds, 
which are certainly not available now, to study these serious 
and what appear to be very common adverse reactions to this 
vaccine as well as other vaccines. I thank you for your 
    [The prepared statement of Dr. Dunbar follows:]
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    Mr. Mica. Thank you for your testimony, and I now would 
like to recognize Dr. Barthelow Classen, president and CEO of 
Classen Immunotherapies, Inc.
    Dr. Classen. Thank you. I am going to talk about the link 
between the hepatitis B vaccine and the increased risk of 
insulin-dependent diabetes. Vaccine policy in the United States 
is based on safety followup of about 30 days or less, that is, 
the child is immunized and they are followed for about 30 days 
for the development of adverse reactions.
    We have been studying the long-term effects of vaccines, 
looking at the development of autoimmune diseases. In 
particular, our model is insulin-dependent diabetes, a model 
for other autoimmune diseases.
    This is some of our published peer review data. Shown here 
is a 60 percent rise in the incidence of diabetes in New 
Zealand following a massive hepatitis B immunization program. 
You would expect to see a large or significant rise in 
autoimmunity following an immunization program because vaccines 
are immune stimulants. They stimulate the immune system. And 
then when we expect it to cause a rise in autoimmunity, we see 
this as shown here.
    The CDC did some studies to verify our findings which are 
published. They found, in fact, in their small preliminary 
study, that hepatitis B immunization, when given after 2 months 
of life, was associated with almost a 90 percent increase in 
the incidence of diabetes, very similar to what we found in New 
Zealand, so confirming our studies.
    They also did some work to confirm another one of our 
studies showing that immunization starting early in life was 
associated with the decreased risk of diabetes, compared with 
getting it later in life. And in their study, they showed that 
the immunization before 21 days was associated with a decreased 
risk, compared to immunizations starting after 8 weeks of life.
    We are doing more studies on the hepatitis B vaccine, but 
we now have confirming data from other vaccines including the 
hemophilus influenza B vaccine, another relatively new vaccine. 
Shown here is one of our studies where we show the incidence of 
diabetes more than doubled in the United States following the 
introduction of the hemophilus influenza B vaccine in the 
Pittsburgh area.
    The FDA relies on the VAERS system as well as the Large 
Link Data base system to look for adverse reactions. Our 
studies, however, showed that vaccine induced diabetes may not 
occur until years following immunization as shown here from 
some data from Finland. The vaccine was given in the first year 
of life, but the extra cases of diabetes occurred many years 
later. As shown here, the red curve is higher than the yellow 
curve as extra cases of diabetes occurred later in life.
    Regarding risk benefits, we characterize this quite for 
hemophilus influenza B vaccine in Finland. We show that there 
are about three cases of diabetes for every child that would 
expect to benefit from the vaccine.
    The data is not as clear for the hepatitis B vaccine. We 
don't have as much data. It appears that there may be one case 
of death from diabetes for every life we save in the hepatitis 
B vaccine, from preventing hepatitis B with the vaccine. 
However, you have to remember the cases of hepatitis B are 
skewed into certain high-risk groups. So, in low-risk groups, 
the risk of diabetes, just one autoimmune disease, seem to 
exceed the benefit of the vaccine.
    Cost effectiveness studies do not involve vaccine-induced 
diabetes. We estimate that there may be 10,000 cases of 
vaccine-induced diabetes in this country every year costing 
over $10 billion a year, with cumulative liabilities reaching 
maybe $250 billion.
    Now, the U.S. law requires vaccine manufacturers to 
demonstrate safety prior to the vaccine being placed on the 
market. However, we have proven that safety has never been 
demonstrated for this vaccine, yet many kids are being forced 
to be immunized. We attribute this to conflicts in interest.
    Our proposal is that first of all, there needs to be equal 
access to the Large Link Data base. Scientists representing the 
parents as well as the established medical community need to 
have access to that Large Link Data base. There needs to be 
more testing on the effect of vaccines on diabetes and 
    Parents need to be aware of toxicity studies in animals and 
in humans linking vaccines to diabetes. Parents also need to be 
aware that funds are not available to cover many adverse 
reactions and the development of safer immunization technology 
that needs to be made a priority above developing new vaccines.
    Mr. Mica. Does that conclude your testimony?
    Dr. Classen. Yes.
    Mr. Mica. Thank you.
    [The prepared statement of Dr. Classen follows:]
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    Mr. Mica. Dr. Katz, you said that you felt there were some 
irresponsible statements being made, either in testimony or 
with this hearing. You have just heard several witnesses here 
testifying. Would you like to comment on anything they have 
    Dr. Katz. I hate to be put in a position of being a critic, 
but let me give you one example.
    Mr. Mica. Go right ahead. That's why we have you here.
    Dr. Katz. Thank you. Dr. Classen quoted all of these data, 
for example, from Finland. A meeting was held sponsored by the 
National Institutes of Health, including the physicians and the 
epidemiologists from Finland who had accumulated those data, 
including experts on diabetes, experts on vaccines, experts on 
immunology, experts on genetics.
    There was unanimous agreement that there was no indication 
whatsoever that there was any relationship of immunization to 
the onset of insulin-dependent diabetes mellitus. Dr. Classen 
was a participant in that meeting. If there was a vote, it was 
128 to 1, and he was the one.
    I am not one who is here to analyze Dr. Classen's 
presentation, but only to tell you that the government in the 
form of the NIH, and the CDC, the Vaccine Safety Institute of 
Johns Hopkins, the Infectious Disease Society's Vaccine 
Initiative, all put up the funds to sponsor that meeting.
    Everyone was given a chance to present, including Dr. 
Classen, and there was absolutely no support for his theory, 
his hypothesis. Hypotheses are fine, but you have to accumulate 
the scientific data to substantiate your hypothesis. At least 
with the diabetes data, Dr. Classen has failed to do that in 
the opinion of worldwide experts.
    Mr. Mica. I don't want to get into a debate, but I did want 
to hear your response on that. One of the things that you just 
mentioned is that we rely on data and the need to study and we 
had the CDC, Dr. Margolis, we had the FDA representative here.
    They said that they felt this whole matter about efficacy, 
about adverse effects and others, needs additional study. They 
said that there are some number of them going on, have been 
going on. I think they said seven, and additional. Do you 
support that continued review?
    Dr. Katz. Absolutely. I would be the last to say that there 
isn't information which we don't yet have regarding vaccines, 
regarding the etiology of autoimmune diseases, similarly to the 
multiple sclerosis question.
    The World Health Organization held meetings to discuss this 
very issue. They were attended by immunologists, neurologists, 
experts on multiple sclerosis, epidemiologists, 
vaccineologists. And they concurred that there was no evidence 
that multiple sclerosis was in any way related to the receipt 
of hepatitis B vaccine.
    Now, I would be very quick to say that if Dr. Dunbar or 
others have theories that they can put to scientific test, we 
should be supporting that type of experimentation. We don't 
ever have the ability to prove the null hypothesis.
    What we don't know today we may know tomorrow. I don't mean 
that we should be complacent, but until we have some 
scientific, concrete evidence to support these hypotheses, I 
don't believe that we should be taking actions based on these.
    Mr. Mica. In your written testimony, you said there is 
absolutely no need to set aside special funds for independent 
vaccine safety research, and you felt that there was also 
    Dr. Katz. I think that you are taking that out of context, 
Mr. Mica. What I was saying was that money that is set aside 
for safety research should be set aside through the peer review 
process; that if the NIH or others have grants submitted to 
them to make these investigations that----
    Mr. Mica. You felt that that was adequate----
    Dr. Katz. That they provide the peer review.
    Mr. Mica. Again, I don't want to take anything out of 
context, but do you feel there is adequate funding, adequate 
opportunity for research for this area? Or is this something 
that Congress is neglectful of and that warrants additional 
    The reason for this hearing isn't to scare anyone about 
vaccines. The reason is to find out if we are doing what we 
need to do. I have been in Congress since 1993. I have never 
had so many requests to be heard on an issue since I came to 
Congress. We merely try to respond and try to do it in a 
balanced fashion and then see if we are doing our job.
    So my question is, are there adequate funds? Are there 
adequate resources? Funds, believe it or not--the NIH is in our 
oversight responsibility and legislative responsibility. What 
do you think?
    Dr. Katz. It's always easy to sit outside of Congress and 
tell you how to spend your money. Let me say this: as a member 
of the Advisory Commission on Childhood Vaccines--that is the 
committee that is the oversight committee for the program, the 
National Vaccine Injury Compensation Act--we report directly to 
Secretary Shalala.
    There is an excise tax that that act put forth which is 
levied on every vaccine that is produced and distributed. That 
excise tax is used to accumulate the funds to reimburse 
families and children who feel that they have, under the 
judgment of independent medical review, that these are 
legitimate adverse events that have happened due to vaccines.
    Those funds are managed very wisely and very judiciously to 
the extent that there has now accumulated over $1 billion in a 
trust fund which is apparently inviolate unless you do 
something in Congress to make that available. Those billion 
dollars could very well be used to fund a number of studies 
such as those you are hearing requested today.
    Mr. Mica. That's your suggestion. Now, Dr. Dunbar, you were 
very specific in your testimony when you advocated additional 
studies and research and funding.
    Dr. Dunbar. Well, first of all, I would like to make two 
comments about the studies that we have heard about all day 
including those I think a lot of scientists are calling, the 
``phantom WHO meeting'' studies.
    For 5 years I have been asking questions of people and I 
have been quoting these studies. None of us scientists could 
get that data. If this committee could get that data for us, 
many of us would appreciate that. The other thing is that, in 
many of those studies, it has become a semantics game. For 
example, where everyone is saying that this is not multiple 
sclerosis. Most of these cases, thousands of cases, we are 
looking into are not MS.
    We have to look at the broad range of autoimmune diseases. 
Most importantly, from the grant funding point of view. I 
myself have been a standing member of NIH subcommittees and I 
am well aware of the politics right down the road here. When 
you send in a grant on this topic, it goes to one of the 
vaccine committees where everybody on the committee develops 
    Most of those people are working with the pharmaceutical 
companies. There is a great prejudice by many scientists on 
those committees against anyone saying anything negative about 
a vaccine. I believe strongly and so do my other colleagues, 
such as Ron Kennedy in Oklahoma and Willy Hildebrand, who is 
head of the National Bone Marrow Association Program, who are 
helping us, that funding is needed.
    Now, fortunately we have private funding for this. But I 
find it sad that we have to get private funding, and that 
government funding is not supporting this, particularly when 
there are so many vaccine mandates out there.
    Dr. Waisbren. May I just make a comment?
    Mr. Mica. Dr. Waisbren.
    Dr. Waisbren. I think we all agree there have to be more 
studies. But I think we have to admit that people like the 
vaccine advisory groups, the CDC, and the FDA have a conflict 
of interest. They have been pounding the drum for universal 
vaccination for 10 years, and they have made every attempt to 
denigrate results to the otherwise.
    They have used institutions, such as the Institute of 
Medicine, as their evidence that nothing has happened. I think 
that the hope would be that a committee such as yours would be 
able to have an independent investigation of the statistics 
upon which the universal hepatitis B vaccination experiment is 
based to see if you can believe that they are adequate by a 
statistical group that has no conflict of interest.
    Mr. Mica. Dr. Katz, we heard from some folks before in a 
panel, one lady in particular, who I think medically has been 
able to verify that through the vaccination she has suffered 
adverse reaction and it has caused some problems.
    Dr. Katz. Are you talking of Ms. Fluck?
    Mr. Mica. Yes. She has not applied to the fund account that 
was set up.
    Dr. Katz. I asked her husband why she hadn't.
    Mr. Mica. One of my concerns--and again I hope that we are 
not acting irresponsibly, but it's 13 years since we passed the 
legislation that provided compensation for those that are 
adversely affected. We have $1 billion in the funds, and we are 
getting complaints that people aren't getting compensated or 
feel that they have access to be compensated. That's one 
    The other problem is that they are saying they are having 
difficulty in determining the causal relationship and verifying 
that it is a result of the immunization.
    Maybe you could comment on this. Is the fund operating 
properly? And then the problem of getting access to the fund 
and verifying cases.
    Dr. Katz. I think it would be very helpful to you if you 
talked to the people who run the fund. The committee of which I 
spoke is actually called a commission, not a committee, and is 
chaired by a gentleman whose child was the victim of an adverse 
event. The parents who sit on that committee are all of that 
ilk. The attorneys who sit on that committee are the attorneys 
who pursue these cases on behalf of plaintiffs who feel that 
they have been injured.
    So, if it is a biased committee, it's biased in favor of 
those who feel that they have been adversely affected. There 
are only 3 of us out of 10 on the committee, actually 2 out of 
10, who are physicians. So it's not a physician-dominated 
committee. There is only one from the pharmaceutical industry 
on the committee, one representative. So the majority are the 
very people from whom you heard today.
    I would urge you to talk to Dr. Geoffrey Evans and Mr. Tom 
Balbier who are the two people who run that program. They issue 
a regular report every 3 months documenting the number of cases 
heard, the adjudications, and the awards made. I think that the 
program is working very well.
    There is one problem, and that is, sometimes people aren't 
aware of it. Every effort is being made to promulgate the 
information so that families who feel that they have had an 
adverse event will know how to file before this committee. They 
have cutoff the grandfather clause. It used to be that you had 
to report within X number of years. They have extended that to 
longer and longer durations so that families that hear about it 
late are not cutoff because it's too late. I don't want to bore 
you with all of this.
    Mr. Mica. No, that's exactly what we wanted to hear. We set 
up the fund and want to know if it was working.
    Dr. Katz. I think it is working wonderfully well.
    Mr. Mica. And you have made some changes that you described 
at length in the eligibility. You also cited through your 
testimony that the fund has accumulated more funds than 
anticipated, and one of your recommendations--and I don't want 
to take words out of your mouth--is possibly some of these 
funds could be used for research. Is that correct?
    Dr. Katz. That's exactly what I hoped to say, yes. I think 
that the issues relating to the whole area are reviewed 
regularly. Dr. Waisbren mentioned the Institute of Medicine. 
The Institute of Medicine isn't funded by the pharmaceutical 
industry or by any other conflict. It is part of the National 
Academy of Sciences, which you and Congress set up under 
Abraham Lincoln, a Republican President, to provide advice to 
the government about unbiased scientific issues.
    Mr. Tierney. I just thought that he and Abe were working in 
tandem at the same time.
    Mr. Mica. I know him well.
    Dr. Katz. That group is one that reviews regularly the 
issue of vaccine-associated adverse events. It's so strict in 
its membership that any of us, if you will, us in an editorial 
fashion, who work with vaccines can't be members of that 
committee because they don't want to have the bias that Dr. 
Waisbren feels is exerted.
    There are immunologists, there are epidemiologists, there 
are people who are knowledgeable about science but who aren't 
biased by being proponents of vaccines.
    Mr. Mica. I want to give the others an opportunity to 
respond. Dr. Dunbar.
    Dr. Dunbar. Well, obviously, I am not a lawyer and neither 
is my colleague, Dr. Katz, but there are clearly some issues on 
the Vaccine Compensation Act, and there are some lawyers in the 
room who I know can deal with that issue. One point is, I 
believe, there is some problem with the fact that after this 
summer, people who had the hepatitis B vaccine are going to be 
restricted from even filing. So, there clearly are some 
problems. I am not familiar with that, and I think that might 
be a good subject for a whole other hearing.
    Mr. Mica. Dr. Waisbren, did you want to comment?
    Dr. Waisbren. I just wanted to make one comment about the 
Institute of Medicine. I have gone over their material 
carefully. They have said often, we cannot prove that the 
vaccine causes any difficulty. They also mention that they 
can't prove that it doesn't. So the question is open.
    But time and time again, I hear people saying the Institute 
of Medicine says that the vaccine doesn't cause any trouble. So 
they cover themselves with the fact that they haven't proved 
that it does occur. All their study is, if you read in their 
books, is they have not proven that it doesn't hurt anybody.
    In view of that, I think that the jury is out. As far as 
the members of that committee, I beg to differ. I corresponded 
with them, and there are vaccine proponents in Seattle and 
other places in the country.
    Mr. Mica. Dr. Katz, I see you nodding.
    Dr. Katz. I keep prolonging this. The Institute of Medicine 
task force categorizes vaccine-associated injuries in several 
ways. One is what Dr. Waisbren has said, that is, that we can't 
prove that this is associated or not. Those are obviously the 
ones where a red flag goes up and where further investigation 
is needed.
    There are others where they say, yes, definitely. This 
association is correct. Thrombocytopenia after measles and 
rubella vaccine is an example. There are others where they say, 
we can state definitively there is no association. So, they 
don't just categorize things one way or the other. They have a 
    Mr. Mica. Thank you. I'm going to yield now to Mr. Tierney, 
the gentleman from Massachusetts, for questions.
    Mr. Tierney. Thank you, Mr. Chairman. Thank you to the 
members of this panel for their testimony. Let me ask generally 
just to get a feel for your opinions on this. Assuming there 
were studies or studying whether or not the hepatitis B vaccine 
might cause other types of issues or problems, are you all of a 
mind that we should stop giving this vaccine in the interim 
period while waiting for the results of these studies?
    Dr. Classen. I believe very strongly. I am a physician. I 
have been immunized with the hepatitis B vaccine, and in 
certain high-risk categories I agree with Dr. Waisbren that, in 
fact, it may have some utility.
    However, I think the forced immunization of children which 
is going on when, in fact, the risk may exceed the benefit as 
some of the data suggest, that again, I think there is a real 
problem there with forcing people to be immunized.
    Mr. Tierney. Thank you. Dr. Dunbar.
    Dr. Dunbar. I concur. I think there are some high-risk 
groups, particularly as we are looking into the genetic 
populations where in some particular parts of the world 
genetically, some people are more likely to have a reaction to 
the vaccine and others in other countries or parts aren't.
    But certainly for high-risk categories I see no problem. 
But we need to have more studies to find out who is going to be 
in the high-risk categories.
    Mr. Tierney. Thank you.
    Dr. Waisbren. I believe very strongly that my 
grandchildren, who aren't as yet sexually active or alcoholics 
or any of those categories, do not have a significant chance of 
getting hepatitis B. And I think that the data that suggest 
that they are, when you examine it, is not there.
    If, at the age of 12, they are wild, I would have no 
objection to them getting it. But to assume that they are going 
to have trouble these first few years of life I think is 
    Mr. Tierney. Just before I left Dr. Katz, are you saying, 
Dr. Waisbren, that those are the only people that can contract 
hepatitis B?
    Dr. Waisbren. I say that the figure of this 30 percent is a 
red flag that cannot be established. I think it is done by a 
questionnaire of people who are blood donors. I suggest that a 
statistician go over the paper in which the CDC claimed that in 
30 percent of hepatitis B cases, there is no evidence that risk 
factors are involved. The data in this regard appears to come 
from a questionnaire sent to hepatitis B patients in only four 
counties in the country. In my opinion, there is no credible 
evidence that what we call lateral spread of this disease 
occurs in any but extremely rare instances.
    Mr. Tierney. Thank you. Dr. Katz, could you respond to both 
of those questions?
    Dr. Katz. Obviously, I disagree with my three colleagues. 
Let me see if I can remember the questions. First of all, 
regarding the use of the vaccine in very young children: I 
think I find Dr. Classen inconsistent. On the one hand, he is 
saying we should give the vaccine before 21 days of age. We 
give it to newborns. That's well before 21 days of age! I don't 
know how that adds up. That's apples and oranges.
    Second, I think the issue of the 30 percent is a very real 
one. You heard one parent today. But that's only one parent. 
There have been very good studies to which Dr. Margolis 
alluded. In Alaska, children under the age of 10 have a very 
high rate of carrying the hepatitis B virus before they were 
sexually active. They had no injectable drugs. There were no 
apparent causes other than close living quarters where there 
were a lot of people who were chronic carriers.
    Since the institution of the hepatitis B vaccine program in 
Alaska, which is 1 of our 50 States, there has been no child 
under the age of 10 in the 10 years since that program has been 
in place in the seven villages that they monitored, who has 
acquired hepatitis B carrier state.
    I think that the vaccine as it is currently available and 
utilized is appropriate. I do not say that we shouldn't 
continue to study, but I think to halt the program at this 
point, which is eminently successful, would be a serious 
    Mr. Tierney. You mentioned, Dr. Katz, that the system to 
assure the vaccines are safe and effective is always improving. 
I think you said that during your testimony. What 
recommendations do you have to make to us about improving the 
system further?
    Dr. Katz. I think there is a vaccine branch of the National 
Institute of Allergy and Infectious Diseases of the National 
Institutes of Health. I think they have a vaccine study section 
to which Bonnie alluded. I think that an infusion of funds that 
were deliberately aimed and targeted--I know that you don't 
like to target funds at NIH--but if you spoke to Dr. Varmus and 
to Dr. Fauci and explained to them what you saw as to the 
severity of this problem, never mind its magnitude but just the 
severity of concern on the part of the people that we have 
heard today, that there has to be an acceleration of research 
aimed to investigate these hypotheses. Individuals who are 
proven investigators can conduct peer-reviewed research. Then 
you would get some further action much more rapidly.
    Mr. Tierney. Thank you. Dr. Dunbar, am I correct in 
understanding that you believe, or have a belief, that 
Caucasians may be susceptible to the side effects of the 
hepatitis B vaccine?
    Dr. Dunbar. We are actually doing some genetic studies to 
try to nail this on the head, as it were. But of the literally 
hundreds and thousands of people who have contacted me or 
doctors, so far they are all Caucasians.
    I feel that if this is just vaccine hysteria, we wouldn't 
be seeing this kind of relationship. And they are all of the 
same types of people that I am studying. In particular, of the 
hundreds we have, they were perfectly healthy and they took the 
vaccine and now they are debilitated for life.
    The other concern is not just the people that are having 
the adverse reactions. Dr. Katz has alluded to the group in 
Alaska where there is a high group of chronic carriers. We also 
know in Asia, where a lot of the clinical trials were done, you 
don't see adverse reactions. But this is a different population 
that we know ``genetically'' responds differently to the virus 
    In fact, another point that was not brought out today is 
that 95 percent of the people that get the virus don't even 
have the flu or don't even know they are sick. So a lot of 
people respond normally without having any long-term side 
    What we don't know about the whole vaccine itself, which 
Mr. Mica referred to this morning. We don't know a lot about 
why the different genetic populations respond differently with 
respect to the disease itself, let alone why the people with 
adverse reactions that we are seeing are responding with 
respect to the genetics. It was curious to me at the Institute 
of Medicine meeting at which I was invited to speak that, when 
we asked about all of these new studies that are being done, I 
said ``great,'' we have the genetic data so we can break this 
out. They said, oh, no, we can't ask those questions.
    So even though these studies are ongoing, we are not going 
to get the data we need. We need to have those studies where we 
can take into account the genetic populations in what we are 
seeing. So from what I could see of what they outlined at the 
Institute of Medicine, the studies that are in the works or are 
being planned are not going to be sufficient to evaluate these 
serious adverse reactions.
    Mr. Tierney. Thank you. In the testimony there was 
reference to a molecular mimicry hypothesis. Could somebody 
there explain to me the relevance that that hypothesis has to 
the hepatitis B vaccine safety?
    Dr. Waisbren. When you look back as we developed--and I 
will try to make this brief--is that all living things have 
certain proteins that are of advantage to them whether they be 
viruses, bacteria, or humans.
    So we have to assume that certain proteins are held in 
common by humans and bacteria and viruses. If those proteins 
are similar enough, when you inject a virus into a person the 
body will mistake that protein for itself and make antibodies 
or T-cells against the body itself, rather than the proteins in 
the virus.
    It has been shown that in the hepatitis B virus, for 
instance, there is molecular mimicry between myelin, which is 
involved in multiple sclerosis, and the hepatitis B vaccine.
    There are studies that should be done and have been done by 
the people of Harvard in which if you give a vaccine, you can 
find out whether or not antimyelin T-cells are circulating. 
This would be one easy way of studying vaccine toxicity. I 
recommended that to the Institute of Medicine 3 years ago at 
one of their meetings, and it just fell on deaf ears. So those 
sorts of things should be done.
    Mr. Tierney. Thank you.
    Dr. Classen. Can I add one point, though? Molecular mimicry 
is only one hypothesis. In fact, there are probably several 
mechanisms of reactions. We are seeing increases in diabetes 
with many different vaccines which suggest that, in fact, there 
are other mechanisms as well.
    Just giving Interferon, plain Interferon, to patients who 
are diseased increases the risk for autoimmunity including 
diabetes. Vaccines are known releasers of Interferon. So just 
by generally stimulating the immune system you would expect to 
see a wide range of autoimmune diseases following immunization.
    Mr. Tierney. Thank you. Dr. Katz, would you like to say 
    Dr. Katz. I was only going to say that there is no doubt, 
as Dr. Dunbar has pointed out, that there has been enormous 
advance in the field of immunology. There are now very large 
grants from the National Institutes of Health to diabetes 
centers around the country to look at the question of 
autoimmunity and what are the inductive factors.
    In other words, diabetes, childhood juvenile diabetes, 
insulin-dependent diabetes may be an autoimmune disease. What 
is not understood is what is the trigger that sets off that 
autoimmune disease.
    We are being besieged day and night by things that you 
inhale, by things you ingest. It isn't just what you inject 
with a vaccine. There are all sorts of proteins and 
carbohydrates, all sorts of antigens to which you and I are 
subject day and night.
    To single out vaccines as the only target is being somewhat 
parochial. I assure you that these study programs that the NIH 
is now funding on diabetes will be looking at vaccines, at 
acquired infections and many other possible stimuli. To date 
there is no evidence that vaccines are the culprits.
    Mr. Tierney. Thank you.
    Dr. Waisbren. There have been official pronouncements by 
the National Diabetes Association and by the Multiple Sclerosis 
Society that juvenile diabetes and multiple sclerosis do not 
occur after the hepatitis B vaccination. You wonder what 
influences these national organizations to make these 
statements in view of information discussed here and in the 
world literature.
    Dr. Dunbar. Just one quick comment, if I may. My medical 
student who has just taken her exam and is graduating today 
said that they had to learn an answer for the exam this year. 
The question in the study guide was, ``what is the safest 
vaccine ever made?'' and the answer was the hepatitis B 
    So it's already infiltrated. Even without saying we haven't 
done these studies, the medical students are already being told 
in their minds that this is the safest vaccine ever made, yet 
we don't have any long-term followup clinical trials.
    Dr. Classen. I would like to make one point. I submitted 
additional testimony, written testimony, which I hope you will 
accept, and also I hope that you will look into the conflict-
of-interest issues, as well, as described in my testimony.
    [The prepared statement of Dr. Classen follows:]
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    Mr. Tierney. Thank you. Thank all of you.
    Mr. Mica. Thank you. Dr. Katz, I have a question. In your 
testimony you said that hepatitis B--and I think I wrote this 
down--is far more contagious than AIDS?
    Dr. Katz. HIV, the virus that causes AIDS, absolutely.
    Mr. Mica. I am not a scientist. I am just a Member of 
Congress and it is pretty scary, isn't it? I just wonder. We 
had Ms. Hahn here. She has hepatitis B. She lives with her 
husband and four children and yet none of them tested positive.
    I'm not sure if that same thing would happen with AIDS. 
Maybe it would. I don't know.
    Dr. Katz. I think that it's inappropriate to compare HIV 
and hepatitis B. I was only using that as an example of the 
contagiosity of hepatitis B. HIV is much more constrained in 
the way that it is passed by blood, by semen, by sexual 
encounter, by injectable drugs.
    Hepatitis B, I was trying to point out, doesn't need any of 
them. I think it was Ms. Hahn who pointed out how long the 
virus survives if you spill it on a table top. HIV is very 
fragile. In a very short period of time if you were to have an 
accident, it is no longer infectious. That was the gist of what 
I was trying to express.
    Mr. Mica. I'm not trying to put you on the spot, just a 
layman's question.
    Ms. Hahn. I will answer that. I praise the Lord.
    Mr. Mica. Maybe that has something to do with it, too. The 
other thing is based on the information that you all have. Do 
you think that we should provide additional warnings of adverse 
potential reactions based on your knowledge, Dr. Katz?
    Dr. Katz. I was a little bit chagrined and disappointed in 
listening to some of these presentations. Not in the 
presentations, but in what was said about physicians who had 
administered vaccines. We are required to provide the so-called 
vaccine information statements to parents and guardians or 
individuals who are old enough to read them for themselves.
    If physicians are failing to do that, then we have failed 
in getting the message across to them that this is important. 
Those statements are clear. They do outline both the benefits 
and the risks of the vaccine, and they should be given to 
parents before they even bring their child in so they have time 
to digest this at home and not in the rush of 5 minutes in the 
waiting room of the office.
    Dr. Dunbar. But these vaccines are being mandated. They are 
even being given by schools and school nurses. Once it's 
mandated by the States, you take away that liability.
    Dr. Katz. They cannot give them in school without the 
parents' permission.
    Mr. Mica. Again, is there adequate notice regarding the 
possible adverse effects, Dr. Waisbren?
    Dr. Waisbren. I would say that the fact is that the vast 
majority of babies are immunized in the hospital without the 
parents being consulted. This is based on my personal 
experience with my patients, my grandchildren, and so on.
    I think that one of the solutions to advising parents is to 
make their physician become responsible for any adverse 
reactions that happen even in the hospitals. They say, well--
the American Association of Pediatricians or someone said that 
it's OK, so it's OK.
    But I think if doctors have to take the responsibility for 
adverse results that perhaps they will look into the 
possibility and warn their patients more adequately.
    Mr. Mica. Dr. Classen, I didn't give you an opportunity to 
    Dr. Classen. Yes. I think absolutely more warning needs to 
be made, both in animal toxicity studies. You have a lot of 
epidemiology data and people who are always going to say, well, 
maybe it's not the causality.
    But animal toxicity data, I think, is crucial; and there is 
a lot of animal data, for example, with vaccines on different 
autoimmune diseases that they can exacerbate it. In that case 
it's clearly that the vaccines are causing and exacerbating 
autoimmunity in animals.
    I think that the parents should be warned of that. I do 
believe that there is a real problem with physicians not 
notifying the patients. I had one classical example where I saw 
a patient with a vaccine adverse reaction. I didn't immunize 
the child. It was clear to me it was a vaccine adverse 
reaction. It was shingles following the chicken pox vaccine.
    So I sent the patient back to the physician who had 
administered the vaccine for followup; and the physician who 
followed up, who administered the vaccine, denied that it was a 
vaccine adverse reaction. The parent had to go to a third 
physician to verify my diagnosis. And even when the result was 
overwhelming, the physicians want to avoid liability by never 
admitting they could have possibly harmed a child.
    I think this is a big problem. This is probably why vaccine 
adverse reactions are not reported to VAERS, because the 
physician doesn't want to admit that they may have harmed one 
of their patients.
    Dr. Katz. But under the National Vaccine Injury 
Compensation Program the physician is not liable. That's the 
whole point of the program, to take it out of the adversarial 
position of having to sue in a tort system. If the case is 
presented, it is sent to the Vaccine Injury Compensation 
    They have experts, whether they are neurologists or 
epidemiologists or pediatricians, depending on the particular 
type of case. They review it, and it is presented to a master. 
There is not the controversy. That was the whole point--not the 
whole point, but one of the points of the whole act, to take it 
out of the tort system and put it into something where parents 
and children would be treated fairly, whether they could afford 
a lawyer or not and whether they could get into the court 
system or not.
    Dr. Waisbren. This is the fatal error in your bill, if you 
will pardon me for telling you.
    Mr. Mica. It wasn't my bill. Mr. Waxman.
    Dr. Waisbren. Your brother's bill. The point is, when you 
take the responsibility away from the doctor and the hospital, 
the doctor is not forced to really think the thing over and he 
says, ``It's not going to hurt me.''
    I would suggest that the bill be kept in, but that it 
should be clearly stated that the person could go to court. And 
I think it is in the bill to get justice if he feels the system 
did not work correctly.
    Mr. Mica. Dr. Katz is determined to get the last word in.
    Dr. Katz. Thank you, Mr. Mica. The physician is liable if 
what he commits is an act which is not within the 
recommendations of his State, his vaccine program. So that the 
physician can be sued if he has transgressed what is the 
recommended approach.
    On the other hand, the idea that the system allows the 
physician to get off stark free is inappropriate. If the case 
is heard before the Vaccine Injury Compensation Board and 
rejected, the family still has recourse to the tort system. It 
is just that they have to go to the compensation program first.
    Mr. Mica. I want to thank each of you for your testimony 
today. We have tried to conduct this in a responsible fashion. 
We have heard from representatives from the CDC, we have heard 
from representatives from the FDA. We have heard from Dr. Katz 
who is representing several very prestigious organizations. And 
we have heard from others.
    However, I do want to announce that I will keep the record 
open for at least--I'm going to keep the record open for 30 
days, which is unusually long, for additional information. I 
know there are some controversial matters in this, but we want 
to make certain that the record is complete and balanced, and 
that we hear from folks.
    The reason for this hearing is not to excite anyone or as I 
said at the opening, to discourage anyone from vaccinating 
their children or anything of that sort. It's to, one, review 
the entire process. The law was passed in 1986. I wasn't here. 
I didn't pass the law. I didn't author the law.
    Once every 13 years we may look at these things whether we 
need to or not and then responsibly see that we are doing our 
job. Is the proper research being done? Is proper notice being 
given? Is the system working?
    And then also to hear from citizens. When a certain number 
of citizens want to be heard in a congressional process--and we 
do oversee the FDA and the CDC and MOPP--we have that 
    Without objection, I will leave the record open for 30 days 
for additional testimony or for input for the record. I thank 
each of you for your testimony today and excuse you at this 
time. Thank you.
    We have one final panel. That panel consists of Thelma 
Thiel, chairman and CEO of the Hepatitis Foundation 
    We also have Barbara Loe Fisher, president of the National 
Vaccine Information Center. This is our fourth and final panel 
today. I would like to welcome both of our witnesses.
    As I mentioned to our previous panelists, this is an 
investigation and oversight subcommittee of Congress. We do 
swear in our witnesses which I will do shortly, both Ms. Thiel 
and Ms. Fisher. We also ask that if you have a lengthy 
statement or additional information that you would like made 
part of the record, we will do that upon request. I would also 
ask you to limit your oral testimony to approximately 5 
    Again, I am pleased to welcome both of you, and if you 
could stand at this time and be sworn.
    [Witnesses sworn.]
    Mr. Mica. The witnesses answered in the affirmative and I 
am pleased to welcome to our subcommittee today our witnesses. 
First of all, we will hear from Thelma Thiel--I hope that I am 
pronouncing it right--chairman and CEO of the Hepatitis 
Foundation International. You are recognized.


    Ms. Thiel. Thank you, Mr. Mica, for giving me this 
opportunity to share our concerns with you. I am representing 
50,000 victims of hepatitis in this organization, plus 300 
support groups with thousands of people who are concerned about 
this disease.
    I am also a registered nurse who lost a precious 4-year-old 
son 29 years ago to cirrhosis. I thought I would like to share 
with you some of the things that he endured with his cirrhosis.
    Because his liver was so badly damaged, even a bloody nose 
was a hemorrhage. When he tripped over a toy, he broke his hip, 
not once but twice. His tummy was terribly distended because he 
had an enlarged liver and spleen and excess fluid.
    His little arms and legs were scrawny because he couldn't 
metabolize proteins to build muscles. He was extremely 
jaundiced, almost to the point of looking green, but worst of 
all, he itched from head to toe, night and day.
    Can you imagine being in a body cast with a fractured hip 
and itching constantly? He asked me one day if I could take his 
foot off because it itched inside.
    Most people don't know that the liver is their internal 
chemical power plant, a very complex and noncomplaining organ 
that detoxifies everything that we eat, drink, breathe, and 
absorb through our skin. It helps us digest our food, stops 
cuts from bleeding and fights off infection. It makes hormones 
and muscles and maintains over 5,000 vital functions to keep us 
alive and alert.
    When this hepatitis virus gets into the blood stream 
through an open cut, a scratch, or a puncture with a 
contaminated sharp needle or an instrument such as those used 
in body piercing or tattooing that was previously used by an 
infected person, even in an abrasion of the mucus membrane or a 
splash of blood in the eye that could happen in the dentist's 
office, this virus makes its way to the liver.
    It quietly kills liver cells replacing them with scar 
tissue which is called cirrhosis. This virus can continue to 
assault the liver until there are so few good healthy liver 
cells remaining that the impact on body functions and healthy 
problems is devastated.
    I had a woman who called me because she had two children. 
She needed to put them in a daycare center. One of them had 
hepatitis B. When she told the daycare center, they wouldn't 
allow her to enter the child in the school.
    This mother had to go to work; and it was important that 
she get this child in daycare. She went to another daycare 
center, and didn't bother to tell them that the child was 
    Now, every time that child gets a bloody nose or scratch, 
everyone in that daycare center will be exposed to this 
insidious disease.
    I had a call the other day from a father who was very upset 
about his 13-year-old son, Rob. He had developed a severe case 
of diarrhea. There had been an E. coli outbreak, and he took 
him to a hospital. They did a thorough examination and found 
out that he had hepatitis B. He also had advanced cancer of the 
liver at the age of 13.
    The father was terribly distressed, however, because he 
wanted to know whether his child who was on the wrestling team, 
might possibly have infected other children. Occasionally they 
get bloodied up during a wrestling match. We advised him to 
tell the school. We also found out that his mom had hepatitis B 
and was a carrier and did not know it.
    Unfortunately, Rob had not been vaccinated at time of 
delivery. He had no signs or symptoms for 13 years with the 
potential to infect other children and now he was facing death.
    Hepatitis B is an insidious disease often called a silent 
killer largely because the liver is a noncomplaining organ. 
Individuals can have serious liver damage without any signs at 
all. With the estimated one and a quarter million carriers of 
hepatitis B in this country, how many of them are sitting in 
the classroom with your child or your grandchildren?
    Could a cut finger or a smear of blood on a page in a book 
shared with a classmate be a threat to your child? A little 
known fact is that the only treatment available for hepatitis B 
is chemotherapy. I can't imagine the guilt I would feel if my 
child became infected when he could have been vaccinated. If 
infected, he would have to go through chemotherapy given by 
injection for 6 months to a year, with only a 40 percent chance 
that he would have a positive response.
    If the treatment fails, they can develop cirrhosis and 
cancer of the liver, going through many of the horrible things 
that my son went through. The other option, of course, is a 
liver transplant. However, organs are in very short supply, and 
we also know that the virus that remains in the body attacks 
the new liver with a vengeance.
    Researchers are trying desperately to develop ways of 
controlling that virus, with limited success this process is 
very costly.
    Losing a child to an incurable liver disease is a heart-
wrenching tragedy, but I can't imagine the overwhelming guilt 
that I would feel if my child became infected and I had had an 
opportunity to protect him and didn't.
    We who are well informed are aware of the risks that 
children can take. We don't always know when they are going to 
become sexually active. We have heard about children doing body 
piercing in the back room. We don't always know what risks they 
are taking. Many are not informed because there has been very 
little education to encourage our children to take 
responsibility for their own behaviors. Often their parents are 
    We have a long way to go, and we are depending on you to 
make certain that you weigh the scientific facts and the lives 
that will be saved by this vaccination against the 
unsubstantiated reports that we have heard today. Thank you for 
giving me this opportunity.
    Mr. Mica. Thank you for your testimony.
    [The prepared statement of Ms. Thiel follows:]
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    Mr. Mica. And we will now hear from Barbara Loe Fisher, who 
is president of the National Vaccine Information Center. You 
are recognized.
    Ms. Fisher. Thank you, Mr. Chairman. My name is Barbara Loe 
Fisher, and I am president of the National Vaccine Information 
Center, formerly known as Dissatisfied Parents Together, which 
I cofounded in 1982 with parents whose children had been 
injured or died from the adverse effects of the DPT vaccine.
    Our nonprofit organization represents tens of thousands of 
Americans, including families affected by vaccine reactions, 
healthcare professionals, and parents. We are working to 
prevent vaccine injuries and deaths through public education 
and to institute safety and informed consent protections in 
vaccination programs.
    Some of us worked with Congress in the early 1980's in a 
bipartisan effort to help create and pass the historic National 
Childhood Vaccine Injury Act of 1986. One of our main goals was 
met in 1996 when a less reactive pertussis vaccine was 
    I want to thank you, Representative Mica, for having the 
courage and the vision to hold this hearing. As you have heard, 
vaccine safety is an issue charged with emotion because whether 
death or disability is caused by a disease or a vaccine, the 
pain is the same. And when children are suffering and their 
parents are grieving for them, there are no words to make the 
pain go away.
    I think what is important at the end of the day is to 
acknowledge that we are all here because we love our children 
and we want to protect them from harm. We need to find ways to 
protect them from vaccine injury and death while we create 
public health policies designed to protect them from the 
ravages of disease.
    There is no reason why we cannot accomplish both of these 
goals if we embrace the principle that every child's life is 
important and no child is expendable.
    The National Vaccine Information Center has received 
hundreds of reports of injuries and deaths following hepatitis 
B vaccination. There is a clear pattern to hepatitis B vaccine 
reaction symptoms, just as there was a clear pattern associated 
with the DPT vaccine reactions, but unlike DPT vaccine where 
most symptoms usually occur within a few days of vaccination, 
hepatitis B vaccine reaction symptoms can take many days or 
weeks to develop and include fevers that come and go, open skin 
lesions and rashes, severe joint pain and head pain, loss of 
vision, muscle strength and memory and crushing, debilitating 
fatigue which leads to chronic disability.
    We have had reports of liver cancer developing in small 
children following hepatitis B vaccinations. There are families 
with two or three members who have become disabled after 
hepatitis B shots. Tragically, for newborns and babies under 2 
months of age, a hepatitis B vaccine reaction can end in death.
    When parents look to the medical literature for answers, 
they find few studies looking into hepatitis B vaccine reaction 
reports. None deal with newborns. Most of the studies look at 
vaccine efficacy, not vaccine safety.
    A 1994 study by the Institute of Medicine, mandated by 
Congress under the National Childhood Vaccine Injury Act, found 
that there have been no large controlled observational studies 
or clinical trials investigating clinical reports of arthritis, 
Guillain-Barre Syndrome, transverse myelitis, optic neuritis, 
multiple sclerosis, and other central demyelinating disease or 
sudden infant death syndrome after hepatitis B vaccination.
    What, then, will be the scientific criteria used to either 
award or deny children compensation for their hepatitis B 
vaccine-associated injuries under the Federal Vaccine Injury 
Compensation Program?
    Serious questions remain about the quantity and quality of 
the scientific evidence used by Federal health agencies to 
license this vaccine for use in children and, in 1991, to 
recommend that all newborns receive their first dose just 12 
hours after they take their first breath.
    Last Tuesday, I filed two detailed Freedom of Information 
Act requests with the FDA and the CDC to make this information 
a matter of public record. We hope this will lead to better 
public understanding of current standards used to license this 
first recombinant DNA vaccine and then recommend all newborn 
infants and children be required to use it. I will provide 
copies of what I receive from the CDC and the FDA to you, and I 
submit my FOIA requests as part of the record.
    Families with vaccine-injured children are trying to cope 
with the knowledge that they tried to do the right thing. They 
did what public health officials and doctors told them to do. 
Most of these children were exceptionally bright, healthy, and 
robust at the time of vaccination.
    They received a hepatitis B shot, and something went 
horribly wrong. In some cases, they were coerced into having 
more hepatitis B shots, even in the face of severe reactions 
because the push for a 100 percent vaccination rate has all but 
eliminated the right to informed consent when it comes to 
vaccination in America.
    This information sheet on hepatitis B produced by the 
Centers for Disease Control in compliance with safety 
provisions in the National Childhood Vaccine Injury Act does 
not come close to meeting the informed part of informed 
    Parents who want to make educated hepatitis B vaccine 
decisions for their children often are threatened when they 
even ask to delay vaccination if the child is sick. The lack of 
informed consent protections in mass vaccination programs is 
leading to fear and mistrust of the whole vaccination system.
    Bottom line, what we are hearing parents tell us is: show 
us the science and give us a choice. So we come before you 
today to ask for, first, an investigation into Federal health 
agency licensing and policymaking standards applied to the 
recombinant hepatitis B vaccine; and, second, consideration of 
special congressional appropriations to fund nongovernment, 
nonindustry conducted scientific research to identify genetic 
and other high-risk factors for reacting to hepatitis B 
vaccine; and, third, the institution of informed consent 
protections in current vaccine policies.
    Again, thank you, Chairman Mica and members of the 
committee, for demonstrating leadership by acknowledging these 
vaccine safety concerns, which is the first important step 
toward addressing them in a way that will save lives. You have 
listened and we are very grateful.
    [The prepared statement of Ms. Fisher follows:]
    [GRAPHIC] [TIFF OMITTED] T3308.185
    [GRAPHIC] [TIFF OMITTED] T3308.186
    Mr. Mica. I thank both of you for your testimony.
    Ms. Fisher, you just testified that you felt the vaccine 
information sheets handed out on hepatitis B are inadequate as 
far as disclosing risks and benefits. What more can we do, or 
what more should we do, or what information should be included 
would be my first question?
    The second is, there are 16 States now that do allow sort 
of an opt-out. How would you go about changing that since you 
have a State-to-State requirement?
    Ms. Fisher. First, I would just like to read that the mild 
problems that are listed on this are soreness at the 
injectionsite and mild to moderate fever. The only severe 
problems listed are serious allergic reaction, and it says very 
    There is no description here of the kinds of symptoms that 
we have heard today.
    Mr. Mica. As far as severe, that is all that is on there?
    Ms. Fisher. Right. Serious allergic reaction they say is 
very rare. They describe serious allergic reaction as 
difficulty breathing, hoarseness, et cetera, which are symptoms 
of anaphylaxis. Anaphylaxis occurs within a very short time 
period after a vaccination is given.
    So the people who testified today, who told you about these 
symptoms, they would be candidates for revaccination according 
to this vaccination sheet; and, in fact, this is part of the 
    We have heard from so many people who are being forced and 
threatened that they have to go forward with hepatitis B 
vaccinations, even after they have experienced fevers that come 
and go, skin lesions all over their body, severe joint pain, 
symptoms that--autoimmune symptoms and neurologic symptoms, and 
they are being ignored.
    Because there is this push for a 100 percent vaccination 
rate, these people are not being screened out. And they are not 
being given full information, and the doctors are not being 
given full information about what to look for after a hepatitis 
B vaccination.
    The manufacturers, frankly, in their product insert, have 
more of a description about some of the reactions that have 
been associated with the vaccine than this sheet.
    What I am concerned about, this sheet was mandated under 
this compensation program, and we fought very hard--the parents 
who were involved in the creation of the system, of which I was 
one, fought very hard for the safety provisions.
    And one of the safety provisions was that parents would get 
proper benefit and risk information prior to vaccination so 
they would know how to make informed decisions and also so they 
could monitor their children following vaccination for signs of 
a reaction so that revaccination would not take place and more 
serious reactions would occur that would end in disability and 
death; and we feel this is woefully inadequate.
    Mr. Mica. Ms. Thiel, do you want to respond?
    Ms. Thiel. Physicians have access to the drug insert. If 
they are giving the vaccination, they should be aware of those 
    Also, the CDC puts out a publication called MMWR which 
identifies the fact that there should have been informed 
consent. There has been a great deal of effort on the part of 
the hepatitis B immunization programs and on the Internet to 
identify the fact that they should be asking the parents to 
sign consent forms.
    The Hepatitis Foundation International created a booklet 
that would go home with the consent forms to identify the 
importance of the liver, the importance of the vaccine, and 
some things parents should be concerned about. This has been an 
effective way of informing the parents of the benefits of the 
    Mr. Mica. What about the question of inadequate research 
that has been raised here today? Do you all have a position on 
that, Ms. Fisher?
    Ms. Fisher. First of all, there are two kinds of research 
that need to be done: basic science research that will look at 
biological mechanisms for hepatitis B vaccine-induced injury or 
death, which would include looking at what happens at the 
cellular and molecular level in the human body after the 
vaccination is given.
    The other concern is that this vaccine is often given with 
other vaccines. Part of my Freedom of Information Act request 
is that the CDC and the FDA go over the different studies that 
we would like to see that hopefully were done before this 
vaccine was recommended in 1991 for universal use in all 
children, particularly newborns. That would include such things 
as how many children were involved in these studies, the time 
periods for followup of vaccine adverse events. In the 
manufacturers' product insert, they list 4 to 5 day followup 
for studies that were used to license this vaccine, and yet the 
reactions we are seeing are taking sometimes longer than 4 to 5 
days to occur. So have we missed in those studies, all of the 
people who testified here today? How good are those studies? 
Did they include racial diversity of infants and children 
enrolled in them?
    Particularly in light of what Dr. Dunbar said, if we have 
genetic predisposition here, if there are certain genotypes who 
are more susceptible to reacting to this vaccine than others 
and we have only done these studies in certain genetic 
populations, we don't really know what is going on. And when we 
give this vaccine and we mandate it and we haven't done the 
studies prior, it is an experiment and we cannot afford to do 
    I think the FOIA requests are important to take a look at--
how was this vaccine licensed and policy made? But also, is the 
system that we use good enough or should we be raising these 
    Mr. Mica. Ms. Thiel, has your group taken a position as far 
as opting out of these vaccinations?
    Ms. Thiel. We feel very much if a person has an objection 
to being vaccinated, they have that right. Of course, it is 
going to be a problem if you get a lot doing that. You are 
going to have more exposure to other children if they are not 
    Mr. Mica. But your group has basically supported the opt-
out ability?
    Ms. Thiel. Right.
    Mr. Mica. One of the other questions that has come up in 
this hearing and also prior to the hearing is a review of the 
1986 law and the access to compensation through that law for 
those who have some type of vaccine-related adverse reaction.
    You were involved in some of that, the development of that 
legislation, and I guess of monitoring, Ms. Fisher?
    Ms. Fisher. Yes.
    Mr. Mica. How do you feel about how that is working?
    Ms. Fisher. We are extremely disappointed in how this 
compensation program is being implemented. In fact, it is 
    Those of us who came to the table in good faith in the 
early 1980's to work with Congress and work with the vaccine 
manufacturers and work with the American Academy of Pediatrics 
feel like we have been betrayed because three out of four 
children are being turned away from this system. And because 
all of the work we did, for example, to set up the table of 
compensable events for DPT vaccine injury and death so that 
this system wouldn't be like a trial and you wouldn't have to 
show the same type of proof and it wouldn't be expensive and 
traumatic--HHS came in and they gutted it.
    They gutted the provisions for awarding compensation for 
DPT vaccine injuries, and there is almost nothing now presumed 
to be associated with DPT vaccine.
    We were promised that it would be a fair alternative to the 
tort system, and we feel like we have been betrayed. And the 
fact that there is $1 billion in the trust fund is a disgrace 
because there are children out there who need that money 
because they have done what they were told to do by doctors and 
public health officials; and they are out there coping and 
suffering with vaccine injuries, and nobody is helping them 
because all the resources of HHS and Justice are brought 
against these plaintiffs.
    Justice represents Secretary Shalala in these cases, and it 
is not a level playing field. I think it is--we absolutely 
oppose the using of any of that billion dollars for anything 
other than compensating these children. The money for these 
studies needs to come out of the billions of dollars that are 
being given to HHS to fund new vaccine development and to set 
up tracking systems to track children in order to enforce 
vaccination and to promote vaccination.
    We have got to do a better job of looking at the existing 
vaccines that we have before we put other vaccines on the 
market, and we have to do a better job of taking care of the 
children who pay the price and are our casualties of our public 
health programs. Our children deserve no less.
    Mr. Mica. Thank you. Ms. Thiel, have you observed the 
operation of the compensation fund, and do you have any 
    Ms. Thiel. Well, I think it could be improved. I think we 
have to look at the fact that we have saved so many children 
and adults from the tragedies of this disease by having this 
vaccine that I think we have to continue.
    When you understand that we have given 10 million doses of 
the vaccine this year with a small number of adverse reactions 
that are very serious. I think we have to weigh the benefit to 
the masses against the unfounded concerns expressed.
    For years we were promoting vaccination for high-risk 
populations, mentioned earlier. This was an abysmal failure 
because we were not reaching those at high risk, many in urban 
    These are the children that are probably going to 
participate in high-risk activities. How can we protect them? 
We have to protect them when they are accessable, which is in 
the school system or requiring immunization before entering 
school. Otherwise, they will be missed. People continue being 
infected, with many developing serious cirrhosis of the liver 
and cancer.
    Children as young as 8 years of age have developed cancer 
of the liver having acquired this disease from their mothers, 
at the time of delivery. The baby's mucus membranes, in their 
eyes, nose, mouth, and genitals are exposed to infected blood 
through the birthing process. Because their immune systems are 
not fully developed, they have a 90 percent chance of 
developing the serious consequences of hepatitis B.
    There are major social factors related to hepatitis B 
infection. If, as a teenager, they become infected and go 
through the chemotherapy treatment and fail, they are going to 
remain infectious for the rest of their life. They must be 
concerned about infecting their sex partners if their partners 
are not vaccinated or immune.
    I think Barbara Hahn was very fortunate that her family did 
not become infected, because she was very careful of any blood 
or body fluid exposure that she had for her family. We also 
know that families living in the household with someone who is 
chronically infected is at higher risk of acquiring hepatitis 
    I use the analogy in 1 teaspoon of blood for the AIDS 
virus, there are about 5 to 10 particles of the AIDS virus 
compared to 500 million of the hepatitis B virus. This gives 
you an idea of how infectious this disease is. Even blood on a 
dry surface can cause the transmission of hepatitis B to 
    Ms. Fisher. I would like to say something to you Ms. Thiel, 
and I thank you very much for supporting the ethical concept of 
informed consent. I think this is really, really important 
because as you know, as a parent, you love your child more than 
anyone ever could. And when a child dies from a disease or from 
a vaccine, it is you, the mother and the father who lives with 
the consequences of that, and that is why the ethical principle 
of informed consent that is applied to every other medical 
procedure in this country that carries a risk of injury or 
death is so important to be applied to vaccination.
    We are not calling for the elimination of vaccine laws. We 
are calling for flexibility within the laws, a humane 
application of the laws. We are asking for the right to 
exercise conscientious belief exemption if we believe our 
children are at great risk of having a reaction.
    I come from a family of serious autoimmune disorders. My 
mother has lupus. I have one child who has reacted and has 
disabilities from a vaccination. How can the State possibly ask 
me to take a risk with another--a vaccine like this one--when I 
know that my children could either die or have autoimmune 
disorders from getting this vaccine?
    Parents have got to have the right to have the information 
and then make informed decisions for their children. Every 
parent wants their child to be healthy. They don't want their 
child to die from a disease or a vaccine. We have to believe 
that parents love their children.
    Ms. Thiel. I believe that we also have to receive informed 
consent. We also have to give them the information so they know 
how serious this disease can be to help them make an 
appropriate decision and not just respond emotionally to some 
of the misinformation they have been hearing about the adverse 
    Ms. Fisher. I totally agree with you.
    Mr. Mica. Ms. Fisher, you advocated several specific 
recommendations. One was increased licensing standards; is that 
    Ms. Fisher. That's right.
    Mr. Mica. What are you talking about specifically?
    Ms. Fisher. The reason that I filed very detailed FOIAs 
with the CDC and the FDA on this was I was hoping--I don't know 
the answer to that question. I was hoping that the committee 
would help us get those answers and do a review of the 
licensing procedures and of the policymaking procedures.
    Mr. Mica. The other item you recommended was nongovernment 
studies. But if it is a recommendation to us, it is going to 
involve government moneys and we have a pretty--well, we have a 
pretty complex manner of funding studies that was made that way 
to keep the studies independent from undue outside influence. 
How can we have a nongovernmental study financed by 
government--I mean, do you have something specific in mind?
    Ms. Fisher. I am not really knowledgeable----
    Mr. Mica. And then get an independent study. I think you 
are questioning the independence of these studies? Again, I 
don't see how we can accomplish that recommendation since it is 
government funding, the studies--unless you have some 
protection and barriers.
    Ms. Fisher. I am not knowledgeable about the grant 
structure at NIH, for example; but I understand there are some 
grants that are more independent. They are given to scientists, 
and they are more independent from control by the CDC or the 
    I don't know exactly what they are called. But I understand 
that there are grants available where the--the problem is who 
is going to be on the peer review committee? Bonnie Dunbar has 
applied twice for an NIH grant to look at genetic 
predisposition to hepatitis B vaccine reactions. She has been a 
vaccine developer for 26 years. She knows what she is doing.
    You don't see these grants being given out to scientists 
who want to look at adverse effects. The grants are given out 
to develop new vaccines and look at the efficacy of vaccines, 
but not to look at clinical reports of adverse events to 
    The public is very suspicious of having industry and 
government be in total control of these scientific studies. And 
so, if there was a way to get the funding, and then have some 
autonomy. So yes, of course, to publish you have to be peer 
reviewed. I don't have the answers, but I would be happy to 
work with the committee to find one.
    Mr. Mica. Thank you. In conclusion, did either of you have 
any final recommendations, anything additional legislatively or 
administratively that we can promote to help address some of 
the problems we have heard described today? Ms. Thiel.
    Ms. Thiel. In response to----
    Mr. Mica. This is additional.
    Ms. Thiel. The advisory committees that review the grants 
that are coming through have lay people on them--they are not 
just physicians who are reviewing these grant requests. They 
have very strict criteria to assess whether they are qualified 
and worthy of the funding that they receive. I think that there 
is a good review system there.
    Mr. Mica. Ms. Fisher.
    Ms. Fisher. We just touched on a few of the problems with 
the compensation program, the implementation of the National 
Childhood Injury Act, and I would just hope that we would have 
another opportunity to look at that program and talk about the 
issues surrounding that program.
    Mr. Mica. Thank you.
    Well, I would like to thank both of our panelists and 
everyone who participated today, our various witnesses, for 
their participation.
    As I said, we will leave the record open for 30 days. I 
have never extended the record that long; but since there is so 
much interest in this subject, we will accommodate additional 
interest for the record, and anyone interested should contact 
the subcommittee on Criminal Justice, Drug Policy, and Human 
Resources with their submission. Without objection, so ordered.
    There being no further business before the subcommittee, I 
will call this meeting adjourned, and I also will make an 
announcement here. There was a request for press availability 
after the hearing, and I will make a very brief statement here 
rather than go out to the Triangle.
    This meeting is adjourned.
    [Whereupon, at 2:34 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record